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Is your medical device vision actually helping you grow - or silently holding you back?If you're a clinician founder with a working prototype but struggling to scale or export your medical device, the problem likely isn't your product — it's your vision. In this episode, Hakeem Adebiyi breaks down why most healthcare innovations stall commercially and how to fix it using a proven, clinician-friendly framework.Here's what you'll learn:Why your current vision might be too generic — and how that's stalling your commercial growthThe DAMP framework: a 4-step system to pressure test your vision for direction, alignment, motivation, and peopleA practical on-the-go exercise to sharpen your vision and guide real business decisions immediately
Join Our Medical Device Sales Program
Join Our Medical Device Sales Program
Medboard: https://www.medboard.com/EuropeEMD Mag Issue 3 - For QA RA people: https://easymedicaldevice.com/emd-mag/EU to simplify MDR and IVDR - Proposal ongoing: https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf - https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_25_3078/QANDA_25_3078_EN.pdf - https://ec.europa.eu/commission/presscorner/api/files/attachment/882087/FACTSHEET%20medical%20devices%20final%20(1).pdfTeam NB Position Paper on Annex VII - Not agreeing all EU Proposal: https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216.pdfMDCG 2025-9 Learn Breakthrough Devices BtX - Guidance for innovative products: https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdfInfographic: https://www.linkedin.com/posts/melazzouzi_medtech-mdr-ivdr-activity-7414590943179202560-jbxH?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuIMDCG 2025-10 on PMS - Learn how to do it with this guidance: https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdfNotified Body Malta Conformity Assessment - 52nd Notified Body for MDR: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=SIMS_INPUT_282916&filter=notificationStatusId:1 ServicesEasyIFU - Manage your eIFU and Labels: https://easyifu.com SwitzerlandSwissdamed registration deadline - July 1st 2026: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/frist-produktregistrierung-in-swissdamed.html - https://swissdamed-webinar.ch/#E402A0UKMHRA Price changing -: More cost for manufacturers: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees RoWFDA: How to use Real World Evidence - Guidance Document offered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devicesAustralia: Preparing for UDI and AusUDID - Checklist for preparation available: https://www.tga.gov.au/sites/default/files/2025-12/preparing-for-udi-in-australia-checklist_0.pdf PodcastPodcast Nostalgia - What was discussed lastly: Episode 367 - From Engineer to Clinical Evaluation Expert - Florian Tolkmitt: https://podcast.easymedicaldevice.com/367-2/Episode 368 - Simplifying EU MDR IVDR with Adam Isaacs Rae: https://podcast.easymedicaldevice.com/368-2/Episode 369 - Last Podcast of the Year: https://podcast.easymedicaldevice.com/369-2/Episode 370 - Verification & Validation with Aaron Joseph: https://podcast.easymedicaldevice.com/370-2/
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Jaeson Bang, Founder & CEO of Future Cardia. Future Cardia is developing a subcutaneous heart-failure monitoring platform designed to capture both electrical and mechanical cardiac signals through a simple office-based procedure.Jaeson brings more than two decades of experience building implantable cardiac technologies across Medtronic, CVRx, EBR Systems, and Abiomed. Drawing on that background, he questioned industry assumptions around miniaturization and invasive workflows — and built a device that prioritizes performance, durability, and clinical practicality instead.In this interview, Jaeson shares how challenging a core constraint unlocked a faster development path, why deep domain expertise matters more than thrift in regulated markets, and how raising capital outside traditional VC can preserve leverage and buy time.If you'd rather read than listen, here's a link to the full interview with Jaeson Bang.
