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2 episodes with 510k
Dr. Lisa Mathew interviews Gary Trendel, vice president of Endoscopy Solutions Ecosystem and Dr. Ruhy Patel, Medical and Scientific Affairs lead for the Endoscopy Solutions Ecosystem and Digital Units at Olympus. Odin Medical, an Olympus company, recently received 510K clearance from the U.S. Food and Drug Administration for the first cloud-based Artificial Intelligence technology designed to assist gastroenterologists in detecting colorectal polyps during colonoscopy procedures. The CADDIE, or computer-aided detection (CADe) device, works by analyzing colonoscopy video in real-time and using visual markers to alert the endoscopist to the potential presence of polyps. A prospective, multi-center randomized controlled trial successfully demonstrated the efficacy and safety of the CADDIE device, underscoring its potential to enhance detection capabilities and patient care without increasing procedural risks or duration. Join Dr. Mathew, Mr. Trendel, and Dr. Patel as they discuss the potential for AI in improving patient care, and what independent GI physicians should understand about AI platforms that assist in detecting polyps during colonoscopy. Produced by Andrew Sousa and Hayden Margolis for Steadfast Collaborative, LLC Mixed and mastered by Hayden Margolis Gastro Broadcast, Episode 75, presented by TissueCypher from Castle Biosciences
Usually, dental technicians frown upon dentists that do their own work. I mean, we get it, but we still want to do the work for you. But some dentists go as far as turning it into a 15 person lab doing work for other dentists. That we can get behind, because at that point they are creating careers for dental technicians. Dr. Donny Domingue followed an uncle to become a dentist. Wanting to do more with implants, he did a residency in New York that allowed him to place many. Once he found his home again in Lafayette, LA, Dr. Domingue started working with labs for his implant restorations. He found that he needed to educate many labs on the proper way to make a custom abutment. That's when he started doing his own. It wasn't long before he was doing them for other dentist and opened Louisiana Dental Implant Lab (https://www.ladentalimplantlab.com/). It was after training a bunch of engineers to be dental technician that Dr. Domingue developed the Vortex screw (https://www.ladentalimplantlab.com/collections/vortex-screws/products/vortex%E2%84%A2-1-4mm-direct-to-mua-screw) to help him with his own full arch cases. Learn more about the Vortex screw: https://www.youtube.com/watch?v=wxu5b6xOGmo https://www.youtube.com/watch?v=-oMGXcDFUFU Advanced Guided Surgery Course – January 2025 with Dr. Danny Domingue and Cory Glenn (https://www.coryglenn.org/product/advanced-guided-surgery-course-january-2025/?fbclid=IwZXh0bgNhZW0CMTAAAR0A06G6U_wDcrar5vjrl_7Hy3Y0n1ui2SrgpAhubyzBWRpywS30gc_ESVg_aem_HZtIXz5MbfnvnPw-ZVfHBw) Make sure you visit Ivoclar (https://www.ivoclar.com/en_us) at LMT Lab Day Chicago 2025 (https://lmtmag.com/lmtlabday). Ivoclar will be in their usual spot at Grand Ballroom A&B in the East Tower, on the Gold Level. Right across from the registration desk. They have a killer line up of speakers including: Mariano Maurizi Lee Culp Dr. Shashikant Singhal Don Yancey Jed Archibald Benjamin Gebhardt Tanya Little Aaron Johnson Jenelle Tabaković Patrick Coon John Wilson Luke LaRocque-Walker Paul Imperius Jonny "exocad" Jakson Yuki Momma Dr. Ken Malament Stephenie Goddard Jessica Love Dr. George Tysowsky Michael Roberts Barbara Warner! Register today! (https://lmtmag.com/ivoclar) Make sure you come see VOICES FROM THE BENCH recording from the Ballroom all weekend! Special Guest: Dr. Daniel Domingue.
Come find Elvis and Barb in 2025! Vision 21 at Caesar's Palace in Las Vegas - January 16-18 (https://www.nadl.org/vision-21) Cal Lab Meeting at the Swissôtel in Chicago February 20-21 (https://cal-lab.org/) LMT Lab Day Chicago in the IVOCLAR BALLROOM - February 20-22 (https://cal-lab.org/) IDS 2025 in the EXOCAD booth in Cologne, Germany - March 25-29 (https://www.english.ids-cologne.de/?_gl=1*10atn6b*_ga*NzI2NTMzNjguMTcyOTQ0NDMzMA..*_ga_F5WGQ8B9S7*MTcyOTk4ODM5Ny4zLjEuMTcyOTk4ODg5Mi42MC4wLjA.) If there is one dental lab in the United States that probably every single dentist in the US has heard of (and probably used at least once), it's Glidewell Dental Labs (https://glidewelldental.com/) in Newport Beach, California. For over 50 years, it has been run by the guy with his name on the building, but about 3 years ago, a new CEO was announced and everyone said Stephenie who? This week we get to know Stephenie Goddard and her history with Glidewell. Starting 18 years ago to run their HR department, she has seen Glidewell go from 1,100 employees to 5,000. She has seen the technology explode and the industry changing Bruxzir enter the field. Just wait until she talks about how she found out that she was going to be the CEO. Stephenie talks about the importance of culture, leadership training, and making sure she doesn't spend too much time "sweating the small stuff". Listen to John Wilson from Sunrise Dental Lab (https://www.sunrisedentallaboratory.com/index.php) and take your own lab to the next level by getting in on some of Ivoclar's End of the Year deals (https://www.ivoclar.com/en_us/campaigns/ivoclar-equipment-promotions-2024?utm_source=website&utm_medium=content_tile&utm_campaign=equipment_promo) on equipment. If you are looking for your first or looking to expand your capabilities, Ivoclar (https://www.ivoclar.com/en_us) has just what you need at a time where it's best to invest. Head over to Ivolcar.com or contact your local rep for all the deals today. Don't let the new year come thinking you should have bettered your lab. Special Guest: Stephenie Goddard.
This week's Espresso covers news from AuraPura, Intelijus, Wenia, and more!Outline of this episode:[00:27] – Brazilian proptech Morada.ai raises $1M[00:37] – Davivienda acquires Colombian payment gateway ePayco[00:55] – AuraPura raises a $550K pre-seed round[01:07] – Intelijus raises $510K in a pre-seed tranche[01:21] – Wenia set to launch debit card in Colombia[01:32] – Barte raises $8M Series A round[01:45] – Tuna raises $360K in a round led by ABSeed[01:57] – Asaas secures $150M in a round led by BOND[02:11] – Carozzi launches corporate venture capital fund[02:25] – Stori launches a fixed-term investment product in Mexico[02:35] – Contabilizei attracts $125M investment from Warburg Pincus[02:48] – Globant acquires Exusia to expand AI and data offeringResources & people mentioned:Startups: Morada.ai, ePayco, AuraPura, Intelijus, Wenia, Barte, Tuna, Mono, Asaas, Stori, Contabilizei VCs: AlleyCorp, ABSeed, BOND, Warburg PincusOrganizations: Davivienda, Grupo BanColombia, Carozzi
In this episode, Our guest, Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt's Life Sciences Department. Her practice focuses on healthcare law; Food, Drug Cosmetic law; pharmacy law and regulatory issues; PBM issues; as well as pharmaceutical and medical device intellectual property including trademark, copyright, trade secret and all aspects of patent law (due diligence, prosecution, opinion work, litigation, and transactional matters). Dr. Rumore has over 15 years of law firm experience in the area of Food, Drug & Cosmetic Law and pharmaceutical intellectual property, counseling on early market opportunities for pharmaceutical clients particularly in the area of ANDA and 510K applications and all facets of Paragraph IV litigation.Dr. Rumore has also worked in Drug Regulatory Affairs in the pharmaceutical industry and hospital pharmacy, both at the Director level. She taught Pharmacy Law and Drug Regulatory Affairs at Arnold & Marie Schwartz College of Pharmacy and Touro College of Pharmacy for close to 20 years and currently teaches Food, Drug & Cosmetic Law at Maurice A. Deane School of Law at Hofstra University.She is a frequent lecturer and has over 200 publications and presentations. Additionally, Dr. Rumore is a Fellow and former Trustee of the American Pharmacists Association, a former Board member of the American Society for Pharmacy Law and the Accreditation Council for Pharmacy Education and is a three-time recipient of the Larry Simonsmeier Legal Writing Award.This in-depth discussion on the current regulatory landscape for compounding pharmacies will look at:Current Regulatory Environment for 503A and 503B CompoundingState Laws and State Board of Pharmacy 2023/2024Important Regulatory Considerations in the 503B to 503A Compounding Model for Community Pharmacies506e Shortages and BeyondUSP 797/795 Six Months LaterGuest - Martha Rumore Senior Counsel mrumore@frierlevitt.com 646.970.3226Host - Hillary Blackburn, PharmD, MBAwww.hillaryblackburn.com https://www.linkedin.com/in/hillary-blackburn-67a92421/ @talktoyourpharmacist for Instagram and Facebook@HillBlackburn Twitter ★ Support this podcast on Patreon ★
Dr. Fred Rosenberg interviews Anthony Borrelli, executive director of product & marketing for Fujifilm's endoscopy division. Fujifilm recently received 510K clearance from the U.S. Food and Drug Administration for CAD EYE, a novel artificial intelligence detection system for endoscopic imaging that enables real-time detection of polyps and adenomas during colonoscopy procedures. The technology is designed to support detection of lesions that may be easiest to miss, such as flat lesions, those at the corner of the endoscopic view, and multiple lesions present in a single frame. When a suspicious polyp is detected by CAD EYE, the physician is given both visual and auditory alerts that are overlaid on top of – but do not interfere with – clinical images in the physician's existing workflow. Join Dr. Rosenberg and Anthony as they explore what the future holds for AI detection systems and other innovations in screening colonoscopy. Produced by Andrew Sousa and Hayden Margolis for Steadfast Collaborative, LLC Mixed and mastered by Hayden Margolis Gastro Broadcast, Episode 56
Paul Anderson, managing director of Orthocell Ltd (ASX:OCC), provides Proactive with an update on the Remplir™ market authorisation study. The first stage of this crucial study has concluded successfully, with all nerve repair surgeries performed without adverse events, using a rat sciatic nerve injury model to evaluate Remplir's safety and efficacy. This milestone is significant for Orthocell's global expansion and pursuit of US market clearance, expected in the early months of 2025. The study, led by Professor Bill Walsh, assessed Remplir's impact on sensory and motor function recovery and nerve regeneration quality. With the surgical phase completed, Orthocell is set to advance to the remaining stages of the study, aiming for completion in the third quarter of this year. Orthocell is also on schedule to submit its 510K market authorisation application to the US Food and Drug Administration (FDA) in the fourth quarter of 2024, with sales anticipated to commence shortly after approval. #ProactiveInvestors #Orthocell #ASX #biotech #Remplir #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews
In this episode, David West discusses Proscia's recent 510K clearance for Concentric AP-DX software. The conversation delves into the significance of 510 k clearance, explaining its role in regulatory approval for medical devices. David highlights the company's global success and previous clearances in Europe, offering insights into the journey of bringing innovative software to laboratories worldwide. We discuss not only the importance of this clearance to Proscia, but also to digital pathology as a whole. Links for this episode: Proscia Proscia Receives FDA 510(k) Clearance For Concentriq AP-Dx Welcome To Concentriq AP-DX Webinar Health Podcast Network LabVine Learning Dress A Med scrubs Digital Pathology Club People of Pathology Podcast: Twitter Instagram
Der US-Markt wird für europäische Hersteller immer attraktiver. Denn zum einen gelingt es den Herstellern, schneller und einfacher die regulatorischen Anforderungen zu erfüllen und ihre Produkte in den Markt zu bringen. Zum anderen ist der US-Markt sehr groß und teilweise homogener als der europäische. Als Folge verlagern immer mehr europäische Hersteller ihren Fokus auf diesen Markt. In dieser Podcast-Episode stellt die FDA-Expertin Margret Seidenfaden die verschiedenen Zulassungsverfahren vor sowie die damit verbundenen Schritte, Kosten und Dauern. Sie berichtet auch über die Bedeutung der FDA Pre-Submission Meetings und beschreibt, wie sie und ihr Team dabei unterstützen, die Zulassung schnell und wie geplant zu erreichen.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by FDA regarding the 510k regulatory pathway. The subject matter of the three were: best practices for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectations with implanted devices. Specifically, the following questions are addressed:Can you please provide a brief explanation of the 510k pathway?Why is the agency attempting to strengthen the program? What is their ultimate goal?With the predicate device, we recently had a podcast on using a recalled device for a predicate. When they say “best practices,” are they suggesting avoiding doing that?What other best practices are tied to the predicate device selection?How do you gather clinical data on a device that's not cleared or approved and just being submitted to the FDA?For what situations is the agency considering clinical data in a submission and why?For the third guidance, can you explain what this is? What are evidentiary expectations with implanted devices?What do these mean to you? What will they mean to medical device manufacturers?What are the takeaways?Listen to this discussion and let us know what you think of any or all of these guidances. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.
This episode of the Global Medical Device Podcast delves into the world of FDA submissions, specifically focusing on the eSTAR program. Host Etienne Nichols leads an insightful discussion exploring the intricacies, benefits, and strategies for using eSTAR effectively in medical device regulatory submissions.To discuss this topic, we brought in the following experts:Patrick Axtell, Ph.D., the Senior Tools & Templates Engineer for the Office of Regulatory Products at CDRHLisa Pritchard, Vice President of Regulatory, Quality, Clinical and Engineering at DuVal & AssociatesKathy Herzog, Senior Regulatory, Quality & Compliance Consultant at DuVal & AssociatesAs of now, all 510K submissions must use the eSTAR program. eSTAR is designed to streamline the FDA submission process, making it more efficient and standardized. This episode is a must-listen for anyone in the medical device industry looking to navigate the complexities of FDA submissions with a focus on the evolving eSTAR program.Expert Insights:Patrick Axtell: Discusses the development of the eSTAR program, its purpose, and benefits, including standardization and automation in the submission process.Lisa Pritchard: Shares her 30-year experience in regulatory space and her initial skepticism about eSTAR, which later transformed into advocacy for the program.Kathy Herzog: Provides practical advice on using eSTAR, emphasizing the importance of understanding and navigating the program effectively.Key Strategies:Use the help features within eSTAR as a quality control check.Start at the beginning of the template to avoid missing critical sections.Prepare your submission content outside eSTAR before populating the template.Consider the executive summary as a mandatory, not optional, part of your submission for effective advocacy.Future of eSTAR: eSTAR is evolving to include more types of submissions (e.g., PMAs, presubs) and may soon incorporate AI and other technological advances for enhanced efficiency.Quotes:"Standardized submission means that the reviewer can quickly find information...a huge benefit for both applicants and reviewers." - Patrick Axtell"Even after 30 years, I always open those help boxes in eSTAR...each submission is unique." - Lisa Pritchard"The key with eSTAR is eSTAR(t). You just have to get started...no substitute for just getting familiar with the template." - Kathy HerzogReference Links:Lisa PritchardKathy HerzogEtienne NicholsGreenlight GuruDuVal & AssociatesClient Alert: "eSTAR & I"FDA eSTAR Program webpageFDA electronic Submission Template guidance for 510(k) Submissions
The choice of a Predicate Device is important and challenging at the same time. Your predicate device is already on the US market, so all you must do is select it and confirm that your device is the same as the predicate and Bingo, you can register your product in the US. But this is not as simple as that. Beat Keller from imt in Switzerland will share with us his experience working on US submissions and provide some hints on what you should or should not do. Who is Beat Keller? Beat is the Head of Regulatory Affairs and Quality Management at IMT, a Swiss Consultancy and Engineering Service provider for medical device manufacturers. He has worked for more than 10 years in the medical device industry first as a software engineer, then as a project leader before he took over the Regulatory and Quality department of IMT. Beat is also active in different standards working group as Co-Convenor of the “conformity assessment” working group of the Swiss standards association and member of different working groups on Swiss, European and International level for medical device standards. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/ imt website: https://www.imt.ch/ US FDA predicate device guidance: https://www.fda.gov/media/171838/download MDCG Guidance on Equivalent Devices: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
Description:In this episode, Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dives deep into the complexities of FDA submissions for medical devices. She sheds light on the nuances of different submission types, such as 510K, De Novo, and PMA, and underscores the criticality of timelines, strategic planning, and a robust Quality Management System (QMS). Reynolds also guides listeners through effective FDA interactions, the eSTAR system, and the significance of building relationships with review teams. Her expertise illuminates the path to successful FDA submissions, emphasizing preparation, organization, and proactive engagement with regulatory bodies.Some of the highlights of this episode include:Strategic alignment of clinical trials with market launch timelines is crucial for successful FDA submissions.Differentiating between submission types (510K, de novo, PMA) and how they are essential for navigating the regulatory landscape.Early interactions with the FDA through Q submissions and how those interactions streamline the market submission process.The importance of understanding and managing FDA review timelines, including potential pauses and extensions.How utilizing eSTAR helps identify documentation gaps and assess submission readiness.How pre-submission meetings with the FDA are instrumental in addressing potential gaps and receiving regulatory pathway guidance.The importance of comprehensive preparation and organization facilitate expedited FDA review, despite uncontrollable factors.Quote:"Interact with FDA early and often. It's what ultimately will make your submissions as seamless as possible." - Ellie ReynoldsReference Links:Ellie Reynolds LinkedInGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!
