Any instrument, apparatus, implant, in vitro reagent, or similar or related article used for diagnostic and/or therapeutic purposes
POPULARITY
Categories
324 episodes with medical devices
214 episodes with medical devices
160 episodes with medical devices
159 episodes with medical devices
225 episodes with medical devices
152 episodes with medical devices
169 episodes with medical devices
175 episodes with medical devices
197 episodes with medical devices
89 episodes with medical devices
159 episodes with medical devices
84 episodes with medical devices
57 episodes with medical devices
71 episodes with medical devices
62 episodes with medical devices
67 episodes with medical devices
37 episodes with medical devices
42 episodes with medical devices
44 episodes with medical devices
55 episodes with medical devices
36 episodes with medical devices
35 episodes with medical devices
41 episodes with medical devices
35 episodes with medical devices
30 episodes with medical devices
55 episodes with medical devices
20 episodes with medical devices
56 episodes with medical devices
17 episodes with medical devices
30 episodes with medical devices
18 episodes with medical devices
11 episodes with medical devices
17 episodes with medical devices
14 episodes with medical devices
15 episodes with medical devices
11 episodes with medical devices
13 episodes with medical devices
13 episodes with medical devices
14 episodes with medical devices
9 episodes with medical devices
15 episodes with medical devices
12 episodes with medical devices
24 episodes with medical devices
14 episodes with medical devices
11 episodes with medical devices
7 episodes with medical devices
25 episodes with medical devices
13 episodes with medical devices
6 episodes with medical devices
15 episodes with medical devices
11 episodes with medical devices
6 episodes with medical devices
9 episodes with medical devices
8 episodes with medical devices
6 episodes with medical devices
6 episodes with medical devices
5 episodes with medical devices
12 episodes with medical devices
6 episodes with medical devices
5 episodes with medical devices
9 episodes with medical devices
4 episodes with medical devices
6 episodes with medical devices
4 episodes with medical devices
4 episodes with medical devices
10 episodes with medical devices
5 episodes with medical devices
4 episodes with medical devices
4 episodes with medical devices
6 episodes with medical devices
8 episodes with medical devices
8 episodes with medical devices
6 episodes with medical devices
4 episodes with medical devices
4 episodes with medical devices
5 episodes with medical devices
3 episodes with medical devices
9 episodes with medical devices
2 episodes with medical devices
4 episodes with medical devices
7 episodes with medical devices
10 episodes with medical devices
5 episodes with medical devices
6 episodes with medical devices
5 episodes with medical devices
3 episodes with medical devices
3 episodes with medical devices
2 episodes with medical devices
4 episodes with medical devices
5 episodes with medical devices
5 episodes with medical devices
2 episodes with medical devices
2 episodes with medical devices
2 episodes with medical devices
3 episodes with medical devices
11 episodes with medical devices
3 episodes with medical devices
6 episodes with medical devices
6 episodes with medical devices
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-515
Conviértete en un supporter de este podcast: https://www.spreaker.com/podcast/almuerzo-de-negocios--3091220/support.
In this episode of the Medical Sales Podcast, Samuel Adeyinka sits down with Jerry Ennett, a medical device sales leader and expert in orthopedic navigation technology, to discuss the future of medical technology, what it really takes to sell complex products in the operating room, and how to build a successful career in medical device sales. Jerry shares his journey from an engineering background to launching new accounts across the U.S., training sales teams, and helping grow a national sales organization supporting navigation technology in orthopedic surgery. He breaks down the differences between robotic surgery and navigation, how technology can reduce both the physical and mental stress surgeons experience in the OR, and what makes a medical device product a compelling investment for hospitals and surgeons. Jerry also reveals the qualities he looks for when hiring successful reps, including clinical acumen, problem-solving ability, the ability to think under pressure, and a willingness to learn. Most importantly, he explains how LinkedIn transformed his own career and became a powerful sales tool, generating opportunities simply by consistently posting about his work, interests, and expertise. Whether you're trying to break into medical device sales, become a top-performing rep, or build your personal brand and generate opportunities through LinkedIn, this episode is packed with practical insights from someone who has seen the industry from both the engineering and sales sides. Connect with Jerry Ennett: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How »
The National Medical Products Administration says the standard will address problems including the dataset's inconsistent quality control. The new standard will take effect on September 1 next year.
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-514
Send us Fan MailNate Post and Antonio “Tony” Valadez bring decades of combined experience leading engineering, manufacturing, continuous improvement, and new product introduction efforts within the medical-device industry. Nate currently serves as Director of New Product Introduction at Edwards Lifesciences, where his career has progressed through manufacturing leadership and NPI roles. Outside of medical devices, he is the founder of Blue Collar Blades, where he handcrafts knives and other tools—a side of his career that combines engineering curiosity, craftsmanship, and entrepreneurship. Tony has spent roughly 30 years in manufacturing, with extensive experience in manufacturing engineering, process improvement, design transfer, validation, lean manufacturing, and engineering leadership. After holding senior engineering leadership roles across the medical-device industry, he recently founded Nexcellence Engineering Solutions, where he provides consulting and training services to regulated manufacturers. But the connection between Nate and Tony goes deeper than a shared industry. Earlier in their careers, Tony managed Nate during his time in R&D pilot manufacturing. Nate remembers Tony telling him that his job as a leader wasn't to change Nate's leadership style to resemble his own, but to help refine it and bring out the best version of the leader Nate already was. That philosophy left a lasting impression and became part of the reason Nate wanted to introduce Tony to the Being An Engineer community. In this conversation, Nate, Tony, and Aaron explore engineering leadership through the lens of an actual mentor-mentee relationship: how leaders recognize potential, give people meaningful opportunities, build trust, provide difficult feedback, and develop the capabilities their organizations will need in the future. They also discuss why technical organizations can't separate people development from business performance—and how engineers can become leaders without losing the qualities that made them effective engineers in the first place. LINKS: Nate Post LinkedIn: https://www.linkedin.com/in/nate-post/ Antonio “Tony” Valadez LinkedIn: https://www.linkedin.com/in/antonio-valadez-946621356/ Guest website: https://nexcellence-engineering--91l1gak.gamma.site/ Aaron Moncur, host PDX 2026 is October 20-21 in Phoenix, AZ. Learn more and register at https://pdexpo.engineer/ Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-514
"It's really hard to justify a test that has any complications if there isn't any reasonable expectation of benefit," says Dr. Rita Redberg, who has spent her career trying to help fellow clinicians consider the actual value of routine screenings and diagnostic testing in asymptomatic patients. Dr. Redberg -- a cardiologist and professor of medicine at the University of California, San Francisco for more than three decades -- is one of the leading voices advocating for a “high-value care” approach, an uphill fight in a healthcare system that tends to reward action over restraint. Her highest profile effort was launching the instructive “Less is More” series in JAMA Internal Medicine when she served as its editor-in-chief for 14 years. On a related track, her research on the assessment of the safety and effectiveness of medical technology, specifically high-risk cardiovascular devices, has yielded a troubling picture. "We found only 1% of devices enter the market through the FDA's most rigorous approval process. The high-quality evidence to support benefit for these devices that I had assumed was present, wasn't actually there.” Join Raise the Line host Lindsey Smith for an eye-opening exploration of what Dr. Redberg considers to be the overlooked risks and false reassurance of common tests and procedures, and her efforts to put the “do no harm” principle of medicine at the forefront of everyday practice.Mentioned in this episode:UCSF School of MedicineJAMA Internal Medicine's Less is More Series If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/podcast
CPR mannequins, medical implants and surgical tools. These are life changing and lifesaving medical devices. But when they are built around male bodies, what does that mean for everyone else?Through expert insight, Dr Ella Hubber and journalist Candice Bailey uncover how gaps in research can lead to higher complication rates in women, why the “one-size-fits-all” design method falls short, and how even the operating theatre can fail women. As awareness grows, they also ask what change can look like and whether the tools used in healthcare can finally serve every body.[EH1.1]Presenter/producer: Ella Hubber Researcher: Elliott Prince Editor: Ilan Goodman
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-513
Medical device regulation continues to evolve across multiple markets. For manufacturers, the challenge isn't simply following every new publication—it's understanding which developments require action, which ones need monitoring, and how they affect existing regulatory strategies.This latest Medical Device Made Easy regulatory update reviews selected developments from July and August 2026 across Europe, Switzerland, the UK, United States, India, Singapore, and Brazil.
