# medtech (audio feeds) — RSS Amplifier Recent posts from the 3 feeds in the RSS Amplifier directory that cover medtech. Page: Feed: --- ## [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 ## [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. ## [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 ## [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 ## [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. ## [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. ## [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. ## [Hire AI-Powered Professionals (Sponsored)](https://crawlproof.com/a/m6SrOC33HnIz) _2026-07-01 · **Sponsored**_ Browse public gigs, message candidates, and run video interviews — free to start. ## [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? ## [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" ## [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. ## [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. ## [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 ## [Stream Torrents and IPTV Instantly (Sponsored)](https://crawlproof.com/a/a1yPUhsvzYZY) _2026-05-20 · **Sponsored**_ Search, index, and play music, movies, books, and live TV in your browser. ## [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 ## [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. ## [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. ## [Make any domain metal (Sponsored)](https://crawlproof.com/a/aVp0iY6M0TDj) _2026-04-21 · **Sponsored**_ Turn any domain into a blacked-out metal landing page with an email waitlist ## [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. ## [Issue 5: Why do I write about recalls?](https://beyondtheregulation.substack.com/p/issue-5-why-do-i-write-about-recalls) _2026-04-14 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ Vigilance requirements are rarely black and white. They depend on your product, how well you know it, your experience, and… context. ## [A Proclamation on the Future of Wearables: The Real Reasons Abbott and Mayo Invested in WHOOP](https://blythekarow.substack.com/p/a-proclamation-on-the-future-of-wearables) _2026-04-08 · Blythe Karow · The Device Files: From Concept to Commercialization_ I feel somewhat obliged at this point to cover WHOOP and Oura events – let me know if you, my dear readers, have grown weary of the topic! ## [Issue 4: Why did I start this newsletter?](https://beyondtheregulation.substack.com/p/issue-4-why-did-i-start-this-newsletter) _2026-04-07 · Beyond Regulation with Ceren: Insights, Career & MedTech_ I am interested in many aspects of regulatory affairs. Not just one corner of it. And more importantly, I have always been interested in people and their careers. ## [Issue 3: I moved from pharma RA to MedTech RA. Here’s what surprised me the most.](https://beyondtheregulation.substack.com/p/issue-3-i-moved-from-pharma-ra-to) _2026-03-31 · Beyond Regulation with Ceren: Insights, Career & MedTech_ What moving from pharma RA to MedTech RA taught me ## [Issue 2: Why I am on a mission to help others in Regulatory Affairs!?](https://beyondtheregulation.substack.com/p/issue-2-why-i-am-on-a-mission-to) _2026-03-24 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ To this day, I’ve had one major and one minor career pivot. ## [Issue 1: Welcome to my world!](https://beyondtheregulation.substack.com/p/issue-1-welcome-to-my-world) _2026-03-17 · Dr. Ceren Karacay-Steinwender · Beyond Regulation with Ceren: Insights, Career & MedTech_ You may know me from LinkedIn, or maybe this is your first time seeing my newsletter. ## [Building a Better Market Pathway: Aligning Regulatory, Reimbursement and Commercialization Teams](https://podcasters.spotify.com/pod/show/michelle4794/episodes/Building-a-Better-Market-Pathway-Aligning-Regulatory--Reimbursement-and-Commercialization-Teams-e3c2grs) _2025-12-08 · Michelle Lott · RAQA Today_ Most medtech teams underestimate the work before FDA submission—and overestimate what happens after clearance. In this episode, regulatory expert Michelle Lott, commercialization strategist Renae Franz, and reimbursement specialist Fernanda Nusbaum unpack the leadership blind spots, strategic missteps, and easily avoidable financial risks that derail medtech companies every day. You’ll learn why… [Listen](https://anchor.fm/s/107f93154/podcast/play/112329020/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2025-11-8%2Faf6fe779-9f71-995e-85c9-6073b5afa286.m4a) ## [How to be the Regulatory Person Everyone Actually Likes | Device & Conquer | S2:E6](https://podcasters.spotify.com/pod/show/michelle4794/episodes/How-to-be-the-Regulatory-Person-Everyone-Actually-Likes--Device--Conquer--S2E6-e3bpa8o) _2025-12-02 · Michelle Lott · RAQA Today_ A practical, lightly spicy guide to becoming the regulatory person teams actually respect—and want in the room. Learn how regulatory and quality professionals can build trust, lower resistance, and communicate across cross-functional teams without becoming the “department of no.” This episode covers communication habits, emotional intelligence, conflict navigation, and how to say no without… [Listen](https://anchor.fm/s/107f93154/podcast/play/112027352/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2025-11-2%2F22330675-43e2-566f-3a8d-c9455190b7b8.m4a) ## [How to Build a Quality System That Doesn't Suck | Device & Conquer | S2:E5](https://podcasters.spotify.com/pod/show/michelle4794/episodes/How-to-Build-a-Quality-System-That-Doesnt-Suck--Device--Conquer--S2E5-e3b562p) _2025-11-18 · Michelle Lott · RAQA Today_ Because your QMS