I traveled to Disneyland Orange County for AACC ADLM back in July to connect with a few folks and walk the floors of the exhibit hall. I was on my way out when Derek Hamre from Launchworks CDMO stood up at his table and got my attention with the best elevator pitch I have ever heard. And that landed him a spot on my podcast. I'll share what it was at the end of this post.*Imagine this scenario. You're in an academic lab or small biotech and you've developed a diagnostic test for a molecule or a disease. How do you go about commercializing your test? Do you need to get a bunch of regulatory approvals? What else do you need to think about? After all, you're in a small research lab stepping into a whole new world. It turns out there are people who do this for a living and can help you plan out your strategy.Launchworks is a CDMO for molecular diagnostics. Services range from commercialization strategy and supply chain management through to fulfillment. A company might come to them with a locked down bill of materials and work instructions for kitting tens to hundreds of thousands of units at a time, or maybe they are early in the process and need help thinking through strategy from the beginning. …one of the reasons that we are pretty present at ADLM, AACC is the RUO kits. Those that are taking an idea from the R&D space and bringing it to the market and that commercialization process is a big, you know, lift for a lot of companies, even if they're bigger. Um, but especially for smaller companies when they have 5, 10 workers that have never gone through the commercialization process.Beyond that, what level of regulatory approval do they want? In some cases, a kit might be sold as RUO (Research Use Only), but a customer's customer might want to take it further:And a lot of our customers, so we won't make those claims, obviously, our customers will go through the FDA filings or whatever, um, but some of our customers will just not want to go through the FDA process, so they'll make their kit RUO and then maybe one of their customers will buy the kit and then go through the FDA or 510K, PMA process… …so allowing another customer or their companies that they're working with to go through that process on their behalf might be the pathway for them. Regardless of the regulatory path chosen, Derek described the four main areas where a CDMO can help get a product to market.* Risk mitigation* Commercialization strategy* Manufacturing process* Supply chainYou'd like to avoid surprises in any of those areas. Taking supply chain, for example, it would be important to know if a supplier might be closing shop in the near future. Will you be able to maintain quality as you scale up?I asked Derek about the logistics of assembling and shipping hundreds of thousands of units from different vendors. Everything is done in-house. Mixing buffers, putting kits in bags, labeling and shipping. Launchworks has about a 30,000 to 40,000 square foot facility in Beverly, Massachusetts. Prior to this I knew that there were CDMOs for pharma, but not for diagnostics. ADLM was an eye opener in terms of the world of clinical chemistry. And this isn't the only episode I recorded as a result of that visit. More in a couple weeks.*I don't remember his exact words, but it was along the lines of “We're helping visitors to ADLM become vendors at ADLM.”Your deepest insights are your best branding. I'd love to help you share them. Chat with me about custom content for your life science brand. Or visit my website.Intro Music stefsax / CC BY 2.5 This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit cclifescience.substack.com
Dr. Antonio Tito is the Founder and CEO of rEthix in Houston, Texas. rEthix is the world's first Liaison Research Organization (LRO) facilitating clinical trials in Mexico and Latin America.A search of clinicaltrials.gov shows that several large pharma companies are currently running trials in Mexico. rEthix is leveraging the ICH (International Council for Harmonisation) guidelines to run these trials in Mexico and use that data to support IND-enabling studies in the US. The ICH sets the guidelines that the FDA and equivalent agencies in other countries follow. COFEPRIS, the Mexico Ministry of Health, assesses the laboratories. rEthix also prepares those laboratories to pass that assessment.One advantage is cost. According to Dr. Tito, the cost of a trial in Mexico may be 15-25% of the cost for a similar trial in the US.Another advantage is meeting your goals for testing diverse populations.While it's common to run trials in Mexico, it is not common to start them there. …that is reflected only that only 3. 5 percent of new drugs are generated out of Mexico. And most of that has to do with communication. It's important that we have these type of channels, like the one that you are promoting, Chris, to teach people that it's okay to start your clinical trial in Mexico. You can approach the FDA about it. Be very transparent with the FDA always. But don't let the communication gap, not only the language, but also the culture… the paperwork is very extensive in Mexico.Don't let that stop you from generating data that you can later use for submitting to your investors and, obtaining more funding.Antonio also mentioned the opportunity to expand into Latin America with, for example, devices already approved in the US.For a 510K device that you already have obtained approval for in the U. S., You can easily transfer that into Mexico very simply because you have all the data that you've used, you've generated it to demonstrate that it works and is similar to other predicate devices out there in the market.And you've generated that information for your filing for the FDA. All that information can be then translated by our team and we can pass it on to COFEPRIS and the process is similar to the U. S. as well. But it's... You get the advantage of tapping into sometimes virgin markets where there is absolutely no other alternative to that device or to that diagnostic in Mexico or Latin America.So you have a winning hand in leveraging tactics to negotiate with, like commercializing agencies in those countries. Whereas in the U. S., you have more competition. It takes longer to get your market traction. So it's a win-win situation.Not subscribed yet? Let's fix that right here.Thanks for listening to the podcast and sharing this post.rEthix is developing an app…Let's say you have a new discovery in your research institute, and you've received approval from your tech transfer office to take your technology out into the commercial markets and you have partnered with us to help you get your innovation out. We are, as part of the app, what it's going to be, it looks at all the data that you have, implements AI, And determines what is the best pathway in terms of the study design, the type of protocol that needs to be developed for better for commercialization for your device or your drug or your diagnostics. Until the app is ready, they are building an incubator in Houston at the medical center to connect life science companies to share ideas and facilitate access to data that will generate traction for IRB studies in Houston.Your deepest insights are your best branding. I'd love to help you share them. Chat with me about custom content for your life science brand. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit cclifescience.substack.com
DescriptionIn today's episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. This is a lesser known program, but there can be significant benefits from using it, which we talk about during the episode. Some of the issues we discussed include:How utilizing this program can accelerate the submission process, or at least remove some uncertainty around the timelineWho this program is for - not just for small startups, but rather how even experienced Regulatory Affairs specialists working at large corporations can benefit from this program.Lastly, we don't usually get into the specifics of cost and expenses, but we even discuss some of the differences in how much you'll pay using the 3P510k route vs. the traditional submission route.Shawnnah Monterrey is the founder of BeanStock Ventures after nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for both startup and mature organization with emphasis on the development of medical instruments, life science, diagnostics, clinical applications.Reference Links:Shawnnah Monterrey on LinkedInBeanstock VenturesEtienne Nichols on LinkedInGreenlight Guru softwareFDAs 3P510k page
Come see Elvis and Barb on stage together for the first time as we record an episode in front of a live audience! Register for the Ladies of the Mill Summit in Chattanooga, TN on July 21-22 (https://www.ladiesofthemill.com/) Let's say you get a nice implant case in the lab. Obviously, there is a need for custom abutments. You can do everything in the lab quickly, except the abutments. You already must scan and design them, but when you send them out, how long do you have to wait to get them back? 4 days? A week? Two Weeks? How would you like it in 20 minutes? The Vice President of Preat (https://www.preat.com/), Ruben Arebalo, comes on the podcast to talk about his history getting to Preat and taking them from attachments to a complete digital implant restorative solution. The CEO of Digital Dental (https://www.digitaldental.com/), Jon Barnes, comes on to talk about getting into dental and running a company that has been making mills since the 70s. They have partnered up to provide a FDA compliant workflow for your lab to mill abutments in your own lab! From validating the mill and milling strategies, to documentation protocol, these two have provided a path for your lab to successfully and safely mill custom abutments. The new PrograScan PS3 and PS5 (https://www.ivoclar.com/en_us/products/digital-equipment/prograscan-ps5-and-ps3-laborscanner) provide true-to-detail, high-resolution and accurate scans for coordinated digital workflows that are precise, fast, and always accurate. The PS3 and PS5 are powered by the popular and intuitive DentalCAD software from Exocad (https://exocad.com/). Whether you are looking for your first scanner, to upgrade or add to your existing scanners, the PrograScan may be the one for you. Reach out to your friendly Ivoclar (https://www.ivoclar.com/en_us) sales representative to select a scanner that matches the needs of your lab Today and tell them you heard about it on the podcast! Special Guests: Jon Barnes and Ruben Arebalo.
Pascal Wettstein is the owner of QDC GmbH. He is the self-proclaimed "SME safari guide in the regulatory jungle." I highly recommend his rather sarcastic LinkedIn posts on European Medical Device Regulations. Beyond Europe, he has extensive knowledge about the 510K regulations in FDA.
Shark, Wagmi and Stablino break down the week that's been.Nothing in the show is financial or any other type of advice.Theme music used under license.Mentioned on the show this week:OHM = Growth Coin!Grail token https://www.coingecko.com/en/coins/camelot-token Silo https://app.silo.finance/silo/0xc413dd03555f3eb29d834b482d386b2999dc2eb0Empire podcast https://youtu.be/ThSPmzIlZ8oDefi Llama launches DLNews https://www.dlnews.com/ - it's great!Berachain - Bong Bears NFT rip upwards 2.2ETH per Bitbear https://opensea.io/collection/berachain-bit-bears - rumors that Berachain launches this month Goblerinos - 1.5ETH floor https://opensea.io/collection/goblinarinos https://twitter.com/KlimaDAO/status/1622480779761836032 Klima https://twitter.com/KlimaDAO/status/1622480779761836032 Nice little bump in our Aura sitting at $510K https://debank.com/profile/0x8caf91a6bb38d55fb530dec0fab535fa78d98fad looks like our $6M in CVX has now been relocked https://debank.com/profile/0x2d643df5de4e9ba063760d475beaa62821c71681 BUT we are still sitting on $200K of unlocked FXS https://debank.com/profile/0xde7b85f52577b113181921a7aa8fc0c22e309475 Council in the discord https://youtu.be/mMKRm-JPZJ0OHM secondary market https://dune.com/spoysp/ohm-bonds-secondary-marketHoney Jar https://twitter.com/0xhoneyjar
When we think of advances in digital dentistry, 3D printing is at the top of the list. Many companies have entered the field, but only a few have stood out as leaders that changed the ways other companies create their product. Once such company is Keystone Industries (https://dental.keystoneindustries.com/). Makers of finger nail acrylics, they hired a lawyer that saw potential. Ira Rosenau admittedly knew nothing about dental. With a lot of hard work, education from friends in the industry, and a lot of smart scientist, Ira brought KeySplint (https://keyprint.keystoneindustries.com/keysplint-soft/) to market. Ira talks freely about what it take to create, design, test, and validate a printed splint material that has forever set the bar for what patients, doctors, and labs need. Does your lab use Magic Touch? If not, you should think about switching just so you can use icortica (https://icortica.com/). Icortica is a program that uses all the data you already collect in Magic Touch and puts it in one easy to see, use, and understand dashboard. Look at every account and see trends, sales, notes, payments, and even remake percentages. Use the data you already have to take your lab and your customer service to the next level. Elvis uses it daily and swears it is a huge part to his success working at the lab. Head over to icortica.com/voices (https://icortica.com/voices-from-the-bench/) to learn more or send a email to Rob Nazzal at rob@icortica.com and tell him you heard about it on Voices From the Bench! Special Guest: Ira Rosenau.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA's use of the word “exempt” and what it means for medical device manufacturers. During this discussion, we look at the relationship between 510k exempt and Class of device. Specifically, the following questions are addressed:Could you please explain what 510k exempt actually means?Are all Class I medical devices exempt and all Class II devices not exempt?What's the difference between Class I exempt and Class II exempt?What is the difference between general controls and special controls? How are these relevant to exempt status?Could you give some examples of products that are Class I exempt and explain why they are afforded that status?Now could you do the same for Class II products that are exempt and give reasons why?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see how 510k exempt may affect your company's products and future regulatory submissions. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.
You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer questions such as: - Why the US market and not the EU? - What was the interaction with consultants for the Quality and Regulatory aspects? - How is it to work with a Quality Management System? - How is the logistic of the product working? - Why perform Clinical Investigations? So I hope this will help you understand the market by listening to the MysteryVibe Journey. Who is Dr.Soumyadip Rakshit? Dr. Soum Rakshit is the Co-Founder & CEO of award-winning sexual health company, MysteryVibe. Their mission is to make sexual health accessible to all – across all ages, genders & orientations. In his role as CEO of MysteryVibe, he focuses on pushing the boundaries on R&D, customer experience and supporting their long-term goal of making sexual health an integral part of our overall health. Soumyadip passionately believes that by empowering people with actionable knowledge & purposeful innovation is the way to make this happen. Soumyadip built and sold his first startup in defence electronics by age 26, and has won 20+ International design awards for his product designs. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video Dr. Soumyadip Rakshit Linkedin: https://www.linkedin.com/in/soum Mysteryvibe website: https://mysteryvibe.com/ Literature on disease targeted: https://eventclass.org/contxt_essm2022/scientific/online-program/session?s=P-07#e524 MysteryVibe LinkedIn Page: https://www.linkedin.com/company/mysteryvibe/ Easy Medical Device Authorized Representative: https://easymedicaldevice.com/authorised-representative-and-importer/
This episode will explain to you the journey of the company Lineus Medical when they tried to register their products in the USA. Initially, they prepared the product to be registered with the 510k Regulatory Pathway but the FDA did not agree and said that they should go through DeNovo. So Spencer Jones who founded the company will tell us how they have done that and he will also give some tips on how he would have done it today if he had to restart again. So benefit from his journey to learn how you should do it. Who is Spencer Jones? Spencer worked for three years in direct patient care as a Certified Nursing Assistant, Licensed Practical Nurse, and as a Registered Nurse. Frustrated with the inefficiencies plaguing the healthcare system, he was determined to improve the delivery of healthcare. While still working as a nurse in the clinical setting, Spencer identified opportunities where improvement was needed around IV complication prevention. This led to the creation of SafeBreak® Vascular and the founding of Lineus Medical in 2015. Spencer graduated from the University of Arkansas with a Bachelor in the Science of Nursing. Spencer is on the Fayetteville Innovation Council and was the Entrepreneur in Residence for the Hub X Life Sciences Accelerator for 2016. He has three issued U.S. patents and several others pending. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links Spencer Jones LinkedIn: https://www.linkedin.com/in/spencer-jones-5a008672/ Lineus Website: https://www.lineusmed.com FDA DeNovo guidance: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
Can a video game help improve attention skills in kids with ADHD? According to Akili Interactive in Boston, the answer is yes. They've created an action game called EndeavorRx that runs on a tablet and uses adaptive AI to help improve focus, attentional control, and multitasking skills in kids aged 8 to 12. And it's not just Akili saying that: In 2020 the U.S. Food and Drug Administration agrees cleared EndeavorRx as a prescription treatment for ADHD, based on positive data from a randomized, controlled study of more than 600 children with the disorder. It was the first video game ever approved as a prescription treatment for any medical problem, and Harry's guest this week, Akili co-founder and CEO Eddie Martucci, says it opens the way for a new wave of so-called digital therapeutics. Even as Akili works to tell the world about EndeavorRx and get more doctors to prescribe the game for kids with ADHD (and more insurance companies to pay for it), it's testing whether its approach can help to treat other forms of cognitive dysfunction, including depression, the cognitive side effects of multiple sclerosis, and even Covid-19 brain fog.Please rate and review The Harry Glorikian Show on Apple Podcasts! Here's how to do that from an iPhone, iPad, or iPod touch:1. Open the Podcasts app on your iPhone, iPad, or Mac. 2. Navigate to The Harry Glorikian Show podcast. You can find it by searching for it or selecting it from your library. Just note that you'll have to go to the series page which shows all the episodes, not just the page for a single episode.3. Scroll down to find the subhead titled "Ratings & Reviews."4. Under one of the highlighted reviews, select "Write a Review."5. Next, select a star rating at the top — you have the option of choosing between one and five stars. 6. Using the text box at the top, write a title for your review. Then, in the lower text box, write your review. Your review can be up to 300 words long.7. Once you've finished, select "Send" or "Save" in the top-right corner. 8. If you've never left a podcast review before, enter a nickname. Your nickname will be displayed next to any reviews you leave from here on out. 9. After selecting a nickname, tap OK. Your review may not be immediately visible.That's it! Thanks so much.TranscriptHarry Glorikian: Hello. I'm Harry Glorikian, and this is The Harry Glorikian Show, where we explore how technology is changing everything we know about healthcare.Can a video game help improve attention skills in kids with ADHD?According to Akili Interactive in Boston, the answer is yes. They've created an action game called EndeavorRx that runs on a tablet and uses adaptive AI to help improve focus, attentional control, and multitasking skills in kids aged 8 to 12.And it's not just Akili saying that.The U.S. Food and Drug Administration agrees.In 2020 the FDA cleared EndeavorRx as a prescription treatment for ADHD, based on positive data from a randomized, controlled study of more than 600 children with the disorder. It's the first video game ever approved as a prescription treatment for any medical problem.Kids are advised to play the game for 25 minutes a day, five days a week. After two months of play, two-thirds of parents of kids in the controlled study said they saw a meaningful change in their children's day-to-day impairments. The FDA's approval of EndeavorRx opens the way for a new wave of so-called digital therapeutics, designed to treat all kinds of problems with cognitive functioning, including depression, the cognitive side effects of multiple sclerosis, and even Covid-19 brain fog.Akili is busy telling the world about EndeavorRx and working to get more doctors to prescribe the game for kids with ADHD and more insurance companies to pay for it. And here today to tell us about all of that is Akili's co-founder and CEO Eddie Martucci.Harry Glorikian: Eddie, welcome to the show.Eddie Martucci: Thanks, Harry.Harry Glorikian: So I'm dying to get into the company and all the things you guys are doing. But, like, before we jump into the company, I'd love our audience to get to know you a little bit. Right, because you're a long time health entrepreneur. You got your PhD at Yale in the departments of pharmacology and molecular biophysics and biochemistry, where you studied structure based drug design. But how did your personal path lead you from molecular biology, which is near and dear to my heart, to video games to treat cognitive impairment? I mean, that that's not exactly the Venn diagram I would see that somebody would just put together.Eddie Martucci: No, it's not. And there is no there is no path for this. Right. Because this is so different and so new. I would say my personal passion is just new science findings. Like I just love brand new science. I was a researcher for a short stint while I did a PhD. I think I had some pretty cool research. But really, if I zoom back, it's new science and new discoveries that are moving the health world forward. And that can be whether it's insights about some part of our biology that we didn't know before, that leads us to understand the human body better. Or in the case of what I've really done from a professional perspective, it's scientific insights that can lead to new treatment modalities. And so that's really what got me most excited. I think the path that was most impactful for me, you know, I was a biochemist at Providence College and a biochemist and biophysicist at Yale, and I love proteins and structural biology and all that. I still do. But I came out of my PhD and and worked with a group called PureTech Health in Boston. And Puretech is really just this unique new health care company where they've done everything from, they have research and development and discovery, but they also have in many ways nailed down a process of starting new companies off of groundbreaking science. And so while I was in grad school, I was exposed to a couple entrepreneurs that really put a light bulb in my head that, wow, this is something I should look into. And then I got training at PureTech in Boston. And that's what kind of got me thinking about brand new medicine and brand new modalities that were never considered medicine before. And the rest is history. Once you get a framework where you can start thinking like that, then it's just work.Harry Glorikian: Yeah. I mean, I knew Daphne, I think when she started PureTech and her advisory board was like, I mean, Nobel Prize winning, who's who sort of. Right. Just watched it evolve over time. But, you know, when you were at PureTech, I think one of their focuses was neurophysiological disorders. I mean, is that the real bridge that helped start Akili? Because I remember that came out of Adam Gazzaley's lab at UCSF, if I remember correctly.Eddie Martucci: Yeah. Adam Gazzaley is where we found the core technology that which we call SSME, which has gone on to power our products, including our FDA approved product. But yes, what I was working on at PureTech, including directly with Daphne, who's really brilliant in helping and bringing new big ideas to life and board members, including people like Ben Shapiro, who used to be at Merck. And he was one of my longest term board members. It doesn't hurt to have folks like Bob Langer in the room once every quarter to bounce ideas off of as well. So like, a very privileged place to start a company. But yes, I was working on novel CNS technologies, in fact. In fact I was working on a few and one in particular that was new devices, new devices for various neurological conditions. And it was really from that effort in thinking about what are the newest modalities of medical devices that we leaped one big bridge further and said in 2010 or about or maybe 2009, could we go further from a user experience perspective now that the whole world is carrying cell phones and tablets every day? Could we go further? Could we could we think about digital? And that was right around the time when everyone and their mother was talking about digital helping medicine. And because we were in the headspace of novel therapeutic modalities, I think it was a natural leap to say, what about digital being the medicine? And then we had to find the science. And that's where I found Adam Gazzaley and, and, and we got off to the races with that technology from UCSF.Harry Glorikian: Yeah. I mean this whole area of digital therapeutics, I've been talking about it for years now and trying to convince people and they look at me really weird when I say digital therapeutics and I try to explain it to them. But so but the game you have built is called EndeavorRx. If I got that correctly. And can you tell? Me more about the game itself. Like, what are the operative features or game mechanics that are thought to increase attention in kids who play the game?Eddie Martucci: You kind of have to back up to the core technology. So the way we build the business is not building one product or one game. We're building a platform technology, meaning a technology that is not made for a single disorder. But instead the problem we're going after and that we started with all of those years ago, about a decade ago, is cognitive functioning. Cognitive dysfunction in medicine is not targeted well by molecular pharmacology. That is the problem statement. We don't target cognition very well in medicine, if at all. And so our whole theory and thesis for the business was, if we could bring in the best technologies in the world, that through software could actually target cognitive functioning directly, then we would be bringing a pillar of medicine that does something much, much different than what medicine does today. So the technology out of UCSF that we started the company around, that we have branded the Selective Stimulus Management Engine, the way this technology works, which will then help you understand how the products in for ADHD children works. The way this technology works is it is giving constant stimulus, both visual and motor. So it's creating conflicting and overwhelming stimulus to activate the part of the brain that controls attention, which is the midline prefrontal cortex. So the front part of the brain that really controls attention and speed of processing and integration, this technology is patented to be able to activate that part of the brain very strongly, but also enhance what's called long range coherence. So as you're using this technology, not only is the front part of the brain activating much more, so you can apply your attention downwards.Eddie Martucci: And I'll get to exactly how this manifests, I promise. It is also more seamlessly based on the neurological data we have. It appears to more seamlessly be helping the brain communicate to the sensory processing regions. And so the way this manifests in ADHD children, when they're using our product EndeavorRx, which is meant for children 8 to 12 years old with ADHD who struggle with the attentional issues. This product is basically experienced like a racing video game where children are running a little alien figure down a course that is ever adapting. And they're getting information, meaning things that fly up to the screen that they have to make decisions on. And that's ever adapting because we have these deep, personalized algorithms so that everyone gets their own experience. So basically what people feel is they're using this technology that feels like a game, and