10,000 amputations happen every single day in India due to chronic wounds like diabetic foot ulcers, a silent epidemic hiding in plain sight. In this episode of Game of Pharma, host Lokesh Sharma sits down with Tarun Bansal, Co-founder of MedVital and former key leader at Pristyn Care and EY, to unpack how advanced medical devices can solve India's massive healthcare white spaces. While India has proven its dominance in global pharma, the medical device sector remains drastically underpenetrated. Tarun breaks down how MedVital is disrupting wound care through accessible Negative Pressure Wound Therapy (NPWT), chitosan-based liquid bandages made from seafood waste, and sheep tissue-derived extracellular matrices to drive complete skin restoration. Discover why medical devices are poised to follow pharma's high-growth trajectory, the realities of scaling a B2B MedTech startup, and how to change doctor adoption behavior on the ground.Subscribe to Game of Pharma for more deep-dive conversations with global healthcare and pharmaceutical leaders!Subscribe for Elite Business & Pharma Insights: / @gameofpharma-podcast Connect with Tarun Bansal on LinkedIn: / tarun-bansal-6a61b3a LISTEN ON PODCAST:Apple Podcasts: https://podcasts.apple.com/us/podcast...Spotify: https://open.spotify.com/show/4EDgDoe...Website: https://gameofpharma.com/GAME OF PHARMA NEWSLETTER:Weekly pharma insights delivered to your inboxSubscribe: https://game-of-pharma.beehiiv.comCONNECT WITH HOST - LOKESH SHARMALinkedIn: / lokesh-sharma-7250a71a9 FOLLOW GAME OF PHARMA:LinkedIn: / game-of-pharma-podcast Instagram: / gameofpharma
What if zirconia could look even more like natural teeth? According to Dr. Ed McLaren, “Of all the zirconia's he's tested, the optical properties of Ivoclar's e.max zirconia are the closest to natural teeth.” (And I second that with everything I've see – if Barb does the read) Discover what's redefining the possibilities with IPS e.max Zirconia. Join Dr. Ed McLaren for Zirconia Reimagined—an informative webinar exploring the latest advancements, clinical insights, and practical applications of zirconia in modern dentistry. October 5th @ 7:00 pm. Register today at Vivalearning.com As full-arch dentistry continues to grow, so do the demands on today's dental laboratories. That's why Knight Dental recently launched SimplyARCH Studio, a dedicated production environment built exclusively for full-arch restorations. To support this specialized workflow, Knight invested in an XTCERA milling system and carefully evaluated multiple CAM software solutions before choosing hyperDENT. The decision came down to exceptional milling quality, minimal hand finishing, and impressive production efficiency. But what truly set hyperDENT apart was the implementation process. From the very beginning, the team provided more than software training—they shared the knowledge and experience needed to build an optimized workflow for complex full-arch cases. With proven expertise in advanced milling strategies and laboratory production, hyperDENT helped ensure SimplyARCH Studio was designed for long-term success from day one.Matt Everatt joins Elvis and Barb for a fascinating conversation that takes a deep dive into his journey through the dental laboratory industry and the story behind his book, The Invisible Profession. From discovering dental technology at 16 and specializing in maxillofacial prosthetics and orthodontics to working in hospitals, developing early sleep-apnea appliances, and nearly leaving the profession altogether, Matt's career has taken some seriously interesting turns. Eventually, he helped co-found S4S, building a successful business around sleep-apnea appliances, occlusal splints, orthodontics, and more before eventually stepping away from ownership. DETAX has been making waves in the dental industry with 3D printing materials, and in this episode, Elvis and Barb sit down with Veronika Perrone from DETAX and Brandon Smith to talk about where digital dentistry is headed—and why flexible printed partials might be one of the most interesting developments yet. Veronika shares her journey from Germany to the United States and her nearly 15 years with DETAX, while giving us a look at the company's history, its roots in medical and audiology materials, and its growing presence in the dental market. Brandon brings the technician's perspective, talking about his path through the lab world, Triad, Whip Mix, 3Shape, and eventually starting his own consulting and training business. The conversation really gets interesting when they dive into DETAX's flexible resin. Brandon explains how the material handles in the lab, from design and nesting to printing, post-processing, bonding and finishing. They discuss the chemical bond between the flexible base and denture tooth resin, the ability to design flexible partials from scans, and how the material can be used for everything from flexible partials and flippers to unilaterals and claspless appliances. They also get into DETAX's lineup of splint materials, printer validations, hands-on training courses, and what's coming next—including retainer and aligner materials and additional crown shades. Whether you're already printing removable appliances or just wondering if it's finally time to bring flexible partials into your digital workflow, this episode is packed with practical information, real-world experience, and plenty of dental-geek conversation.Special Guests: Brandon Smith and Veronika Perrone.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Deanna Harshbarger, CEO of Cala Health.Cala Health developed the Cala kIQ® System, a prescription wearable therapy for action hand tremor.Deanna holds a degree in chemical engineering and brings more than 20 years of commercial medtech experience to Cala. Before joining the company, she held senior leadership roles at Johnson & Johnson, Boston Scientific, and Medtronic, and helped develop and commercialize technologies across interventional cardiology, neuromodulation, and diabetes care.In this conversation, Deanna shares how she empowers leadership teams to execute, building clinical evidence step-by-step, how patient observation shapes product development, and why raising capital is both a sprint and a marathon.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Deanna Harshbarger, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:34) - Deanna's journey from J&J, Boston Scientific, and Medtronic to Cala Health (08:16) - How Cala personalized therapy around each patient's unique experience (11:53) - Operating lessons Deanna carried from strategics to startups (22:27) - The unboxing interview that changed Cala's product design (29:16) - How Cala balanced feasibility studies, RCTs, and real-world evidence after its commercial launch (34:33) - Years of clinical evidence helped Cala win reimbursement for a new therapy (38:52) - The case for holding back when you're ready to commercialize (44:30) - Why fundraising is both a sprint and a marathon
