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The FDA's Center for Devices and Radiological Health (CDRH) has launched a groundbreaking initiative aimed at improving the efficiency and speed of recall communications for medical devices. Here are the five key strategies from the FDA's new medical device recall initiative: Faster Alerts for High-Risk Devices: The FDA aims to reduce the time between discovering a recall-worthy issue and notifying the public, especially for high-risk devices in areas like cardiovascular, gastroenterology, renal, and OB/GYN.Collaborative Approaches with Stakeholders: The FDA invites industry players to engage more closely during this pilot program, emphasizing proactive communication and swift action from manufacturers.Patient-Focused Strategies: The initiative prioritizes patient safety with a focus on transparency and minimizing risks. Device manufacturers must align recall strategies to put patient needs at the forefront. No Immediate Changes for Non-High-Risk Areas: While the pilot program focuses on high-risk areas, non-high-risk devices are not currently affected, but manufacturers should stay vigilant for any potential future changes.Building on Recall Program Improvements: This initiative builds upon the FDA's decade-long efforts to enhance the medical device recall system, aiming to strengthen safety and effectiveness for patients.Support the show
In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings. They explore how home use devices, such as CPAP machines and infusion pumps, can differ significantly from hospital-based devices in terms of design, post-market surveillance, and user interaction. The discussion is grounded in real-world examples, most notably the Philips Respironics recall, which became the largest medical device recall in history due to design oversights and failure in post-market surveillance. This episode sets the stage for a deeper dive into technical, regulatory, and user-related challenges in the next installment.Key Timestamps:[00:01] – Introduction: Etienne introduces the episode and topic of home use medical devices, along with a quick sponsor message.[02:30] – Defining Home Use Devices: Mike Drues explains what qualifies as a home use medical device from a regulatory standpoint.[07:50] – Why Home Use Devices Matter: Discussion on why home use medical devices are a strategic priority for CDRH in 2025 and the safety issues identified by the Emergency Care Research Institute (ECRI).[12:15] – Case Study: Philips Respironics Recall: Mike discusses the technical and regulatory issues behind the Philips Respironics recall and its implications for manufacturers.[25:45] – Post-Market Surveillance and Complaint Handling: The challenges of post-market surveillance and complaint handling for home use devices, and the role of regulatory compliance.[35:30] – The Importance of Intended Use Environment: Exploring how intended use environment should influence design and usability considerations.[45:20] – Teaser for Part 2: Mike and Etienne preview topics for the next episode, including labeling challenges, human factors, and usability testing for home use medical devices.Key Quotes:“A home use device isn't just a device that could be used at home; it's one that's intended and labeled for use outside traditional clinical settings.” — Mike Drues“When post-market surveillance fails, it's not just a compliance issue—it's a safety issue that can put lives at risk.” — Mike Drues“Regulatory logic goes beyond the written rules—it's about understanding the intent behind them to ensure devices are safe wherever they're used.” — Mike DruesKey Takeaways:Latest MedTech Trends:Home Use Device Surge: There is a growing trend toward designing devices for non-clinical environments, driven by technological advancements and patient demand for convenience.Regulatory Focus on Safety: Regulatory bodies like the FDA are increasingly prioritizing the safety of home use devices, as seen in CDRH's 2025 strategic priorities.Impact of High-Profile Recalls: Large-scale recalls, like the Philips Respironics case, highlight the need for robust design controls and post-market surveillance practices for home use devices.Practical Tips:Design for Real-World Use: When designing home use devices, consider environmental factors like temperature, humidity, and patient handling to prevent unintended failures.Emphasize Post-Market...
On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie discusses the definitions, scope, and expectations of combination product manufacturers, addressing the FDA's inspection types, regulatory requirements, and expectations. Laurie also highlights common misconceptions, especially among contract manufacturers (CMOs) and the importance of proper audit and supplier management practices. Laurie shares insights and practical advice for ensuring compliance, emphasizing the gaps between drug and device regulations and how to effectively bridge them. Chapters: 00:56 Understanding FDA Compliance Programs 02:33 Types of FDA Inspections 03:04 Mock Audits and Process Validation 03:45 Combination Product Manufacturer Definition 04:38 Inspection Guides and Compliance 06:47 Supplier Controls and Responsibilities 09:20 Challenges in Mock Pre-Approval Inspections 16:32 Supplier Management and Quality Agreements 24:19 Contract Manufacturers and Design Control 25:03 Conclusion Laurie Auerbach is an industry consultant with over 20 years of experience in quality and regulatory compliance, serving in management and consulting roles for startup to major global manufacturers in the medical device, in vitro diagnostic, and combination product industries. Laurie conducts internal and supplier audits and mock pre-approval and post-approval inspections for compliance with ISO 13485, ISO 14971, §820, and §4, and EU MDD, IVDD, and EU MDR. She also conducts training for biopharmaceutical sponsors and device platform manufacturers on combination product regulatory requirements, including focused training on design control, risk management, CAPA, supplier controls, and inspection readiness. Laurie serves as Vice Chair of the ISPE Combination Products Community of Practice and is an active member of PDA, AAMI, RAPS, TOPRA, and DIA.
This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com. Thank you for tuning in.
In the first episode of the new Medtech POV series on AI in health care, AdvaMed President and CEO Scott Whitaker sits down with Troy Tazbaz, Director of the Digital Health Center of Excellence within FDA's Center for Devices and Radiological Health. The two discuss the rapid innovation in health care and the path forward as we see more AI/ML-enabled medical technologies in the doctor's office. AdvaMed, the Medtech Association, is the world's largest trade association for the medical technology industry, representing nearly 500 companies around the world that are developing life-changing and life-saving medical technologies for patients. To learn more about AdvaMed, the Medtech Association, visit www.advamed.org.
From simple biomarker tests to cutting-edge precision medicine, the diagnostics industry is navigating a complex landscape of regulatory changes and technological advancements. In this episode, Andrew L'Huillier, a leader in the diagnostics industry and Director of Regulatory Affairs Liaison - Diagnostics at Merck, discusses his work on FlowScript and other groundbreaking diagnostic products. Learn about the challenges and opportunities in regulatory compliance, drug discovery, and the implementation of cGMP guidelines. Tune in and discover how precision medicine is revolutionizing healthcare and improving patient care! Resources: Connect with and follow Andrew L'Huillier on LinkedIn. Follow Merck on LinkedIn. Explore the Merck Website! Subscribe to the CDER, CBER, and CDRH newsletters! Discover AgencyIQ and 360Dx!
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Edwards recently made two acquisitions totaling $1.2 billion in the heart device sector, while also reporting a slowdown in its core business. Owens & Minor agreed to a $1.36 billion takeover of Rotech to expand its home medical equipment offerings. Inspire Medical's COO is leaving to become CEO of a cardiology-focused medical device company. CDRH director Shuren is stepping down after 15 years, with Michelle Tarver serving as acting director. Boston Scientific anticipates strong growth for Farapulse after a successful launch, reflecting the ongoing trends and changes in the medtech industry.Tenet's earnings beat expectations, prompting an increase in full-year guidance. Hill Democrats are working to codify the Chevron doctrine, with a bill introduced by Warren and other lawmakers. Adventist Healthcare has appointed a new CEO, while PBMs are facing scrutiny from lawmakers. Molina's Medicaid growth offset redetermination pressures in Q2. AI is being used to transform unstructured patient data into structured reports, as well as in clinical trial protocol development. Overall, the healthcare industry is experiencing shifts and reforms as various players navigate challenges and opportunities.Sanofi's immunology pipeline shows promise as sales of Dupixent rise, Viking plans to accelerate its obesity drug into late-stage testing, and Kamala Harris takes a stance on key pharma issues. Warren and Democratic lawmakers introduce a bill to revive the Chevron doctrine, while Pfizer's hemophilia gene therapy meets late-stage study goals. The pharma industry is racing to develop GLP-1 drugs for obesity treatment, with the market expected to surpass $100 billion. The newsletter covers a range of topics in biotech and pharma, including clinical trials, drug pricing, gene therapy, and more. Biopharma Dive provides in-depth journalism and insight into the most impactful news and trends in the industry.AI-designed drugs have shown promising results in phase 1 testing, with an 80%-90% success rate compared to traditionally developed drugs. However, in phase 2, the success rate falls closer to the industry average of 40%. The sample size of phase 2 candidates was small, with just 10 drugs included, as few AI molecules have advanced that far. Despite this, pharma companies and biotech investors are still backing the AI dream, with companies like Mubadala Capital investing in life sciences companies leveraging AI platforms for drug R&D. The future success of AI-designed drugs in clinical trials remains to be seen as more AI molecules progress through the pipeline. Meagan Parrish discusses where Alabdallah of Mubadala Capital sees promise in biotech and why he continues to support AI platform companies for drug development. Additionally, the newsletter covers Kamala Harris' stance on key pharma issues, tips for a successful therapeutic launch, and resources on testing cognition in Alzheimer's disease clinical trials and using data to upgrade drug commercialization strategies.