it's just constantly challenging them in different ways. What's happening in the brain and this is how it's designed, is that the game is presenting very specific stimuli for each user that is pushing them at the edge of their processing ability. And that's part of the IP we have, is how to do that in a really seamless way so that by the end of using a game you haven't just been using a game, you have been essentially taxing the weak link in your attentional processing every single second for hours.Harry Glorikian: I think every CEO of that we may know mutually needs to be prescribed this game.Eddie Martucci: You know, CEOs and investors have been probably the most common people that in meetings will stop me and say, hey, I think I need this.Harry Glorikian: Yes. So how did you ideate and test the game mechanics?Eddie Martucci: Yeah. This is this is really a tenet of the business where we decided early on that to truly—we want to disrupt medicine and we want to create and integrate our type of medicine into mainstream medicine. Far too often, digital is kind of left to early adopters or on the sidelines of real medicine, excuse me. And our whole thesis was you have to run real validated and literally gold standard, rigorous clinical research. So when we had done this, no one had done a well designed trial before to study something that looks like a video game. And so that's really where we spent the first handful of years of our existence is after we built the kind of data infrastructure, which we can talk about, and the adaptive algorithms. We then invested years in how to run good clinical trials with this type of product that's an experiential product. So our goal all along was being able to run the same or better rigor of randomized controlled trials that you'd expect from a drug for this same disease area. Obviously, as an interactive product that you can see and you interact with, that means you have to take a little bit of a different approach.Eddie Martucci: So we had to do a lot of work with some of our advisors and with places like Duke University on how to blind the protocol. Because it has to blind very differently. And how to how to have a control, an active controller sham that is actually controlled. And there's many nuances like that. But at the end of the day, the trials we run are meant to replicate or be analogous to drug trials, where you have really strong controls up front, that you're not biasing individuals and that the outcomes—and this is the differentiator in digital—that the outcomes are gold standard accepted outcomes for whatever you're studying. And so that was what we've done. What we did the first time we were in a trial, we were like, it took a lot of work and we were nervous about it. But we have a clinical ops team now and we've run a few dozen trials across, I think, nine or ten disease populations, so we've become pretty good at it.Harry Glorikian: Yeah, I was going to say, I mean, coming up with the first one, everybody's probably scratching their head trying to figure out, are we doing the right thing? But, and I have this discussion with some of the people I work with all the time, what's the proprietary special sauce in the case of digital therapy? I mean, is there a defensible algorithm or insight at the heart of something like EndeavorRx that would be comparable to a patented small molecule in the you know, in the traditional drug industry?Eddie Martucci: In our case, yes. And I'll tell you about that. I think what this really comes down to, though, that question about digital therapeutics, it's like a business question for the industry. To answer that question, it's important to recognize there's nuance in the industry. So the vast majority of digital approaches, I think, are tough to protect because they're taking well known human practices and putting them into an app. Right. So there's 90 percent of the digital therapy companies or products out there are using different forms of behavioral therapy or disease management techniques or strategies, and they're bringing them into an app that is not bad. It's hopefully very, very good for patients. There's a few validated products there that are, no question, good for patients. I think it does make those types of products harder to protect. We've taken a bit of a different tack. We're a little bit, I guess, iconoclastic within the industry in that what gets us excited is software that even though it's software, it's more drug like in that it's directly targeting and activating the dysfunctional physiology in the body. You can measure that and by virtue of that, you're having a really unique effect. Eddie Martucci: The second big difference is we are using algorithms that have not been ever reported on before. So we take much more of a drug lens where we actually do protect we patent our technology. So we call this whole class “physiologically activating digital therapeutics.” Some people have referred to them as mechanistic digital therapeutics or disease modifying. There's different phrases, but this idea of unique algorithms that you actually can protect with patents and copyrights, which we do. So we have about 50 issued patents for the technology that underlies EndeavorRx and another 100 that are filed on our various technologies. And you can demonstrate this has a real, unique physiological effect. I think what it enables, at least for these types of products is a feeling from the health care world that this is much more what I'm used to seeing in my traditional medicine where it's unique. I can't just go get this anywhere because I trust that this one product is the only one that has this unique technology. And by the way, it's been proven to work. And I trust that they're a stable company that's going to be around for a while. Those things are really important to our model.Harry Glorikian: Well, it's a good thing that I've been explaining it to people the right way. So at least now that we've talked, you know, my explanation is aligning correctly. So I'm happy about what I'm reading is correct. Let's take a step back. So, there's a lot of kids with ADHD who have no problems concentrating on something for hours if they're really interested in it. But it strikes me the key feature of the of the product is not just keeping kids engaged. It's supposed to build or improve those skills. Is that the key thing that makes the game special or unusual or different from any other pastime, say, building LEGO spaceships?Eddie Martucci: Yes, absolutely. So the engagement is critical, but the differentiator is the challenging and improving of that core cognitive functioning. And you don't get that just by engaging in something. And actually, the vast majority of entertainment products you engage with will allow you to either passively engage, meaning you could watch YouTube videos for hours and hours, but you're not actually challenging your brain or actively engage, but in a way that you don't really have to challenge what you don't do well. So in most video games, you can choose what most of us do in life, choose the path of least resistance, because we like certain ways of using a product. Our product is unique in that this this patented algorithm forces you—it's essentially measuring second by second where you're weak and processing the various streams of information and it is forcing you to work on those areas where you are weakest. But it's doing it naturalistically. It feels like you're using a treatment, but it's really that level of focus on, for lack of a better word, it's really that level of focus of delivery of that algorithm that's actually going to stress you where it, for lack of a better word, hurts the most. That is the differentiator. The other big differentiator is, is the personalized algorithms that that we built in. And this is where, frankly, technology and data rich medicine has never gone before. But within seconds of using the experience, this product is tailoring to each individual user. And this is true whether we're talking about kids with ADHD or some of our trials and products and adults with depression or MS, these products can actually tailor to your functional level and then move you along from there. So those two those two bits of how the algorithm works are critically important. The engagement is really the delivery vehicle to make sure you're getting that level of medicine.Harry Glorikian: Yeah, definitely, if this was available to people in a larger age range, there are people that I definitely need to recommend this to when well then that becomes available.Eddie Martucci: But well, that's the interesting thing about cognitive dysfunction, right? The way I talk about it sometimes is cognitive functioning and or problems with cognitive functioning go across disease, right? They're in many ways disease agnostic. Almost anything that touches the brain results in some level of cognitive dysfunction or at least some proportion of patients that have longer term cognitive dysfunction. But it also goes above and below disease, meaning subclinical. So there are people that are not diagnosed with issues that, you know, that probability-wise there's 20 or 30 percent that are significantly below the mean they're struggling with these things. So this is a this is a basic human function that rears its head in a really nasty way in many diseases, but is actually relatable to all of us.Harry Glorikian: Yeah. So. I mean, there's a lot of challenges when you're trying to design something like this. A ten year old will not spend much time playing a mobile game unless it's it's just as compelling as, you know, anything that they could download as a mobile app. So. How did you guys, what steps did you guys take? You know, it's almost like game design and, you know, therapeutic outcome, you know, together in one package. And so how did you guys, what steps did you guys take to make sure this thing was fun?Eddie Martucci: Correct. Yeah. And it does depend on the population. Right. So we have products, obviously a marketed product in for children with ADHD, but we're developing products and have trials and data and adults of various ages. The I think you're right. If you focus on children, there's a there's an engagement bar that is not easy. Right. Kids are highly discerning. They know a good game and a bad game. And what we like to say is we have no delusions that we're going to come out with the next blockbuster entertainment game. That is not how we built the company. However, we do want to have a game that looks and feels like the type of games that you actually like to play. So it has to be worlds better than edutainment, as people call it, educational software, because kids know. And so the way we did that is this is one thing that makes Akili very unique. Instead of outsourcing or kind of outsourcing game development or adding game development at the end of our development cycle, we actually have built the company to have cognitive science, clinical science, and game development fully integrated from the earliest days. And data science, for what it's worth, is really a kind of foundational thread for all of those. And it's hard. It's really hard. I mean, developing a product that has both these things, the strong science and the engagement, is really hard, but it's also really hard for people from all these different industries to, you know, be speaking the same language and work together because the development processes are different, the language you use is different. Your mindset of how you think about developing is different. And so for us, what I always talk about is it's literally daily attention. I'm unwilling to sacrifice or give up on it. We have to do both. Well, I think where we are today with EndeavorRx as our first product out of the platform, it's a really good product. It was built to show clinical efficacy and engage people to a minimal degree. It does that. Some kids love it. They will play for months at a time, you know, five days a week for four months. But yeah, there's a lot of people that kind of get through it and then plenty of kids that say, I really don't want to use this. So we've built features around the edges, things like an app for parents to allow them to track and monitor and incentivize their children. And we try to educate our users on why you're doing this. And so it's got to be a mix of the engagement itself, but also a little bit of inherent motivation that, hey, your doctor's in the loop, this is your medicine. It's important to put the work in and accomplish it.[musical interlude]Harry Glorikian: Let's pause the conversation for a minute to talk about one small but important thing you can do, to help keep the podcast going. And that's leave a rating and a review for the show on Apple Podcasts.All you have to do is open the Apple Podcasts app on your smartphone, search for The Harry Glorikian Show, and scroll down to the Ratings & Reviews section. Tap the stars to rate the show, and then tap the link that says Write a Review to leave your comments. It'll only take a minute, but you'll be doing a lot to help other listeners discover the show.And one more thing. If you like the interviews we do here on the show I know you'll like my new book, The Future You: How Artificial Intelligence Can Help You Get Healthier, Stress Less, and Live Longer.It's a friendly and accessible tour of all the ways today's information technologies are helping us diagnose diseases faster, treat them more precisely, and create personalized diet and exercise programs to prevent them in the first place.The book is now available in print and ebook formats. Just go to Amazon or Barnes & Noble and search for The Future You by Harry Glorikian.And now, back to the show.[musical interlude]Harry Glorikian: What makes you optimistic? Because I've been, you know, enamored with this space for a while now and trying to watch like where it's going to grow and what's going to get in its way. And so what makes you optimistic about digital therapeutics, either as a venture scale business or a public company. Because I know you guys are thinking about that. Tell me what you're thinking.Eddie Martucci: Yeah, a couple of things that make me very optimistic. I think the foundational groundwork is now done and we've shown it can be done. So we know that these products now can be developed, they can be protected, they can be brought through clinical trials and actually help patients. That's the most important thing. They can undeniably with strong clinical data, help patients and they can be brought through the FDA and now being prescribed by docs. So these prescription digital therapeutics, there's only a couple of them on the market. But literally at this point there's been now thousands of docs, not merely tens or hundreds, but we're talking now about thousands of docs who have prescribed prescription digital therapeutics to patients, where a couple of years ago that would have been essentially zero. So the foundations are there more. Every month that goes on, it becomes a a self-fulfilling cycle where doctors and patients hear about it, they're aware of it. They know someone who's tried it. And it's becoming a little bit common nature to think, wait, isn't there something digital that I've heard about for this? I think that will flip in the coming years to I expect to have a digital treatment or I expect to be told the digital option for my doc. So that makes me that makes me optimistic is that the groundwork is there. We know it can be done.Eddie Martucci: The second thing is, frankly, society is demanding better medicine in many different ways. They're demanding, and mainly I'm talking about patients in many respects, they're demanding more accessible medicine. They're obviously…we all got the efficiency bug of telemedicine during COVID. And while I've seen the data that that has significantly receded, I don't think the concept of online or digital in medicine has receded from anyone's mind. I think we all know that it's far more efficient and we should expect to see more products that are digital in nature, whether that's scheduling with a doc or taking a treatment. And so I think there's this kind of wave in society that is that is pushing people to recognize that we should be open to these types of products. The other thing is, whereas docs and patients years ago when we did market research, there was a level of skepticism that was pretty healthy. I now see a level of openness where if there's good data and there's especially in our case, things like FDA approval and strong clinical data, there's a better chance than not that both patients and doctors are going to be not only acceptable or accepting, but they're going to want to at least try something like this. So all the groundwork is there. We've just got to keep keep plugging away because it's new.Harry Glorikian: I talk about the whole digital therapeutic space in my book. And I always tell people look, if a product like this works for you, you're not going to have a side effect profile the way you have with some of the small molecule drugs that I've seen. It's trial and error with those things. And sometimes things don't go as well as you want them to and you end up with a very angry child if the drug doesn't do what it's supposed to do.Eddie Martucci: It's egregious. It's egregious. I mean, medicines, pharmacological medicines for neurological conditions are critically important. Don't get me wrong, I think they're critically important. And EndeavorRx is not meant to be an alternative to medication, especially if it's working well for for a child. But the problem is, there are many components of these conditions that are just not well addressed. And so you're left as a clinician to try to use these blunt instruments, these molecules which weren't delivered for these problems or rather weren't designed for these problems. You're trying to use them, but you're fighting the side effect profile as much as you're fighting the efficacy the whole time. And so you're right. Trial and error is the right phrase. Like the fact that we're still doing trial and error in CNS conditions all these years later is crazy. And there's a better way because we now can have these more targeted products that are part of the patient's toolbox.Harry Glorikian: Yeah, and we need more of them, so. Yeah, great. But let's talk about the business model, right? I mean, this is, you know, feels like fresh territory, right? And if I think about mobile games generally don't make money unless you sell millions of copies. Right. So you have you must have a different business model in mind from the beginning. I suspect this business model revolved around, you know, selling Akili games as a prescription based therapeutic at a cost that would be more typical for a drug than a mobile game.Eddie Martucci: Right. Right. So the concept here is we want the products to get to the patients that really need them and we want to involve the doctor in the loop and we want to have products that are proven. And so all of that to me says a core medicine model, meaning prescription treatment, as you said, covered ideally by insurance largely, but with a little bit of out-of-pocket burden from the patient. You're right, the general cost is a little bit more in line with pharmacology, although the good news in mental health and behavioral health is that's that's relatively inexpensive. We're not talking about multi-thousand-dollar therapies here. We're talking about something that is in the low hundreds per month. And for the patient, really more like $30 to $50 a month. So these are the cost structures that we think are tenable and have been working well in behavioral medicine. And that's really where we're starting. But we're in the early days. I think one of the beauties of digital is we don't have to just stay there, meaning that is the core of the model, a prescription that scales and is paid for by both insurance and patient.Eddie Martucci: But I think there's a lot of potential to evolve and iterate the model that has more consumer elements to it. For instance, like your best technology products, we can adapt the product itself to grow with you. Like your best technology products. We can serve, you know, services and help on the side beyond or in between your use of the actual treatment. So there's a level of connectivity with our end user and consumer that is that actually looks a lot more like best in class consumer software where you can have a long term relationship with a patient. Now, we have not pulled any of those levers yet, but I think what we're most excited about is the bringing both of those models to bear. A medical model, but that has some aspects to it that can actually grow and extend more like software. I actually think that's where the field will go. But it is early days. We'll have to see how this we'll have to see how this shakes out.Harry Glorikian: Well, that's why I always I always tell people, like, you know, once you digitize something like you get to have a broader imagination about what is possible in that realm as opposed to, you know, sticking to exactly what we did before.Eddie Martucci: Exactly.Harry Glorikian: But taking a step back here, no one has ever marketed a prescription based video game or won marketing approval from the FDA for such a product. Right. So how did you frame yourself? You walk in there and you say, “Hey, here, play this. And you're going to like it.” What were the hurdles? What did you have to overcome to get regulatory approval for this? What was it like dealing with the FDA?Harry Glorikian: No, it's a great question. Yeah, the FDA process is fascinating. We know it is rigorous, it's long, it's mostly collaborative. Right. The FDA wants to learn and help. But I think, number one, most importantly, there's unfortunately a myth out there today that digital therapeutics are actually medical devices generally don't have to go through efficacy analysis by the FDA. So I see this myth all the time. People say, well, you know, on the medical device side, they only look at safety. And so, unfortunately, with broad brushes, people have painted digital therapeutics as part of that. They've said, well, digital therapeutics may or may not have evidence, but the FDA looks at safety. I can unequivocally tell you that could not be farther from the truth. I would say 95 percent of our interactions with the FDA, which took the better part of two years because our product was so novel, you can imagine we were not only innovating the delivery mechanism, it's a video game. We were innovating the target, which is cognitive functioning, which there are no products labeled for cognitive functioning. And we were trying to look at what are the endpoints that, you know, that read on cognitive functioning. All of this is new, but not 95 percent of the questions we had, and that's—please don't quote me on the specifics, this is not a deposition—but in that range, were about efficacy. And we went through every little bit of our efficacy data so that the FDA could understand it, so that they could audit it.Eddie Martucci: We even, midway through our regulatory process, brought on a fifth study. So we have five studies in our FDA label package. So we brought on the most recent study to show to address some questions FDA had around efficacy in the longer run or efficacy along with medication. So this was a very rigorous process. I always tell people the good news about this is you can trust it when it comes out because this is something that looks and feels a lot like the drug process, right? There's a lot of scrutiny put on the trials and the legitimacy of the trials. So so it looked a lot like that. It's highly iterative. From a business side, the one tough part with FDA is when you're when you have a new classification for a product, so a 510K de novo, so they're creating a classification, there is no hard timeline on the review. And so when you're a startup and you're building a business, you kind of just keep iterating until you get to a label or not, right? And luckily in our case, we did. But yeah, I mean, as a startup, you're going through a nearly two-year approval. It's stressful. It's stressful, but it's good for the industry, I believe, because it's really forcing a high bar of science.Harry Glorikian: Well, no. And I mean, that's what you want. You don't want a low bar and then things go wrong, like you want it to be held to a higher standard. And usually when the FDA is taking on something new, they've also got to take the time to catch up to where you are. Right. They can't just walk in the room and be ready for this. So you're sort of paving the path for everybody that's coming behind you, which is a I guess there's a good part of that and a bad part of that.Eddie Martucci: Yes. Yes.Harry Glorikian: So there's a lot of stakeholders and gatekeepers in this space that we're talking about, right. Patients, parents, physicians, payers. I mean, each one of them needs to be persuaded that digital therapy or digital therapeutics are, you know, beneficial and worth prescribing or worth paying for. So, anything special you're doing to sort of win them all over?Eddie Martucci: Well, we're doing the work to put time and attention towards it. So you're right. Just because it's digital does not mean people will use it or understand it. So you've got to sit with patients and educate. Just because docs have a new tool doesn't mean they'll trust it. So you've got to spend time to make sure they understand the data and more importantly, understand where we're trying to play in the treatment paradigm. Right. Because, again, we're not … the easy answer for a digital is, “Oh, this is supposed to be a digital equivalent of a drug.” No. It's more nuanced than that. This is supposed to help in a very specific way. And insurers are probably the biggest barrier because it's so new for them. Right. This is this is very new. They don't really, they're not really built to be able to adjudicate digital products. Right. And unfortunately, we've got some of these types of myths floating around, like the FDA medical device myth, which understandably makes insurers uncomfortable. Right. If they if that's what they've heard, they say, well, how in the world am I supposed to adjudicate efficacy if the FDA doesn't? I guess I'll look at this with all the other hundreds of wellness apps out there.Eddie Martucci: So it's education time. Honestly, it's education time to unravel these myths, to really sit and make sure these stakeholders understand the data and the utility of the product. In terms of special things, one of the one of the nice things about growing a company, especially with digital company in this day and age, is you can test and iterate really quickly on all of these fronts. And so when we test you've got to have the meetings and you've got to fit into their review cycles. But for patients and docs, you know, we, we take a very clear test and learn approach. We are releasing certain types of educational content or certain types of marketing messages in pilot phase. Right now we see what works, we see what doesn't. We adapt. We do the same thing with the distribution infrastructure, frankly. Like how in the world do you get a video game therapeutic from your doctor? We built the infrastructure. We tested, we changed, we scrapped half of it and started again. So that is the beauty of living in a digital world. We can we can do that type of testing and learning.Harry Glorikian: And good old AB testing on what works and what doesn't.Eddie Martucci: Totally.Harry Glorikian: All right, let's step out of ADHD for a minute. You've been talking about other neurophysiological sort of conditions. And I think the website, if I'm not mistaken, mentions depression, cognitive dysfunction, multiple sclerosis, autism spectrum disorder, and a few other future treatments is. Is there something about the EndeavorRx platform or the proprietary adaptive algorithm that gives you the ability to sort of generalize? And I think you mentioned that earlier, but sort of to dig into that a little bit.Eddie Martucci: Yeah. So it really starts with what technology are looking for. And so we don't source technologies that are meant for any one condition. That is more common in the behavioral therapy space where there's behavioral therapy for disease X because it's a tried and true technique specific to the disease. The way we work is looking for technologies that actually activate specific brain regions and have data that they do that well. And so the interesting thing that we found about cognitive functioning, and we knew a little bit about this, but you know, I don't like to have revisionist history and say we we knew it all, with cognitive dysfunction and disease, independent of the etiology or the cause of why the brain is having issues, the downstream manifestation actually tends to bucket into very similar issues. And so our theory was, and so far it's proven true, is if you could bring technologies that are meant for the neurological processing issues, not the disease, not specifically the disease, then any condition