# medtech (podcasts) — RSS Amplifier Recent posts from the 7 feeds in the RSS Amplifier directory that cover medtech. Page: Feed: --- ## [Too Much News, Not Enough Wednesdays](https://blythekarow.substack.com/p/too-much-news-not-enough-wednesdays) _2026-08-19 · Blythe Karow · The Device Files: From Concept to Commercialization_ I don’t know what the schedule is for everyone else reading The Device Files, but in the southern United States kids are back in school! ## [Episode 274 | Joe Tumolo, Founder & President at JTSC | Why Relationships Win in MedTech Commercialization](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-274--Joe-Tumolo--Founder--President-at-JTSC--Why-Relationships-Win-in-MedTech-Commercialization-e3n82ld) _2026-08-17 · Project Medtech · Project Medtech_ In this episode, Joe Tumolo shares why the best medtech companies don't just build innovative products; they build relationships that drive commercialization. Drawing on more than 25 years in healthcare and life sciences, Joe reveals how founders can strengthen fundraising, hire the right sales team, navigate healthcare adoption, and create commercialization strategies that lead to lasting… [Listen](https://anchor.fm/s/1e555244/podcast/play/124045421/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-7-10%2F429597877-44100-2-6efa8c507b857.mp3) ## [Burn the Haystack: Understanding the Investor Mindset, Part Three](https://blythekarow.substack.com/p/burn-the-haystack-understanding-the-79f) _2026-08-12 · Blythe Karow · The Device Files: From Concept to Commercialization_ The Real Secret to Attracting an Investor ## [Episode 273 | Caron Trumbo, Vice President of Operations at VirginiaBio | Building a Biotech Ecosystem That Actually Works](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-273--Caron-Trumbo--Vice-President-of-Operations-at-VirginiaBio--Building-a-Biotech-Ecosystem-That-Actually-Works-e3mgkk1) _2026-08-10 · Project Medtech · Project Medtech_ How do you build a thriving biotech ecosystem? In this episode, Caron Trumbo, VP of Operations at VirginiaBio, shares how collaboration, workforce development, commercialization support, and statewide partnerships are helping Virginia become a growing hub for life science innovation. Learn why connecting startups, universities, investors, and healthcare systems is key to turning breakthrough ideas… [Listen](https://anchor.fm/s/1e555244/podcast/play/123277377/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-6-24%2F428559520-44100-2-026f137536589.mp3) ## [Burn the Haystack: Understanding the Investor Mindset, Part Two](https://blythekarow.substack.com/p/burn-the-haystack-understanding-the-22a) _2026-08-05 · Blythe Karow · The Device Files: From Concept to Commercialization_ The Ick Factor ## [Issue 16: Same Title, Different Career: How to Read MedTech RA Roles](https://beyondtheregulation.substack.com/p/issue-16-same-title-different-career) _2026-08-03 · Beyond Regulation with Ceren: Insights, Career & MedTech_ The same Regulatory Affairs title can describe completely different careers. What the role actually looks like often depends on multiple factors. Read the details in this week´s edition. ## [Episode 272 | Mike Monovoukas, CEO & Co-founder at AcuityMD | The Future of Medtech Commercialization: AI, Data, and Smarter Growth](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-272--Mike-Monovoukas--CEO--Co-founder-at-AcuityMD--The-Future-of-Medtech-Commercialization-AI--Data--and-Smarter-Growth-e3mgjqs) _2026-08-03 · Project Medtech · Project Medtech_ What does it take to successfully commercialize medical technology in today's rapidly evolving healthcare landscape? In this episode, Mike Monovoukas, CEO and Co-Founder of AcuityMD, shares how a failed startup inspired him to build one of medtech's leading commercialization platforms. From leveraging AI and data to helping companies launch products more effectively, to raising an $80M Series C… [Listen](https://anchor.fm/s/1e555244/podcast/play/123276572/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-6-24%2F428557781-44100-2-309b29fdb4f69.mp3) ## [July 2026 at the London