On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reauthorization and the Food and Drug Omnibus Reform Act) 15:51 International Harmonization Efforts 22:36 Combination Products and Policy Work 30:10 The Importance of Advocacy and Education 35:22 Closing Thoughts and Personal Insights Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor's degree in Bioengineering from the University of California, Berkeley, his doctorate and master's degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.
On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry. Industry Comments are DUE 9/29/2024. Alan Stevens is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products. Rumi Young, Meng, RAC is the Director of Regulatory Policy at Novo Nordisk. Rumi joined Industry from FDA where she spent four years in CDRH's Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.
Radiological Health (CDRH) at the US Food and Drug Administration (FDA). With a distinguished background as a board-certified ophthalmologist and epidemiologist, Dr. Tarver is at the forefront of transforming the evaluation and inclusion of medical devices in underserved and underrepresented populations. In this episode, Dr. Tarver introduces the FDA and the CDRH Division, explaining the definition of a medical device by FDA standards. She discusses the creation of the Chief Transformation Officer role within the FDA, highlighting its importance and the strategic vision behind it. We explore the critical importance of diversity, equity, and inclusion (DEI) in evaluating medical devices, and how these efforts are essential for ensuring equitable healthcare for all. Dr. Tarver introduces the innovative “Home as a Health Care Hub” initiative by the FDA/CDRH, explaining its potential to revolutionize healthcare delivery. Dr. Tarver also addresses the broader transformation needed in the healthcare system to ensure no one is left behind, emphasizing the role of partnerships in achieving this goal. She delves into the role of Virtual Reality (VR) and Artificial Intelligence (AI) in making the home a central hub for healthcare, discussing this ambitious initiative's current status, challenges, and long-term objectives. Additionally, we touch on Dr. Tarver's impressive background, including her leadership roles within the CDRH and her academic achievements at Spelman College and Johns Hopkins University. Finally, we discuss the value of having the FDA in the BioHealth Capital Region and its impact on advancing healthcare innovation. Tune in to BioTalk for an insightful discussion with Dr. Michelle Tarver as we explore the future of medical devices, healthcare transformation, and the pivotal role of the FDA in shaping a more inclusive and innovative healthcare landscape. Dr. Michelle Tarver is a board-certified ophthalmologist and epidemiologist, serving as the Deputy Center Director for Transformation. In this role, Dr. Tarver facilitates the development, implementation, and direction of CDRH's transformative projects and strategic initiatives. Under her leadership, CDRH is advancing efforts to include underserved and underrepresented populations in the evaluation of medical devices. Her CDRH career has included many leadership roles, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement. Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health.
On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses: 03:11 The Formation and Impact of the Office of Combination Products 04:16 Challenges and Changes in the Regulatory Landscape for Combination Products 07:53 Understanding FDA Titles and Organizational Structure 11:03 From FDA to Biogen: Transitioning to Industry and Building Medical Device Competency 16:41 Insights into FDA and Industry Dynamics: Conferences, Regulations, and Mindset Shifts 20:05 Combination Product Mindset in Large Organizations vs. Startups 21:54 Navigating Small Company Dynamics and Supply Chain Management 22:29 The Importance of a Combination Product Mindset 25:14 Challenges and Evolution of Combination Products 26:42 Global Perspectives on Combination Products 27:30 Digital Health: The New Frontier 35:02 Quality Culture and Open Communication Anthony started his career as a naval officer on ships before transitioning to the civilian side of government. He served nearly 20 years at FDA as a reviewer, branch chief, and division director. In his time at FDA, he was one of the original regulatory policy-makers for combination products on the CDRH side. He has led the development of sevral guidance documents that are still in use more than 10 years after he left FDA. He has been active in industry advocay groups and standards efforts related to combination products for nearly 20 years. Since leaving FDA in 2013, Anthony has been developing and leading device and combination product teams in biotech, biopharma, and digital health companies from startups to global scale. He is presently the Vice President of Regulatory Affairs and Quality at Windgap Medical, a drug delivery device startup in Watertown, Massachusetts. He is also an adjunct professor at Northeastern University in the Regulatory Affairs Program and advises companies in the digital health field. LinkedIn url: https://www.linkedin.com/in/anthony-w-77abaa3?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=android_app
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: Connected Devices and Combination Products How Regulators approach regulating new technologies Traceability Technologies and what they mean for manufacturing and use Comparability Protocols and Pre-Determined Change Controls for Drugs and Devices Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH's Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: How FDA Reviews Combination Products Industry's role in shaping policy Essential Performance Requirements IMDRF and International Harmonization Opportunities Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH's Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.
What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today's episode covers the newly-released guidelines and addresses important questions about these guidelines specifically and about the practice of releasing these guidelines in general.Today's conversation is with regular guest Mike Drues. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. In this episode, you'll hear what Mike has to say about what's on the FDA's A-list and B-list for the fiscal year 2023, what isn't on the list but perhaps should be, and what differences exist between draft guidelines and final guidelines. Some of the highlights of this episode include:What the CDRH proposed guidelines for fiscal year 2023 are about and why it's important to think about themThings that stick out on the FDA's A-list of guidelinesItems that are surprising or exciting on the A-listWhat is on the FDA's B-list of guidelinesWhat's missing from the A-list or the B-listHow collective wisdom is shared across various organizationsWhether the FDA should be giving guidance to help companies get products to marketThe difference between draft guidance and final guidanceIdentifying changes between versions of guidelinesWhether you have to do something if it's in the guidelinesMemorable quotes from Mike Drues:“Not to be too arrogant here, but I'm very proud of the fact many of the things that I've done in submissions over the years, whether it's with AI or BioComp or other kinds of testing has actually gone into guidance for the future.”“That's why there's a guidance document database, so you and I don't have to memorize such esoteric trivia.”“It's really not FDA's job to help a company bring a product on the market.”“All guidance, indeed all regulation, is very evolutionary. It's a work in progress.”Links:Mike Drues LinkedInFDA Website: CDRH Proposed Guidance's for Fiscal Year 2023RAPS Article: FDA device center guidance priority lists targets COVID, digital health (RAPS, 18 October 2022)Greenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru
What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and differences, as well as the four quadrants of UDI that companies need to be aware of? Don't underestimate your time to comply because it always takes longer than expected.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Gary Saner, Senior Manager of Information Solutions for Life Sciences at Reed Tech, about UDI and the current state of global implementation.Gary has been helping companies achieve UDI compliance on a global scale for years. He is considered to be a thought leader and recognized authority on medical device UDI compliance.Some of the highlights of this episode include:As the U.S. FDA Class I UDI deadline approaches, companies should refer to the FDA's final guidance, which describes the compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products.Delays seem to be a part of the history of UDI. Manufacturers face challenges and pitfalls from UDI being rolled out easily. There are a number of issues with the brand new requirement in the United States.The four quadrants of UDI are identifying a product, reprocessed/reused products, reporting attributes, and documenting standard operating procedures (SOPs) in a quality management system (QMS).The EU has a complicated UDI implementation schedule, as well. Delays have been announced, but the impact was due to the European Commission completely revamping the regulatory platform. In Europe, UDI becomes one of the many things that a manufacturer has to learn, be educated on, and respond to. There's no grandfathering of products, notified bodies, and patients. Portfolios are re-evaluated to meet new regulations.With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some health authorities around the world base their policies on one or the other. However, good global harmonization is not in place.Memorable quotes from Gary Saner:“This is a challenge in that this particular dataset has never really been assembled before. So, there's no precedent for this.”“The other issue is sometimes you find the data and it's not accurate or it hasn't been touched for a while. It's not current. It's obsolete. There's issues with formatting. Sometimes, the formatting of that data that's held for internal processes is not the format that actually gets submitted to the FDA.”“There's a little bit of a nuance about making sure the acknowledgements that come back from CDRH, there's three acknowledgements, and making sure that they're all complete for every single record.”“UDI becomes one of the many things that a manufacturer has to learn and be educated on and then respond to and there was no grandfathering of products.”“With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some of the other health authorities around the world will kind of base their policies on one or the other - US or EU.” Links:Information Solutions - Life Sciences at Reed TechGary Saner on LinkedInThe Ultimate Guide to UDIFDA - Unique Device Identification (UDI) SystemFDA - Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain DevicesCenter for Devices and Radiological Health (CDRH)European Union Medical Device Regulation (EU MDR)EU In Vitro Diagnostics Regulation (IVDR)EUDAMEDGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru MedTech Lifecycle ExcellenceGreenlight Guru YouTube ChannelEtienne Nichols on LinkedIn
In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials. Because this guidance applies to all medical products, CDER, CBER, and CDRH all contributed, but this draft was led by Project Equity from FDA's Oncology Center of Excellence (OCE). “It is important that we be able to evaluate new therapies in the context of a diverse population that will use these medical products because the diseases for which these products are intended present in variable fashion across the population and because populations respond variably to medical products,” explains OCE Project Equity Lead Lola Fashoyin-Aje. “But we should reconsider the question regarding why diversity in clinical trials is important. Because the question really ought to be: What are we missing when trials are not diverse, when the study population in the clinical trial is not diverse? What are the missed opportunities for advancing science or advancing clinical medicine and, ultimately, for driving improvements in population outcomes?”