that results in similar issues, you should be able to have a functional impact on. Because we're not we're not targeting, you know, dopamine reuptake and a dopamine driven disorder. We're not targeting myelination in am anti-myelinating disorder. We are targeting the end result, which is how well the brain is communicating. So we've because we start there, we, we theoretically have the ability to go across disease, and we've actually shown it now. So the same technology that has a treatment label for ADHD has been able to power two studies, including a larger randomized controlled study in multiple sclerosis adults, and showed clinically meaningful, large changes in speed of processing and related cognitive functions. That's the same technology under the ADHD product. ADHD and MS could not be farther from each other in terms of cause, but because the resulting functionally in the same in the same area, that's then you get that benefit. So that's our theory and that's how we're going to continue to develop products and take a functional and a neural network approach, if you will. And, and ideally, we have a much more efficient product pipeline because of it.Harry Glorikian: So. In your mind, like what are the biggest unanswered questions, either for EndeavorRx or for the Akili business. Is it more product? Is it more market? I mean, for example, do you worry about whether it'll work, you know, in the real world, as well as it did in your initial studies, whether doctors will prescribe the game, whether payers will cover it. There's all these issues. And so I'm just wondering where you think the biggest hurdles lie?Eddie Martucci: Sure. Yeah, I think I think my number one is not about the product. It's really systemic to the to the health care system and industry, which is it's important to me that the insurance industry, the doctors write prescriptions, but more importantly, the insurance industry and broader we could call it the payer industry. Right. Anyone that should be paying for medicine pays for digital therapeutics. Right. I don't think this should be the only class of medicine where patients bear the entire cost. That makes no sense. So we are not there yet for sure. Right. We're in such the early days that I think some payers are waiting, but I think we're starting to see a turn. We're beyond skepticism, beyond intrigue, probably into early acceptance. And I think the work needs to be done. And frankly, we need we need a couple folks in this industry and by folks, I mean both people, but also organizations to step up as the early pioneers for their patients. I think that's really important. Now, again, I have empathy for why that part of the industry moves slower. They're trying to protect patients. There's obviously cost arguments as well. And there are some of these myths or misconceptions out there about the industry. But I think when education is done right and when payers really engage, we're going to start to see a broader payer ecosystem adopting this like they would any other medicine. So I think that's kind of the biggest near-term barrier. And slightly longer term, I think the business model is a question. Which no one likes to hear, no investor likes to hear. And we're a company that's going to go public. I don't mean the business model is a question in that we don't know if we can make money or build a business. I just mean, what is…so, the foundations we know are there. Doctors will prescribe, patients will pay, payers are starting to pay. It has a benefit in people's lives. So the foundations are there. The business will grow. What the eventual business model is, is TBD, frankly. What is the top end business model that's going to allow a company to thrive at scale? I think we have to invest to learn that. And I'd say the same thing about the product. In terms of the product, it's not whether it will work, it's not whether it can help patients on the market. We've shown all of that. It's at this point, how well can you develop that product on the market so that it engenders long term compliance so that engenders loyalty and use in the future? And so I think in both those scenarios, I guess the health care system's got to get there. Which is a secondary priority, more like an opportunism. We don't want to miss the opportunity to find the best business model or to iterate on the products because we have the ability to do so. I don't want to miss that opportunity to grow the best business model we possibly can.Harry Glorikian: So you mentioned going public once or twice, and so I saw that there's paperwork with the SEC to go through a public filing with a special purpose entity backed by Chamath, whose I think it was Social Capital, through his venture fund. What's the thinking behind becoming public? Why now?Eddie Martucci: Yeah. I think I always had a mantra and I didn't come up with it. This is from advisors to me and mentors: Stay private as long as you possibly can for the business to be able to adapt and iterate and a little bit more of a clean way. But I think that time has come, and the reason I say that is we have a product that is being prescribed by doctors now and we have a pipeline where I've already talked about it. We could help potentially up to dozens of different populations who are struggling today. On top of that, the need and urgency around mental health and behavioral health has had a step function change in the last year. Right. We know that President Biden talked about it at the State of the Union. The surgeon general has put out a national state of emergency on youth mental health. So the time is right for a real investment here and the time is right for the company to fill that need. We know all the all the foundations are right. So I've always wanted to wait till that moment why we chose this specific entry point and vehicle, which we hope is kind of middle of this year, that Akili becomes a publicly listed company is, I think, the opportunity to not only have capital and the type of flexible capital that the public markets gives you, but in the case of a special purpose acquisition company, the expertise of that acquiring entity, in this case, Chamath Palihapitiya, who's extremely well known and amazing at building disruptive technologies for different industries that scale to ubiquity using technology and data.Eddie Martucci: But actually that the SPAC vehicle here is Social Capital Suvreta. Suvreta being a well known biotech hedge fund who specializes in early commercial biotech companies. So rarely do you get to become public with the right amount of capital, but also some new expertise around the table, strategic expertise in a disruptive business. And I think we get both of those with this deal. So we're still, it's too early to tell if the whole thing will go through. We're certainly crossing our fingers and hopefully if people listen to this in the longer future, Akili is already a public company and thriving.Harry Glorikian: Well, I mean, it's a good thing I spoke to you now so that we could speak a little bit more freely than when you're under that public rubric.Eddie Martucci: But oh, no, I'm already I'm already watching my words. It is important. It's a level of maturity as a business. Now, we have we've grown for about a decade. We grew methodically and slowly. We have over 100 employees now. And, you know, businesses change and mature. And I think it's the right time for us to do it.Harry Glorikian: Oh, yeah. I mean, a lot of the companies that I interact with as an investor, I mean, when we're going to go public, it's like, “Oh, we got to do this, we've got to get that ready. We got to get accounting ready. We got it.” I mean, you've got to go through it methodically because being public is is not for the faint of heart for sure. So, well, I wish you the greatest success. I look forward to staying in touch and, you know, keeping up to date on how things are going with the company. And, you know, I hope a ton of people listen to this because it's easier for them to hear it from you than hear it from me.Eddie Martucci: Thanks, Harry. This is a lot of fun. And thanks for your focus in innovation and these new areas that are really going to transform patients' lives. So I'm hoping we're doing our part there.Harry Glorikian: Thanks.Harry Glorikian: That's it for this week's episode. You can find a full transcript of this episode as well as the full archive of episodes of The Harry Glorikian Show and MoneyBall Medicine at our website. Just go to glorikian.com and click on the tab Podcasts.I'd like to thank our listeners for boosting The Harry Glorikian Show into the top three percent of global podcasts.If you want to be sure to get every new episode of the show automatically, be sure to open Apple Podcasts or your favorite podcast player and hit follow or subscribe. Don't forget to leave us a rating and review on Apple Podcasts. And we always love to hear from listeners on Twitter, where you can find me at hglorikian.Thanks for listening, stay healthy, and be sure to tune in two weeks from now for our next interview.
If you're a parent, you've probably had this experience many times: Your young child has a high fever, and maybe a sore throat, but you don't know exactly what's wrong. Is it a bacterial infection, in which case an antibiotic might help? Or is it a viral infection, in which case, you just have to wait it out? The symptoms of bacterial and viral infections are often the same, and most of the time, even a doctor can't tell the difference. Viral infections are more common, but sometimes, the doctor will prescribe an antibiotic anyway, if only to help the parents feel like they're doing something to help. But what if doctors didn't have to guess anymore? What if there were a fast, easy blood test that a doctor could run in their own office to look for biomarkers that discriminate between bacterial and viral infections? Well, that's the seemingly simple problem that a company called MeMed has been working on solving for 13 years now. Recently MeMed's first testing product got approval from the FDA, and now the company is finally beginning to roll out it out commercially in the US. And here today to tell us more about how it got built, how artificial intelligence fits into this picture, and how rapid diagnosis could change the practice of medicine, is MeMed's co-founder and CEO, Eran Eden.Please rate and review The Harry Glorikian Show on Apple Podcasts! Here's how to do that from an iPhone, iPad, or iPod touch:1. Open the Podcasts app on your iPhone, iPad, or Mac. 2. Navigate to The Harry Glorikian Show podcast. You can find it by searching for it or selecting it from your library. Just note that you'll have to go to the series page which shows all the episodes, not just the page for a single episode.3. Scroll down to find the subhead titled "Ratings & Reviews."4. Under one of the highlighted reviews, select "Write a Review."5. Next, select a star rating at the top — you have the option of choosing between one and five stars. 6. Using the text box at the top, write a title for your review. Then, in the lower text box, write your review. Your review can be up to 300 words long.7. Once you've finished, select "Send" or "Save" in the top-right corner. 8. If you've never left a podcast review before, enter a nickname. Your nickname will be displayed next to any reviews you leave from here on out. 9. After selecting a nickname, tap OK. Your review may not be immediately visible.That's it! Thanks so much.TranscriptHarry Glorikian: Hello. I'm Harry Glorikian, and this is The Harry Glorikian Show, where we explore how technology is changing everything we know about healthcare.If you're a parent, you've probably had this experience many times: Your young child has a high fever, and maybe a sore throat, but you don't know exactly what's wrong. Is it a bacterial infection, in which case an antibiotic might help?Or is it a viral infection, in which case, you just have to wait it out?The symptoms of bacterial and viral infections are often the same, and most of the time, even a doctor can't tell the difference.Viral infections are more common, but sometimes, the doctor will prescribe an antibiotic anyway, if only to help the parents feel like they're doing something to help.But what if doctors didn't have to guess anymore? What if there were a fast, easy blood test that a doctor could run in their own office to look for biomarkers that discriminate between bacterial and viral infections?Well, that's the seemingly simple problem that a company called MeMed has been working on solving for 13 years now. Recently MeMed's first testing product got approval from the FDA, and now the company is finally beginning to roll out it out commercially in the US.And here today to tell us more about how it got built, how artificial intelligence fits into this picture, and how rapid diagnosis could change the practice of medicine, is MeMed's co-founder and CEO, Eran Eden.MeMed has a growing office in Boston, but I reached him at the company's first office in Haifa, Israel.Harry Glorikian: Eran, welcome to the show.Eran Eden: Thank you very much for having me.Harry Glorikian: It's great to have you here, I know that there's a significant time difference, so I appreciate like but it still looks like it's really bright and shiny out there right now. So what time is it in in Israel right now?Eran Eden: Five o'clock in the evening,Harry Glorikian: It's five o'clock. All right. Well, you guys have a lot more sun than we do anyway because we're in the middle of winter, but absolutely.Eran Eden: So this, here, is actually full of people as well. So yeah, you don't stop innovation as five o'clock in the evening.Harry Glorikian: So, you know, I was looking at your background and I mean, it's really it's interesting. It's diverse. You have a degree in biology, computer science, systems biology. You were first job was in computer vision data and analysis. But then all of a sudden you wound up starting a company that builds sensors and software for infectious disease. Like, how did you end up down this path, and do you feel like everything that you were doing until you got here was preparing you for it?Eran Eden: Well, I think... A great question. So I think, on the face of it, it obviously the background in data science, as you know, in molecular biology, obviously all of that relates to what we're doing is part of our day to day and it is a good starting point. But in reality, there's a very big gap between what I was trained to do and today, my every day, day to day activity. I would say that probably the most important training that I got during my days at the Weizmann Institute has got less to do with differential equations or molecular biology, and it was more about a story that my mentor, Professor Uri Alon, told me when I was three years into the PhD, about three years into the PhD, he asked me, Am I already in the cloud? He said what? And he said, are you in the cloud? I said, Well, what is the cloud? He said, Well, every PhD, every scientist, when you start your PhD, you know, you have you go you go and read the latest papers in Science and in Nature and you see how somebody starts at Point A, makes a hypothesis about point B and then take the straight line from A to B, and then you say, OK, I'm going to do the same thing and you start at Point A, the known. You shoot for the unknown and you start going and suddenly you hit a roadblock. And then you hit another one and another one. At a certain point, you'd really lose direction, which he called the cloud. You're in the cloud. And then if you have enough perseverance and luck, you find a point C which is not exactly where you thought you're going to end. You go there with, you know, your last energy. And if you're lucky enough, then you publish another paper about how you started at point A, went to point C and connected between the two dots with a straight line. And then you have another generation of PhDs that are asking themselves, Well, why am I the only one that's struggling? And that lesson about how to be in the cloud, how to deal with uncertainty, to deal with failure and still move on. That is probably more important in the training that I got to become an entrepreneur and CEO of a company than any specific scientific knowledge.Harry Glorikian: Ok. Yeah, no, I mean, trial and error, dusting yourself off, getting up and moving forward is, you know, my wife calls me crazy when I keep doing it, but I think you have to be a little on the edge to constantly keep repeating and being willing to fail and then stand up and then move on. Maybe it's a, I think I was reading a paper recently that said forgetting quickly is evolutionary, you know, a positive trait so that you forget what happened, that wasn't good and you keep moving forward. So. But let's talk about your company, MeMed, like you started that in, I believe, it was 2009. And what was your founding vision? I mean, if you can talk about what you and your co-founder did when you came up with this idea, I think you were both studying at the Technion at the time?Eran Eden: Yeah, so so he was studying at the Technion, M.D., Ph.D. I was studying at the Weizmann Institute and Data Science and Biology. And frankly, I would love to tell you a story about a vision, but it started with a game. I don't think we had the presumptions to have really something that would grow to what MeMed actually became today. It was playing. We both have had different reasons first of all for doing this. I can say that from my my end, it was probably a pretty big gap between the places, the caliber of where we were able to publish high impact journals. And when I was looking at myself in the mirror and I was asking myself, Is this actually going to have an impact on real patients? I couldn't really see the connection. There's another reason why I decided to found MeMed or co-found MeMed. That's probably off topic for today. We can take this on a beer some time when we meet face to face. But so it's first of all, it didn't start with a vision. It started with a scratch wanting to apply a some of the know how that we had had in converting between molecular immunology and data science, and to try to solve big, ugly problems that don't have a good solution in 21st century medicine and trying to find something pragmatic now rather than having it a eureka moment. You know, some pioneers describe a eureka moment where suddenly you have the best and coolest idea in vision. For us, it was darkness for almost a year rather than the eureka moment. It is was more like an evolutionary process. Trial and error. We tried a bunch of solutions to problems that didn't really exist until eventually we came up with what we want to work with, but again was no, no eureka, and the way that it actually started was again, Kfir was coming from from med school talking about this problem of of AMR, antimicrobial resistance and the problem of distinguishing between bacterial infections and given our different backgrounds, we said that's interesting. How can we apply immunology and then science to try to solve that, and then at that point, we formulated what was to become MeMed's vision. And MeMed is based on a very simple premise, a very simple idea. Our immune systems have evolved to tell us what's going on our bodies and all we do at MeMed is we listen to the immune response with biochemical sensors and machine learning and what have you. And we use that to translate or decode the immune system into insights that can potentially transform the way that we manage patients with acute infections and inflammatory disorders. The first problem we went after, because that's a very lofty goal, was potentially the most prevalent clinical indication on the face of this planet. A child with sniffles. Our elderly patients that coughs. Come to the doc, they have a fever. As a parent, you're many times hysterical, you're asking yourself, is it a bacterial infection or bowel infection. If it's a bacterium, antibiotics. It's a viral infection, chicken soup. And we said, Well, what if we can harness the immune system? What if we could measure or listen to the immune system in real time and use that to try to aid clinicians to tackle this seemingly simple problem? So the vision was listening to the immune response. In the first embodiment of the first problem we went after is this huge intractable problem, B versus V versus. Bacterial versus viral infection. To treat or not to treat.Harry Glorikian: Yeah, I mean, you know, it's funny, you say simple, and I've worked in this area for a long time and now not simple, not simple, but I've been watching dozens of companies over time try and tackle this problem, and everybody always comes at it and says, Yep, we should be able to do it. And I'm like, OK, that's a big hill, you know, to go and try and die on so. But you got FDA approval for your device in the U.S., and I want to talk about that later. But it did take 13 years. Like to, you know which parts of the process turned out to be harder or slower than you thought it would be?Eran Eden: Before I answer that, I just want a minor correction. I didn't say it's simple. I said it's a seemingly simple problem. In reality, it's an extremely difficult problem to go after. I think some of the most the biggest challenges that we have can be phrased in a very simple manner. But as you alluded to, yeah, it's an intractable problem. Bacterial and viral infections are often clinically indistinguishable. And it took us over a decade to take this from my idea on a napkin and grandmother's kitchen. That's where we found with no garage, it was Grandmother's Kitchen to what is considered a landmark FDA clearance that I think many folks did not believe we're going to be able to get this because it required so many innovations, not only on the technological side, but also on the regulatory side. And when you ask why only a decade? I think it's, we're very lucky that it took us only a decade and it sounds there, let's not call them challenge. Let's call it problems. Challenges is something I always envy the people that have challenges. We have problems with immune, and we work every day to solve those problems, right? So. So there's many problems or hurdles you have to go through. So there's first of all, you have to overcome some pretty big research issues, where do you find these hypothetical molecules of the immune response that go after bacteria and viruses. So research, then you learn the hard way.Eran Eden: The research is very different from development, and development is very different than product, and product is very, very, very different than manufacturing, and manufacturing is very different than regular regulation, and regulation is very different than reimbursement in marketing, which is a very different than commercial, et cetera, et cetera. So it's not good, it's not enough to excel in one thing. You have to really reinvent the wheel on several things, and as a company and as a team, reinvent yourself, and that's probably one of the biggest challenge, probably your biggest impediment to progress is yourself and your team because you might be an excellent data scientist, but you have to talk with the clinician. You might be an excellent clinician, but you have to talk the language of the molecular immunology. You might be very versed in all these three, but it's still not product and it's still not the graphical user interface. And how is that connected to manufacturing and really creating a culture or a team that can combine these seemingly very diverse elements within a small company. That is a very, very daunting and big task, and again, we frankly failed on multiple avenues there. We had to go back, we were in the cloud and we had to reinvent point C again and again and again. So, you know, we were in a very far position that we are today that we thought we were going to be at this stage.Harry Glorikian: So I'm going to ask at some point, you know, after this whole interview is I'm going to encourage you to write the next IVD book because everything you said is absolutely the way that I've seen it over time is, you know, having to bring all these pieces together is not trivial in our world. But let's step back here for a second for everybody that's listening, right? Talk a little bit about basic immune system biology and the, you know, technology behind your diagnostic system. So if someone presents with an inflammatory response, why is it so hard for doctors to destroying distinguish between the bacterial and viral infection?Eran Eden: Because bacterial and viral infections are clinically indistinguishable and you don't have to be an M.D. to to understand this. Intuitively, we know our kids so well. But still, you know, when they have a fever or runny nose, you know, we know that it's 80 percent, 85 percent a viral infection. But what if? What if there's a lingering bacterial infection? And it just it turns out that because of the clinical manifestation is very similar. It's really hard to figure it out. Not only children, also adults with suspected LRTI or a fever without sores, and even when we apply modern, I would say diagnostics, there's still a big gap that remains. So for example, when as a scientific community or a clinical community, when we approach this problem, we have tools at our disposal. A rapid strep test. A rapid influenza tests. Multiplex PCR. In today's world, I think everybody, even my grandmother is talking to me about the difference between rapid antigen tests suddenly becomes a really interesting topic over, you know, weekend dinners, culture. So there's technologies out there. And going back to your question, why is it still, why is there still a gap? And we've identified several things. The first one is probably the most trouble is time to results. Many of the clinical encounters, you want to have the solution here and now where whereas that technology that we have often provide solutions in hours and even days, and that's not always good.Eran Eden: That's one hurdle. Not the biggest one. The second one is that many times the infection site is inaccessible. Take, for example, otitis media, an ear infection or sinusitis or bronchitis or pneumonia. It's really hard to reach the infection side and therefore identify the pathogen. It's one in four patients in the most prevalent disease on Earth. That's really hard. Third, even if you use the best, most broad technology diagnostics to try to identify the bug, say a multiplex PCR. In more than 50 percent, five, zero percent of the cases, you're not be able to put your hands on any microorganism, but you still, as a clinician, have to make a decision. And lastly, there's the issue of colonization. So even if you're lucky, the infection that is readily accessible and you do get some sort of a virus, for example, that you detect, say, for example, an influenza or or let's take a rhinovirus, the rhinovirus is very prevalent in children. That's a problem. It's very prevalent in children. Even if you take seemingly healthy children in a very high percentage of those children, they're going to have a rhinovirus. So mere detection does not apply causality. All this complexity is sunk into this few minutes that the clinician basically needs to make a decision, and it's a really hard dilemma because it's hard to know to distinguish between the two and the ramifications could be quite significant.Harry Glorikian: So I know the answer to the question, but I'm going to ask it so you can explain it is: So who cares? I mean, I know that it's ineffective to treat a viral infection with antibiotics and that only you know, that only work against a bacteria, but you know. We've been doing a trial and error, so what's the downside of doing that?Eran Eden: So it's actually a pretty deep, it's a very deep question because there are several layers. You're right, this sometimes people actually say there's several layers to answering because the first one is, well, if you treat erroneously, with antibiotics, antibiotics, because of this uncertainty, there's a lot of antibiotics overuse that one of the consequences of this it drives anti microbial resistance, which basically means that the drugs don't work anymore. And if we continue on that path, we will potentially lose modern medicine because if you lose the potency of antibiotics, you cannot treat infants when they have an infection. Or an oncology patient that would succumb to a parasitic infection, or even yet have your wisdom tooth pulled out, because antibiotics won't be effective. And there's several quite influential studies that came out in the last few years. The last one actually in The Lancet came out two weeks ago portraying a world without antibiotics, which is, you know, we're seeing right now the consequences of COVID SARS-CoV2. Some might argue it's not a smaller problem. So that's and it has both clinical and health economic consequences. According to Jim O'Neill, over $100 billion by 2050 in lost GDP.Eran Eden: And. And it's a big number, right? It's a really, really big number. And maybe, maybe it's overly inflated and maybe it's conservative, but it's a big problem. The issue is that nobody cares. Sometimes the individual doesn't care because the doctor, right now, when he has a patient in front of him, he doesn't think about the masses. He thinks about the patient. So you might ask, well, what the doctor care. Why does the patient care? And it turns out that there is an angle on the personal level as well, not only the societal level. If you give erroneous antibiotics, you can drive anaphylactic responses. You can drive allergies, which have a toll. But then there's another element that people are less aware of. In addition to overuse, there's also simultaneously underuse. One in five patients that have a bacterial infection are not receiving antibiotics in time. There's much less publication on that. But it is a reality. And that also has consequences, including prolonged disease, duration and sometimes even morbidity and mortality. So it's a really delicate equation, right? You don't treat. And you don't want to get ... some countries overtreat, some undertreat. And again, at the end of the day, the day to day, it does have ramifications both from the patient and on the doctor.Harry Glorikian: You know, if we could accurately treat people right, I think there would be a whole host of issues that could get solved and a whole host of issues that wouldn't emerge because of overtreatment or treating the wrong people that you know, we could spend hours over a beer discussing the microbiome and allergies and all sorts of other consequences of doing this. [musical interlude]Harry Glorikian: Let's pause the conversation for a minute to talk about one small but important thing you can do, to help keep the podcast going. And that's leave a rating and a review for the show on Apple Podcasts.All you have to do is open the Apple Podcasts app on your smartphone, search for The Harry Glorikian Show, and scroll down to the Ratings & Reviews section. Tap the stars to rate the show, and then tap the link that says Write a Review to leave your comments. It'll only take a minute, but you'll be doing a lot to help other listeners discover the show.And one more thing. If you like the interviews we do here on the show I know you'll like my new book, The Future You: How Artificial Intelligence Can Help You Get Healthier, Stress Less, and Live Longer.It's a friendly and accessible tour of all the ways today's information technologies are helping us diagnose diseases faster, treat them more precisely, and create personalized diet and exercise programs to prevent them in the first place.The book is now available in print and ebook formats. Just go to Amazon or Barnes & Noble and search for The Future You by Harry Glorikian.And now, back to the show.