Institute for Healthcare Engineering](https://lihe.substack.com/p/july-2026-at-the-london-institute) _2026-07-31 · LIHE · Engineering Better Health_ Proceed with confidence and pace in taking your MedTech innovation to market. ## ECRI's 2026 Top 10 Health Technology Hazards _2026-07-30 · Medtech Matters_ In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re reviewing the list of top health technology hazards identified by ECRI. ECRI is an independent, nonprofit organization that improves the safety, quality, and cost-effectiveness of care across all healthcare settings. Each year, they publish this Top 10 list to help bring awareness to… [Listen](https://www.buzzsprout.com/265418/episodes/19521906-ecri-s-2026-top-10-health-technology-hazards.mp3) ## [Burn the Haystack: Understanding the Investor Mindset](https://blythekarow.substack.com/p/burn-the-haystack-understanding-the) _2026-07-29 · Blythe Karow · The Device Files: From Concept to Commercialization_ Part 1: Why Investors Think the Way They Do, and Why That’s Rational ## [Watch Chovy Code Live (Sponsored)](https://crawlproof.com/a/7DSAwl60peei) _2026-07-29 · **Sponsored**_ Join live coding streams with real-time collaborative screen sharing, open source and free. ## [Episode 271 | Christopher Gates, Founder & CEO of arsMedSecurity | The First Five Things You Need to Know About Medical Device Cybersecurity](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-271--Christopher-Gates--Founder--CEO-of-arsMedSecurity--The-First-Five-Things-You-Need-to-Know-About-Medical-Device-Cybersecurity-e3m4bl6) _2026-07-27 · Project Medtech · Project Medtech_ Cybersecurity has become one of the biggest challenges facing medical device innovators, and it's about much more than protecting data. In this episode of Project Medtech's mini series, cybersecurity expert Christopher Gates breaks down the first five essential principles every medtech company should understand, from designing secure devices from day one to navigating FDA expectations and staying… [Listen](https://anchor.fm/s/1e555244/podcast/play/122874982/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-6-15%2F428012734-44100-2-c0b97b8a3f36a.mp3) ## [Is Remote Monitoring About to Face a Reckoning? Reviewing the New CMS Rule Change Proposal](https://blythekarow.substack.com/p/is-remote-monitoring-about-to-face) _2026-07-22 · Blythe Karow · The Device Files: From Concept to Commercialization_ Last week The Centers for Medicare & Medicaid Services (CMS) published their Calendar Year 2027 Medicare Physician Fee Schedule proposed rule, a 1,592-page document.1 In those proposed new rules were some pretty interesting suggestions around Remote Patient Monitoring (RPM). ## [Issue 15: Where Does Regulatory Affairs End and Quality Assurance Begin?](https://beyondtheregulation.substack.com/p/issue-15-where-does-regulatory-affairs) _2026-07-21 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Why are Regulatory Affairs and Quality Assurance often combined in MedTech SMEs and what does this mean for your career? This issue explores RAQA integration, a peanut allergen reagent recall involving false-negative risks, and the importance of robust manufacturing controls ## [Episode 270 | Franco Kraiselburd, Founder & CEO, Asclepii | Reimagining Wound Care Through Accessible Innovation](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-270--Franco-Kraiselburd--Founder--CEO--Asclepii--Reimagining-Wound-Care-Through-Accessible-Innovation-e3lsnlf) _2026-07-20 · Project Medtech · Project Medtech_ What if the biggest breakthrough in wound care is making advanced treatments simpler? In this episode, Franco Kraiselburd, founder of Asclepii, shares how mentorship from stem cell pioneer Arnold Kaplan inspired a mission to transform wound care through accessible innovation. He discusses the launch of Poseidon, an innovative silver nanoparticle hydrogel designed to improve healing while… [Listen](https://anchor.fm/s/1e555244/podcast/play/122625135/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-6-9%2F427679937-44100-2-e60a04806f3c6.mp3) ## [The Return of Carnac the