I recently had a truly unique opportunity to discuss a complex yet rapidly evolving topic of how to use and update our social media and digital communication policies with social and healthcare responsibility while improving our impact on the quality and timeliness of medical decisions! Darshan Kulkarni, PharmD, MS, Esq is a dynamic expert educator in this field who owns his private law firm, is a life sciences counselor, speaker, author, board member, and host of the DarshanTalks podcast who shared his perspectives on the latest developments in this field. Below are the highlights from our discussion. 6:20 Pharma and device social media / digital communication policies are highly variable across small and mature companies. Some smaller teams are building them from scratch, yet others are not updating them either deliberately, not prioritizing them, or are not addressing off-label discussions and their impact. 7:52 There have been several court cases that have admonished the FDA for being overly aggressive with its enforcement. The FDA released a 60-page memo in which it acknowledged that it does not know what to do with off-label discussions in social media or via multiple digital channels.8:30 In 1998 there were 195 or so warning letters from the FDA's DDMAC division and last year there were only 6. The FDA is trying to get its bearings on what is happening. Many companies have not updated their HCP engagement policies. The Pharma organization updated its policy in mid-January. There are discussions around "space limited" engagements. On social media, you have to decide whether or not your will have social media pages that are product based, company based, or claims-based. 11:44 What are any differences in risk and liability of a Medical vs Sales organization in pharma today? The DOJ had several court cases in the early 2000s that said either you have a Medical Affairs department that is absolutely separate or you both abide by commercial speech standards, not Amendment 1. For decades, the FDA regulated based on approvals, so if the requirement based on the standard of "truthful not misleading" is thrown out it may upend the entire regulatory schema that existed. So the court responded that the 1st amendment has been changing since the 1980's but the FDA has not updated it. 16:03 The FDA is convening a Task Force to address 1st Amendment application concern in pharma. 17:22 Most pharma companies are still operating under a clear distinction between Medical and Sales from early 2000s but this will likely change in the next 2-5 years. 17:40 Q: What are some types of social media activities that are safe vs others that are more scrutinized? 21:48 CDRH in Medical Devices has significantly less resources than CDR's OPDP in pharma, and this is why the regulations in medical devices are much more loosely defined. 25:05 Has the line of "misleading" changed over the last few years? How can we balance the misleading medical information used by patients themselves? 27:05 Confident and Reliable Scientific Evidence (CRS) FDAMA114 - lowest level of truthful not misleading information. The second is Substantial Scientific Evidence (SSE) which is rarely if ever used. The third level of information used for claims is Substantial Evidence, classically referred to as two randomized controlled studies (RCTs) needed for drug approval. The New Patient Focused Drug Development FDA guidance is now advocating for pharma to communicate with patients. EMA has lay summaries to communicate clinical trial results in a language accessible to the general public. Many ICMJE journals now require for trial sponsors to provide a lay summary for patients prior to consideration of publication. 41:20 How are the current latest regulations impacting how transparent we can or have to be in reporting clinical trials? There are 7 levels of clinical trial transparency (discussed in detail).
This is the audio from RQM+ Live! #46, recorded 13 January, 2022. As we enter 2022, we'd like to reflect on what's happened over the past year in the world of FDA and medical devices. We'll be sharing our insights to how the Agency did in 2021 and a recap of the most important, cross-cutting regulatory changes. Additionally, we'll provide a forecast of what we can expect in 2022. This discussion will cover the following and more: Impact of COVID on FDA resources and submission timelines in 2021 Updates on breakthrough and new developments for innovative devices, such as the Safer Technologies Program (STeP) FDA Process Improvements, including the eSTAR pilot FDA 2022 focus areas, including MDUFA V Negotiations expectations and CDRH 2022 Guidance Priorities The panel of former FDA CDRH and industry subject matter experts: Kevin Go – Project Engineer, RAC – RQM+ (former FDA CDRH Lead Reviewer) Allison Komiyama, Ph.D., RAC – Former Founder and Principal Consultant, AcKnowledge Regulatory Strategies (now with RQM+) Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services, RQM+ Bryan Pinder – Project Engineer, RAC – RQM+ (former FDA CDRH Lead Reviewer) Ryan Randall – Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) - Questions: 3:40 -- What was 2021 like on the inside at FDA? 13:21 -- Could you summarize the updates and changes at FDA in 2021? 14:52 -- Allison, you've worked on many STeP applications - what's been your experience? 20:08 -- Let's talk about the eSTAR program... good, bad, any experience with it so far? 27:21 -- What is new in digital health at FDA? 31:58 -- Are you able to get Q-Sub meetings now? 33:17 -- What's taking up FDA's time? It can't be EUA's, right? 35:37 -- Is there any data on the clearance time using eSTAR? (the answer is no) 36:00 -- How about the status of EUAs... what's going on with them? 40:35 -- Any other impactful changes at FDA that people should be aware of from 2021? 46:47 -- What about biocompatibility? 48:10 -- How about MDUFA? 49:06 -- Any other key things anyone wants to point out before we wrap up? - Next RQM+ Live! show: 27 January: RQM+ Live! #47 — Have we been looking at EU MDR equivalence requirements all wrong? - Stay informed: See all expert content Subscribe to our blog Follow us on LinkedIn - About RQM+ RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com. --- Send in a voice message: https://anchor.fm/deviceadvice/message
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.
Opportunities for companies to engage with FDA during the development and review of new devices have grown over the years. And if Jeff Shuren, Director of the agency's Center for Devices and Radiological Health, has his way, there will be even more fundamental change in the years to come. In this conversation, Shuren talks about the evolution of FDA-sponsor interactions that has occurred over his tenure, the “real-time” engagements during COVID-19, and CDRH's proposal for a TPLC Advisory Program (TAP), which Shuren says will be a game-changer, allowing companies unprecedented access to FDA, payors, providers, and others along the development route. View the full article: https://bit.ly/2USj8Gi View the latest issue of Market Pathways: https://bit.ly/2UEqmO9 About Market Pathways Your premium guide to global medical device regulation, reimbursement and policy. Market Pathways delivers incomparable intelligence exploring the people, challenges, and opportunities impacting the global medtech regulatory and reimbursement community. View the latest issue of Market Pathways on MyStrategist.com
No resumo dessa semana, confira como foi a Assembleia de Docentes que definiu os representantes para o 12º Conad Extraordinário do ANDES-SN. E em época de festa junina, a gente te convida para o Forró Solidário, que ADUSC, AFUSC e CDRH realizam na próxima quarta. ▶️ Ouça agora!