should be a safety net—not a set of handcuffs. In this episode of Device and Conquer , Michelle and Ti break down how to build a quality management system (QMS) that doesn’t suck —or suck the life out of your MedTech team. From the shift to FDA’s new QMSR aligned with ISO 13485:2016 to risk-based thinking, supplier controls, and right-sizing your documentation, this episode gives… [Listen](https://anchor.fm/s/107f93154/podcast/play/111367705/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2025-10-18%2F8f3ade94-d09d-4e06-8dae-bad490cc9d81.m4a) ## [Due Diligence for MedTech Investors: What You Really Need to Know Before Writing That Check](https://podcasters.spotify.com/pod/show/michelle4794/episodes/Due-Diligence-for-MedTech-Investors-What-You-Really-Need-to-Know-Before-Writing-That-Check-e3b36oa) _2025-11-17 · Michelle Lott · RAQA Today_ If you’re thinking about investing in medtech, congratulate yourself—you’ve chosen one of the most exciting, innovative, and occasionally stomach-churning sectors out there. But between regulatory hurdles, clinical workflow quirks, and the fact that even great ideas can wither in the wild, medtech due diligence is…well, a sport. In a recent webinar, industry veteran Renee Franz (Lean RAQA) teamed… [Listen](https://anchor.fm/s/107f93154/podcast/play/111302858/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2025-10-17%2F561abf05-4282-0c7a-5a1b-7ef8b77a2936.m4a) ## [Why Picking a Predicate Can Make or Break Your 510(k) | Device & Conquer | S2:E4](https://podcasters.spotify.com/pod/show/michelle4794/episodes/Why-Picking-a-Predicate-Can-Make-or-Break-Your-510k--Device--Conquer--S2E4-e3aqnp3) _2025-11-11 · Michelle Lott · RAQA Today_ Choosing a predicate device can make—or break—your 510(k) submission, so it's important to choose wisely. In this episode of Device and Conquer , Michelle Lott and Ti Benson break down one of the trickiest parts of the FDA clearance process: how to select a predicate that passes the “substantial equivalence” test without raising new questions of safety and efficacy. You’ll learn how to build a… [Listen](https://anchor.fm/s/107f93154/podcast/play/111025379/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2025-10-11%2F609ffa7a-c645-fd71-116a-0697a4f9282c.m4a) ## [How to Build a 510(k) Without Losing Your Mind | Device & Conquer | S2:E3](https://podcasters.spotify.com/pod/show/michelle4794/episodes/How-to-Build-a-510k-Without-Losing-Your-Mind--Device--Conquer--S2E3-e3aessk) _2025-11-03 · Michelle Lott · RAQA Today_ Building a 510(k) isn’t just about filling in forms — it’s about telling the FDA a story they can’t say no to.In this episode of Device & Conquer , Michelle Lott and Tianna Benson unpack what really goes into preparing an FDA 510(k) submission — from substantial equivalence and predicate devices to the eSTAR template , testing requirements , and why your submission is basically a regulatory novel.… [Listen](https://anchor.fm/s/107f93154/podcast/play/110637396/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2025-10-3%2F53f66642-df03-4ed3-9007-1a5eabf18899.m4a) ## [How to Submit a Pre-Sub (like a Pro) | Device & Conquer | S2:E2](https://podcasters.spotify.com/pod/show/michelle4794/episodes/How-to-Submit-a-Pre-Sub-like-a-Pro--Device--Conquer--S2E2-e3a5nu8) _2025-10-28 · Michelle Lott · RAQA Today_ The FDA pre-submission (Q-Sub) process can save you time — or sink your submission. In this episode of Device and Conquer , Michelle Lott and Tianna Benson explain how to Pre-Sub like a pro. They explain when to use a pre-sub, how to structure your questions, and what to expect from FDA’s new eSTAR electronic template. Plus: insider tips on labeling, clinical protocols, and the art of “Does FDA… [Listen](https://anchor.fm/s/107f93154/podcast/play/110337416/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2025-9-28%2Ff1a76eb8-9e03-52bc-ce6a-0257917e7e17.m4a) ## [FDA Strategy 2025: Policy, Pressures and the Path to Medtech Clearance | Part I | leanRAQA Today | S5:E6](https://podcasters.spotify.com/pod/show/michelle4794/episodes/FDA-Strategy-2025-Policy--Pressures-and-the-Path-to-Medtech-Clearance--Part-I--leanRAQA-Today--S5E6-e39tmkq) _2025-10-22 · Michelle Lott · RAQA Today_ The FDA state of the union in 2025 - deregulation, QMSR, and a toilet paper shortage? Listen in as Michelle Lott and Tianna Benson tackle the wild world of FDA policy shifts and what they mean for medical device manufacturers. From the administration’s sweeping deregulation mandates to the long-awaited transition from QSR to QMSR, they connect the dots between chaos, comedy, and compliance. You’ll… [Listen](https://anchor.fm/s/107f93154/podcast/play/110073946/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2025-9-22%2F009b57b1-d5bf-e437-aa04-43dea455587b.m4a) ## [How to Speak FDA (Without a Translator) | Device & Conquer | S2:E1](https://podcasters.spotify.com/pod/show/michelle4794/episodes/How-to-Speak-FDA-Without-a-Translator--Device--Conquer--S2E1-e39rgq8) _2025-10-21 · Michelle Lott · RAQA Today_ Think you speak English? The FDA might disagree. In the Season 2 kickoff of Device &Conquer , hosts Michelle Lott and Tianna Benson break down the unique language of the U.S. Food and Drug Administration — a dialect every medtech professional needs to understand to survive regulatory conversations. From decoding words like “should,” “non-binding,” and “substantial equivalence” to navigating… [Listen](https://anchor.fm/s/107f93154/podcast/play/110002440/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2025-9-21%2F5a6d54f1-de53-f45f-e2ad-ce9d4ab7fd04.m4a)