Guests:Dr Mihai Lomora, Scientist with CÚRAM, the Research Ireland Centre for Medical Devices based at the University of GalwayDr Jessamyn Fairfield from the School of Natural Sciences at the University of GalwayDr Fergus McAuliffe, Head of Research Engagement and Impact at Trinity College Dublin
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 9.5 weeks, earning $113,760 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
How do you go from being the Ohio State University mascot to an ICU Nurse, and finally to a top-tier Pharmaceutical Sales Rep at Pfizer in just 11 weeks?In this episode of Medical Sales U, I sit down with Corey Stewart to break down his incredible career transition.- The "Hospital Cafeteria" Interview: The insane story of how Corey interviewed for Pfizer while his wife was in labor (and still crushed it).- The STAR Method: Watch a live roleplay of how to answer the "Tell me about a time..." question using courage and clinical experience.- Salary Negotiation: Full transparency on the numbers. See how Corey negotiated a $112k offer up to a $158k total first-year package.-Networking Strategy: Why reaching out to the team is more important than reaching out to the manager.If you are a nurse, teacher, or athlete looking to break into Medical Device or Pharma Sales, this will give you some insight.CHAPTERS0:00 - Intro: Meeting Brutus Buckeye & The "Expert of One" Mindset2:15 - Why Leave Nursing? Burnout, Family, and Income8:45 - The Strategy: Networking with Peers vs. Hiring Managers15:30 - Master Class: Using the STAR Method in Interviews (Live Example)24:10 - The "Courage" Story: Challenging a Surgeon in the ICU32:45 - Must See: Interviewing for Pfizer While His Wife was in Labor!40:20 - The "Re-Close": How to Tell Them You Got the Job45:50 - Money Talk: Negotiating Base Salary, Commission, & Relocation ($158k Total)52:10 - Final Advice: Betting on YourselfWANT TO BREAK INTO MEDICAL SALES? Ready to leave the bedside or the classroom and start a 6-figure career? Apply to Medical Sales U today: medicalsalesu.com/ABOUT THE GUEST: Corey Stewart is a former Ohio State "Brutus" mascot, a Cardiovascular ICU Nurse, and now a Pharmaceutical Sales Representative at Pfizer. He successfully transitioned into the industry in just 11 weeks using the Medical Sales U coaching program.#MedicalSales #Pfizer #NurseToSales #SalaryNegotiation #OhioState #BrutusBuckeye #PharmaSales #CareerTransition #InterviewTips #DaveSterrett #MedicalSalesUDisclaimer: The views expressed in this video are those of the speakers and do not necessarily reflect the official policy or position of any other agency, organization, employer, or company.
We talk with Matt Trentini, Principal Software Engineer at Planet Innovation, about using MicroPython for professional embedded development—including medical devices. Matt shares how he was drawn back to embedded development after becoming jaded with traditional C-based workflows, and explains why MicroPython's interactive REPL and rapid development cycle have become game-changers for his team.We explore the practical realities of using an interpreted language on microcontrollers: how Planet Innovation uses it for Class B medical devices, what the performance trade-offs actually look like, and how features like the Unix port enable robust testing. Matt walks us through deployment considerations, explains how to integrate C code when needed, and shares compelling stories about real-time client demos that would be impossible in C++.Whether you're skeptical about high-level languages in embedded systems or curious about alternatives to traditional development workflows, this conversation offers a grounded, engineering-focused look at what MicroPython can—and can't—do in production environments.Key Topics[03:30] Matt's background and why he left embedded development before MicroPython brought him back[08:45] What MicroPython is: a complete re-implementation of Python for microcontrollers with REPL, filesystem, and machine module[13:20] How Planet Innovation introduced MicroPython through an OpenMV vision processing project[17:15] The game-changing power of the REPL for interactive hardware development and testing[21:40] Running MicroPython code on x86 for testing, and the mock machine library approach[26:30] Python library compatibility: what works, what doesn't, and memory considerations[29:50] Integrating C and C++ code through extension modules for performance-critical sections[33:10] Performance realities: 10-100x slower in interpreter, but can always drop to C speed when needed[37:45] Tooling: MPRemote, the magical mount feature, and development workflow[42:20] When NOT to use MicroPython: cost-sensitive high-volume products and resource constraints[45:30] Using MicroPython in Class B medical devices