Magnificent](https://blythekarow.substack.com/p/the-return-of-carnac-the-magnificent) _2026-07-15 · Blythe Karow · The Device Files: From Concept to Commercialization_ It looks like I have to don the turban again. ## [Episode 269 | Edwin Lindsay, Principal Consultant at CS Life Sciences | Unlocking Innovation with Strategic Roadmaps](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-269--Edwin-Lindsay--Principal-Consultant-at-CS-Life-Sciences--Unlocking-Innovation-with-Strategic-Roadmaps-e3lkce1) _2026-07-13 · Project Medtech · Project Medtech_ What does it take to move a medical device from an idea to a solution that reaches patients? In this episode, Edwin Lindsay (Medtech's Guinness Guy) shares how 20+ years in medical devices shaped his hands-on approach to helping startups overcome regulatory, quality, and clinical challenges. He discusses why innovators need more than advice—they need experienced partners who help make decisions,… [Listen](https://anchor.fm/s/1e555244/podcast/play/122351489/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-6-3%2F427309501-44100-2-8eb0f84019921.mp3) ## [The Big MedTech Players Are Coming for Wearables](https://blythekarow.substack.com/p/the-big-medtech-players-are-coming) _2026-07-08 · Blythe Karow · The Device Files: From Concept to Commercialization_ OK, slightly behind on news here with the “year end” wrap-ups, but there was an interesting press release on June 4th. ## [Issue 14: How Regulatory Affairs Changed the Way I See Everyday Things?](https://beyondtheregulation.substack.com/p/issue-14-how-regulatory-affairs-changed) _2026-07-07 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Ever noticed how regulatory affairs changes the way you look at everyday things? This week's issue is about exactly that. ## [Episode 268 | Ethan Drower, Co-Founder & CEO of CiteMed | Breaking Down Barriers with Clinical Evidence](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-268--Ethan-Drower--Co-Founder--CEO-of-CiteMed--Breaking-Down-Barriers-with-Clinical-Evidence-e3labsm) _2026-07-06 · Project Medtech · Project Medtech_ In this episode, Ethan Drower, co-founder and CEO of CiteMed, shares the story behind Evidence Cloud, an AI-enabled platform transforming how medtech teams approach clinical evidence. Built to simplify complex literature reviews, strengthen regulatory submissions, and create a clear, traceable foundation for clinical claims, Evidence Cloud helps companies navigate one of the most critical steps in… [Listen](https://anchor.fm/s/1e555244/podcast/play/122023254/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-5-26%2F426871613-44100-2-960508a196759.mp3) ## [June 2026 at the London Institute for Healthcare Engineering](https://lihe.substack.com/p/june-2026-at-the-london-institute) _2026-07-01 · LIHE · Engineering Better Health_ Proceed with confidence and pace in taking your MedTech innovation to market. ## [Find it on Amazon (Sponsored)](https://crawlproof.com/a/ptWSPxXA855Q) _2026-07-01 · **Sponsored**_ Open the Amazon product listing to see details and availability ## [One Year of The Device Files: WHOOP, Oura, AI, FDA, CMS, and the First Ever Device Files Awards!](https://blythekarow.substack.com/p/one-year-since-the-device-files-launched) _2026-07-01 · Blythe Karow · The Device Files: From Concept to Commercialization_ Your chance to Vote (and Nominate) for the 2026 Device Files Reader Awards! Plus a year-end wrap up, what the future will bring, and our quarterly overview. ## [Episode 267 | Michelle Ottey, President of CIC Campuses & Labs | Strategic Growth & Community Building in Innovation Spaces](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-267--Michelle-Ottey--President-of-CIC-Campuses--Labs--Strategic-Growth--Community-Building-in-Innovation-Spaces-e3kkf9n) _2026-06-29 · Project Medtech · Project Medtech_ In this episode, Michelle Ottey, President of CIC Campuses and Labs, unpacks what it really takes to build thriving innovation ecosystems and why flexible lab space is only the beginning. Michelle shares her personal journey from genetics and cell biology research into enabling entrepreneurship, and