[musical interlude]Harry Glorikian: So your system, which is, I love, is a basic blood test, right? So the MeMed BV looks at three immune system proteins in the blood: TRAIL, IP 10 and CRP. So how are these proteins related to infection and how can measuring their levels tell you about the nature of the infection?Eran Eden: Ok, so. Each one of those proteins that you just mentioned plays a critical role in the immune response to different invaders, bacteria and viruses. What's special about this particular trio, is that they work really well as a team. Maybe if you take a step backward to identify them, we had to run for about four years what is arguably the largest prospective proteomic study ever to be conducted of the human response to acute infections. And start with a host of multiple tens of thousand proteins bioinfomatically and then down-select this eventually to three. And these three, while none of them is perfect in itself, they cover one another's blind spots. So let's go one level deeper. When we went on this, one of the things where we were surprised to find out that is a clinical community, we've been obsessed with the bacterial side of the equation. Every biomarker that you have in 21st century medicine, 20th and 21st century medicine, has been mostly predominantly upregulated in bacterial infection. Procalcitonin: bacterial infections, CRP: bacterial infections, white blood count: bacterial infections, absolute neutrophil count, which we use as part of routine day to day care: bacterial infections. What about the viral side of the equation? We couldn't find one that was used or cleared by FDA as part of 21st century medicine. The last. The reason the FDA cleared us, we actually just cleared the first viral protein ever to be cleared by FDA. And so we went on this fishing expedition and four years into the process, again, this was 2009-2013. We identified this trio. TRAIL Is a protein that shoots up in your bloodstream when you have a viral infection, whether it's a common influenza A, influenza B, parainfluenza or corona, and it has this very unique property that it goes down when you have a bacterial infection, why nobody really understands the reason. But it really creates a very dramatic full change because of this up and down type of a response. And the story there, there's a lot of interesting stories around TRAIL, but one of the ways mechanisms by which it does that it causes the cells that are infected by viruses to commit apoptosis. Cells suicide. And by that, protect the brethren cells. So that's one of the mechanisms that the body is using.Eran Eden: The second one is called IP 10, which is an interferon. This protein basically shoots up in your bloodstream if you have a general infection, and more so if you have a viral infection. It recently got a lot of headlines in the context of SARS-CoV-2 and hyperactivity of the immune response. It's also associated with lung injury, but a really interesting biomarker that plays a critical role there in clearance of infections. The third one is called C-reactive protein, that's been around for about 40 years. Goes up in bacterial. And the nice thing about them? They work as a team. So as I said, they're not perfect. So take, for example, CRP. It's reasonably OK after 48 hours. But because it takes it to about 48 hours to reach maximum level, but in the early phases, you have a blind spot. Whereas TRAIL, at time of symptom onset, it's already differentiated, so they cover one another. By the way, we didn't identify this. The computer identified that. This is a lot of insights that we had in hindsight when we were looking.Harry Glorikian: Yeah, that was going to be my next question, which is. You know, the the heart of the show is always like, you know, artificial intelligence and its whole basket of tools and biology. So how does machine learning come into this process? Is there some corpus of training data that shows that certain levels of these three proteins correlate? Or can you tell us, you know, how you developed that part of the system?Eran Eden: Absolutely. And I think again, I was teaching a machine learning at the Weizmann Institute over a decade ago before it was a sexy topic. You know, people are using the term machine learning and data science so often so frequent. I think what's important to say is that machine learning is part of the component technology, but there's hardcore immunology and molecular biology. So it's not just one technology that we're, you know, it's a it's a very high entry barrier because of that and adds to the complexity. So that's one thing, just to put machine learning in context. Where machine learning plays an important role here is two places: in the development and in the final product. In the development, there's a process of how do you find the optimal team of biomarkers that would give you the the best performance? And over there, there's a lot of activities around using publicly available data sets and and proprietary data sets and data analysis and statistical analysis and feature selection and find the right models, et cetera, et cetera, coming up with what is the right model. Some of these are more conventional tests. Some of these are more cutting edge tests in the final product. It basically uses what's called a supervised learning approach, which basically means the following. Imagine every problem in here, I'm going to be a little bit technical here. Imagine you have, let's say one feature. Say a viral biomarker. TRAIL. High levels, viruses, low levels, bacteria. You find some sort of cutoff that separates between the two. It was the most informative biomarker that we found.Eran Eden: Is it good? It's reasonably good, but there's no perfect biomarkers out there. We don't have them, nor do we believe they exist. Nor do we believe in unicorns, even though my daughter is trying to continually persuade me that there is one. Then you add another biomarker to that. Imagine that you have right now a two dimensional grid. And now suddenly, every patient is met this two dimensional coordinates and you have a cloud of bacterial and the cloud of viruses. And you find a line that separates the two. And then a third dimension and a fourth and so forth and so on. And eventually, the problem becomes how can I find this type of plane or hyper surface that separates between the cloud of bacteria and the cloud of viruses? This is the essence of the machine learning and the way you go about this. You train give it a lot of patients, a lot of data, and then you train the system. And the more data you have, the smarter it becomes. The same principle applies for doing diagnostics in oncology, span detection, computer vision and what have you. It's the same underlying, often similar underlying principles to try to solve many of these problems. So hopefully I was able to to simplify and somewhat exaggerate how this is actually working and where the AI plays here.Harry Glorikian: So what's that accuracy rate of the diagnosis from your system? And is there are certain things, let's say it's good at in certain things, it's maybe not so good at?Harry Glorikian: Yeah, absolutely. So so if you look at the overarching population, if you look at our pivotal FDA study, the AUC, the area under the operating curve, the entire population was 0.9 to 0.97 across different cohorts, which is considered very high. So that's the short answer. The more we see deeper level, it's there's obviously nuances across different populations. One of the things you have to show is what happens in children versus adults. Upper respiratory tract infections, lower respiratory tract infections, et cetera, et cetera. So we've shown a relatively consistent and robust response. That's how the system was developed. But there are, for example, certain viruses that we know that we perform less accurate. For example, adenoviruses. Adenoviruses are notoriously hard to to treat well. By the way, they're one of the most prevalent, for example, viruses in children, why? Because the immune response looks like a bacterial infection. For many, many reasons. So white blood count is going to be elevated. Procalcitonin is going to be elevated, CRP is going to be elevated and we're often going to overtreat with antibiotics. So if you look at our performance in that particular sub-cohort, our performance drops somewhat from, you know, a 0.90-something to maybe 0.89, but that's actually one of the viruses that we see the most added value because compared to standard of care, it's many times close to flipping a coin.Eran Eden: So even though our performance is eroded in this particular virus. The standard of care in this particular situation is particularly challenged, and it's almost 0.5, 06. so that's one example. There's multiple examples. We can study the immune response to pathogens again for almost a decade now. This is just one interesting anecdote. And I think just connecting this to the who cares question that you had. So here's an interesting case that we had a few weeks ago. A child, young, three years old, coming to a major medical center, not really sure if it's a bacterial or viral. Ran a PCR, came positive for adenoviruses and it looked a little bit bacterial. But yeah, OK. Adenovirus explains everything. Released home. Got a 99 score. 99 probability of bacterial infection. So they start to do additional follow up and then it eventually turned out to be a bacterial axis in the spinal cord of that particular child. It had to be mechanically removed. This is a very dramatic case. This is one of those potentially underused cases that could be very dramatic. This is very rare. It doesn't happen often. But again, it's hard. It's really, really tricky to distinguish between infections and we added this right now, this is how everything maps together to the adenoviruses and and to why we think this could be helpful.Harry Glorikian: So, you know, like I said earlier in the show, you know, you got FDA approval and granted 510K clearance back in September, which congratulations, that's a huge step. But you know, for everybody listening, what Gates does, does that open for you. What's the pathway to getting the device out into the market?Eran Eden: So as you said, first of all, you have to get the clearance, which I think took us almost five years working with FDA. FDA, by the way, we've worked with them extremely collaboratively and they've been instrumental in helping us form and shape, what's the methodology to actually prove something. We didn't talk about this? But how do you prove that absence or presence of bacterial viral infection in the absence of a true gold standard? So let's put that thing aside. We were able to work with FDA and come up with a methodology to do that. So now, what is required to take it to the next step? There's several things. The first one you need, and we didn't talk about this, you need a way to measure those biomarkers. You need a platform. Right, one of the challenges that we had is that in the early days, none of the big strategic players, the Roches, the Abbotts, the DiaSorins of the world were willing to bet on this because the risk were so high, as you alluded to in the beginning, the graveyard. And nobody got FDA clearance, so they basically they wouldn't. They were not willing to bet on us today. Some of them become partners and we're working with them. So it's, you know, there's been great development. But at that time, it was really hard. The platform is also challenged because some of the proteins are picograms, some are nanogram and some are micro per mil, which poses again the challenge from a technological perspective. Again, not going too much into the technology side, but we've been able to come up with a technology or a platform that can actually measure multiple proteins across almost a six to nine order of magnitude range. And so you have to have a platform and can do that in about 15 minutes right now, serum working in whole blood.Eran Eden: The second thing you need, you need obviously manufacturing capability, which is again, a different story, you have to manufacture the cartridge. The third thing you need is building the clinical evidence beyond, I mean, FDA's great, but you have to create what's called a clinical utility, real world evidence, what have you, working with peers. Work with partners or with clinicians working the societies. Publishing. Building a commercial team which we're right now established commercial team in the U.S. So there's multiple things. And probably last but not least, this is too big of a challenge to go at it by yourself. You need to have partners. Whether it's governments, the U.S. Department of Defense, the European Commission have funded this heavily and have been amazing partners, whether it's strategic partners, you can take it by yourself versus vs not one market. It's markets. You have patients in the wards and the EDs and the urgent care physicians' offices, retail clinics. No single player has enough of a presence in one platform that covers it all. So again, we've announced about a year ago, you know, the first partnership with DiasSorin, which has today almost a thousand installed installed across Europe and the US in these large automated immunoassay machines. And that's covering certain parts of the market that are overlapping or, sorry, that are complementary where we're going at. So that's a little bit of what needs to be done. But again, it's changing the boundaries of what what we've been doing so far, and that's always a it's always a challenge, but also an opportunity.Harry Glorikian: So you guys raised I believe it was $93 million, if I remember the number correctly, in new funding, which sort of really adds to the firepower of being able to take that next step, but. You know, can you can you envision a future where we get a solid diagnosis and an appropriate treatment plan, you know, quickly while you're in the doctor's office?Eran Eden: Oh, yeah.Harry Glorikian: That was the shortest answer you've given yet.Eran Eden: I think you can be much more radical. I think there's several things that are happening. There's two major discontinuities. There's a technological discontinuity. There's a regulatory discontinuity. And I'll actually add another one, which is there's a psychological discontinuity. The technology that we can do today that we have today, the tip of our fingers can do can provide so much valuable information that can help make better decisions. The regulatory framework has changed because of COVID, it's basically shattered a lot of things. And from a psychological perspective, I think there's a push to polarization, right? Both decentralization and centralization at the same time. And so I definitely see that happening. I think we can take this several step further. How can we take it from physician's office, also retail clinics and even further? And that will take time, obviously, because we're dealing here with some pretty, pretty deep questions. But I think the world across multiple fields and this is not different than anything else. I think it's definitely going in that direction.Harry Glorikian: Yeah, no, I mean, I was going to, you know, looking at what you've created and, you know, obviously first getting everybody on board, but then seeing how it can be deployed at a CVS or something like that, it could drum, you know, you could have a dramatic impact on how we manage patients. The whole antibiotic dynamic and maybe even relieving stress on the system so that, you know, it doesn't get overwhelmed by what your system may be able to sort of help get to a much faster, much more accurate answer too.Eran Eden: I wanted to say relieving stress from stressed mothers and fathers. But yeah, I agree with you also, relief. And by the way, as you start going from more centralized to decentralized, there's obviously additional workflow challenges. How do you make this simpler? There's regulatory bars that you have to meet. How do you go from a mod complex to a clear waived test that can actually go to those directions so that there's we still have we have work, there's work, work to be done. But I think we've been able to potentially break a glass ceiling in terms of getting the clearance. And now I think with that, there's going to be additional innovation that will come in both by us and others who are entering the space.Harry Glorikian: So. Just slightly moving to one side is like, how has MeMed responded to say, COVID-19? I think you guys have developed a test that runs on your platform and predicts how severe the infection will be. How does that test work? Did your previous work, you know, and also did your previous work like on the platform prep you for this virus? Just curious how it works and how you got there?Eran Eden: Absolutely so. So it always starts with the clinical question. I mean, many of us are technophiles, but at the end of the day it's about solving a real problem. And the problem here is the following. You have see SARS-CoV-2 positive patient presenting to the ED. And one of the questions that we have in mind is whether that patient is going to deteriorate or not. Do we escalate treatment or not? And it's a real question, right? And the more you know, the more stress the system is feeling because, you know, because of the the peak of a pandemic, the more important that is. So we said, Well, how can we harness the technology? Is the framework that we created host response in general, right? The biomarkers we've developed, the platform that we have, the Biobank and what have you. And so and how can we take a process that maybe took 10 years and now collapsed into something maybe that's 10 months? How do you get a 10 X? And and first of all, with amazing partners around the globe, you start running huge clinical studies to basically collect patient samples. We also use again information from the public domains, our own repositories, our own previous data because from many perspectives. Sars-cov-2 is very interesting, but guess what? Similar to SARS and to other types of severe viruses, there's differences, but also commonalities.Eran Eden: So we use a lot of the bioinformatics, the previous data samples. Current data samples. The know how and the platform that's readily available right now. They can measure basically anything to collapse this and develop. This is probably just got clearance in Europe that basically allows to take a snapshot, the main response again in real time. Give you a risk stratification regarding the probability of a patient to experience severe outcome defined as ICU level of care and mortality within two weeks. Again, it's only clear right now in Europe, not cleared in the U.S. and we view this also as a stepping stone going beyond just COVID severity to a general severity signature. So what you do, both B versus V and severity, what if you could do it in the same cartridge or what have you? So I think what's what's really interesting, we build here this core technology. We went after one big problem, B versus V, but now that you have that, you're like a child in a candy store. There's many more things that you can do. And rather than taking you a decade, you can start to collapsing things because there's a lot of there's a lot of. Resources that you can now leverage or platform that you can leverage, so that's a story around MeMed and COVID severity.Harry Glorikian: Yeah, platforms are wonderful in that way, right, that I like a platform more than I like, like a, you know, sharpshooter bullet, from an investment perspective. Thinking about it that way. But so. You recently got COVID. We were supposed to talk like over a week ago, and I, you know, we had to postpone it. Did you use the test on yourself? I mean, if you did, like did it work the way you thought it was going to?Eran Eden: Yeah, so so yeah, I got my I got it from my daughter. We went on a trip and five out of five family members got infected. So yes, it was at least from our small experiment. It was very infectious. We got the Omicron. Actually we didn't have symptoms, apart from the fact that I think it just jacked up the energy level of my kids. So before we talk about running around the house and thank God, you know, my wife didn't didn't kill any one of them. So there's no casualties from this, from this infection. So because we didn't have symptoms, we didn't go to the ED. It was not relevant. You have to have SARS-CoV-2 symptoms. So in that case, no, no, no need. I mean, we were pretty much hunky dory. But what I can tell you is that on the B versus V. Again, it's potentially bacterial and viral infections are potentially the most prevalent indication in children. And my children, those little incubators of bacteria and viruses, are no exception. So I had a chance to use the technology on my kids many, many times, including last time was about a month and a half ago, and my eldest daughter, who is four, before going to a business trip. And my wife is asking, is it a bacterial infection? I said, I don't know. She spits on me. The shoemaker is going barefoot. So we ran it. It was a viral infection. No antibiotics. Went back to school. So and I got a lot of brownie points with my wife and my mother in law, which is obviously always very, very strategic.Harry Glorikian: That's that's a good one. That's always helpful. Exactly.Eran Eden: So we're actually using this quite often in our families as well. And it's very very gratifying.Harry Glorikian: Interesting. Excellent. So now you guys are, you know, I believe you have an office in Haifa, which I remember as being beautiful and hilly and wonderful food, and then you have Boston. You know. What are the strengths of being in these two locations. What happens in Boston that can't happen in Haifa and vice versa?Eran Eden: Well, again, we're going after a global problem and you have to have a global team to have a global perspective. Whatever you have in San Francisco today, you have tomorrow in Shanghai and the day after that in Tel Aviv. So you have to look at this from a global perspective, number one. Number two, since the US is the primary market, as I said, we have to build a very significant presence in the U.S.. Why specifically Boston? Very talented pool of, a pool of talent that's very wide in the domain. There's a big overlap in terms of hours between Boston and Tel Aviv, so you can grow one unified team. And that's basically, that's where we're basically building our U.S. headquarter. And the team is quite complementary. Again, we've we've recruited by now roughly 25 to 30 folks, folks with a very strong background, both IBD, Troy Battelle, formerly Thermo Fisher, who's buying commercial for microbiology in the Americas. Fred, who is running Corp Dev, from bioMérieux. Again, another large multinational, Jim Kathrein was former head of sales for BioFire. Again, not sure if your audience is familiar with but and so forth and so on.Eran Eden: And Will Harris was running our marketing global marketing, is ex-Amazon and then before that, 15 years in IBD. So it's really bring here a blend of, we call this affectionately an anti disciplinary team. We don't care about disciplines, we care about solving big, ugly problems. So you have to bring the IBD experts with the clinicians, with the folks and the big data science side or in the molecular immunology and the manufacturing. And nobody knows, single location has all the know how, no single location has the recipe because frankly, we're doing here something new. There is no real tech like this. And so bringing those this pool of talent, I think has really helped us, propels us moving forward. And it is the bridge to be able to to launch in the U.S., a U.S. very focused, commercially marketing product where a lot of the I would say more of the molecular immunology data science team is more in Israel. I'm simplifying and exaggerating. That's some of the team.Harry Glorikian: So the last funding round, was that the argument to the investors, like we need to hire these types of people to help blow this out? What was what was the rationale for that last round?Eran Eden: So, so basically three things. Number one, commercialization. U.S. Europe, Israel. That's our initial focus and then the rest of the world. Second is product pipeline, so we talked about bacterial versus viral infection and a bit about COVID severity. But what would you do if you had a blank canvas and these platforms to go after the new response to measure the immune response? What additional big problems would you go after? So it turns out that there's some pretty interesting stuff in. We're working on additional activities. So that's the second thing product pipeline. And the third thing is a scaling manufacturing. So as I think people have a new appreciation for manufacturing and supply chain during COVID times, it's a really big topic and critical for success. So this these are the three major elements that we raise the funds for.Harry Glorikian: No sounds I've I've been I've seen this rodeo a few times, so yes, I understand completely. So, well, you know, especially because I come from the diagnostic world and I can't wish you enough success because we need more products like this out on the market to help us manage patients and help give physicians better information so that they can make better decisions, right? More informed decisions than just, you know, looking at a patient and trying to figure out what's going on. So I wish you incredible success and I'm, you know, great. Great to have you on the show.Eran Eden: Thank you so much for for the kind invitation. Enjoyed our discussion.Harry Glorikian: Thanks.Harry Glorikian: That's it for this week's episode. You can find a full transcript of this episode as well as the full archive of episodes of The Harry Glorikian Show and MoneyBall Medicine at our website. Just go to glorikian.com and click on the tab Podcasts.I'd like to thank our listeners for boosting The Harry Glorikian Show into the top three percent of global podcasts.If you want to be sure to get every new episode of the show automatically, be sure to open Apple Podcasts or your favorite podcast player and hit follow or subscribe. Don't forget to leave us a rating and review on Apple Podcasts. And we always love to hear from listeners on Twitter, where you can find me at hglorikian.Thanks for listening, stay healthy, and be sure to tune in two weeks from now for our next interview.