A critical department at the FDA, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health through medical device innovation. Dr. Jeffrey Shuren, one of the longest-serving directors of the CDRH, sat down with MedTech POV to share his insight on how medtech and government can work together to solve today's toughest health challenges.
This week, Stacey is joined by Roberta Goode to talk about patient safety and how medical packaging is a key component of that. Stacey and Roberta discuss the nuts & bolts around “Selecting medical device packaging materials and sterilization methods to achieve appropriate sterility assurance levels and sterile barrier integrity throughout the labeled shelf life.” Resources from this episode: ISO 14971:2019 Medical devices – Application of risk management to medical devices - https://www.iso.org/standard/72704.html ISO 24971:2020 Medical devices – Guidance on the application of ISO 14971 - https://www.iso.org/standard/74437.html ISO 11607:2019 Packaging for terminally sterilized medical devices - https://www.iso.org/standard/70799.html ISO 13485:2016 Quality Management System for medical devices - https://www.iso.org/standard/59752.html 21 CFR 820 Quality System Regulation - https://www.govinfo.gov/app/details/CFR-2011-title21-vol8/CFR-2011-title21-vol8-part820 ASTM D4169 -16: Standard Practice for Performance Testing of Shipping Containers and System - https://www.astm.org/DATABASE.CART/HISTORICAL/D4169-09.htm ISTA 2a: Partial Simulation Performance Tests - https://ista.org/test_procedures.php Roberta Goode, Principal, Altrec Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
What are the 2021 strategic priorities for FDA's Center for Devices and Radiological Health (CDRH) and what impact will these initiatives have on the medical device industry? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about CDRH's previous, current, and future strategic priorities, including those impacted by the COVID-19 pandemic.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a number of the priorities Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), has mentioned in recent presentations. The agency had also laid out several priorities in a document a few years ago to be acted upon from 2018 through 2020, which has now been extended to 2021. Specifically, we address a number of questions, including:What are the important priorities for CDRH in 2021?Tracking of submissions and electronic templatesDecentralized clinical trials with CDER and CBERFeedback from patients through new Collaborative Communities forumDigital Health Center of ExcellenceHow will the COVID-19 pandemic impact these priorities and CDRH operations moving forward?What’s been the impact on non-COVID devices? Are new devices still being developed or being reviewed by the agency?What about the impact of politics and the new incoming administration?Listen to this episode and see what you think of communication with the FDA and if there are methods you could use which you aren’t. 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. 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.
This is the audio-only version of DEVICE LOVE Live! #15, originally recorded August 13, 2020. The rules of requests for feedback and pre-submission meetings with FDA are covered under FDA Guidance Document, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program," issued May 7, 2019. The FDA Q-Submission (formerly known as pre-sub) Process can be intimidating, beginning with the decision as to whether to request a Q-sub at all. It's a great opportunity to align with FDA or pressure-test on critical items like predicate assignment or test plans before getting too far along in development and spend, however many fear that FDA is more critical of data in the Q-sub than they would be seeing it for the first time in a 510(k) submission. This uncertainty combined with the time commitment to have one often makes it difficult for an RA lead to get the product development team on board with a Q-sub strategy. In this show, talk with our FDA submission experts including recent CDRH staff about when to use the pre-sub process, real and perceived risks associated with the process, tips and tricks to achieving a successful meeting, and case studies of our experiences. Here's the panel: Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q Kevin Go — Senior Engineer (former FDA CDRH Lead Reviewer), R&Q Bryan Pinder — Project Engineer (former FDA CDRH Lead Reviewer), R&Q Carol Vierling — Senior Principal Advisor, Consulting Services, R&Q Moderator: Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com. The and means more. --- Send in a voice message: https://anchor.fm/devicelove/message
This is the audio-only version of DEVICE LOVE Live! #12, originally recorded July 2nd, 2020. Whether you're on your first 510(k) submission at a startup or your 50th at a large company, you likely have some anxiety over the unpredictability of the process. Let our submission experts will help ease your mind! The panel includes recent CDRH staff who will discuss their tips and tricks for a smooth 510(k) submission process. We'll cover best practices in all aspects of 510(k) submissions: Content Compilation Format Internal review Communication with FDA Refuse-To-Accept (RTA) issues Fulfilling requests for additional information Here's the panel: Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q Kevin Go — Senior Engineer (former FDA CDRH Lead Reviewer) Bryan Pinder — Project Engineer (former FDA CDRH Lead Reviewer) Michael Wolford —Senior Principal Specialist, R&Q Moderator: Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com. The and means more. --- Send in a voice message: https://anchor.fm/devicelove/message
Jeff Shuren discussed CDRH’s recent successes and his plans for the remainder of 2020, including priorities for upcoming MDUFA negotiations, in an exclusive interview with Medtech Insight. Check out our podcast or read the transcript.
Stacey Bruzzese welcomes Roberta Goode back to the show. Today, Stacey and Roberta will be covering the essentials of designing for manufacturability. Roberta details the 8 essentials of DFMWhy is Designing for Manufacturability important for medical device manufacturers?Does standardization of materials help shorten the product development cycle?What’s the next step after determining the practical part count?What is Poka-Yoke?What other points should be considered when scaling up manufacturing? DFMA ReferencesAssembly Automation and Product DesignG. Boothroyd, Marcell Dekker, Inc. 1992Product Design for Manufacture and AssemblyG. Boothroyd and P. Dewhurst, G. Boothroyd Dewhurst, Inc. 1989Marcell Dekker, Inc. 1994Design and Analysis of Manufacturing SystemsProf. Rajan Suri University of Wisconsin 1995Product Design for Assembly: The Methodology AppliedG. Lewis and H. ConnellySimultaneous Engineering Study of Phase II Injector Assembly LineGiddings & Lewis 1997Design for Manufacturing Society of Manufacturing Engineers,(VIDEO)Introduction to Design for (Cost Effective) Assembly and Manufacturing DavidSteinstra, Rose-Hulman, 2015IVT’s Medical Device Handbook: http://www.ivtnetwork.com/article/medical-device-validation-handbookTwice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s emphasis on human factors (or ergonomics or usability) testing. Medical device manufacturers need to ensure they are not only satisfying this need, but also fulfilling any potential liability involved. Specifically, we address a number of questions, including:What is human factors as it relates to medical device development?Were human factors always required by the FDA?What is the difference between human factors testing and a clinical trial?What types of medical devices are required to go through human factors validation testing?If you’d like to review the FDA’s Human Factors guidance document before listening to this podcast, you can find it by clicking here. Listen to this episode and see what you think of the FDA’s human factors requirements. 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.
In the second part of this Medtech Matters podcast series of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s emphasis on human factors (or ergonomics or usability) testing. We mention what medical device manufacturers should be concerned with for less than satisfactory testing protocols, and how the FDA may not even be the worst thing they should be worried about. Specifically, we address a number of questions, including: Are there certain areas of human factors the FDA is emphasizing or paying closer attention to? Do you have suggestions or real-world examples on how a company may perform human factors testing? How does human factors testing for a medical device differ based on where the product is intended to be used (for example, in the home versus in a hospital room or used by a physician versus the patient directly)? What type of trouble with the FDA can a company get into for not accomplishing human factors testing in a satisfactory manner? What are the key takeaways device manufacturers should consider with regard to human factors/usability? If you’d like to review the FDA’s Human Factors guidance document before listening to this podcast, you can find it by clicking here. Listen to this episode and see what you think of the FDA’s human factors requirements. 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.