Sandy Wright, Head of Devices at Scarlet, the first notified body built specifically around software as a medical device. A former doctor who moved from clinical practice into digital health. Sandy now sits on the assessment side of the table, reviewing the very submissions most manufacturers dread putting together.In this episode, we start with the question that trips up so many companies. What actually turns a piece of software into a medical device and why is the wellness boundary still so blurry that entire businesses are straddling the divide without realising it. Sandy shares some of the more unusual examples out there, including AI ambient scribes and augmented reality tools that let surgeons revisit patient scans mid-operation.We then go inside Scarlet itself. Sandy explains why they see themselves as a technology company first and a notified body second, how a combination of expertise, redesigned process and their own internal tooling means customers are not sitting at the back of a queue for months and what genuinely drives faster conformity assessment.The most valuable part for anyone in this space is Sandy's breakdown of where nonconformities actually come from. Clinical evaluation, post-market clinical follow up treated as an afterthought, incomplete software requirements and risk analyses that are too narrow. We also cover the EU AI Act and how it may or may not intersect with MDR, what makes a genuinely good PCCP and Sandy's parting advice on the underrated power of narrative in a regulatory submission.Timestamps[00:01:00] What Actually Turns Software Into a Medical Device[00:03:39] AI Scribes and AR Headsets: SaMD You Might Not Expect[00:06:10] Why Scarlet Sees Itself as a Technology Company First[00:08:43] How Scarlet Cut Assessment Timelines Without Cutting Corners[00:12:12] Clinical Evaluation: The Most Common Source of Findings[00:13:18] Why Post-Market Clinical Follow Up Is Treated as an Afterthought[00:16:20] Risk Management and Why a Narrow Lens Causes Problems[00:16:55] The EU AI Act and How It May Intersect With MDR[00:19:56] From Foundation Doctor to Babylon Health and Beyond[00:22:42] What Separates a Good PCCP From a Box-Ticking OneConnect with Sandy - https://www.linkedin.com/in/wrightsandy/Learn more about Scarlet - https://www.scarlet.cc/Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwalMedical device training courses delivered by Karandeep through Bywater - https://www.bywater.co.uk/
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-512
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-512
Developing a medical device successfully requires several pieces to work together. Manufacturers must demonstrate that the product meets its requirements, maintain reliable design documentation, and understand how regulatory expectations differ—or increasingly align—across global markets.In this Easy Medical Device podcast collection, we explore three connected topics that represent different stages of this journey: Verification & Validation, Design History File remediation, and IMDRF and regulatory reliance.Making Verification & Validation PracticalVerification and Validation are fundamental parts of medical device development, but the distinction between them can sometimes create confusion.Verification focuses on whether the device has been developed according to defined requirements, while validation considers whether the resulting device meets its intended use and user needs.Understanding how to plan and execute V&V effectively helps manufacturers build stronger evidence around device performance and supports a more structured development process.When Your Design History File Needs RemediationWhat happens when the product has already been developed, but the Design History File doesn't properly demonstrate the development journey?DHF remediation can become necessary when documentation is incomplete, fragmented, poorly traceable, or does not adequately demonstrate how design controls were applied.The discussion explores the importance of rebuilding those connections and creating documentation that clearly demonstrates the relationship between requirements, design activities, V&V evidence, risk management, and design decisions.The objective isn't simply to create more documentation. It's to create a coherent and traceable design history.IMDRF, Regulatory Reliance and Global Market AccessOnce a device is ready for market, manufacturers face another challenge: navigating multiple regulatory systems around the world.The International Medical Device Regulators Forum (IMDRF) plays an important role in encouraging greater regulatory convergence internationally.Regulatory reliance takes this concept further by allowing authorities, where applicable, to leverage assessments or decisions from other trusted regulatory authorities rather than unnecessarily duplicating the entire review process.For manufacturers seeking international expansion, understanding these developments can become an important part of building an efficient global market access strategy.Connecting the Entire JourneyThese three topics may appear separate, but they represent a logical progression:Verification & Validation → Design Documentation → Global Regulatory ApprovalsFirst, manufacturers need evidence that the device performs as expected.Then, they need documentation that clearly demonstrates how the device was developed and controlled.Finally, they need a regulatory strategy capable of bringing that device into different markets.For MedTech companies, getting these elements right can create a stronger foundation for compliance, regulatory submissions, and international market access.A successful regulatory journey doesn't begin with the submission—it begins with how the device is designed, tested, documented, and prepared for the markets it intends to enter.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. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
The wood in Ian Funk's house came from the business he now owns. He did not know that when he bought either one. In this episode of the Woodpreneur Podcast, host Jennifer Alger sits down with Ian Funk of American Barnwood, a reclaimed wood yard on California's central coast that he acquired at the end of last year after twenty five years in medical device marketing. His job there was translating between surgeons and engineers, and he is candid that a reclaimed barnwood lumber yard was not the obvious next step. What made it click was a coincidence. The house he had bought in Paso Robles came with barnwood beams, doors and shelving, and a sheet of paper explaining that the wood had come from barns in Indiana. When he went looking for a small business in recycling and repurposing, he found the reclaimed wood shop that had supplied it. He says it sounds like a Hallmark movie, and it does. You will hear what actually transferred with the business and what did not. It came with twelve years of local reputation, a single reliable supplier in the Midwest, and a physical system for handling the wood that the previous owner, an engineer, had worked out and passed on. It did not come with systems or customer records, and the previous owners were straightforward that they had run it to the level they needed on the way to retirement. Ian talks about the discipline of provenance, which is the part that separates a reclaimed wood yard from a lumber pile: because the material is effectively single sourced, they can trace a board to a named barn in Indiana, and an academic historian reads construction methods to date the building and reconstruct who built it, what crops they raised, and what the structure meant to its community. That research gets condensed onto a sheet that travels with every piece of wood. For anyone weighing a late career pivot or buying rather than building, this is an unusually honest account of being a novice on purpose in the reclaimed wood trade. Ian's answer to not knowing the trade is simply to say so and then go find out, and his read on the market is equally plain: he is not right for every project, but there is nothing between the Bay Area and Los Angeles offering what he offers, so the job is making sure local contractors, designers and architects know the resource exists. You will also hear why Craigslist still works for his customers, why shipping is the real constraint on growth, and the line that sums up his change of career better than anything else, which is that there are no barnwood emergencies. Chapters: 00:00 From 25 Years in Medical Device to a Barnwood Yard 05:58 The House That Led Him to the Business 12:34 There Are No Barnwood Emergencies 13:57 What Came With the Business, and What Did Not 18:18 Becoming the Reclaimed Wood Resource on the Central Coast 24:04 Tracing the Provenance of Every Board 31:29 The Pergola That Became a Community Space The Woodpreneur Podcast brings stories of woodworkers, makers, and entrepreneurs turning their passion for wood into successful businesses - from inspiration to education to actionable advice. Hosted by Steve Larosiliere and Jennifer Alger For blog posts and updates: woodpreneur.com See how we helped woodworkers, furniture-makers, millwork and lumber businesses grow to the next level: woodpreneurnetwork.com Empowering woodpreneurs and building companies to grow and scale: buildergrowth.io Connect with us at: Instagram: https://www.instagram.com/sawmillsnearme/ Facebook: https://www.facebook.com/woodpreneurnetwork/ Join Our Facebook Group! https://www.facebook.com/groups/woodpreneurnetwork Join our newsletter: https://substack.com/@woodpreneurnetwork You can connect with Ian at: https://americanbarnwood.co/ https://www.instagram.com/americanbarnwood.co/