explains how CIC’s “invisible infrastructure” helps life science and medtech founders move faster… [Listen](https://anchor.fm/s/1e555244/podcast/play/121305847/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-5-10%2F425909922-44100-2-832dee5d1ca91.mp3) ## [Final Episode of Commercialization Confidential: Best Practices for Hospital Commercialization with Jess Richter](https://blythekarow.substack.com/p/final-episode-of-commercialization) _2026-06-24 · Blythe Karow · The Device Files: From Concept to Commercialization_ If you’ve been reading The Device Files for a while, you know the usual format. ## [Issue 13: Free Resources to polish your technical knowledge](https://beyondtheregulation.substack.com/p/issue-13-what-are-you-doing-with) _2026-06-23 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Q4 is one of the quarters when companies hire the most. Are you preparing for it? ## [Episode 266 | Laura Corcoran, CEO & Founder of Dignity Care | Innovating Compassionate Solutions for Pregnancy Loss](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-266--Laura-Corcoran--CEO--Founder-of-Dignity-Care--Innovating-Compassionate-Solutions-for-Pregnancy-Loss-e3kd7sr) _2026-06-22 · Project Medtech · Project Medtech_ In this powerful episode, Laura Corcoran, CEO and Founder of Dignity Care, shares the deeply personal experience that drove her to invent the Miscarriage Collection Cradle, a patented Class I medical device designed to bring practical support and dignity to women managing miscarriage or pregnancy loss. Laura walks through the realities of home miscarriage management, the need for reliable… [Listen](https://anchor.fm/s/1e555244/podcast/play/121068891/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-5-5%2F425594870-44100-2-92704cd3b38f5.mp3) ## [Everyone Thinks They’re Doing It Right](https://blythekarow.substack.com/p/everyone-thinks-theyre-doing-it-right) _2026-06-17 · Blythe Karow · The Device Files: From Concept to Commercialization_ OR "The Farmer and the Cowman Should be Friends" ## [Episode 265 | Dr. Malcolm Townes, Innovation Fund Manager at Washington University | Strategic Medtech Commercialization: Lessons from the Gap Fund](https://podcasters.spotify.com/pod/show/projectmedtech/episodes/Episode-265--Dr--Malcolm-Townes--Innovation-Fund-Manager-at-Washington-University--Strategic-Medtech-Commercialization-Lessons-from-the-Gap-Fund-e3ka6n9) _2026-06-15 · Project Medtech · Project Medtech_ In this episode, Dr. Malcolm Townes breaks down how WashU is building a more execution-focused commercialization engine through its Gap Fund, designed to advance non-drug, non-therapeutic technologies by funding the technology (not startups) to avoid conflicts and drive sharper development decisions. He shares why hands-on, milestone-based funding and rigorous customer discovery are essential to… [Listen](https://anchor.fm/s/1e555244/podcast/play/120969385/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-5-3%2F425461206-44100-2-3cebe81afb6cd.mp3) ## [A Comedian, a Cult Movie, and a Question About the Future of Medicine](https://blythekarow.substack.com/p/a-comedian-a-cult-movie-and-a-question) _2026-06-10 · Blythe Karow · The Device Files: From Concept to Commercialization_ The Doctor Is the Safety Check. About That. ## [Issue 12: Change Control Approved: Switching to Summer](https://beyondtheregulation.substack.com/p/issue-12-change-control-approved) _2026-06-09 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Give me a beach, a cold drink, and absolutely no agenda. That is my summer. ## Measuring Regulatory/Quality Team Member Performance _2026-06-03 · Medtech Matters_ In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re speaking about how to best determine the efficacy of regulatory and quality team members. A variety of real-world examples are provided that demonstrate the need to “trust but verify” the actions of these team members. During this conversation, the following questions are addressed:… [Listen](https://www.buzzsprout.com/265418/episodes/19290139-measuring-regulatory-quality-team-member-performance.mp3) ## [CLI-first