and safety-critical applications[49:15] Garbage collection: simple, predictable, and controllable—can be disabled when needed[52:40] Real-time client demo story: modifying state machines during a call and showing results immediately[56:20] Deployment: frozen code, disabling REPL and filesystem, and OTA considerations[01:01:30] Common mistakes: logic errors and inadvertent allocations rather than memory corruption[01:05:45] Threading, AsyncIO, and the Global Interpreter Lock across different ports[01:08:20] State machine frameworks: StateChart, Yasme, and PyTransitions[01:11:40] Junior developer productivity: faster onboarding compared to C/C++ embedded development[01:15:10] Getting started: board bring-up as an ideal first use case for MicroPython[01:17:50] Hardware-in-the-loop testing as a low-risk way to try MicroPythonNotable Quotes"It's hard to overstate how game changing the REPL is. Particularly as an embedded engineer, once you see that you can interactively talk to a peripheral, you can generate your own I2C, squirt it across and see what the peripheral does with it—suddenly driver development has just become easy to experiment with." — Matt Trentini"My trite answer is that MicroPython is slow—10 to 100 times slower than C in the interpreter. But my flip side answer is that it can always be made as fast as C because you can always drop into C to write things." — Matt Trentini"There was a moment in a recent project where we were discussing the workflow of a state machine with the client, and while we were on a call, another engineer was actually making changes to MicroPython code. Literally a couple minutes after we'd been hashing out the details, they showed the changes in the state machine using the REPL. The client was blown away—in 25 years of development, I have never had that kind of turnaround in C and C++." — Matt Trentini"If you want to make a good friend of your electronics engineers, give them a build of MicroPython that can run on their custom board. In the past, they would typically be waiting for weeks or sometimes months before a software resource could be assigned. Now I can turn around a MicroPython build in a day or two, and they can test I2C, GPIOs, and UARTs themselves." — Matt Trentini"The irony is that the people who have embedded C knowledge are actually the people that can benefit the most from MicroPython. It's like having a superpower—you understand what MicroPython is doing in the background, you know you're just effectively writing a lot less code." — Matt TrentiniResources MentionedMicroPython Official Site - The official MicroPython project website with documentation and downloadsOpenMV - Computer vision project using MicroPython for camera-based applicationsMPRemote - Tool for interacting with MicroPython devices, including the magical mount featurePlanet Innovation - Medical device consultancy using MicroPython in production devicesStateChart - State machine library compatible with Python and MicroPythonYasme - Yet another state machine library developed at Planet InnovationPyTransitions - Popular Python state machine library being ported to MicroPythonCircuitPython - Adafruit's fork of MicroPython with additional features and CPython compatibility focus You can find Jeff at https://jeffgable.com.You can find Luca at https://luca.engineer.Want to join the agile Embedded Slack? Click hereAre you looking for embedded-focused trainings? Head to https://agileembedded.academy/Ryan Torvik and Luca have started the Embedded AI podcast, check it out at https://embeddedaipodcast.com/
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 9.5 weeks, earning $113,760 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026.The episode reflects on a full year of continuous content creation, including:Weekly podcast episodes covering global medical device regulationsIncreased focus on artificial intelligence and its impact on QA/RA rolesEducational initiatives such as EMD Mag, designed to make complex regulatory topics more accessibleDevelopment of digital tools like EasyIFU, labeling automation, and eQMS solutionsExpansion of consulting, back-office services, and international presenceThe discussion also addresses upcoming challenges:Increasing pressure on Notified BodiesRisks for late MDR/IVDR transitionsThe importance of anticipation and regulatory strategy for new and existing manufacturersMore than a recap, this episode is a strategic pause — an opportunity to reflect, learn, and prepare for the years ahead in a rapidly evolving medtech regulatory environment.Who is Monir El Azzouzi?Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice
Start making $150k - $200k+ in your first year of medical sales. Stop chasing crowded "old school" roles like Orthopedics and Spine. The real money—and the life-saving innovation—is in Oncology and Specialty Pharma. Today, I reveal the exact blueprint to reinvent your career and break into the most lucrative sector of healthcare. Whether you're a nurse, a teacher, or stuck in a "middle-class mindset," this episode breaks down why your background doesn't matter. Only your preparation does.I share my personal journey from a non-profit minister making $70k to a high-level oncology rep, and explain why "casual advice" from friends will get you rejected. If you want to master the interview, crush your clinical knowledge, and build a 6-figure life, this is the masterclass you need.WHAT YOU WILL LEARN IN THIS EPISODE:- The "Gold Rush" Shift: Why you should ignore Orthopedics and focus entirely on Oncology, Diagnostics, and Genetic Testing.- The 3 Essential Mindset Shifts: How to move from "winging it" to becoming an obsessively prepared candidate.- Real Success Stories: How Kanika (immigrant to Dallas), Sydney (nurse), and others went from zero experience to $200k roles.- The "Ride-Along" Trap: Why you need a brutal coach, not a nice mentor.- The HEART Framework: The 5 character traits (Humility, Energy, Active Listening, Resilience, Trust) that hiring managers look for.- Confidence vs. Arrogance: How to show "grit" without sounding like a jerk.- Daily Habits of Top 1% Earners: The 5 AM club, the "20 LinkedIn adds" rule, and why your degree (MBA) has a lower ROI than coaching.- The Michael Jordan Rule: Why even the greatest of all time hired coaches for their specific weaknesses.TIMESTAMPS00:00 - Introduction: The Program Focus (Oncology vs. Orthopedics)01:34 - Dave's Story: Reinventing Career from Ministry to Medical Sales03:44 - Success Stories: How Nurses & Immigrants Got Hired (Kanika, Sydney)06:47 - Mindset Shift #1: Be Coachable (Why Friends Can't Help You)09:20 - Mastering Virtual Interviews (Lighting, Camera & Background)10:32 - Mindset Shift #2: Be Curious (Understanding Clinical Trials & FDA)12:32 - Salary Reality: Device Associate ($80k) vs. Oncology ($155k+)13:55 - Mindset Shift #3: Collaboration (Working with MSLs & Nurse Navigators)16:28 - Confidence vs. Arrogance (The "Grit" Trap)18:02 - The H.E.A.R.T. Framework (Humility, Energy, Listening, Resilience, Trust)19:00 - Daily Habits: 5 AM Wake-ups, LinkedIn Strategy & Handling Rejection20:00 - The"Middle Class Mindset" Trap: Why Degrees Have Low ROI22:25 - Using AI for Resumes Without Sounding Like a Robot25:55 - The "Why": Patient Outcomes & Life-Extending Impact29:35 - The 3 Questions You Must Ask Yourself31:01 - The Michael Jordan Analogy: Why Even the Best Hire Coaches.ABOUT MEDICAL SALES U: Medical Sales U is the premier training program for professionals looking to break into high-paying careers in Medical Device, Pharmaceutical, and Genetic Testing sales. We turn "outsiders" into top 1% candidates.CONNECT WITH US: Learn more about coaching and career support at medicalsalesu.com/#MedicalSales #OncologySales #CareerPivot #SalesCoaching #HighIncomeSkills #DaveSterrett #MedicalSalesYou #InterviewTips #SalesJobs #PharmaceuticalSales
Send us a textThis episode is a rerun.Rob Donley has a deep understanding of how engineering works. Kicking off his engineering career from a young age building RC cars and model rockets, he has provided design and leadership capabilities for many companies over the years, and brings to the table not just the ability to design something, but to understand the many facets that accompany development of a new product such as manufacturing, supply chain, financial strategy, and project management. Download the Essential Guide to Designing Test Fixtures: https://pipelinemedialab.beehiiv.com/test-fixtureAbout Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community. The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us
The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability.In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety.The discussion covers:Key shortcomings of the current MDR/IVDR frameworkThe impact on innovation, availability of devices, and SMEsThe eight reform pillars, including proportionality, digitalisation, international cooperation, and improved coordination with EMA and Notified BodiesHow upcoming EU legislation (AI Act, Cybersecurity Act, Biotech Act) will interact with medical device regulationsThis episode provides practical insights for manufacturers, regulatory professionals, and policymakers seeking to anticipate regulatory changes and adapt their strategies accordingly.Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.Links Adam Linkedin: https://www.linkedin.com/in/adam-isaacs-rae/Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter:https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