In this episode of the Harvest Growth Podcast, Jon LaClare sits down with Chris and Jason Abboud, co-founders of Pressure on Wounds, to discuss how they developed an entirely new approach to bleeding control—and what it took to bring their patented invention to market.The idea began when a dialysis nurse described having to manually apply pressure to patients' wounds for at least 15 minutes after treatment. Because these patients are often older, have sensitive skin, and take blood-thinning medications, stopping the bleeding can be especially challenging. Chris, a mechanical engineer and inventor, immediately began developing a bandage that could apply constant, targeted pressure automatically.Chris and Jason share how they tested early prototypes in a dialysis clinic, refined the product through repeated iterations, and solved the challenge of combining textiles, plastic components, gauze, and adhesives into something simple enough for anyone to use. By proving the product in one of the most difficult bleeding-control environments, they created what marketers call a “torture test”—demonstrating that a product capable of solving an extreme problem can also handle more common situations.The conversation also explores the business behind the invention. Chris and Jason explain how live demonstrations at trade shows helped them validate the product, improve their messaging, earn support from experienced first responders and military professionals, and form a strategic partnership with another exhibitor. They also reveal how much work remains after a product is finished—from packaging and product photography to Shopify, Amazon, social media, trade-show materials, and other essential launch assets.If you're developing an original product, testing a new idea, or preparing to launch a brand, this episode offers valuable lessons about identifying real problems, validating difficult use cases, improving through customer feedback, and building the marketing infrastructure needed to reach the market successfully.In today's episode of the Harvest Growth Podcast, we cover:How a dialysis nurse inspired the creation of Pressure on WoundsWhy constant, targeted pressure can be more effective than applying pressure manuallyHow Chris and Jason validated the concept through real-world testingWhy testing against the most difficult use case can strengthen your marketingThe challenges of combining textiles, plastics, gauze, and adhesivesHow repeated prototyping helped simplify the final productWhy an effective product demonstration can communicate value instantlyHow trade-show conversations helped refine the brand's messagingWhy fellow exhibitors can become valuable customers and strategic partnersThe hidden work required between completing an invention and launching itHow Harvest Growth helped accelerate the brand's path to marketAnd so much more!Want to learn more about Pressure on Wounds?Visit PressureOnWounds.com or search for Pressure on Wounds on Amazon to explore its pressure strips, pressure wraps, and first-aid solutions.Do you have a product you'd like to launch or scale?Visit HarvestGrowth.com to book a free consultation and learn how our team has helped launch hundreds of products and generate more than $2 billion in sales.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Michael Mangano, President and CEO of ABK Biomedical. ABK's Eye90 is an investigational Y90 radioembolization device for treating unresectable liver cancer.Michael brings over 30 years of medical device experience, including 15 years at Boston Scientific in commercial and international leadership roles. He previously served as CEO of ReShape Medical and as President of the Americas for Sirtex Medical, scaling regional revenues from $34 million to over $130 million.In this interview, Michael discusses the thinking behind ABK's pivot into Y-90 radioembolization, what it takes to execute a 120-patient pivotal trial while retaining ownership over the clinical function, how to build capabilities that competitors can't quickly catch up to, and why the player-coach culture gives startups an execution advantage.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Michael Mangano, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:09) - Michael's journey from Boston Scientific and Sirtex to leading ABK Biomedical (04:54) - Why Michael pivoted ABK from embolization to radioembolization as soon as he joined as CEO (09:24) - How ABK reimagined Y-90 around physician control and patient-specific dosing (21:08) - What a functioning player-coach culture looks like inside a startup (27:26) - Lessons learned from a complex 120-person pivotal trial and how ABK remained the face of the study while partnering with a CRO (37:13) - How ABK is building advantages competitors can't easily replicate (42:50) - Michael's framework for choosing the right investors
The Signal Relief Patch – Powerful, reusable relief A drug-free wellness patch that works with your body's own signals to calm everyday discomfort. https://SignalRelief.com/MelK Disclaimer: Signal Relief is a Health and Wellness product. The Product is not a Medical Device and is not intended to diagnose, treat, cure, mitigate, or prevent any disease or medical condition. Use the Product only as directed. Consult a physician before use if you have diabetes, circulatory problems, chronic pain, skin conditions, nerve disorders, any other medical condition, or any implantable devices. Do not use if pregnant. CLIENT REVIEWS ★★★★★ Miracle It really works. Amazing product. – Ralph C. ★★★★★ Extremely grateful for Signal Relief Purchased my first patch to give it a try. Having back issues for years finally found something that has worked is such a blessing. – Kerin H. ★★★★★ A real miracle!! Got this for my dad who has been suffering for years… It's amazing how much better he gets around now! This patch hasn't just changed my dads life. It's changed my family's life. We all have so much more joy not seeing dad hurt anymore!! – Joshua B. ★★★★★ It works! A friend purchased one for me. It worked so well I purchased another one. As someone said, "I don't know why it works, but it does". – Karen C. ★★★★★ Finally relief I am now able to have relief when standing, walking, driving, climbing stairs, and sleeping. I put the patch in different areas of my lower back-where it is needed. – Patricia Learn more about Signal Relief: https://SignalRelief.com/MelK
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-511