decentralized compute (Sponsored)](https://crawlproof.com/a/rUZDaIQ6dphv) _2026-06-03 · **Sponsored**_ Run and pay spare GPUs from the CLI — transcode, coinpay (DID+escrow), infernet (AI). ## [Two "Whoop Killers" in Two Weeks? Don't Trust the Headlines.](https://blythekarow.substack.com/p/two-whoop-killers-in-two-weeks-dont) _2026-06-03 · Blythe Karow · The Device Files: From Concept to Commercialization_ The Fitbit Air launched on May 7, 2026. ## [May 2026 at the London Institute for Healthcare Engineering](https://lihe.substack.com/p/may-2026-at-the-london-institute) _2026-05-29 · LIHE · Engineering Better Health_ Proceed with confidence and pace in taking your MedTech innovation to market. ## [The Company That Cracked Wearable Blood Pressure - And Made It Free](https://blythekarow.substack.com/p/the-company-that-cracked-wearable) _2026-05-27 · Blythe Karow · The Device Files: From Concept to Commercialization_ Commercialization Confidential Episode 5: Gaurave Kohli, CEO of VitalFriend ## [From Innovation to Adoption: The Realities of Medical Device Market Entry](https://podcasters.spotify.com/pod/show/michelle4794/episodes/From-Innovation-to-Adoption-The-Realities-of-Medical-Device-Market-Entry-e3ju9kb) _2026-05-26 · Michelle Lott · RAQA Today_ Brilliant technology is not enough. In this episode, Renae Franz unpacks the realities of medical device commercialization — including regulatory strategy, reimbursement, clinician adoption, usability, and market validation. Through real-world medtech case studies, the conversation examines why technically strong products fail when they ignore workflow, reimbursement, or the “voice of the… [Listen](https://anchor.fm/s/107f93154/podcast/play/120579147/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-4-26%2F2607f20b-1589-1773-0bb4-a995a4cf6c35.m4a) ## [Issue 11: How to Choose? Small company vs Corporate Setting](https://beyondtheregulation.substack.com/p/issue-11-why-staying-current-on-regulatory) _2026-05-26 · Beyond Regulation with Ceren: Insights, Career & MedTech_ This issue focuses on why staying updated with RA news matters for interviews and how to think about the “small company vs corporate” career choice. I also highlight an interesting LinkedIn post that shares a useful tip for reading job descriptions. ## [Has CMS Finally Cracked the Breakthrough Device Coverage Code?](https://blythekarow.substack.com/p/has-cms-finally-cracked-the-breakthrough) _2026-05-20 · Blythe Karow · The Device Files: From Concept to Commercialization_ RAPID, TCET, NTAP: CMS’s Latest Coverage Shuffle Explained ## [Issue 10: Regulatory Affairs: The Art of Stakeholder Debate](https://beyondtheregulation.substack.com/p/issue-10-regulatory-affairs-the-art) _2026-05-19 · Beyond Regulation with Ceren: Insights, Career & MedTech_ What each stakeholder prioritzes in MedTech, interesting recall and career transition to RA from other departments in MedTech ## FDA's Third-Party Review Program _2026-05-14 · Medtech Matters_ In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing the FDA’s third-party review program. This option is available for certain 510k reviews. It is performed through an independent organization that is not part of the agency. As such, there are additional costs involved but the time savings could potential make up for that… [Listen](https://www.buzzsprout.com/265418/episodes/19176514-fda-s-third-party-review-program.mp3) ## [Whatever Happened to TCET, CMS’s Breakthrough Device Coverage Pathway?](https://blythekarow.substack.com/p/whatever-happened-to-tcet-cmss-breakthrough) _2026-05-13 · Blythe Karow · The Device Files: From Concept to Commercialization_ This is part two of a three-part series on what the breakthrough device coverage problem looks like from inside CMS, in conversation with Dr. ## [Issue 9: Why I Sit Through the Whole Audit?](https://beyondtheregulation.substack.com/p/issue-9-why-i-sit-through-the-whole) _2026-05-12 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Another audit with a Notified body, my takey from 2,5 days of audit and implementing regulation that will change the everyday life of RA and QA