Are you a nurse or healthcare professional feeling burned out, underpaid, and stuck in a cycle of bureaucracy?Today, I reveal the 3-3-3 Framework: a blueprint specifically designed for bedside nurses who want to break into the high-paying world of Pharmaceutical and Medical Device Sales.If you are tired of missing holidays and hitting a salary ceiling, this episode explains exactly what you actually need to do to land offers like our student Sydney, who went from $68k to a $138k package.IN THIS EPISODE, YOU WILL LEARN:The 3 Reasons to Leave: Why burnout and lack of creativity are signs it's time to pivot.The 3 Barriers: Why relying on your degree and "following orders" kills your chances in sales interviews.The 3 Solutions: How to leverage your clinical edge and tap into the 10,000+ open roles in biotech right now.READY TO LAND YOUR DREAM JOB? Apply to Medical Sales University and learn how we help nurses double their income in 12 weeks: medicalsalesu.com/TIMESTAMPS00:00 - Intro: The shift from Bedside to Sales01:38 - The 3 Reasons healthcare workers are leaving (Burnout & Bureaucracy)03:13 - Why your career growth has stalled04:10 - The 3 Barriers: Why you aren't getting hired yet05:00 - The "Middle Class Mindset" trap (Degree vs. Skills)06:12 - Mindset Shift: From Compliance to Ownership09:18 - The 3 Solutions: How to finally break in10:52 - Success Story: How Sydney landed a $138k Oncology role12:50 - Why mentorship beats doing it aloneABOUT THE HOST: Dave Sterrett is the founder of Medical Sales University, the #1 program helping nurses, PTs, and healthcare professionals break into pharmaceutical and oncology sales.ABOUT MEDICAL SALES U: Medical Sales U is the premier training program for professionals looking to break into high-paying careers in Medical Device, Pharmaceutical, and Genetic Testing sales. We turn "outsiders" into top 1% candidates.CONNECT WITH US:Learn more about coaching and career support at medicalsalesu.com/#MedicalSales #NursingCareer #PharmaSales #NurseBurnout #CareerChange #MedicalDeviceSales #HighPayingJobs #Nurselife
Hey everyone! We're back and we hope you didn't miss us too much. In this episode, we're diving right back in and talking about Medical Devices - what they are, how varied they can be, and how they're regulated (in general terms!) Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It's fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents https://www.fda.gov/media/82395/download https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements https://hollandhoudek.com/implants
Send us a textJoin us on-site at Stryker as we explore the world of packaging engineering with Eric Richins, a packaging engineer with 10 years of experience in the industry. In this insightful interview, Eric discusses the various aspects of packaging from primary to tertiary, highlighting the importance of packaging in maintaining product sterility and efficiency in production. He shares intriguing details about the automation of packaging processes, the regulatory challenges faced, and the critical role packaging plays in the medical device industry. Eric offers a behind-the-scenes look at the complexities of packaging engineering and what it takes to ensure seamless operations. Tune in to learn about the nuances of this often-overlooked field and the unique skills required to excel in it.Aaron Moncur, hostAbout Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community. The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us
Episode 329 hosts Dr Ferial Fanian (Dermatologist from Paris, France) In our 'Masterclass Series' we host global experts to teach us about fillers, bio-stimulators, bio-remodellers, polynucleotides, exosomes and other products. (For toxin insights, check out our other mini-series, 'The Tox Talks') In Chapter 11 we go on a deep dive into the science of 'biostimulation' . With collagen stimulation now a seemingly generic term used for many new products launched, we aim to differentiate how these products can be classified and how they actually biostimulate. We also cover some basics of daily skincare, skin analysis, skin hydration and the history of NCTF (New Cellular Treatment Factor 135 HA). 00:00 Introduction 00:40 Special Guest: Dr Ferial Fanian 01:06 Event Experience and Masterclass Topic 01:52 Dr Ferial's Background and Expertise 02:55 Role with Filmed and Clinical Practice 05:56 Understanding Biostimulation 08:44 Categories of Biostimulation Products 18:10 Skin Health and Analysis 25:03 Patient Consultations and Objective Measurements 25:29 The Importance of Quantification in Dermatology 25:49 Investing in Medical Devices 25:58 Budgeting for Equipment 26:19 Community and Support for Injectors 27:12 Priming vs. Biostimulation 28:10 Daily Skincare Routine 28:37 The Role of Hydration and Defense in Skincare 29:48 Adapting Skincare to Seasons and Hormonal Changes 30:42 The Importance of Changing Skincare Products 33:19 Cosmeceuticals and Priming 33:45 Injectables and Hydration 34:55 Understanding NCTF and Cellular Scaffolds 41:05 The Role of Hyaluronic Acid in Skincare 48:23 Future of Injectable Products 50:07 Conclusion and Final Thoughts SUBSCRIBE TO OUR ONLINE PLATFORM FOR WEEKLY EDUCATION & NETWORKING CLICK HERE TO BROWSE OUR IA OFFERS FOR DISCOUNTS & SPECIALS CLICK HERE IF YOU'RE A BRAND OR COMPANY & WANT TO WORK WITH US CLICK HERE TO APPLY TO BE A GUEST ON OUR PODCAST CONTACT US