Send us Fan MailMichael Brooks is the founder and CEO of BayCath Medical, a Silicon Valley medical-device company specializing in the design, development, and contract manufacturing of catheter-based products. BayCath was created to give startups and fast-moving R&D teams a more collaborative manufacturing partner—one capable of supporting rapid prototyping, iterative development, pilot production, and smoother transfers into manufacturing. Michael launched BayCath after seeing catheter development lead times grow and watching delays interfere with customer timelines. His vision is to create an environment where engineers, physicians, and manufacturing specialists can work closely together, explore multiple solutions, and make informed design decisions without wasting valuable time or capital. Before becoming a founder, Michael held program management, engineering, and manufacturing roles throughout the medical-device industry. Across those positions, he gained experience in braided and coiled catheters, material selection, process development, design for manufacturing, validation, manufacturing transfers, fixture development, supplier management, and regulatory support. He also led high-priority customer programs, helped establish project-management processes, and coordinated complex work across technical, operational, and customer-facing teams. Michael earned his bachelor's degree in biomedical engineering from the University of California, Davis, along with a minor in technology management. His career has placed him at the intersection of hands-on engineering, customer communication, program leadership, and entrepreneurship—giving him a valuable perspective on what it takes to move medical-device ideas from early prototypes toward production and, ultimately, patient care. LINKS: Michael Brooks LinkedIn: https://www.linkedin.com/in/micbrooks10/ BayCath Website: https://www.baycath.com/ Innovation Week: https://www.baycath.com/workshops MedTech Bay Area Networking LinkedIn: https://www.linkedin.com/company/medtech-bay-area/ Aaron Moncur, host PDX 2026 is October 20-21 in Phoenix, AZ. Learn more and register at https://pdexpo.engineer/ Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus
Bringing a medical device to market requires more than achieving regulatory approval. The decisions made early in product development can influence classification, clinical evidence, risk management, labeling, identification, and ultimately the entire market access strategy.In this Easy Medical Device podcast collection, we focus on two important regulatory topics: defining a proper Intended Use and understanding Master UDI-DI.Intended Use: The Foundation of Your Regulatory StrategyIntended Use may look like a simple statement, but it can influence almost every part of a medical device's regulatory pathway.A poorly defined Intended Use can create downstream problems with device classification, clinical evaluation, risk management, and regulatory submissions.Even small changes in wording can have significant consequences, particularly for areas such as Software as a Medical Device (SaMD).The discussion also explores a common misconception: manufacturers cannot simply use a disclaimer or change their labeling to avoid medical device regulation when the actual intended purpose and claims bring the product within the medical device framework.Understanding Master UDI-DIDevice identification is another increasingly important part of regulatory strategy.Master UDI-DI introduces an additional layer that MedTech manufacturers need to understand when managing device identification and regulatory information.Understanding how it fits into the broader UDI framework can help manufacturers prepare their documentation and data strategy while avoiding mistakes that could create additional regulatory or operational work later.Building a Stronger Market Access StrategyAlthough Intended Use and Master UDI-DI address different regulatory challenges, they share an important principle: regulatory strategy should be considered early rather than treated as an administrative task at the end of development.Clearly defining your device, understanding its regulatory implications, and preparing the right identification strategy can help create a more predictable path toward market access.For Regulatory Affairs professionals and medical device manufacturers, these conversations provide practical insights into two topics that can significantly influence the regulatory journey from product development to market.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. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with we sat down with Murthy Simhambhatla, CEO of SetPoint Medical.SetPoint is commercializing the first FDA-approved neuroimmune modulation implant for rheumatoid arthritis.Previously, Murthy was CEO of Evolus, leading the company through its IPO, and held multiple leadership roles at Abbott, including President of Abbott Medical Optics and head of the company's Ibis Biosciences molecular diagnostics business. Earlier in his career, Murthy led development of Abbott's XIENCE drug-eluting stent platform following Abbott's acquisition of Guidant. Murthy holds a Ph.D. in Polymer Engineering and is a Fellow of the American Institute for Medical and Biological Engineering.In this interview, Murthy discusses building commercial conviction years before launch, how to sequence platform indications around adjacent markets, and why SetPoint built its reimbursement function in-house rather than outsourcing it.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Murthy Simhambhatla, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:18) - Murthy's journey from Guidant, Abbott, and Evolus to leading SetPoint Medical (09:53) - How SetPoint stimulates the vagus nerve to reprogram the immune system (11:32) - Why SetPoint built a reimbursement hub around the entire referral workflow (21:36) - A guide to building technical and commercial conviction for a novel therapy (26:58) - The trifecta Murthy wanted in place before commercial launch (30:56) - Why rheumatoid arthritis became SetPoint's first indication (36:11) - How commercial adjacency shapes platform expansion (42:20) - A business case for handholding patients through reimbursement (48:03) - The two lessons behind every skeptical investor question
Discusses regulatory considerations for research involving medical devices, particularly given the rise of AI and software as a medical device. Our guest today is Lauren Hartsmith, who is a consultant at The HRP Consulting Group and a human subjects protection professional with over 15 years of experience in research compliance, Institutional Review Board oversight, and regulatory affairs. Additional resources: FDA Software as a Medical Device: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd FDA Clinical Decision Support Software Guidance: https://www.fda.gov/media/109618/download HRP Consulting Resources: https://thehrpconsultinggroup.com/resources/ CITI Program's Tech Ethics solution: https://about.citiprogram.org/solutions/tech-ethics/
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-509