professionals. ## [Is CMS Killing Breakthrough MedTech? A View from the Other Side](https://blythekarow.substack.com/p/is-cms-killing-breakthrough-medtech) _2026-05-06 · Blythe Karow · The Device Files: From Concept to Commercialization_ This article is part one of a three-part interview series with Dr. Lee Fleisher, former Chief Medical Officer of CMS, on what the breakthrough device coverage problem looks like from CMS's point of view. ## [Issue 8: Why Nobody Teaches You How to Get a Job in Regulatory Affairs?](https://beyondtheregulation.substack.com/p/issue-8-why-nobody-teaches-you-how) _2026-05-05 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ Explore why preparation is key to success, the use of ChatGP for interview prep, and signs of a fake QMS. ## Is Europe still worth it for Medtech Companies? | Oliver Bisazza | Medtech Europe _2026-05-05 · Career Diaries by Elemed_ Oliver Bisazza is the CEO of MedTech Europe. With a background in EU policy and regulatory leadership, Oliver has played a key role in shaping Europe’s medtech landscape, now focused on strengthening competitiveness, advancing regulation, and improving patient access to innovation. Oliver has watched this industry from the inside for nearly 20 years. He's lived through the MDR chaos, the pandemic,… [Listen](https://www.buzzsprout.com/814173/episodes/19101661-is-europe-still-worth-it-for-medtech-companies-oliver-bisazza-medtech-europe.mp3) ## [Jamie Grooms on the Week Axogen Almost Went Under - and the Commercialization Lessons That Came Out of It](https://blythekarow.substack.com/p/jamie-grooms-on-the-week-axogen-almost) _2026-04-29 · Blythe Karow · The Device Files: From Concept to Commercialization_ A Quick note before we start: I have to say a MAJOR Thank You to Jamie Grooms for this podcast for two reasons: ## [Issue 7: Why do I suggest free courses?](https://beyondtheregulation.substack.com/p/issue-7-why-do-i-suggest-free-courses) _2026-04-28 · Beyond Regulation with Ceren: Insights, Career & MedTech_ There is a lot of information available. Regulations, guidance documents, videos, posts, discussions. But without context, it often feels like pieces that don’t fully connect. ## [How to Lose Your Best Sales Reps Without Even Trying: Lessons from the Boston Scientific Pacemaker Recall](https://blythekarow.substack.com/p/how-to-lose-your-best-sales-reps) _2026-04-22 · Blythe Karow · The Device Files: From Concept to Commercialization_ Do you ever absentmindedly decide to check on your stock portfolio and then instantly wish you didn’t? ## [Crisis Communication Playbook](https://blythekarow.substack.com/p/crisis-communication-playbook) _2026-04-22 · Blythe Karow · The Device Files: From Concept to Commercialization_ Managing Your Team Through Recalls, Restructuring, and Financial Crises ## [Issue 6: Why breaking into Regulatory Affairs is "that hard"?](https://beyondtheregulation.substack.com/p/issue-6-why-breaking-into-regulatory) _2026-04-21 · Beyond Regulation with Ceren: Insights, Career & MedTech_ Everyone says breaking into Regulatory Affairs is “hard.” And honestly? They’re not wrong. ## Triaging Your QMS: Considerations Based on the New QMSR _2026-04-17 · Medtech Matters_ In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing the FDA’s recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regulation incorporates ISO 13485:2016, which is expected to help align medical device regulations globally. In this podcast, we focus on what device manufacturers… [Listen](https://www.buzzsprout.com/265418/episodes/19033831-triaging-your-qms-considerations-based-on-the-new-qmsr.mp3) ## [The New CMS ACCESS Program is Extending its Application Deadline through May 15. Should You Apply? WHOOP Just Did.](https://blythekarow.substack.com/p/the-new-cms-access-program-is-extending) _2026-04-16 · Blythe Karow · The Device Files: From Concept to Commercialization_ Last week I joined the first ever MedTech Innovator Radar Forum in Manhattan Beach, a really great event that showcased approximately 150 MedTech companies through seven rounds of pitch events, plus additional content and networking.