NASA work produced a wool filter that is effective at removing particulates in high-moisture environments, making it the perfect choice for medical devices.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down Dr. Adam Kadlec, practicing urologist and co-founder of Rivermark Medical.Rivermark is a clinical-stage company developing FloStent, a first-line, reversible device therapy for benign prostatic hyperplasia (BPH).Before launching Rivermark, Adam built a thriving urological practice in Milwaukee and consulted for several device companies — experiences that ultimately revealed how early true device development begins and why physicians rarely get the chance to influence innovation upstream. Partnering with medtech operator Andy Doraiswamy, Adam transitioned from clinician to CEO and is now leading Rivermark through its pivotal trial.In this interview, Adam shares why workflow integration is one of the most overlooked drivers of adoption, how physician-innovators can build the right decision-making infrastructure, and why understanding who actually enrolls patients at clinical sites can make or break a trial. He also touches on the mindset required to stay resilient through the ups and downs of building a medtech startup.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Adam Kadlec.
Are you trying to break into medical sales but stuck deciding between Pharmaceutical and Medical Device? Or maybe you're curious about the high-growth world of Diagnostics and Genomics?Today, we discuss the differences in pay, lifestyle, and entry-level requirements for each path. Whether you want the adrenaline of the Operating Room or the stability of a $130k+ base salary in Pharma, this episode covers the 12 key distinctions you need to know before applying. IN THIS EPISODE YOU WILL LEARN:The Personality Test: Why "Engineers" love Device and "Scientists" love Pharma.The Paycheck: Real breakdown of base salaries vs. uncapped commissions.The Hidden Third Option: Why Oncology Diagnostics/Genomics might be the "Goldilocks" career path.Work-Life Balance: The reality of on-call surgical hours vs. the 9-to-5 pharma life.Success Stories: How a nurse (Sydney) and an immigrant (Kanika) broke in with $150k-$200k packages.READY TO BREAK IN? If you are struggling to get offers or don't know where to start, we help people from all backgrounds (nurses, coaches, teachers) launch their medical sales careers.Apply to Medical Sales U at medicalsalesu.com/TIMESTAMPS:00:00 - Intro: The common dilemma (O.R. vs. Samples).01:06 - The 3 Paths: Pharma, Device, and Diagnostics.02:15 - Science vs. Engineering: Which fits your brain?04:35 - Salary Reveal: Entry-level Pharma Pay ($95k-$135k base).06:10 - The "Associate" Role: Why Device base pay starts lower.07:40 - The Top 1%: Earning potential ($300k - $750k).09:15 - Diagnostics Pay: The sweet spot?10:30 - The Sales Process: Who are you actually selling to?13:50 - Lifestyle Check: Early mornings vs. Family flexibility.17:15 - Career Advancement: From Rep to Regional Director.22:15 - Student Success: From $68k to $200k total comp.ABOUT MEDICAL SALES U: Medical Sales U is the premier training program for professionals looking to break into high-paying careers in Medical Device, Pharmaceutical, and Genetic Testing sales. We turn "outsiders" into top 1% candidates.CONNECT WITH US:Learn more about coaching and career support at medicalsalesu.com/#MedicalSales #PharmaceuticalSales #MedDevice #SalesCareer #DaveSterritt #CareerAdvice #HighPayingJobs #SalesTips
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Government Accountability Office (GAO) Podcast: Watchdog Report
The Food and Drug Administration (FDA) is responsible for overseeing the safety of medical devices sold in the U.S. and issuing recalls when they're found to be unsafe. But recent headlines and high-profile lawsuits have drawn attention to the…
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 9.5 weeks, earning $113,760 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