Having an ISO 13485 Quality Management System in place does not automatically mean that your quality processes are effective.A strong QMS should help an organization identify problems, evaluate their significance, capture information from the market, investigate systemic issues, and continuously improve.In this Easy Medical Device podcast collection, we examine several situations that can reveal whether a QMS is truly functioning—or simply looks good on paper.Understanding NC vs CAPAOne of the most misunderstood areas of quality management is determining when to open a Nonconformity and when to escalate an issue into a CAPA.Not every isolated problem requires a complete CAPA investigation. However, when an issue becomes recurring, systemic, significant, or potentially high-risk, a deeper investigation may be necessary.The objective isn't to create as many CAPAs as possible. It's to recognize the problems that genuinely require root cause investigation and corrective action.Why “We've Never Had a Complaint” Can Be DangerousZero complaints may sound like excellent news, but it can also raise an important question:Is your organization effectively capturing all sources of customer and post-market feedback?Potential complaints may appear through distributor communications, service reports, customer emails, returned products, training feedback, or other customer-facing channels.If this information isn't properly evaluated, the organization may miss important product performance or safety signals.The Fake QMS ProblemA Quality Management System can look excellent on paper.Procedures exist. Forms are available. CAPA processes are defined. Risk management documentation is complete.But if employees don't follow those processes in daily operations, the QMS can become disconnected from reality.That's the core of the “fake QMS” problem: the documented system and the way the company actually operates become two different systems.During an audit, this gap can quickly become visible.Building a QMS That Actually WorksAn effective QMS should be integrated into everyday operations rather than maintained only for certification or audits.Problems should be identified and evaluated appropriately. Customer feedback should feed into complaint handling and post-market activities. Significant and recurring issues should trigger investigation, and lessons learned should contribute to continuous improvement.Ultimately, the goal isn't to create a perfect-looking Quality Management System.The goal is to create a QMS that helps your organization consistently identify problems, manage risk, improve processes, and support the delivery of safe and effective medical devices.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. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
From Non-Profit to Medical Device Sales in 60 Days with Shannon Donohue | Medical Sales UCan you land a 6-figure medical sales role without a background in B2B sales or healthcare? Yes—and today's guest proves exactly how to do it. In this episode of Medical Sales U, host Dave Sterrett sits down with Shannon Donohue, a former Non-Profit Director who pivoted her career into medical device sales and landed an Associate Sales Representative position at Baxter in under two months. If you are a non-profit worker, nurse, recent grad, or sales professional trying to break into the medical sales industry, Shannon's story shows you how to turn your past experience into your greatest asset. TIMESTAMPS:00:00 - Meet Shannon: Non-Profit to Capital Equipment Sales 01:30 - Shannon's "Why" & Leaving the Non-Profit World 06:57 - How Non-Sales Experience Translates to Medical Sales 09:15 - Making an Impact vs. Making Money (The Corporate Shift) 11:37 - Why Cold Applying Fails & How to Network 16:17 - The Brag Book Strategy That Got Attention 20:51 - Overcoming a Terrible Interview Practice Session 25:32 - The Baxter Interview: HireVue, RSMs & Mock Pitches 27:50 - Final Advice for Job SeekersReady to jumpstart your career in medical device or pharmaceutical sales?
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-508
A growing gap between device complexity and organizational knowledge is turning service reliability into an enterprise‑level risk for regulated industries. In this episode, Ryan Makely, Senior Director of CALID Service at Bruker Scientific, breaks down how fragmented documentation, rapid loss of expert judgment, and inconsistent field diagnoses undermine both operational performance and any future AI‑enabled support capability — in conversation with Emerj's Marilie Fouché. Leaders will hear practical themes around building structured knowledge foundations, reducing repeat‑visit failure cycles, and preparing service teams for scalable AI adoption. This episode is sponsored by Aquant. Learn more about how Emerj drives pipeline for other AI brands - download our media kit at emerj.com/AD1
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-508
Quality and regulatory compliance are fundamental to bringing safe and effective medical devices to market. As regulations continue to evolve and technologies become more complex, manufacturers must adopt a proactive approach to quality throughout the entire product lifecycle.This podcast collection explores key topics shaping today's medical device industry, including the FDA's transition to the Quality Management System Regulation (QMSR), effective validation and supplier management strategies, and structured approaches to managing software defects in Software as a Medical Device (SaMD).Together, these discussions highlight how strong quality systems extend beyond documentation. They emphasize the importance of risk-based thinking, supplier oversight, software quality, and continuous improvement to ensure compliance while protecting patients.Whether you're working in Quality Assurance, Regulatory Affairs, Engineering, or Product Development, these conversations offer practical insights to help strengthen your Quality Management System and prepare for the evolving regulatory landscape.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. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Content Note: This episode contains open conversations about chronic pain, trauma, medication, addiction, suicidal thoughts, and medical gaslighting. These experiences are shared with honesty, hope, and the intention of helping others feel less alone. Please listen gently and take the space you need.In this raw and inspiring episode, Lyndsay Soprano sits down with fellow CRPS warrior, executive coach, and author Alesia Briggs to share the realities of living with chronic pain—and the strength it takes to keep choosing hope.Together, they share the realities of living with chronic pain, fighting to be believed, navigating difficult diagnoses, and learning to advocate for themselves in a healthcare system that doesn't always have the answers. Alesia opens up about her journey through CRPS, the challenges of medication, spinal cord stimulation, and the unexpected moments that changed the course of her healing.Throughout the conversation, Lyndsay and Alesia explore the importance of finding the right medical team, protecting your energy, setting boundaries, and leaning on the people who continue to show up when life feels impossible. They remind us that healing isn't about pretending everything is okay—it's about adapting, asking questions, and refusing to let pain write the ending of your story.This episode is raw, validating, and filled with hope for anyone navigating chronic illness, trauma, or the uncertainty of an invisible condition. Because even on the hardest days, there is always another page waiting to be written.Episode Highlights:(00:00) Introduction to Lyndsay and Alicia Briggs(04:04) Alesia's early struggles with diagnosis and medication(07:00) The dangers of medication side effects and mental health(09:52) Alesia's experience with hallucinations and medication risks(12:58) The importance of mental health support and therapy(17:02) Managing energy and workplace communication(20:45) Sharing health issues at work and building trust(27:01) The journey with spinal cord stimulators(34:01) Alesia's story of pregnancy and nerve rewiring(40:13) Hope, resilience, and community support(43:07) Closing thoughts and resourcesFollow Alesia Briggs Online Here:Website: www.coachbriggs.comInstagram: @coach.briggsLinkedIn: Alesia BriggsBook: Finding the Off Switch: There is Another PageSubscribe on YouTube | Merch Shop is OPEN!! | COMING SOON: The Pain Hub - A Women's Healing Community. Subscribe Now!Unfiltered convos. Dark humor. Real healing. This is where pain meets purpose — and you're not doing it alone.++Want to be a guest on Giving Pain Purpose with Lyndsay Soprano? Send her a message on PodMatch, here: Be a Guest on The Show