What top priorities can medical device professionals and patients expect in 2020 from the Center for Devices and Radiological Health (CDRH)? Today’s guest is Mike Drues from Vascular Sciences. We discuss the recent FDA report that outlines CDRH’s regulatory science priorities, all of which are important, some more than others. However, there are a couple big ones missing. Listen to this episode for actionable tips on how you can develop your own list of priorities for 2020. Some of the highlights of the show include: - A comparison of historical context from the same reports in 2016 and 2017 to 2020, identifies 8 out of 10 of the same top priorities: - Big Data, biocompatibility, real-world evidence, clinical performance, clinical trial design, computational modeling, patient input, and digital health/cybersecurity. - What two priorities are missing in 2020 report? - Reprocessing reusable medical devices: Not all devices are properly reprocessed to prevent deaths and cross-contamination between patients. - Human factors and usability: Companies still struggle with the concept of making medical devices easy to use and/or understand. - Why did these two priorities drop off 2020 list? A lack of high-profile reports from popular press about companies and medical devices causing problems. - What two top priorities from past reports reappear for 2020? Healthcare-associated infections, and precision medicine and biomarkers. - Medical device industry should develop its own list of top usable and actionable priorities. Effective communication with FDA may result in a consensus.
In the second part of this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Specifically, we address a number of questions, including:What is change management and why is it important?How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?Aesthetic change, such as color or size of a font?Design change, such as the shape or size of the device?Material change, such as the replacement of one material with another or the combination of two materials?Labeling change, such as modifying an existing claim or adding a new one?Change in the manufacturing process, such as for improving efficiency or reducing rejection rate or what about if the product is sent to a contract manufacturer?Software change, such as for a security update or to add functionality?Supply chain change, such as a testing vendor or something many may need to address, sterilization change?How does change management for medical devices differ from those for drugs and which is used for combination products (drug/device)?Do you have a suggested process to handle change and more importantly, can you defend it?What is the relationship between change management and product liability?What can happen if a company mishandles their change management procedures?What are the most important takeaways for listeners concerned with change management?Listen to this episode and see what you think of the tips and best practices for handling change management. 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.
In this two-part Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss change management with regard to how to address it with the FDA. The type of change and the overall implications of it to the functionality and efficacy of the device should dictate which route a company should take—letter-to-file or a Special 510k. Specifically, we address a number of questions, including:What is change management and why is it important?How does a company or regulatory individual decide when to handle the change internally, such as via a letter-to-file, vs. notifying the FDA with a special 510k or PMA supplement?Does it matter what type of change is being made? And I have a list of examples. Perhaps we can take these one at a time?Aesthetic change, such as color or size of a font?Design change, such as the shape or size of the device?Material change, such as the replacement of one material with another or the combination of two materials?Labeling change, such as modifying an existing claim or adding a new one?Change in the manufacturing process, such as for improving efficiency or reducing rejection rate or what about if the product is sent to a contract manufacturer?Software change, such as for a security update or to add functionality?Supply chain change, such as a testing vendor or something many may need to address, sterilization change?How does change management for medical devices differ from those for drugs and which is used for combination products (drug/device)?Do you have a suggested process to handle change and more importantly, can you defend it?What is the relationship between change management and product liability?What can happen if a company mishandles their change management procedures?What are the most important takeaways for listeners concerned with change management?Listen to this episode and see what you think of the tips and best practices for handling change management. 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.
On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the final part of our 3-part series. Stacey and Roberta review the steps necessary for a successful product launch.Stacey and Roberta cover a variety of topics:Roberta outlines the steps associated with the final phase prior to product launchDo you still need to be thinking about verification and validation?Is this the right time to be thinking about marketing and branding?What data are you looking for with a product release into Limited Test Markets or Clinical Trial Sites?How thorough should your completed technical documentation need to be prior to full product launch?Roberta reviews all that is needed to fully launch the productWhat does the post-market surveillance entail and how long does it take to complete?What are the best practices for capturing this data?How does cloud-based computing affect the requirement for maintaining post-market data integrity?What kinds of problems could occur after product launch?Roberta talks about how listeners can make use of the information presented in this 3-part seriesThe following links have useful companion information for this episode:Post-Market Requirements:https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devicesIVT’s Medical Device Validation Handbook:http://www.ivtnetwork.com/article/medical-device-validation-handbookTwice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the second part of our 3-part series. Stacey and Roberta dive into the design and development of medical devices.Stacey and Roberta cover a variety of topics:What are the tasks that make up the design and development phase?Do people develop prototypes and when is the right time to do that?How is human factors design applied to engineering medical device?What records and documents need to be considered during the design and development?How do Design for Manufacturing and Six Sigma get incorporated?Roberta highlights the typical challenges when planning for packaging, labeling and product deliveryWhat’s the difference between validation and verification?How does managing compliance through the risk management cycle help ensure quality and safety are built into the product?How do labeling requirements affect the expiration date?The following links have useful companion information for this episode:FDA Labeling (General)https://www.fda.gov/medical-devices/overview-device-regulation/device-labelingUDI System:https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-systemInvestigational Device Exceptions:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812Test method validation article on IVT Network:http://www.ivtnetwork.com/article/test-method-validation-medical-deviceshttp://www.ivtnetwork.com/article/method-validation-medical-devices-regulatory-guidanceMethod Validation Guidelines:https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelinesDesign Controls:https://ubm.box.com/s/gwkqg1wweccrjs683bjp28x8zsu7qnhc Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Roberta Goode, the founder of Goode Compliance. Stacey and Roberta talk about the planning stage to get your medical device to market.Stacey and Roberta cover a variety of topics:Roberta start by outlining the steps covered in this first episodeHow do we ensure we’re building a product the meets a clinical need?What goes into a product launch plan?What are the considerations if you plan to introduce the product outside of the United Sates?Why do investors need to be aware of how regulatory bodies classify your product?How does the business plan for a medical device differ from other products?What should be included in an initial risk management plan?What are the key elements to streamline the funding process?Should I try to fund the full project or just the first few phases/milestones?The following links have useful companion information for this episode:EU Medical Device Standards: http://eumdr.com/Risk management Standards: ISO 14971 - https://www.emergobyul.com/services/worldwide/iso-14971-consultingEU Directory: https://ubm.box.com/s/2nqk6h7m0r69gb8bp4a3gvx7j16zlm9pFDA: CDRH Guidance: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-developmentSearchable product classification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfmFDA Good Guidance Practices: https://ubm.box.com/s/ejdhq3ta2n8j0jzaod0bb3qjm3bre6pcFunding ResourcesFDA 510(k) Premarket Submission https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfmTwice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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.
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.
FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medical device companies, manufacturers, and service providers to discuss biocompatibility, in vitro diagnostics, clinical trials, and other areas. On today's episode, Mike Drues of Vascular Sciences and Jon talk about the advantages and disadvantages of this program that encourages reviewers and companies to spend more time together. The better the reviewers understand the development processes that medical devices go through, the better they can work effectively with the companies to get medical devices on the market. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● Who's job is it to teach CDRH staff on how medical devices are developed? ● When an FDA visitor is in the building, will the visit be realistic to open and honest discussion? Or filtered and sanitized? ● Visits could work to your advantage. You can “toot your own horn” as a medical device company that has a good regulatory process and sets the bar for quality. ● Skeptics may view the program as a sneaky way for FDA to come in, inspect what's going on, and force changes - involves companies taking calculated risks. ● CDRH wants to teach staff about certain areas. They should already have subject matter expertise, but may have never been trained. ● CDRH should share information and experiences with medical device companies to improve collaboration without disclosing confidential details. ● Visits offer opportunities for two types of companies: 1) device manufacturers and 2) service providers. ● No good deed goes unpunished. So, make sure you have all your “ducks in a row.” If you want to schedule a visit, there's a submission deadline of Sept. 26.
Medical device standards seem to change and evolve all the time. Is it impossible to keep up with them? Do you know the latest and greatest when it comes to IEC 60601? FDA's CDRH standards program? Consensus standards database? FDA's ASCA pilot program? On today's episode, we have Scott Colburn of the FDA and Leo Eisner of Eisner Safety Consultants to discuss what's currently happening in the medical device industry when it comes to standards. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● New versions of IEC 60601 are in the works; every five years, standards are reviewed to address collaterals, issues, and recommendations. ● Policy updates have been made regarding the appropriate use and recognition of voluntary consensus standards. ● FDA values such standards because of consistency, predictability, and credibility of science-based decisions around patient safety. ● FDA trains staff on standards and provides the medical industry with information on how to use FDA's programs - working together to improve use of standards. ● Guidance is updated to be more efficient, consistent, and nimble: Process of recognizing and withdrawing standards. ● Describing the changes made regarding declaration of conformity vs. general use of standard. ● Some changes to standards are significant and affect requirements, such as updating normative references. ● Declaration of Conformity is a legal statement that shows you followed a specific path and applied a standard in accordance with its intent.
FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Inspections of Device Establishments. Mike Drues of Vascular Sciences joins Jon Speer on the Global Medical Device Podcast this week to discuss the importance of this document and how it relates to 483 observances and warning letters for medical devices. Some of the highlights of the show include: - What prompted nonbinding feedback guidance, and is it necessary? CDRH's increased number of site inspections resulted in more warning letters. - CDRH is more aggressive with annual inspections because some medical device companies and their employees do stupid things, instead of the right things. - Goal of guidance is to improve communications with medical device companies concerning corrective actions in response to inspectional observations. - There are differences between a 483 and warning letter. A 483 is an inspectional item with room for improvement; a warning letter indicates a serious violation. - Guidance Process: Inspection is performed, company receives a 483, analyzes the observation, generates a response, and FDA returns nonbinding feedback. - If company's response is appropriately implemented, FDA states: Response appears to be adequate, partially adequate, or inadequate. - Nobody wants to receive a 483. It's usually inevitable, but not the end of the world. Be proactive and respond appropriately to avoid escalation. - A company needs to respond to FDA in a timely manner, which is within 15 business days. FDA tries to return nonbinding feedback within 45 calendar days.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the brand new (in fact, yet-to-be-launched) Safer Technologies Program (click to review the guidance). Since it was only recently introduced, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:What is the safer technologies program?How does this program differ from the Breakthrough Designation Program?So like BDP, STeP is not a regulatory pathway on its own, correct?What are the criteria for eligibility into STeP?What are the mechanics of STeP?Is STeP an already active program?Are the BDP and now STeP part of an effort by the FDA to encourage true innovative technologies and perhaps disrupt the history of incremental innovation within the industry?I know the FDA is hosting a pair of webinars to help explain the program. Can you tell us why there are two of them and only a day apart?Further, there is the mention of two webinars being conducted by the FDA that are relevant to this new regulatory option. You can find them via the following links. (Click the name of the webcast for information about how to view it.)Webinar—Safer Technologies Program: Draft Guidance (scheduled for November 6, 2019.)Webinar—Safety and Performance Based Pathway Performance Criteria (scheduled for November 7, 2019.)Listen to this episode and see what you think of the Safer Technologies Program. 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.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two recently issued FDA guidance documents. As they can be coupled together, we discussed both in one podcast. They are:Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions (August, 2019) (Click here to read the guidance.)Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August, 2019) (Click here to read the guidance.)Specifically, we address a number of questions, including:Can you please provide a brief overview of what's in these guidances and what their purpose is? Why is PMA, HDE and de novo included but 510k is NOT included in this guidance?When is higher risk acceptable and what is the tie-in to the term uncertainty?What else is important in these guidances and what are the most important takeaways for listeners?Listen to this episode and see what you think of these two benefit risk determination guidances. 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.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the still relatively new Breakthrough Devices Program (click to review the guidance). Since it was only introduced last year, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:What is the purpose of the Breakthrough Devices Program and why does it exist?Is the BDP a “pathway” to market like the 510k or PMA?How early in the product development lifecycle should we consider a BDP?What are the requirements of the Breakthrough Devices Program?What are the mechanics of the process?What goes into the BDP Pre-Sub Package?What is the benefit of BDP status?What if you don’t like FDA’s decision, can I appeal?Is there a database of BDP devices?Should we issue a press release announcing our BDP designation?What’s the most important thing to remember about the BDP program?Listen to this episode and see what you think of the Breakthrough Devices Program. 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.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the third most commonly used (although still substantially less than the 510(k) and PMA) regulatory pathway available to medical device manufacturers. Since it is not nearly as common as the two primarily used pathways, the De Novo is not nearly as understood as them. In order to shed light on when this option could be most beneficial or be the best option for a regulatory submission, we attempt to provide an overview of it—a De Novo 101, if you will. Specifically, we address a number of questions, including:What is the De Novo regulatory pathway?How does the De Novo differ from the PMA and 510(k) regulatory pathways?For what situation or type of device is the best case to use the De Novo pathway?When shouldn’t the De Novo be used?Do you have any suggestions or best practices for using a pre-sub meeting when planning to use the De Novo pathway?Listen to this episode and see what you think of this regulatory pathway. 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.
Changes are in progress, with more to come, in both the US and EU. FDA’s Center for Devices and Radiological Health (CDRH) is undergoing a significant reorganization in terms of both personnel and office responsibilities. In the EU, the new Medical Device Regulation will take effect in less than a year. RAPS invited Allison Komiyama, PhD, RAC, and expert on the US device environment, and John Beasley, RAC, whose primary focus is EU devices, to discuss those changes and their impact on device manufacturers.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently announced cancellation of the FDA’s alternative summary reporting program, the reasons it existed, why it was cancelled, and what manufacturers will need to do going forward. Specifically, we address a number of questions, including:What is the alternative summary reporting program?Was the reporting of the “discovery” of this program fair or was it media hype?Why did the FDA recently cancel the program?What will medical device manufacturers be required to do now?What is the ultimate result of this ban/change?What are the takeaways and/or lessons to be learned?Listen to this episode and see what you think regarding the FDA’s decision to cancel the alternative summary reporting program. 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 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.
In the first part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around what this guidance is, what’s new about it, and whether or not it’s actually something we need. Specifically, we address a number of questions, including:What’s lead to this new guidance? Do we really need it?Why is FDA doing more inspections?What is the goal of this guidance/program?What is the difference between Form 483 and Warning Letter?What is the process described in this guidance?What does FDA respond with?Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. 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 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.
In the second part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue our discussion of a recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around the timeline for the communication with the agency, types of 483s involved, definition of non-binding, what happens if a manufacturer ignores the FDA recommendation, and the most important takeaways from the guidance. Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. 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 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.
In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s letter from March 15, which provided a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeffrey Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions. Specifically, we address a number of questions, including: What were the main contents of this announcement with regard to the evaluation of materials by the FDA? Are there certain materials they are expected to target early in this review process? What are technology-specific guidances and how do they relate to this effort? Will the FDA ban specific materials if they do not meet a certain criteria or have too high an incidence of reactions among patients? Will this effort ultimately lead to a regulatory pathway to approve materials for medical device manufacture? Does having a review process for materials that would be approved for use in medical devices run counter to allowing for a broad selection of materials for a given device and ultimately limit options for innovation?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.
FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Inspections of Device Establishments. Mike Drues of Vascular Sciences joins Jon Speer on the Global Medical Device Podcast this week to discuss the importance of this document and how it relates to 483 observances and warning letters for medical devices. Some of the highlights of the show include: - What prompted nonbinding feedback guidance, and is it necessary? CDRH’s increased number of site inspections resulted in more warning letters. - CDRH is more aggressive with annual inspections because some medical device companies and their employees do stupid things, instead of the right things. - Goal of guidance is to improve communications with medical device companies concerning corrective actions in response to inspectional observations. - There are differences between a 483 and warning letter. A 483 is an inspectional item with room for improvement; a warning letter indicates a serious violation. - Guidance Process: Inspection is performed, company receives a 483, analyzes the observation, generates a response, and FDA returns nonbinding feedback. - If company’s response is appropriately implemented, FDA states: Response appears to be adequate, partially adequate, or inadequate. - Nobody wants to receive a 483. It’s usually inevitable, but not the end of the world. Be proactive and respond appropriately to avoid escalation. - A company needs to respond to FDA in a timely manner, which is within 15 business days. FDA tries to return nonbinding feedback within 45 calendar days.