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Many of us wear wireless, battery-powered medical sensors on our wrists in the form of our smartwatches or fitness trackers. But someday soon, similar sensors may be woven into our very clothing. Harry's guest this week, Nanowear CEO Venk Varadan, explains that his company's microscopic nanosensors, when embedded in fabric and worn against the skin, can pick up electrical changes that reveal heart rate, heart rhythms, respiration rate, and physical activity and relay the information to doctors in real time. And that kind of technology could move us one step closer to a world where we're far more intimately connected to the medical system and doctors can catch health problems before they turn into disasters.Nanowear's leading product is a sash called SimpleSense that fits over the shoulder and around the torso. Last month the company won FDA approval for the software package that goes with the SimpleSense sash and turns it into a diagnostic and predictive device. It's currently being tested in a network of clinics as a way to monitor and manage congestive heart failure.Varadan trained in biochemistry at Duke, earned an MBA at Columbia, and spent about a decade in pharmaceutical sales and marketing and technology investment banking before co-founding Brooklyn, NY-based Nanowear in 2014. His father Vijay Varadan, MD, PhD, now an emeritus professor in the Department of Engineering Science and Mechanics at Penn State, is the other co-founder and the company's chief innovation officer. "Nanowear's technology was actually the culmination of his life's work," Venk says.Please rate and review The Harry Glorikian Show on Apple Podcasts! Here's how to do that from an iPhone, iPad, or iPod touch:1. Open the Podcasts app on your iPhone, iPad, or Mac. 2. Navigate to The Harry Glorikian Show podcast. You can find it by searching for it or selecting it from your library. Just note that you'll have to go to the series page which shows all the episodes, not just the page for a single episode.3. Scroll down to find the subhead titled "Ratings & Reviews."4. Under one of the highlighted reviews, select "Write a Review."5. Next, select a star rating at the top — you have the option of choosing between one and five stars. 6. Using the text box at the top, write a title for your review. Then, in the lower text box, write your review. Your review can be up to 300 words long.7. Once you've finished, select "Send" or "Save" in the top-right corner. 8. If you've never left a podcast review before, enter a nickname. Your nickname will be displayed next to any reviews you leave from here on out. 9. After selecting a nickname, tap OK. Your review may not be immediately visible.That's it! Thanks so much.Full TranscriptHarry Glorikian: Hello. I'm Harry Glorikian. Welcome to The Harry Glorikian Show, the interview podcast that explores how technology is changing everything we know about healthcare.Artificial intelligence. Big data. Predictive analytics. In fields like these, breakthroughs are happening way faster than most people realize. If you want to be proactive about your own health and the health of your loved ones, you'll need to learn everything you can about how medicine is changing and how you can take advantage of all the new options.Explaining this approaching world is the mission of my new book, The Future You. And it's also our theme here on the show, where we bring you conversations with the innovators, caregivers, and patient advocateswho are transforming the healthcare system and working to push it in positive directions.Everyone's used to the idea that if they're being treated in a hospital, they'll probably get wired up to sensors that track their heart rate or respiration rate or blood oxygen level.We've talked on the show before about a new generation of portable medical sensors for everyday life, like continuous glucose monitors for people with diabetes.And some people even wear medical sensors on their wrists in the form of their Fitbit or Apple Watch. Some of these devices can go beyond fitness monitoring to alert wearers to problems like cardiac arrhythmia.But what if medical sensors were woven into your very clothing? My guest this week is Venk Varadan, and he's the CEO and co-founder of a company called Nanowear that's taken a big step in that direction. Nanowear has developed a way to put microscopic nanosensors inside clothes .If that cloth is worn against the skin, it can pick up electrical changes that reveal heart rate, heart rhythms, respiration rate, and physical activity and relay the information to doctors in real time. Nanowear's leading product is a sash called SimpleSense that fits over the shoulder and around the torso. And last month the company won FDA approval for the software package that goes with the SimpleSense sash and turns it into a diagnostic and predictive device.But Varadan says that in the future the nanosensors and the software could be put into even more places, like headbands, conventional clothing, or bed sheets. That's just one example of the explosion in mobile health technology that's putting more power into the hands of patients. And it's also one of the topics in my book The Future You, which is available now in Kindle ebook format. You can get your copy by going to Amazon.com and searching for "The Future You," by Harry Glorikian. The book grows partly out of conversations like the ones I have here on the podcast with medical researchers and entrepreneurs. But it goes even deeper into the impact of wearable sensors, AI, and so many other technologies that have the potential to help us live longer, healthier lives. So I hope you'll check it out.And now on to my conversation with Venk Varadan.Harry Glorikian: Venk, welcome to the show.Venk Varadan: Thank you, Harry.Harry Glorikian: So, look, we all know that with with technology startups, there's always this sort of chicken and the egg question what what came first in the mind of the inventors: the market need or the product that needs to address it. You know, ideally they come together simultaneously and there's a back and forth dialogue between founders and potential customers. And you end up with what the startup community calls--what is it?--product-market fit, if I talk to my, you know, my Silicon Valley nephew of mine. So in the case of Nanowear, you know, did you start to think about the problem and how to solve it? Or did you start out with the technology? Which in your case involves a way to embed these tiny nano-pillar sensors into cloth and then look at ways to make it sellable. So which one was it for you?Venk Varadan: Great question, Harry, and again, thanks for having me on the podcast. We were squarely the latter and I think most entrepreneurs are the former. But we had this great advanced material, a cloth based nanotechnology that could pick up really, really high fidelity clinical grade biomarker data off the body. And we didn't really know what to do with it. Do we start as a consumer company? Work on fitness, B2B, sports? Do we think about industrial safety, military use cases? They've been trying to figure out smart textiles forever. Or do we go into health care? And I think stubbornly so, and a little bit of altruism, we chose the harder route, which was health care. But I think it was probably more premised on that we believed in the quality of the sensor. It was doing something from a quality and quantity standpoint that no other on body sensor or non-invasive sensor out there could do, whether it was consumer grade off the shelf or health care based electrodes. So all we really knew when we started is that we wanted to be a health care company, but we didn't know the right application to start with.Harry Glorikian: Yeah, I was going to say, let's, let's pick the hardest one and see if we can get over that hill. So let's back up here and talk about like the medical need you're trying to address. I mean, at a high level, why is portable diagnostic sensing so important for people's health?Venk Varadan: I think it was always important because of an access issue, right? Not everybody can go see a physician or can do high cost diagnostic tests that require a facility or diagnostic tools in person. And there's a cost even to running a blood pressure cuff or checking your heart with a stethoscope or running a hemodynamic monitor, all the way up to more expensive tests like sleep studies and sleep labs. So I think it started, remote diagnostic needs started with an access issue, and it's not like we haven't had telemedicine in the past. But even that was sort of limited due to access issues. You needed a broadband network, you needed particular devices, you needed smartphones, and there were a lot of industry, I guess, pressures holding this sort of need to sort of push health care out into the more wide stream for those that have access issues. And we all said that this was going to happen one day. Virtual care, telemedicine, remote monitoring at home, replacing offices at home. And it was a nice sound bite. And COVID kind of forced the issue and I think completely accelerated that 10 year frame on the need, right? Because folks were still sick. Folks still have chronic disease. Folks still needed acute procedures. But you weren't really able to do a lot before, during and after, if you had to have these people camped out in the hospital or in outpatient clinics or acute surgical centers. So that's when while everybody thought it was cool and one day I'll employ these digital technologies, it really took COVID to shut their business down or they didn't have any patients, to force them to adopt. So I think a lot of our, companies like us, we were all doing the right thing. And we also are the first to admit that we got fortunate that the pandemic sort of accelerated the need for our solutions.Harry Glorikian: Yeah, I mean, I remember I put together, god, it's got to be like 15 plus years ago, I put together a distributed diagnostics conference, because I was like, "This is going to happen." And, well, OK, eventually. But so let's talk about, let's step back for a minute and talk about some of the specific medical conditions where continuous, high resolution, high fidelity data is useful. Like, I know we need to probably start with congestive heart failure.Venk Varadan: Yes, so that's where we actually started before COVID. That was the sort of market need where our technology, our ability to sort of simultaneously and synchronously look at biomarkers from the heart, from the lungs, the upper vascular system in a sort of contiguous way and sort of map the trends over the same period of time as you would with a stethoscope or blood pressure cuff and electrocardiogram or hemodynamic monitor if they were all in one platform. That's really what we're replacing as part of our solution and our device-enabled platform. But the economics of heart failure and the business need were really what was pulling us there in the sense that there were penalties from CMS to avoid that next hospitalization within 30 days. And many of these patients are, one in four are being readmitted within 30 days. One in two are readmitted within six months. So this isn't a problem that we can just medicate our way out of. We have to understand when decompensation of the heart is happening before symptoms show up, because once symptom show up in fluids accumulating in their lungs, it's already too late. So I think there was a good product need for us, as well as the economic need with reimbursement and solutions for something that can be done outside the body that a patient could be be using at home.Venk Varadan: And then I think, you know, COVID hit and the market applications really just exploded beyond heart failure. Heart failure is still on our roadmap. Our clinical study to prove that ALERT algorithm of, we take all these data points, send it into the cloud, do a risk based predictive algorithm to predict worsening heart failure or decompensated heart failure weeks before fluid accumulates in the lungs. That's still firmly on our roadmap. We've just got to restart the study that was halted due to COVID. But the same product that does the same parameters with a different sort of algorithmic use cases opened up a lot of other applications that now have a business need and economic need to use us. So the two that we're starting with is pos-procedural or post-surgical follow up in an acute use case setting. And the second is outpatient cardiology longitudinal care for someone who unfortunately probably has to see a cardiologist for the rest of their life.Harry Glorikian: And if I'm not mistaken, congratulations are in order because of an FDA approval.Venk Varadan: Yes, so we actually got our third 510K just two days ago. September 21st, sorry, September 22nd, we got our third 510K. This is actually an example of our of our first digital-only clearance. So our first two clearances, our first clearance in 2016 was primarily around the advanced material, the nanotechnology, to get FDA comfortable in its safety and efficacy profile. The second was for our product, which is the SimpleSense shoulder sash, which simultaneously and synchronously captures data across the heart, lung and upper vascular system biomarkers, feeds that data through a mobile application and into the cloud. And then this clearance is sort of for an end-to-end digital infrastructure that circularly includes ingestion of our 85 biomarkers and then analytics circularly across our spectrum that continues to sort of process and then has the ability to push insights or algorithmic alerts down. So that last part is not included. But if you think about it, Harry, we kind of had a strategy before we got to the AI part. Now everything we submit with FDA has nothing to do with the device, has nothing to do with software infrastructure, has nothing to do with what would be MDDS or what wouldn't be. We can simply send in statistical analysis on the AI algorithms based on the inputs that we've already cleared and then looking retroactively on the outcomes. So it was it's a nice win for us to kind of show that we're not a device company, we're a device-enabled platform. But I think what it's really exciting the market on is that we're ready for AI diagnostics. We hope to have a first one and our fourth 510K, I guess here with FDA pretty soon in the complex chronic disease state. So really exciting times for us.Harry Glorikian: Yeah. And I mean, as an investor, I mean, I, you know, I've been in diagnostics forever and I, you know, I'm so focused on Where's the data? Show me the exponential nature of the data and then what we can do with it and really like blow that up, right? That's where I see the value in these platforms and technologies. But there are technically other methods that had been used, right, that you might say you might or might not say are competitive in some way. But one of them is called a Holter monitor, right? Which people put on their skin to monitor, you know, electrocardiogram and EKG rhythms outside the hospital. And I don't want to say the name wrong, but I think it's SimpleECG for yours and then the SimpleSense vest, [how does it] compare to that. What are the alternatives? How long do you wear it and how do you compare it to the existing status quo?Venk Varadan: Sure. So, you know, a Holter monitor has a specific use case. It's looking at your electrocardiogram rhythm to see if you have a rhythm or abnormality, right? So we one of the metrics we capture is an electrocardiograph, right, and we do multiple channels of that. So it's not a single lead. So we could certainly compete against that application and just look at rhythm abnormalities in the same way. Companies like iRhythm have that, and Apple Watch has that 30 second feature on it. We are not playing in that space. And the difference between us, even though our signal quality, we would argue, is much cleaner than a Holter monitor that's using standard electrocardiographs, with those you have to shave your chest, you have to stand the dead skin down. You have to put gel on for the electrode to get a conductive signal. We don't have to do any of that because of the nanotechnology. But what the nanotechnology also affords, in addition to a better experience and better quality, is the ability to do more than just a Holter monitor, right? So imagine if that same Holter monitor wasn't just looking at rhythm abnormalities, it was also looking at the acoustics of your heart and your lungs, the sounds of your heart in your lungs. It was looking at the flow characteristics. The blood injection times, the fluid accumulation in your lungs. It was looking at your breathing rate, your breath per minute, your lung capacity, your changes in lung capacity over time, if it was looking at your pressure related issues at the aorta, systolic and diastolic blood pressure. In addition to being a better experience in all of these and sort of kind of replacing a Holter monitor and a stethoscope and what have you, the real value is being able to do all of that at the same period of time over the same period of time. So even if I'm monitoring for, our use cases are about 30 minutes to an hour in the morning, 30 minutes or at night. And because we're getting such dense quality and quantity of data over that time period, we can actually see trends across the cardiopulmonary and upper vascular complex, which is actually the first company and platform that can do that. And that may not have been important before COVID. But COVID, I think, was revelatory in the sense that COVID may have started as a respiratory disease, but it affects the heart. It affects the upper vascular system. You can get a DVT from it. And I think it opened the world's eyes into understanding. We're not looking at all of these systems, the heart-lungs-upper-vascular system that all work together and work uniquely in each of our own bodies. We're only getting a risk based signature on just cardiac rhythm or just breaths per minute or just the sound murmurs of your heart, whereas we're doing it now.Harry Glorikian: Yeah. So for a guy like me, like, I'm like, Oh my god, how do I get one of these? I want one of these right now. I'm thinking like, Oh, I could use it right after I work out. And I'm, you know, forget the I'm sick part of it. I want to use it as a wellness monitoring and sort of to see, get a baseline. Tell me where I'm going, right, over time. That's what I'm always discussing with my my physician is we need a baseline because I don't know how it's going to change over time. If I only look at it at that point in the future, I don't know what it was. So, but the other side, I think to myself, there are physicians listening to this show that are probably all excited about this. And there are physicians going, "That's a lot of different data points. How in the hell am I going to make sense of that?" And so I'm I'm assuming what you're going to tell me is you've got this amazing software that lets you visualize, you know, and make sense of all these different parameters together.Venk Varadan: And that's exactly right. You know, we were actually stubbornly annoying to our KOLs, our clinical teams, as well as our original customers in beta rollouts, because Harry, we agreed with you. We looked at where Gen 1 and Gen 2 sort of digital health companies struggled in health care. Health and wellness is a little bit different right? I mean, to each their own, right. I mean, if you market well, you'll find that pocket of people that want to be overwhelmed with data or what have you. But we really listened to what digital health was doing for the provider and patient relationship. There were some good things there and there were other bad things, and the bad things we realized actually wasn't monolithic between clinics. Some people thought that bad things were "I'm alerted too often." Others wanted to be alerted all the time. Some were like, "This is noisy data. It's too unclean." Others were saying, "I just need, you know, 70 percent C-minus level data," right? And then we were thinking about all of those aspects which we couldn't get consensus on. How do you bring all of those aspects that gives control to the provider so the provider can say, how often are they alerted, how much data and the raw signals do I want to look at, how much do I not want to look at? And really, with the thesis of building the platform on them, spending less time than what they do before? Because I think Gen 1 and Gen 2 products unfortunately actually added more time in adjudication and frequency of the provider being notified, and also cause some anxiety for patients as well because they were looking at their screen and their data at all times.Venk Varadan: So we really tried to be sponges of all of those different devices that were tech enabled and sort of moving from hundred-year-old devices to now Gen 1, Gen 2, pushing into the cloud. And really listened on... And I'll tell you, it was mostly from staff. It wasn't necessarily from the physicians and the surgeons themselves. It was mostly from triage nurse, from health care staff, the people that are running around coordinating the follow up visits, coordinating the phone calls from patients that were doing poorly or feeling bad after feeling sick after a procedure. And I just think we just kept our ears open and didn't go in saying, we know what you need. We were asking, What do you?Harry Glorikian: All right, so let's talk about the technology itself, the SimpleSense wearable sash. How does the cloth sensor in the garment work? I mean, on a microscopic level, what are the kind of changes that this nano pillar detects and how?Venk Varadan: Yeah, so not to get to sort of, you know, granular into the physics, although I'm happy to Harry, if you if your audience ends up sending me some questions. But think about our ability to just detect a difference in potential action potential from point A to point B. And it's an oversimplified way of describing what we do, but the reason we can do it better than anybody else with any other sensor -- and that's what really feeds the cleanliness and the quality of our data and allows us to derive so many biomarkers that other others can't, which obviously feeds the ability for AI -- is because we've got these billions of vertically standing nano sensors per centimeter of surface area. The differential or the potential difference that we can find because our signal quality so clean is so narrow. Whereas other sensors that might be treated as noise, we can consistently see deltas from point A to point B and know exactly what caused those deltas, right? And that's unique to us and our vector orientation. And it's probably a little too wonky here, but if you have a vector across the largest slice of the heart, across the largest slice of the lungs, across the upper vascular system in its entirety, with that finite ability to get really microscopic level changes in potential, irrespective of what signal you're looking at. Because once you we know what signal we're looking for, we just set the frequency bands for those, right? Right. And that's really, in a nutshell, how it works across the multiple parameters that we can capture from a biomarker standpoint.Harry Glorikian: So you said 85 biomarkers, right? We're not going to go through all of them because we'll be at the end of the show. But what are the kinds of, let's say, physiological data that you're pulling in and that you're differentiating on?Venk Varadan: Sure. So I probably summarize it into several different buckets that each have maybe 20 or 30 derivatives under it. But, you know, cardiopulmonary biomarkers. So the coupling between the cardio and pulmonary complexes, impedance cardiography, thoracic impedance and then looking at not only the means and the median trends across those metrics, but the standard deviation. So one of our board members famously said, Nadim Yared, the CEO of CVRx, You will learn so much more from the standard deviations than you will from the trends. Don't just look at the sort of the trend. So that's an example. Cardiopulmonary: We look at the electrical signals of the cardio complex and electrocardiographs. We look at a combinatorial methodology of cardiographs, acoustics, BMI, height and weight. And then we tie activity, posture, movement. What is your sleep orientation? Are you sleeping on your left side? Are you sleeping on your right side? All of these sort of things together actually enable some really interesting insights from a machine learning standpoint. And again, the beauty of our ability to sort of understand them and see more biomarkers. Eighty-five is where what we know right now, what we've validated. There's probably a lot more that we will discover under certain disease states. But what we're able to sort of mesh together from all of those are really cool aspects like blood ejection times. That's not a physical, raw metric we're getting. That's a derived metric and combining a lot of these aspects cardiac output, stroke volume, you know, these are things that could only have previously been done with an arterial line in your body and in a hospital system. So I don't know if that answers your question.Harry Glorikian: Well, no. I mean, listen, I mean, this