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with David Veino, President and CEO of Neuros Medical.Neuros is commercializing the FDA-approved Altius Direct Electrical Nerve Stimulation System for chronic post-amputation pain.Before Neuros, David held senior commercial leadership roles at Cardiovascular Systems (CSI) and Stryker, and helped grow CSI's coronary and peripheral business from approximately $50 million to more than $250 million in annual revenue while leading key amputation-prevention initiatives. He also serves as a private equity advisor with Sectoral Asset Management. In this interview, David discusses how commercialization begins by mapping the patient journey upstream, what it takes to generate gold-standard clinical evidence for a novel therapy, how investors assess scalable medtech businesses, and how to build an investor pitch that earns the next meeting. Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with David Veino, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:02) - David's 30-year medtech journey from cardiovascular devices to leading Neuros (04:38) - How Neuros is treating chronic post-amputation pain with on-demand neuromodulation (11:08) - Why Neuros completely changed its strategy halfway through the pivotal trial (15:36) - Why commercialization starts with referral pathways, not end-users (18:09) - How prosthetists became one of Neuros' most important referral sources (26:11) - What it takes to generate gold-standard clinical evidence for a first-of-its-kind therapy (37:41) - Building an investor pitch that earns the next meeting (41:42) - What gets David excited enough to invest in a medtech company
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-507
Cybersecurity has become one of the biggest challenges facing medical device innovators, and it's about much more than protecting data. In this episode of Project Medtech's mini series, cybersecurity expert Christopher Gates breaks down the first five essential principles every medtech company should understand, from designing secure devices from day one to navigating FDA expectations and staying ahead of evolving threats powered by AI and quantum computing. Whether you're building your first device or scaling an established company, this conversation is packed with practical insights to help you strengthen your cybersecurity strategy and bring safer technologies to market.Christopher Gates LinkedInarsMedSecurity WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Vijit Sabnis, co-founder and CEO of Adaptyx Biosciences.Adaptyx is a Stanford spinout developing wearable technology for continuous molecular monitoring.Over the past 20 years, Vijit has worked at the intersection of deep technology as an inventor, founder, and investor. Before Adaptyx, he was a Partner at Khosla Ventures and co-founded Solar Junction to commercialize high-efficiency solar cell technology. He holds a Ph.D. in Electrical Engineering from Stanford.In this interview, Vijit discusses how to recognize when a scientific idea is worth building a company around, how to build startup-style learning cycles when spinning technology out of academia, and designing products that are easy for clinicians and consumers to adopt. Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Vijit Sabnis, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:17) - Vijit's path from Stanford, solar energy, and venture capital to building Adaptyx (07:25) - How Adaptyx is trying to do for hormones what continuous glucose monitors did for diabetes (13:50) - The signals Vijit looked for before founding Adaptyx (25:35) - How Adaptyx turned academic research into startup-speed learning cycles (32:15) - Why cortisol became the company's first clinical application (36:26) - How Adaptyx is designing new molecular data to fit existing clinical workflows (42:12) - Why new consumer health platforms opened new paths to commercialization (47:24) - Fundraising in an era of shorter attention spans
The Signal Relief Patch – Powerful, reusable relief A drug-free wellness patch that works with your body's own signals to calm everyday discomfort. https://SignalRelief.com/MelK Disclaimer: Signal Relief is a Health and Wellness product. The Product is not a Medical Device and is not intended to diagnose, treat, cure, mitigate, or prevent any disease or medical condition. Use the Product only as directed. Consult a physician before use if you have diabetes, circulatory problems, chronic pain, skin conditions, nerve disorders, any other medical condition, or any implantable devices. Do not use if pregnant. CLIENT REVIEWS ★★★★★ Miracle It really works. Amazing product. – Ralph C. ★★★★★ Extremely grateful for Signal Relief Purchased my first patch to give it a try. Having back issues for years finally found something that has worked is such a blessing. – Kerin H. ★★★★★ A real miracle!! Got this for my dad who has been suffering for years… It's amazing how much better he gets around now! This patch hasn't just changed my dads life. It's changed my family's life. We all have so much more joy not seeing dad hurt anymore!! – Joshua B. ★★★★★ It works! A friend purchased one for me. It worked so well I purchased another one. As someone said, "I don't know why it works, but it does". – Karen C. ★★★★★ Finally relief I am now able to have relief when standing, walking, driving, climbing stairs, and sleeping. I put the patch in different areas of my lower back-where it is needed. – Patricia Learn more about Signal Relief: https://SignalRelief.com/MelK
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-506
Breaking into medical device sales—or landing your next opportunity—has never been more competitive.In this episode of the Chase MedSearch Podcast, Jordan Chase sits down with recruiter Jay Waggoner to share three decades of hiring experience and discuss what separates candidates who consistently receive offers from those who never make it past the interview.Whether you're trying to break into medical device sales, advance your career, or simply understand how top MedTech companies evaluate talent, this conversation is packed with practical, real-world advice from professionals who interview thousands of candidates.In this episode, you'll learn:How to stand out in today's competitive medical device job marketThe biggest mistakes candidates make during interviewsWhat hiring managers actually look for beyond the résuméHow networking can accelerate your careerThe habits and characteristics shared by top-performing sales professionalsAdvice for recent graduates, experienced reps, and career changersWith more than 30 years of executive recruiting experience and thousands of successful placements, Jordan shares lessons learned from helping many of the industry's leading medical device companies build high-performing commercial teams.Whether your goal is your first medical device sales role or your next leadership opportunity, this episode will help you approach your job search with greater confidence and a clearer strategy.Connect with Chase MedSearch
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-506