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 episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the impact of personalized medicine on the medical device sector. Specifically, we address a number of questions, including:As far as we’re concerned with regard to the medical device industry, what is personalized medicine?For the few devices that have been “personalized” for an individual, how has the FDA handled their approval process?What are the challenges to pursuing personalized medicine given the current regulatory environment as it relates to finished devices?What are the most significant changes that would need to occur within the regulatory environment to enable the review and approval of personalized medicine technologies?What is the impact on the manufacturing side with regard to regulating protocols involved with the development of personalized medicine technologies (for example, additive manufacturing and 3D printing)?There was also reference made to a previous podcast on the topic of regulating the practice of medicine. This relates to the use of additive manufacturing technologies within the healthcare space, such as fabricating an implant right in the OR. 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.
This is part 2 of a two-part podcast series. If you haven't listened to the first portion yet, click here to first listen to that part.In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the November/December issue of MPO, My Holiday Wish List (for Industry) (click here to read that Letter). In this Letter, I outlined a few things that I would like to see for the benefit of the medical device industry. The items included an improved image for the industry, pain management technologies market success, reform or improvment in reimbursement and CMS, and a couple other items. In part 2 of this two-part podcast series, we continue the "wish list" discussion with a focus on pain management technologies and their opportunity to grow in popularity given the anti-opioid environment. We also discuss the reimbursement process and the opportunity for improvement there.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 episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss my lastest Editor’s Letter that appeared in the October issue of MPO, Regulating the Practice of Medicine (click to read that Letter). In it, I pose several scenarios regarding the industry’s direction and whether the FDA’s mission needs to be altered such that it would ultimately regulate the practice of medicine to some degree. This is primarily based upon a comment from a reader who offered feedback based on my Editor’s Letter in MPO’s sister publication, ODT. That comment is shared and Mike and Sean discuss it, along with several other points brought up in the October MPO Letter.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.
FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medical device companies, manufacturers, and service providers to discuss biocompatibility, in vitro diagnostics, clinical trials, and other areas. On today’s episode, Mike Drues of Vascular Sciences and Jon talk about the advantages and disadvantages of this program that encourages reviewers and companies to spend more time together. The better the reviewers understand the development processes that medical devices go through, the better they can work effectively with the companies to get medical devices on the market. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● Who’s job is it to teach CDRH staff on how medical devices are developed? ● When an FDA visitor is in the building, will the visit be realistic to open and honest discussion? Or filtered and sanitized? ● Visits could work to your advantage. You can “toot your own horn” as a medical device company that has a good regulatory process and sets the bar for quality. ● Skeptics may view the program as a sneaky way for FDA to come in, inspect what’s going on, and force changes - involves companies taking calculated risks. ● CDRH wants to teach staff about certain areas. They should already have subject matter expertise, but may have never been trained. ● CDRH should share information and experiences with medical device companies to improve collaboration without disclosing confidential details. ● Visits offer opportunities for two types of companies: 1) device manufacturers and 2) service providers. ● No good deed goes unpunished. So, make sure you have all your “ducks in a row.” If you want to schedule a visit, there’s a submission deadline of Sept. 26.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we conclude our conversation on the Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. Throughout all three parts of this podcast series, we highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this third and final part include: The dismissal of nine reviewers from the FDA who brought up concerns regarding certain processes and products.The lobbying power of the medtech and pharma sectors.The call for less innovation by several people in the documentary.A J&J executive admitting on film during a deposition that they were aware of issues with their mesh product.The observation that doctors seemed to require more evidence to abandon a product they were using then it took to initially have it approved.The money paid to doctors by the medtech industry.Before listening to the podcast, it would be best to view the documentary via Netflix. 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.
Medical device standards seem to change and evolve all the time. Is it impossible to keep up with them? Do you know the latest and greatest when it comes to IEC 60601? FDA’s CDRH standards program? Consensus standards database? FDA’s ASCA pilot program? On today’s episode, we have Scott Colburn of the FDA and Leo Eisner of Eisner Safety Consultants to discuss what’s currently happening in the medical device industry when it comes to standards. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● New versions of IEC 60601 are in the works; every five years, standards are reviewed to address collaterals, issues, and recommendations. ● Policy updates have been made regarding the appropriate use and recognition of voluntary consensus standards. ● FDA values such standards because of consistency, predictability, and credibility of science-based decisions around patient safety. ● FDA trains staff on standards and provides the medical industry with information on how to use FDA’s programs - working together to improve use of standards. ● Guidance is updated to be more efficient, consistent, and nimble: Process of recognizing and withdrawing standards. ● Describing the changes made regarding declaration of conformity vs. general use of standard. ● Some changes to standards are significant and affect requirements, such as updating normative references. ● Declaration of Conformity is a legal statement that shows you followed a specific path and applied a standard in accordance with its intent.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue a discussion that will span several parts. The conversation is centered around the recently released Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. We highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this part include:Alleged recommendation by FDA for the da Vinci Surgical System to be submitted as a 510(k) rather than as a PMA as originally submitted by Intuitive Surgical.Clinical trials for drugs compared to those for medical devicesFootage of the Essure review meeting and comments made during the meetingThe MAUDE event reporting systemBefore listening to the podcast, it would be best to view the documentary via Netflix. 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.
CDRH Director Jeff Shuren spoke to Medtech Insight at the MDIC Annual Forum about a risk-benefit uncertainty guidance US FDA released that day. He says he hopes the guidance will provide clarity to industry about the circumstances when FDA will accept different levels of uncertainty.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we begin a discussion that will span several parts. The conversation is centered around the recently released Netflix documentary, The Bleeding Edge. The documentary presents harsh criticism of the industry in terms of how devices are approved and what is done when problems arise. We highlight a good number of points brought up in the documentary and analyze whether each is a fair criticism or not. Discussion topics in this first part include: Overall impressions of the documentaryThe statement that a recalled device can be used as a predicate device for 510(k) clearance.The impact and concerns involved with a “daisy chain” of device reviews or “predicate creep” within the regulatory 510(k) review process.Should implantable devices be required to have a removal protocol included in its regulatory submission in order to gain approval/clearance?Before listening to the podcast, it would be best to view the documentary via Netflix. 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 relatively new FDA regulatory review option—the Breakthrough Designation Program. Do you have questions about this program, how it impacts the device review process, what types of products are accepted, or other inquires? If so, this podcast is perfect as Mike explains a variety of factors that would impact a company’s decision as to whether the program is right for their product. Specifically, the following questions are addressed:What is the breakthrough designation program?How does a manufacturer apply for breakthrough designation?Why are nearly half of breakthrough designation applications rejected and what should be done to avoid that?What are the options for a company if its breakthrough designation application is rejected?Are there non-regulatory advantages of obtaining breakthrough designation, such as public relations, fund-raising, etc.?As mentioned during the podcast, further information about the Breakthrough Designation Program can be found at the FDA’s website in its draft guidance, which can be viewed here: Breakthrough Devices Program Draft Guidance [PDF file]. 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 continue the 15 year anniversary theme that ran throughout the June 2018 issue of MPO and within my lastest Editor’s Letter that appeared in that issue, The More Things Change... (click to read that Letter). In it, I take a look back at the very beginnings of MPO and see what topics were relevant then that still resonate today within the magazine and industry. Given that theme, in this podcast, we discuss lessons learned from the last 15 years of getting products through the FDA and into the market. The 15 “best practices” (or at least factors to keep in mind during the development of a new product) are provided to help ensure a smoother ride through the regulatory approval or clearance process. Following is a quick list of these 15 tips along with the timestamps in case you are interested in hearing only a few (but hopefully, you stick around to gain insights on all 15). Expanding on each of these, Mike Drues provides his “lessons learned” for each. Mike Drues’ 15 Tips for Getting a New Product Through the FDA 1. This is a poker game in every sense—(00:56) 2. Consider regulatory from the beginning—(01:57) 3. Employ a competitive regulatory strategy—(03:22) 4. Use label expansions to your advantage—(05:00) 5. No submission should ever be rejected—(07:05) 6. Communicate early and often with FDA—(08:52) 7. Don't treat FDA as your enemy—(11:10) 8. Don’t be the regulatory police—(13:40) 9. Think globally—(16:40) 10. Don’t reinvent the wheel—(17:33) 11. Don't just copy others—(18:33) 12. Know all your options—(19:32) 13. Don’t be myopic about risk—(19:44) 14. New is not necessarily your friend—(20:30) 15. Design your label like you design your device—(21:50) 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 May issue of MPO, The Power of My Voice (click to read that Letter). In it, I provide my own opinions on the technology, how it’s being used in medical devices, and how it could potentially be used for healthcare in the future. I also offer an example of a partnership between the Mayo Clinic and an Israeli company, Beyond Verbal, where voice-enabled technology is being tested as a diagnostic tool for coronary artery disease. I don’t, however, get into the regulatory concerns and potential pitfalls of voice-enabled technology so we discussed it on this episode of Mike on Medtech. Sharing his own thoughts on this topic, Mike Drues delves into the FDA’s oversight of voice-enabled medical devices and how they are treated. 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 my lastest Editor’s Letter that appeared in the March issue of MPO. Click here to read that Letter. In it, I bring up a potential future view of healthcare and more specifically, how technology is delivered. I ponder if hospitals or doctor’s offices will employ the use of 3D printing to develop devices, implants, and instruments. One aspect of this topic, however, I was unable to address within the Letter was the regulatory and liability issues that go along with such a plan. As such, that’s the topic of discussion for this episode of Mike on Medtech. Listen to this episode and then see if you think this practice will become accepted in the near or far-off future, or will it never materialize at all. 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 two terms that are sometimes used interchangeably, but are, in fact, unique in purpose and definition—quality and regulatory. Should they be best treated as separate entities or addressed as a unit? Listen to this episode and then see what you think. Specifically, the following questions and topics are addressed in this discussion:What’s the difference between quality and regulatory?Should we separate quality and regulatory?Would we have fewer problems if we did not separate them?What are the challenges for the future?Real world and medical device industry examples provided.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.