is why I invest in this space because, you know, theoretically, as I get older, I may be a patient and you know, the better these technologies get, the better off I'm going to be. But so let's talk about for a second, where did where did this originate from? And I think your dad, your father had something to do with this, if my research is correct.Venk Varadan: He sure did. This may be a little bit of a long winded answer, Harry. But but for your audience, I'll tell the story because it's important for dad to be happy at all times, even though I'm 40 years old. So, Dr. Vijay Vardhan is our co-founder and Chief Innovation Officer. My father, 40 plus year academic researcher in the fields of materials, research and biomedical engineering and this was actually, Nanowear's core technology was actually a culmination of his life's work. Back in the 80s and the 90s when I was still a young pup and he was convincing me to go be a doctor, he was doing research in this field, and it wasn't even called nanotechnology back then. There wasn't a term for it, but he was doing defense related projects in the ability to detect very minute signals at very, very, very, very difficult detect detection environment. So an example is submarine coating, right? Submarines when they're below water are picking up their external environment information through sonar. The deeper they get in the ocean, the harder that sonar frequency is to be able to differentiate. Is that a a school of plankton? Is that a whale? Is that a thermal geyser that's sending me the signal? Or is it a Russian sub, right? And his thesis was, if I have a really big footprint of sensors and exponentially higher surface area of sensors and not just one sensor or two or one hundred but billions across the hull, I can start to differentiate over time the nuanced differences between the sonar a whale emits, the sonar a thermal geyser emits, or oh, by the way, what are our friends in the USSR emitting, right? And that's an example in really, really hard to detect environments. He did the same with observatory jets and missile defense systems at 75,000 feet, you know, the opposite, very high frequencies at very high speeds. So that original thesis, the human body is also a very complex environment and hard to detect environment as well, right? So long story short, he kind of took that same thesis over many years of playing around in the lab and publishing papers and doing great work for our government and our Department of Defense, but also with an eye to the future on what could this do in the human body one day?Harry Glorikian: Right. Well, that's great. I mean, it's I'm sure he's very happy that you two are working together to bring this to market.Venk Varadan: He's not as disappointed in me about not going to med school anymore. Let's put it that way.Harry Glorikian: Yeah. Keeping parents happy is is a is a difficult thing. I know many people are like, Are you going to be a doctor or are you going to be a lawyer? You know, I know the I know the joke. So you've got FDA approval for a number of, as you said, you're building on top of, this layering that you've been doing from an FDA approval standpoint. What did it take to get them to sign off? What sort of evidence did they need to see?Venk Varadan: Yeah, it's a great question. I think that we kind of had to create our own playbook with them. I'm sure if they're listening, they don't want to hear this because you're not supposed to sort of commend and compliment the agency. They're just supposed to be there as sort of the gatekeepers. But we used to hear just a lot of horror stories like, "Oh man, you know, working with the agency, it's really tough. You know, they're really tough on this." I mean, we always looked at them as our partners, you know, we were bringing a novel technology to the world. We chose to go into a regulated environment because we believed in the promise of saving patients. We were not taking a sort of anti-regulation attitude that I can fix this, government get out of my way. I'm a patient first. I like living in a country with FDA where something is scrutinized that I have to take when I'm sick. And I think that attitude and going into it from us as a product and R&D team, first of all, helped in clarifying our understanding of FDA's processes because it's a lot, and you really need to dig through the guidance in that. But I would say this is really hats off, Harry, to our founding engineers. I mean, they went from being engineers to really understanding process, and that's really what FDA is. Our first clients we met with, we went down to Washington 11 times in person to demo to ask questions continuously. And "Hey, we read this part of the guidance. Does this make sense for us?" And we shut up and listened when we didn't agree with them. We said, "But what do you think about this? Doesn't this solve it?" We weren't trying to go around them, and so we were trying to develop sort of new understandings of it.Venk Varadan: And I think collaboratively we put together a good playbook with FDA to clear a material that they had never seen before. Right? It would be one thing if we use the standard electrode like all Holter monitors do and combined it with something, and did different things on the software side. That would be somewhat straightforward because they know the data that's being generated is often the standard electrode. But for us, we had to do a lot of different and in many cases, much more rigorous testing, which that was painful. Don't get me wrong, but totally worth it, right? I mean, our sort of boundaries and our understanding of what FDA put us through, it turned out to be a boon in disguise. I mean, our whole team can sort of run through the needs now of FDA and we feel very experienced and very well equipped on how they think. And now that they're comfortable with the sort of data we capture, all the great things we can do on the AI side, which is still scary to a lot of people. You just say I've got a black box and I'm combing electronic medical records, and here's what the unsupervised learning tells me. I was a regulator. I'd be like, Wow, I'm not touching that with a 10-foot pole, you know? So it's different with us, right? I mean, we can define everything that's coming in and we can define the outputs. Yes, the AI in the middle is the magic, but we're not sort of defining everything until the outcomes, right, which is where I see a lot of companies got into trouble. So I think it was worth it with the FDA.Harry Glorikian: Well it's funny because, I mean, I always say to people, I'm like, Listen, they're not the enemy, actually. They can make your life easier because and I say, people tell me, "Well, I'm not going to go until I'm absolutely done." I'm like, If you wait that long and they tell you you're wrong, you just spent a whole lot of money for "and you're wrong." Right? So you should look at them as your partner. Right. And I'm assuming you went to, you worked with the digital health group at the FDA.Venk Varadan: We worked predominantly, consistently we work with CDRH [the Center for Devices and Radiological Health] and now actually as a as a board member on Advamed, sitting on the executive leadership group for digital health, Advamed is a trade association that helps with FDA and with CMS on on industry innovation. CDRH does have its own sort of digital health group within it that's focused on a lot of these issues that we're talking about A.I., data privacy, cybersecurity, which in this sort of next decade, I think is going to be the main sort of frontier for the industry government relationship that we all sort of signed up for when we decided to go into health care, because even the most sleepy widgets right that we use consistently, they're all tech enabled now. Everything is digital, you know?Harry Glorikian: So yeah, and I mean, they're they've been creating that from the ground up. I remember talking to the the gentleman that runs it and he's like, I feel like I'm running a startup because, right, most of the stuff that we're, you know, we need to figure out has never been done before at the regulatory agency. And so we're sort of creating it from scratch, right? So I mean, in a way that that's good because he understands the pains that the companies are having to go through in creating something that hasn't been done before.[musical interlude]Harry Glorikian: Let's pause the conversation for a minute to talk about one small but important thing you can do, to help keep the podcast going. And that's to make it easier for other listeners discover the show by leaving a rating and a review on Apple Podcasts.All you have to do is open the Apple Podcasts app on your smartphone, search for The Harry Glorikian Show, and scroll down to the Ratings & Reviews section. Tap the stars to rate the show, and then tap the link that says Write a Review to leave your comments. It'll only take a minute, but you'll be doing us a huge favor.And one more thing. If you like the interviews we do here on the show I know you'll like my new book, The Future You: How Artificial Intelligence Can Help You Get Healthier, Stress Less, and Live Longer.It's a friendly and accessible tour of all the ways today's information technologies are helping us diagnose diseases faster, treat them more precisely, and create personalized diet and exercise programs to prevent them in the first place.The book is now available in Kindle format. Just go to Amazon and search for "The Future You" by Harry Glorikian.And now, back to the show.[musical interlude]Harry Glorikian: So let's go back for a second to, you know, 2020 in the first wave of coronavirus pandemic, right? You partnered with some medical centers in New York and New Jersey to start using it to monitor patients. And what did you learn from those studies and how did the device help improve treatment?Venk Varadan: There were two things I think. One, it was all anybody was talking about, and there were so many unknowns about it that we recognized that this was a, you know, a virus that was affecting the cardiopulmonary complex. Those that were getting sick and we're going to the E.R. had issues there, and that's what we were doing. And so in the same way that we're looking at potential use cases with the ultimate goal of assessing someone's risk, right, which is really what we're what we're doing as a remote diagnostic company or a remote hospital at home patient monitoring company, we went into COVID with that same thesis in doing so. And obviously in our backyard in New York, we got punched in the mouth first in the USA. With that, pretty much everybody I know was infected in March. We were all riding the subway together, you know, up until the last day as sardines. So it was not escapable here. And we're a dense city, right? We all sort of live on top of each other and our hospitals almost in a week. There were patients in the cafeteria. They were we were making tent villages for additional beds in Crown Heights, Brooklyn. It was completely overwhelming. And so we really feel it felt like we wanted to do something about it now. We would have gotten on patients right away, but. We did have to go through the IRB processes, which would take time, unfortunately, but we learned a couple of things and the two things actually that we learned are is that we're not necessarily super helpful in a acute virus that hits you really fast.Venk Varadan: The patients that this is sending to the ICU, it's doing so very quickly. It's rare that someone is sick for three or four weeks. They progress so badly that then they go to the ICU. They have a drop pretty quickly when it happens. So what we found was, our study was really to go on patients while they were in the general ward, and the endpoint would be when they were transferred to the ICU because they had gotten so sick a morbidity event or they were discharged. And I think we were unable, to be candid, we were unable to find the lead up to that point because we just simply didn't know what patients were coming in. I would have loved data on them from 48 hours beforehand. Right? We could have learned so much, even very basic functions that Fitbit and the Apple Watch are trying to market. "I saw a spike in heart rate from the all patients that got infected with COVID 48 hours before." That is the premise of where I would have loved to go with our granular data, but we're not the type of device that somebody just wears at all times, whether they're sick or not, right? So I think that was a learning experience for us that if there's an unknown of when something's going to hit, it'll be challenging. Venk Varadan: For infectious disease that becomes chronic disease, I think we're going to be in much better shape, and I think we could definitely do a longitudinal study for the long hauler community, right> You know, the folks that have been infected with COVID and have literally seen symptoms for a year or two, I think there's a lot we can learn longitudinally from there. And that's really where I think our study with our with our great partners at Maimonides Medical Center in Brooklyn and Hackensack, New Jersey and others across the country would, we would be more than happy to to participate in some of those longitudinal studies because, you know, we don't know what the long hauler is going to look like in five to 10 years, right? Or even people that have been infected before the vaccines now. That's still a let's figure it out type thing. So it's not you have to balance sort of running a sales product business versus a research part, but with the right resources and the right partners we would love to continue that work in COVID because it's not going anywhere as you know.Harry Glorikian: Well, listen, I actually want you to put it into a T-shirt and send me one so that I can wear it and monitor myself. But let's talk about where this technology is going in the future, right? The SimpleSense sash looks, you know, comfortable, convenient, way more comfortable than, say, a Holter monitor. But you'll correct me if I'm wrong, but it's still a specialty device. It isn't made from off the shelf materials, et cetera. But do you think there's like we're moving to a day where you can sort of embed these sensors in, as I said, a T-shirt, familiar cloth items. I'm looking at digital health and saying it has the ability to monitor me and sort of help identify problems before they come up so I can get ahead of them. And so that's how I'm thinking about this technology, because those sensors look pretty small and thin, at least from what I could see visually in the picture.Harry Glorikian: We're the first to say we don't know when we don't know, Harry. I know the market wants you to always have an answer for everything. A lot is going to depend on the additional aspects that we all use in technology stack. Where does 5G take us? Where does increased broadband take us? You know, 10 years ago, we didn't realize everyone in the world would have a smartphone, right? Villages in India and Africa, they have these now, you know what I mean? They may not have running water, but they've got, you know, a Samsung device, right? And so we may have never thought that monitoring in remote places like that because we couldn't find an economic model to sell shirts or bed sheets for a dollar out there. But maybe with the volume and with the right partners, that's where we could go. We certainly built our our stack with that sort of dream in mind. We filed IP and got patents awarded to embed in clothing and bed sheets and upholstery on cars and seatbelts and on the steering wheel and. You know, this could be in the gloves of a pilot one day. You know, this could replace your sort of neurological monitoring. We've got a prototype of a headband that's calculating all your EEG and EOG signals could replace an 18 lead one day. I think when you throw in real good advances in automated supply chain and 3D printing, there's a lot that can be done in this space and it's going to be done through partnership. We're not going to do it all on our own.Harry Glorikian: No way. I was going to say Venk, get to work, man! What are you doing? Like, you're using this in a in a medical application, but I really want to understand: so especially if, you must have believed in it because you filed the patents, but do you think that this sort of sensor technology could just be a normal part of preventative health care in healthy patients?Venk Varadan: I think that was always the goal, Harry. What can we do to really help a physician provider and ultimately a payer understand someone's risk without them coming in to a hospital or doing a visit? Because really the only people you should be seeing in person are people that need to be seen, not me, for an annual physical. Not you for an annual physical. Not, you know, somebody in the villages in Africa who really just needs to understand why they have a fever, whether there's something really wrong inside them. That's where I think this should go. It always was that case. We never knew what the right problem was to start to build a business around it. But this should replace your your annual physical, your annual checkup for healthy people. This should replace the follow up visit for your post-surgical, whether you get a knee replacement and angioplasty or a stent in your heart and should replace your chronic disease visits. If you have sleep disorder or heart failure where you know, do you really have to go get a $10,000 test every three months to see if you're regressing, improving or if you're staying the same? I think that this can democratize all of that in some way, and it's cloth. We all wear clothes every day, right? So yeah.Harry Glorikian: I mean, I look at I've looked at all these technological advances and I look at them as deflationary in a sense right. We're allowing people to get higher quality care from these technologies because of the information that comes off of it and then utilizing AI and machine learning and, you know, different forms of data analytics to sort of highlight trends and problems or hopefully, no problems, and then if one comes up, it sort of sticks out like a sore thumb, but it gives you a longitudinal view on that patient. And that's where I see all of this going, I mean, COVID has just pulled everything forward a lot faster than. You know, anybody could have guessed, and I agree with you, if you look at 5G and all these things coming together, it's just it's going to take it one more leap forward that much faster. I mean, I can imagine a partner for you would be Apple or Google thinking about, you know, clothing. Or Lululemon, for that matter, I guess. But somebody that that can incorporate this into their into their materials and make it more available. Because I got to believe that there's a consumer application that somebody could take advantage of rather than just a hardcore medical need, if that makes sense.Venk Varadan: No, you're absolutely right, and again, this sort of went through our strategic thinking when we were thinking about what we wanted to be when we grew up. And we think that the our unique cloth nanosensor technology, which good luck trying to replicate and copy that for anybody who's interested, I mean that again, this was 40 years of work that sort of how to create it and we're bulletproof, protected from a from a patent standpoint. But we think this can enable all of those markets. Our thesis was always, Harry, if we could start in health care we'd have the need-to-have population. The people that don't have a choice, right? I mean, I can go out for a jog or I don't need to go out for a jog, right? I can run with a monitor but I don't need to. But there's a good percentage of the population that doesn't have a choice. They must be monitored. If we could start with that, need to have population and prove it, prove that it works, that it's changing outcomes. Why would the nice-to-have market use something that you know, is already working for for sick people, right? And that was kind of always our thesis. We don't really have a timeline on when we're going into the consumer market, but because, you know, there are different aspects that are involved there from a business standpoint, customer acquisition marketing are the obvious ones, but sexiness, fit, we did not focus on "Do we look cool?" We were focusing on, you know, design is important on everything, don't get me wrong, but we first started with "make it work." We didn't start with "It has to be this big" and then figure it out, right? We started the other way around.Harry Glorikian: Well, and if you think about all the existing wearable technologies, they incorporate a sensor that everybody understands very well, right? There's no question that temperature monitoring, there's no question that, you know, if you can have a CGM on you, you can sort of understand what foods affect you positively or negatively. You're right. We need the scientific publication to prove that the technology that you built does what it needs to do, and it's probably all the time going to give you new information. You're going to be like, I didn't know we could figure that out, right? Which is the beauty of having 85 biomarkers. You're going to find something new all the time, but you could easily see that certain applications would then become accepted and then make its way into mainstream.Harry Glorikian: Yeah, absolutely. And I think the more that folks are using and the cool thing or not, maybe not cool, maybe it bothers some people, I'm sure, but technology goes one way. It does not go backwards, right? And COVID sort of shifting virtual care into the forefront, which is what technophiles did before. "Oh, I just talked to my doctor on the phone." I would have laughed. I was like, What can they do with that right before I started Nanowear, right? But that's not going back right. If you don't have to go see your position in person and you've got an alternative now that replaces it, why wouldn't you do that right? So. Yeah, I think as people get more accustomed with devices, they'll understand how to differentiate from them. You know, I'm not taking shots at our friends in Cupertino, but there's only so much you can do on the wrist, righHarry Glorikian: Absolutely.Venk Varadan: If you're not going across the heart, across the lungs, across the brain, you're going to be limited in what you can do if you just have an armband device that's picking up your pulse rate and your skin temperature, you're limited in what you can do, right? So I think what we're excited about, maybe not just on this form factor in this product, but understanding its application around the body. You can't put a smartwatch around your body, but you can put a cloth around your body. You can put a sheet around your body, right? I think that hopefully the understanding is going to come that there is a delineation between something that's great for the consumer and something that's great for, you know, the health care population. And where does that nexus come together? I think that's going to be driven by patients. I don't think it's going to be driven by us. I don't think it's going to be driven by the provider or the payer. I think the patients are going to demand, you know, as they are doing now, right? I mean, the reason providers are buying our solution right now is because the patients are demanding it right. The payers are kind of demanding it. To some extent, cardiologists would love to see 40 patients a day in their office again. They were really used to that, right?Harry Glorikian: Yeah. This is a longer debate over a beer at some point.Venk Varadan: It is Friday!Harry Glorikian: Listen, it was great to talk to you. Healthy congratulations on the on the latest approval and look forward to seeing other approvals as as you're taking this thing forward. And you know, I can only wish you great success. I mean, obviously since I'm an investor, I have a soft spot in my heart for every entrepreneur out there.Venk Varadan: Thank you, Harry, and thank you for the opportunity to spend some time with you and and your audience. Hopefully, it's the first of many and I can come back and give an update in a year or so. And hopefully by then, it's not just about FDA approvals, but I'm showing we really built sales here because I know investors care about that. Just selling our product in the enterprise for the first time this month in September, and early numbers are great. So it's a really exciting time. I think six and a half years into the journey and being able to do it starting with dad has been pretty special. So so thanks for having us and appreciate you following our progress going forward. Harry Glorikian: Excellent.Thanks for participating.Venk Varadan: Thanks, Harry.Harry Glorikian: That's it for this week's episode. You can find past episodes of The Harry Glorikian Show and MoneyBall Medicine at my website, glorikian.com, under the tab Podcasts.Don't forget to go to Apple Podcasts to leave a rating and review for the show.You can find me on Twitter at hglorikian. And we always love it when listeners post about the show there, or on other social media. Thanks for listening, stay healthy, and be sure to tune in two weeks from now for our next interview.