Many medical device startups assume they're audit ready because they have documented procedures, completed templates, and a Quality Management System in place.However, successful audits require much more than organized documentation.In this episode of the Medical Device Made Easy Podcast, we welcome Chiratana Pot from Enlil to discuss what true audit readiness looks like and why continuous compliance is far more effective than preparing only when an audit is scheduled.What You'll LearnWhat Is an Audit Really?Many organizations view audits as exercises designed to uncover mistakes.In reality, audits evaluate whether your Quality Management System is implemented effectively and consistently—not simply whether procedures exist.Compliance vs. Audit ReadinessBeing compliant and being audit ready are not always the same.The discussion explores how companies can move beyond documentation and demonstrate that their processes are actively followed throughout the organization.Common Startup MistakesDrawing from experience working with MedTech startups, Chiratana shares the most frequent challenges organizations encounter before their first audit, including assumptions that often lead to unexpected findings.Why Traceability MattersOne of the central themes of the episode is traceability.We examine how effective traceability connects requirements, risks, design decisions, verification activities, and documentation—making change management more efficient and strengthening overall compliance.How Enlil Supports Connected DevelopmentThe conversation concludes with an overview of Enlil's approach to connected development, explaining why integrating quality into product development from the beginning helps organizations maintain continuous audit readiness rather than relying on last-minute preparation.Key TakeawayAudit readiness is not a checklist completed before an inspection.It's the result of building a culture where quality, traceability, and compliance are embedded into everyday work.For MedTech startups, developing this mindset early can simplify audits, improve product quality, and create a stronger foundation for long-term regulatory success.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. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Who is Chiratana (CP) Pot? Chiratana (CP) Pot is Senior Director of Product at Enlil, a cloud-native, AI-driven development traceability platform built for medical device and life sciences organizations. Enlil connects quality, regulatory, R&D, manufacturing, and operations teams through a unified system of record, enabling traceability, auditability, and regulatory readiness across the product lifecycle. CP works with MedTech organizations to strengthen design controls and audit readiness. He is a frequent contributor on topics including design controls, lifecycle traceability, and regulatory readiness, helping organizations move beyond documentation compliance to evidence-based product development.LinkChiratana's linkedin: https://www.linkedin.com/in/chiratana-pot/Website: https://enlil.com/Enlil's LinkedIn: https://www.linkedin.com/company/enlil-inc/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Medical technology is evolving faster than many manufacturers can adapt to, and falling behind can now happen in months rather than years. In this episode, Seth Rowan, Director of Business Development at Harmac Medical Products, discusses how AI, data integration, and digital transformation are reshaping medical device manufacturing. He explains why clean data is essential for successful AI adoption, how manufacturers can identify bottlenecks before they grow, and why companies need scalable manufacturing partnerships to bring single-use medical devices from design through commercialization. Tune in to learn how manufacturers can turn rapidly changing technology into practical solutions without losing sight of execution, quality, and scale. Resources: Connect with and follow Seth Rowan on LinkedIn. Follow Harmac Medical Products on LinkedIn and explore their website!
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Bob Paulson, President and CEO of Sonex Health. Sonex's UltraGuideCTR device is a minimally invasive technology that enables ultrasound-guided carpal tunnel release procedures to be performed outside the surgical suite using local anesthesia, expanding patient access and reducing the cost of care.Before joining Sonex, Bob led multiple venture-backed medical device companies through commercialization, including NxThera, acquired by Boston Scientific, Restore Medical, acquired by Medtronic, and VentureMed Group. Earlier in his career, he held senior leadership roles at Medtronic, Advanced Bionics, and Endocardial Solutions, which was acquired by St. Jude Medical.In this interview, Bob explains how to build a reimbursement strategy before your first clinical study, drive physician adoption when introducing a new care pathway, and raise capital aligned with value inflection points. Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Bob Paulson, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:19) - Bob's path from Medtronic to multiple medtech exits before joining Sonex (05:38) - Why 80% of eligible carpal tunnel patients avoid surgery — and how Sonex is changing that (11:11) - The reimbursement challenge that reshaped Sonex's clinical evidence strategy (19:07) - Reimbursement is a three-leg process: FDA, CPT, and payer coverage (22:07) - Reverse engineering your company from the exit you're trying to achieve (29:35) - How Sonex helped surgeons move carpal tunnel procedures out of the OR (39:06) - Sonex's "pitcher-catcher" approach to physician and patient adoption (41:59) - Bob's framework for choosing investors who can finance the entire journey, not just the next round
Behind Closed Doors: Male Victims Of Intimate Partner Violence Men make up nearly half of the victims of intimate partner violence, so why do so many survivor programs focus only on women? Our experts shed light on this frequently overlooked crisis, exploring the heavy realities of male victims of intimate partner violence and challenging the gender stereotypes that surround domestic abuse. Guests: Dr. Denise Hines, Elizabeth Shirley Enochs Endowed Professor of Social Work, George Mason University College of Public Health Aaron Ellis, survivor & advocate Host and producer: Kristen Farrah A World Of Silence Pt.2: Is Early Intervention Safe For Infant Hearing Loss? The FDA recently lowered the age criteria for children to receive cochlear implants to just seven months old, a shift that promises better developmental outcomes but leaves many parents deeply hesitant. Our experts this week demystifies the procedure – including why the actual surgical recovery might be far easier than families expect. Guests: Dr. Nancy Young, medical director of Audiology and Cochlear Implant Programs, The Ann & Robert H. Lurie Children's Hospital of Chicago, Lillian S. Wells professor in pediatric otolaryngology, Northwestern University Feinberg School of Medicine Doug and Eva Tweedy, parents Host: Greg Johnson Producer: Kristen Farrah Facebook: ingoodhealthpodX: @ ingoodhealthpodIG: @ingoodhealthpodYouTube: @ingoodhealthpodSpotify Apple Podcast In Good Health PodcastSubscribed to the newsletterFull ArchiveContact UsBecome an Affiliate Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-505
Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-504
Medical technology is moving quickly, and the companies that succeed will be the ones that stay connected, think strategically, and solve the right problems. In this live episode from DeviceTalks Boston, Etienne Nichols, MedTech Guru at Greenlight Guru and host of the Global Medical Device Podcast, discusses the major shifts shaping the medical device industry. He shares insights on global regulatory harmonization, tougher funding conditions, the growing role of AI, and why data strategy matters more than ever. Etienne also explains why companies need to understand their true user population, challenge assumptions in product development, and prepare for a future where medical devices work together as connected systems. Tune in to learn how medical device companies can navigate change, use data more strategically, and build solutions that better serve users and the broader healthcare ecosystem! Resources: Connect with and follow Etienne Nichols on LinkedIn. Follow Greenlight Guru on LinkedIn and explore their website. Listen to the Global Medical Device Podcast here.
© 2020-2026 Ivy Podcast Discovery LLC