CDRH Director Jeff Shuren sat with Medtech Insight in an exclusive interview to talk about his latest strategic priorities for the center over the next three years. They include improving employee engagement, creating more collaborative communities and streamlining the device center’s core processes.
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss what the implementation of a regulatory approval pathway for biomaterials would mean for medical device manufacturers, patients, and the healthcare industry. While such a pathway doesn’t currently exist, the potential advantages are explored. Further, the competitive advantage such a pathway could offer to materials manufacturers and suppliers is presented. Specifically, the following questions and topics are addressed in this discussion: Currently, can biomaterials be approved by FDA?Drugs are approved, and a drug is sort of a “biomaterial” so shouldn’t biomaterials be approved?If we haven't had a biomaterial approval pathway thus far, why do we need one now?How many companies developing new medical devices vs. how many companies developing new biomaterials?What are device manufacturers more likely to do: develop a new device using an existing material vs. developing a new device using a new material? Which would you choose?Would there be advantages to having a biomaterials approval pathway?Would there be disadvantages to having a biomaterials approval pathway?What is the likelihood of this happening?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 the use of an FDA pre-sub (or pre-submission) prior to making a formal submission of a 510(k) or PMA to the agency. While a number of companies are taking advantage of this, as of right now, still free opportunity, many others are not. When submissions are being rejected at such high percentages (Mike offers the numbers in this podcast), it only makes sense for more companies to utilize this opportunity. Specifically, the following questions are addressed in this discussion: What is a “pre-sub” and why should engineers need to care about it?How early in the product development lifecycle should companies involve FDA?What is a pre-sub lite?What part in a pre-sub do engineers play, say with regard to testing matrix?In September, we received guidance revisions with regard to the pre-sub. What was of significance in these revisions? You can review the pre-sub guidance discussed during the podcast at the following URL: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program (CDRH, Sept. 2017) 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 the use of human factors (or ergonomics or useability) in medical device design, the FDA’s increased interest in its use, and how different users impact the device development (such as patient/home use versus physican/hospital use). Specifically, the following questions are addressed in this discussion: What exactly are human factors with regard to the development of medical devices?Last year, the FDA put out human factors guidance for medical device manufacturers. Have human factors always been a part of the FDA’s processes in some way or is it a relatively new element?How do manufacturers or how should manufacturers conduct human factors testing?As more devices are being sent home and used outside a healthcare environment, can you share the considerations for human factors development with devices used directly by patients? Also, during this discussion, reference is made to two FDA guidance documents relevant to the use of human factors with medical device development. You can find those here:List of Highest Priority Devices for Human Factors Review [PDF]Applying Human Factors and Usability Engineering to Medical Devices [PDF]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 the passage of MDUFA IV and the changes that are associated with it. Further, we discuss the potential impact this law will have on medical device innovation. In an era of politicians calling for greater healthcare technology and a reduction of healthcare costs, stagnating innovation in medtech seems to be counterintuitive to this demand; unfortunately, that’s exactly what MDUFA IV could do. This law could adversely impact the design and development of medical devices based on companies seeking to avoid the increased fees. Examples of companies changing their product submission strategy are also shared. Specifically, the following questions are addressed:This is the fourth version of MDUFA, which has been around for quite some time now. Why is this latest version significant?What are the significant changes in this version of MDUFA ?What about those companies who are currently in the submission process? What should they do? Get more information regarding the MDUFA IV legislation via the following links:Overview: Medical Device User Fee Amendments (MDUFA) Specific Fee Schedule: FY 2018 MDUFA User FeesListen 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 many of the concerns and issues involved with the off-label use of a medical device. Further, we talk about the advertising and promotion of such use, what’s permitted, and what will get a company in trouble. Specifically, the following questions are addressed:What is off-label use as it relates to a medical device?What are the limitations of off-label use? Where is the real line between what’s allowed and what’s not?How are off-label use and real-world evidence connected?Can a device manufacturer advertise off-label use without going to jail? How might FDA’s view of advertising off-label use change in the future?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 the differences between materials and biomaterials, biocompatibility, biofriendly, biostable, and bioabsorbable. Specifically, the following questions are addressed: What’s the difference between a material and a biomaterial?What’s the difference between a biocompatible material versus a biofriendly material?How is a biostable material different from a bioabsorable/biodegradable materials?Do bioabsorables pose additional challenges?Do the regulatory rules for biomaterials differ from the ones that are currently followed for more traditional materials?What’s your response to companies who would rather not attempt to introduce a new material (or biomaterial) to the regulatory approval process?Check out the guidance mentioned in this podcast—ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." 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 the impact 3D printing has made on the current medical device industry, the challenges that are restricting greater use, and a couple of examples of bleeding edge applications that will likely play a substantial role in medtech and healthcare very soon. Always an interesting topic, this podcast likely represents only the first of a series of discussions that center around 3D printing in healthcare. Check out the video mentioned in this podcast where we discuss the FDA’s additive manufacturing guidance. 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 recent Editor's Letter that appeared in the March 2017 issue of MPO. In it, I wrote about a blog Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, authored regarding findings of recent hospital inspections as related to medical device reporting. Suffice to say, changes are needed with regard to the reporting of incidents by those involved in healthcare. How might we resolve the issue? Listen to this episode to hear what suggestions are made. 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 the use of real world evidence in the medical device approval process, which has gained much attention lately due to several reasons. It was specifically mentioned in the 21st Century Cures Act and it was also the topic of a recently released FDA Guidance document (PDF). Further, we seek to gain some additional insights on what real world evidence actually is, why it matters to medical device manufacturers, and how they might be able to make efficient use of it. 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.
On this week's podcast, "Gray Sheet" reporters and editors discuss FDA's dump of human factors policy documents for device and combination products, the ongoing independent assessment of CDRH, Zika virus diagnostics development and Capitol Hill updates.
On this week's podcast, we spoke about progress for FDA Commissioner-nominee Robert Califf, and a committee report critical of companies and FDA policies over duodenoscope infection outbreaks. We also discussed company updates from the JP Morgan Healthcare Conference, a federal preemption update and CDRH's two-year policy agenda.
A play-by-play of the latest FDA CDRH guidance CDRH entitled “General Wellness: Policy for Low Risk Devices.” Learn what defines a low-risk general wellness product, and how to tell if YOUR product falls under this guidance. Comments on this draft are open for 30 days starting January 20, 2015. Call Frestedt Inc. if you have […]
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