Hospitals face tough choices about who gets ICU beds; Fauci predicts three doses of COVID vaccine may be best; Fauci: Moderna booster may come later than Pfizer; Average of new daily cases is up 800% since Memorial Day; Israeli officials to brief FDA on booster shot data next week; Labor Day travel slows from summer highs amid COID surge & CDC warning to the unvaccinated; 1.63M travelers passed through airports on Sunday; Biden White House defends Afghanistan evacuation efforts; Source: U.S. not aware of Americans held hostage by Taliban, as claimed by GOP Rep McCaul on Sunday; Taliban hope to announce new government in “a few days”; Biden approval rating hits new low after Afghanistan withdrawal; WH: Manchin “very persuadable” on $3.5T reconciliation plan; Unemployment benefit expire today for 7 million Americans; Kinzinger: GOP shouldn't win house majority if it embraces conspiracies; Some GOP wary Texas abortion law could cost seats; Attorney General Garland pledges to protect abortion clinics in Texas that may come “under attack”; Big push by Dems in final days before recall vote; Newsom puts focus on union workers one week before recall; 510K+ in Louisiana still without power one+ week after Ida; Hundreds still displaced in Mamaroneck, NY; Caldor fire evacuation orders lifted for South Lake Tahoe, but new CA fires ignite; Droughts & fires threaten California's sequoia trees; Police identify ex-marine as gunman in rampage that leaves 4 dead; ex-marine charged with killing 4, including mom holding infant son; Sherriff: ex-marine had no known connection to victims of rampage; Sherriff: suspect's girlfriend says he suffers from PTSD; To learn more about how CNN protects listener privacy, visit cnn.com/privacy
Gurus, what are the 3 musts of developing a relationship with a Key Opinion Leader? How about the key best practices to fund raising? How can you as a Guru streamline the 510K process? Dave Dolan Executive Chairman & Co-Founder of Multifunctional Imaging covers all of this and more! Get you note pads out as Dave is a wealth of information!
Nicholas Curtis, CEO of LENSAR, got some of his entrepreneurial spirit seeing his grandfathers (“pappous” in their Greek homeland) and father own and operate bars and restaurants. A football scholarship took him to Northwestern University in Chicago, and the rest has been what he calls “a circuitous route, with some serendipity.”Curtis traces his route in this episode of the OIS podcast, through his first job, at IBM, where he was trained in the company’s philosophy of a needs satisfaction approach to selling. He said, “It was all about building a relationship, and ultimately earning the right to ask for the business.”That position led to one with American Hospital Supply, where Curtis met Bill Link, (now Managing Partner of Flying L Partners), who became president of American Medical Optics (AMO) and recruited Curtis to join him. Curtis later joined Lensar as chief commercial officer, and was named “interim” CEO in 2012. Lensar is currently developing the Ally system, which Curtis says is “the first femtosecond laser for cataract surgery that integrates a next-gen laser with a Swiss-engineered phaco-emulsification device in a very small compact cataract treatment removal system.” The company is looking to file a 510K early in 2022, and hopes to bring the product to market in the 2nd part of 2022. Curtis also discusses tips for being successful including:Teamwork is important, members should share corporate valuesSurround yourself with good peopleHave respect for different points of viewAlways have integrityBe customer focused, meet customer needTreat customers as partnersDon’t be afraid of making a mistake, but moving on is criticalClick play to hear Nick Curtis describe his ongoing business path!
Chloe works as a nurse and has a current net worth of 640K. Of the 640K, 110K is in cash and the remaining 510K is invested in the stock market. Chloe discusses her background which includes earning scholarships and grants while attending a public school and incurring no student loan debt. She shares mistakes and advice and talks about managing investment risk tolerance with her husband. Chloe has a current goal of reaching 1M by age 40 with a longer term goal of 1.5M in net worth. Email us at - millionairesunveiled@gmail.com Website - www.millionairesunveiled.com Twitter - @Mill_Unveiled
**Vote for Voices From the Bench for best dental podcast of 2020!!! (https://dentalpodcast.org/vote-for-your-favorite-dental-podcast-2020/?fbclid=IwAR2MgKcWLw7_L5M1Sbgjtxqq4XJSebIB2EcY5Be9DGGsTEhEdmN164ylAfI) This podcast is all about featuring people from and associated with our industry. But it's not very often that we get to talk with someone that 100% of the people in dentistry have heard of. Jim Glidwell from Glidewell Laboratories (https://glidewelldental.com/), comes on the podcast to talk about how he accidently and without a plan grew to be one of the largest and most successful dental laboratories in the world with multiple locations worldwide. Jim is a technician at heart that explains that you have to "constantly mess up" to deal with the "Constant Change". From his kitchen table to 5,000+ employees, there is sure to be something learned from him. Jim talks about the importance of advertising, popularizing monolithic zirconia, how COVID affected him personally and the lab, and his new book coming out December 8th "Constant Change" Order the book "Constant Change: Adventures in business and life – my journey from start-up to 5,000 employees" today! (https://www.amazon.com/Constant-Change-Adventures-business-employees/dp/0857198971/ref=sr_1_1?crid=288IR7AW6HEKX&dchild=1&keywords=constant+change+jim+glidewell&qid=1607184647&sprefix=constant+chan%2Caps%2C181&sr=8-1) The UP 3D P5 milling maching (https://www.aurident.com/p5/) from Aurident (https://www.aurident.com/)is a 5 axis, efficient, dry mill. Great for milling zirconia, PMMA and wax. It boasts software that produces high precision and fast milling. It can mill a crown in 14 minutes and the tool life yields about 60-80 hours of quality restorations. A game changer for labs of all sizes, big and small. For under $20K, a small lab can now do their own milling instead of outsourcing and reducing their profits. Quite impressive! Give Aurident a call at 800-422-7373 or you can visit their website at aurident.com. Whip Mix (https://whipmix.com/) has developed VeriSplint OS (https://whipmix.com/products/verisplint-os-3d-print-resin/), a popular 3D printed resin that is rigid, durable and affordable. This popular resin was the first 510K accepted splint material that is transparent, biocompatible and polishes to a high, clear shine. All of this, and a low cost, averaging between $5.00 - $6.00 per splint. If you’d like more information about VeriSplint OS, visit Whip Mix’s website at whipmix.com or call the 800-626-5651. Special Guest: Jim Glidewell CDT.
Biologics are increasingly being marketed and used to improve outcomes for orthopaedic patients, but the requirements for evidence of safety and effectiveness vary greatly. Leaders from the AAOS Committee on Devices, Biologics & Technology discuss the regulatory landscape, the AAOS Biologics Initiative, and the Academy’s investment in this evolving area of medicine, They also explain how the new AAOS Biologics Dashboard is designed to help members navigate the approval status of biologic-based interventions. Learn more about the AAOS Biologics Initiative and access the dashboard. Hosted by: Kristen Coultas, AAOS Advocacy Communications Director
June is CDT and Dental Technician Appreciation Month. There is no better way to celebrate than talking to a couple of people who have volunteered their time to help promote, educate, and strengthen our industry. First up is Dennis Urban CDT from Dental Services Group (https://www.dentalservices.net/) who is also the Chairperson on the National Board of Certification (NBC) (http://nbccert.org/homepage.cfm). Dennis talks about getting his CDT, finding the motivation to get on the board to promote it, and what the NBC is doing to make sure technicians still have the opportunity to get certified during these difficult times. Then we talk to Sean Siegel from Castable Ceramics (https://www.castableceramics.com/) (also the Chairperson of the Foundation of Dental Laboratory Technology (http://dentallabfoundation.org/)) and Shawn Nowak from Nowak Dental Supplies (https://www.nowakdental.com/) (also the Fiscal Officer of the Foundation). They give us an update on the Foundation, all the grants and scholarships that are available, and how the Foundation plans on being stronger than ever once we get back to normal. Whip Mix (https://whipmix.com/) has developed VeriSplint OS (https://whipmix.com/products/verisplint-os-3d-print-resin/), a popular 3D printed resin that is rigid, durable and affordable. This popular resin was the first 510K accepted splint material that is transparent, biocompatible and polishes to a high, clear shine. All of this, and a low cost, averaging between $5.00 - $6.00 per splint. If you’d like more information about VeriSplint OS, visit Whip Mix’s website at whipmix.com or call the 800-626-5651. Special Guests: Dennis Urban CDT, Sean Siegel, and Shawn Nowak.
Way back in January 2020, the National Association of Dental Laboratories (NADL) put together a meeting in Las Vegas called Vision 21. This outstanding dental laboratory business meeting is a must attend for anyone on the business side of their lab. While there they gave Elvis and Barb a table to record some of the high profile attendees and speakers. This first episode from Vision 21 features 5 amazing people from our industry. Sean Siegel - Castable Ceramics, Steve Killion CDT - Killian Dental Ceramics Don Albensi - NDX Albensi Heather Voss CDT - Legacy Dental Arts Denise Burris CDT - By Design Dental Studio They talk about the Foundation of Dental Laboratories, one of the Keynote Speakers, becoming part of the NDX family, and the 2019 CDT of the Year! It's a lot of conversations, with a lot of people, for a whole lot of fun. See what you missed! Keynote Speaker mentioned: Diana Kander (https://dianakander.com/) Order her book HERE! (https://www.amazon.com/gp/product/0692135944/ref=dbs_a_def_rwt_bibl_vppi_i1) March 26 – 28 Dental Laboratory Association Texas Conference – Grapevine, Tx (https://members.dlat.org/membership/conference-registration-portal/) *Ortho Technicians!!! Register for the AOLP meeting! * (https://assocolp.org/2020-conference-and-expo/) Last year was a huge success and we loved this show. We are back this year at the ARGEN (https://www.argen.com/#/) booth recording all weekend long. If you are in the area, attend. If you are not in the area, you should still think about attending. It’s worth it. Register HERE! (https://members.dlat.org/membership/conference-registration-portal/) Thursday March 26, the good people at Alien Milling (https://www.alienmilling.com/) is hosting a evening event to kick of the DLAT Conference. We will be at Top Golf for fun, drinks, and podcasting. That’s right, we will be recording at the event. How fun is that! If you are going to the DLAT conference, don’t wait. Sign up here to join the fun! (https://www.facebook.com/events/205710270597594/) Did you know that Nowak Dental carries all Roland Milling machines? Not only do they have an amazing price and trade in promotions on the unit but they are also offering an extra year of warranty on any new mill purchase. Reach out to the Nowak Dental Digital team at 855-669-2533 or visit the website at www.nowakdigital.com. Did you know that Whip Mix (https://whipmix.com/) manufactures a full array of 3D print resins, featuring the only FDA cleared splint resin? The latest resin in the group of printable resins is VeriSplint (https://whipmix.com/products/verisplint-os-3d-print-resin/), which was the first and presently only 510K cleared print material that prints quickly, and results in an accurate and economical hard splint. So, whether you are printing splints, models, surgical guides, casting patterns or trays, consider increasing your productivity and your profitability with Whip Mix VeriBuild resins (https://whipmix.com/product-category/3d-print-resins/). Check them all at www.whipmix.com. Alien Milling Technologies (https://www.alienmilling.com/) is a cutting-edge Dental Milling Center known for using the latest methods and technologies in milling top dental prosthetics. They can help your lab by milling everything, like crowns, abutments, partials, guards, and even titanium bars. Best part is that they are all milled right here in the USA. The team at Alien Milling Technologies is comprised of talented computer and dental technicians who are passionate about mastering the newest and most effective technologies. See all they have to offer at www.alienmilling.com. Special Guests: Denise Burris, CDT, Donald Albensi, Jr. , Heather Voss, CDT, Sean Siegel, and Steve Killian, CDT.
There are many questions and often a critical level of misunderstanding about medical device validation so on this re-released throwback episode from Season 2, we went right to the source and interviewed validation expert Don Tumminelli, Senior Technical Manager, Client Services at HIGHPOWER Validation Testing and Lab Services. When a manufacturer designs a medical device, specifically a Class II device that requires 510K clearance by the FDA, they need an IFU that outlines how the device is to be safely cleaned and sterilized. Listen to Don talk about biocompatibility testing (compatible with the human body), sterilization validation and cleaning validation of the devices that sterile processing professionals work with and prepare every day for safe surgery. Do testing facilities such as this mimic the hospital setting? Listen now to find out! Complete The Exam For CE Credit! #BeyondClean #WeFightDirty #MedicalDeviceValidation #HIGHPOWER #Biocompatibility #SterilizationValidation #CleaningValidation #Season2ThrowBack #SterileProcessing #Podcast #MDR #CSSD #SPD #Surgery
Michelle Lott is my guest and will help us understand the 510k registration process with the US FDA. Should you use it? Is this changing? Learn everything in 1 episode. The post How to register your Medical Device through 510k with Michelle Lott appeared first on Medical Device made Easy Podcast.
Every startup has one key metric to grow their business to the next level. In applications requiring FDA certification, revenue is not the key metric, but rather FDA approval is. For medical device companies the key metric is cycle time through the 510K application and approval process. The purpose of a 510k submission is to demonstrate that your medical device is at least as safe and effective as an existing medical device on the market today. The cycle time for approval varies based on type of device and ranges anywhere from 50 to 300 days. Your key metric compares your performance against the standard cycle time for your type of device. Thank you for joining us for the Startup Funding Espresso where we help startups and investors connect for funding. Let's go startup something today!
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Safety and Performance Based 510k pathway, which offers a pathway for medical device manufacturers to use performance criteria in place of a predicate device for clearance. This option, previously known as an Abbreviated 510k, is only available for a select group of well-understood devices that meet FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Specifically, we address a number of questions, including:What is the Safety and Performance 510k?How does it differ from other variations of the 510k, such as the traditional version or the Special 510k?When should a manufacturer consider using this 510k?How does using performance criteria differ from citing a predicate device?Is this simply another way to get “me too” products to market quicker or is there more to it than that?Is this a incentivized way to have companies use more recent products for the comparison without implementing a hardline “10 year” directive?What are the most important takeaways for device manufacturers with regard to this 510k pathway?If you’d like to review the FDA’s Safety and Performance Based 510(k) program guidance document (finalized September 2019) before listening to this podcast, you can find it by clicking here. Listen to this episode and see what you think of the Safety and Performance Based 510(k). If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.
This week's throwback episode of Beyond Clean gives listeners a look inside the process of gaining 510k approval and building a quality system that includes a risk analysis component. While there can be great pressure to cut corners in sterile processing in order to meet demand, Shawn Flynn , Consultant, Entrepreneur, and Medical Device Inventor, encourages technicians and managers to have the backbone to say no and advises that the good device representatives will support the smart and safe decision. Hank Balch and Justin Poulin then raise the topic of UDI (unique device identifier) regulation and the interview closes by addressing the important question of whether employing an expert in sterile processing would help the technical writers develop instructions that can be more easily interpreted. Tune in now! Complete The Exam For CE Credit! #BeyondClean #WeFightDirty #sterileprocessing #podcast #season1 #throwback #510K #medicaldevice #surgery #MDR #CSSD #SPD
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Special 510(k) program, which offers a pathway for medical device manufacturers making modifications to its own legally marketed device. It is a method for device makers to avoid the need to completely resubmit their device as a new device to the agency. Specifically, we address a number of questions, including:What is the Special 510(k) program and how does it differ from the standard 510(k) program?When is it appropriate for a device manufacturer to use this program?In January 2018, we discussed the then new alternative 510(k) (click here to listen to that podcast). How is this different from that?Is this yet another specialized version of the 510(k) to better address the industry needs? Are we creating too many “special case” 510(k) variations or is this ultimately a good thing?What are the most important takeaways of this guidance listeners should keep in mind?If you’d like to review the FDA’s Special 510(k) program guidance document (finalized September 2019) before listening to this podcast, you can find it by clicking here. Listen to this episode and see what you think of the Special 510(k). If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.
We're in the last days of 2016, and it's a good time to look back as we plan for the future. On today's episode, Mike Drues and Jon go over the many happenings in the medical device industry over the past year. Mike is a frequent guest on our show, and today we will be talking about the year in review. Some of the topics you'll hear discussed include: - Some of the significant guidance documents that were new in 2016, including one on medical device reporting for manufacturers. - Two guidances on when to submit a 510K and why these in particular are important. - General wellness devices: What they are and what makes them different from regulated devices. - Thoughts on the Use of Real-World Evidence guidance document. - Why the guidance on 3D printing is so impactful. - What might happen from a regulatory perspective in 2017, including more specific guidances and focusing on usability. - Thoughts on whether the FDA should be in the business of putting out guidance documents.
Good documentation is about doing it once. We explore how to use the Design Controls to build a core Technical File, and to use it to create DHF, DMR, Design Dossier and regulatory filings such as 510(k) and PMA. We will also explore the impact of the MDR to your Technical File.Presenters: Terrance Thiel and Grant Bennett, Brandwood Biomedical.
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s announcement of their effort to modernize the 510(k) regulatory pathway. This podcast is an extension of the MPO January/February Editor’s Letter on the same topic. (Click here to read that Editor's Letter.) Specifically, we address a number of questions, including:Late last year, the FDA announced their efforts to modernize the 510(k) clearance pathway. Predicate devices seems to be a focal point. Is there a reason for the agency to seek to cut off the predicate device at 10 years or is that really just an arbitrary number they selected?If we were to cut off predicate devices at a certain time from being used, are we doing a disservice to all stakeholders involved? Do older predicate devices still offer advantages to the regulatory approval process?Is this a reactionary move to the bad press the FDA (and industry as a whole) suffered last year, such as the release of the findings from the International Consortium of Investigative Journalists and The Bleeding Edge documentary or was this already in the works?Is the current version of the 510(k) pathway worth saving or is it long since outdated from when it was first launched?In my Editor’s Letter, I reference an article that’s also running in the same issue, which focuses on value-based healthcare. In that article, the author, Vicki Anastasi of ICON, explains that a PMA pathway for device approval could be a better option for a company from a financial or reimbursement standpoint. Do you agree?Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the April issue of MPO. Click here to read that Letter. In it, I reach out to a number of industry experts on regulatory strategies and compliance to ask about a number of changes happening worldwide. One of the primary topics is the European MDR and how its transformation will affect companies’ strategies for the launch of their product. Specifically, the potential of the U.S. to become a “first to market” target going forward versus what has been an EU/CE mark first strategy for quite some time. Having his own comments on this topic, I posed similar questions to Mike during this episode to get his insights and what shifts he saw as potential outcomes of the MDR changes. During the discussion, there is mention of a previous podcast topic—the Alternative 510(k). Click here to listen to that podcast. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recently announced alternative 510(k) pathway that attempts to trim the time to clearance for medical device manufacturers. Is it, however, an option that already exists packaged in a new wrapper or is it a truly new option put forth by Gottlieb's FDA? Listen to this episode and then see what you think. Specifically, the following questions and topics are addressed in this discussion: What is the “new” alternative 510(k)?What are the types of 510ks and how do they differ?What does “least burdensome” mean?Does abbreviated 510k mean less time or less work for the company?How does this compare to what’s available in the EU?Which is a better system between the new MDR and this 510k?What are the lessons to be learned/advice moving forward?For Further Reference Check out the following links for more information about this topic.New Steps to Facilitate Beneficial Medical Device Innovation The Least Burdensome Provisions [PDF] What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and MoreListen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.
Genteel Device Takes Pain Out of Glucose Monitoring Genteel LLC manufactures and sells a lancing device for those with diabetes who either avoid, or limit, their blood glucose checks because of the anxiety and pain of the dreaded finger stick! Developed by Dr. Christopher Jacobs, biomedical engineer, Genteel is the only stand-alone lancing device, 510K […] The post Genteel Device Takes Pain Out of Glucose Monitoring appeared first on Business RadioX ®.
We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On today’s episode, Mike Drues and Jon go over the many happenings in the medical device industry over the past year. Mike is a frequent guest on our show, and today we will be talking about the year in review. Some of the topics you’ll hear discussed include: - Some of the significant guidance documents that were new in 2016, including one on medical device reporting for manufacturers. - Two guidances on when to submit a 510K and why these in particular are important. - General wellness devices: What they are and what makes them different from regulated devices. - Thoughts on the Use of Real-World Evidence guidance document. - Why the guidance on 3D printing is so impactful. - What might happen from a regulatory perspective in 2017, including more specific guidances and focusing on usability. - Thoughts on whether the FDA should be in the business of putting out guidance documents.
In this concluding volume of the interview podcast with Lawrence White, Radiology Senior Marketing Manager from GE Healthcare. Lawrence provides his thoughts on the following: - Cloud Adoption for Radiologists - Meaningful Use Implications for Radiologists - mHealth
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