MedboardEurope48% disruption in the EU - I hope you are all healthy: https://health.ec.europa.eu/document/download/13b2c812-b144-4489-af1f-e76af5bc97fd_en?filename=md_availability_study_presentation_2024.pdfConsultation: SCHEER asks you - Are Brain Stimulators for non-medical purpose dangerous: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-scientific-opinion-health-hazards-and-risks-associated-use_enQ&A Medicines used with Medical Devices - Revision 6 with new questions: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdfEUDAMED is Mandatory - From 28 May 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502371 - https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_enUKBetter Call MHRA - But we don't consult: https://www.gov.uk/guidance/medical-devices-get-regulatory-advice-from-the-mhraStandardISO 10993-1 mutation - Nothing is automatic anymore: https://www.youtube.com/watch?v=AkSZVNSz5a0ISO 18969 draft - Comments until 28-01-2026: https://www.youtube.com/watch?v=zCR9HlHJ5l0EasyIFUCreate your Labels with EasyIFU - UDI included: https://easyifu.comRest of the WorldArgentinaArgentina: Simplified application - Class I/A or Class II/B: https://www.argentina.gob.ar/noticias/anmat-establece-un-regimen-simplificado-para-la-habilitacion-de-establecimientos CanadaCanada: Modernization of the MDEL - Some changes: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-modernizing-mdel-framework-phase-ii.htmlCanada: Medical Device License Application - Guidance on how to do it: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/managing-applications-licenses.htmlBrazilBrazil: Digitalisation of Certificates - You can request that online now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-lanca-nova-ferramenta-para-emitir-certificados-de-dispositivos-medicosPodcastPodcast Nostalgia - Let's review previous podcastsEpisode 363 - The journey of a CRO with Helene Quie: https://podcast.easymedicaldevice.com/363-2/Episode 364 - What is changing with the new ISO 10993-1 with Marina Daineko: https://podcast.easymedicaldevice.com/364-2/Episode 365 - How to become a Lead Auditor with Rob Packard: https://podcast.easymedicaldevice.com/365-2/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice
HSBC Innovations is the global bank's financing arm for American and European startups, especially in the healthcare and life sciences industries. The bank's semi-annual Venture Healthcare Reports document trends in the investment market.Key Tech's Andy Rogers welcomes the report's author, HSBC Innovation Managing Director Jon Norris in Episode 43 of the MedTech Speed to Data podcast.Need to know· Four core market segments — HSBC Innovation's Venture Healthcare Reports cover investments and exits in Biopharma, Dx/Tools, Med Device, and Healthtech.· Sourcing investment data — Norris enriches Pitchbook data with additional structure and analyses, making the report more relevant to these market segments.· Sourcing exit data — Norris supplements media and industry publications with market research and conversations with industry leaders.· An investment data tapestry — The reports provide “an honest picture of what's going on in the market” so investors and innovators alike “can make targeted smart decisions.”The nitty-grittyAndy and Norris discuss the investment market's recent history before exploring drivers of today's investment headwinds.“2021 was a record-setting year,” Norris recalls. “Every record that could be set for deals and dollars was set across all the sectors.” Things changed in 2022 as new BioTech IPOs struggled, prompting investment reprioritizations.“VCs had done all these… frothy valuations,” Norris says. “They had to go back and look at their own portfolios and say, does this company have enough capital? How do you want to put money to work?”Investments rebounded in 2024, but not the number of deals. Investors poured money into their existing portfolios to boost their exit chances, resulting in today's nine-figure megadeals.“Basically, they're smooshing two rounds together and extending the investors coming in to support that round,” Norris says.Headwinds stiffened in 2025 as tariffs, a more litigious competitive space, and other factors amplified business uncertainty.Norris attributes this progression to the psychology of venture capital. “When you think about what makes these folks tick,” Norris explains, “they want to continue to raise new venture funds because they get paid management fees. But in order to raise their new venture funds, they have to show their investors that they've actually gotten returns.”That means reaching an acquisition or IPO. “They're very focused on getting to exit right now. That's why they're so focused on their existing portfolio. And because of that, they haven't been doing as many new investments.”New investments still happen, of course, but the criteria have changed. “While the dollars are actually up in some of these sectors, especially Med Device,” Norris says, “you're seeing that being put to work on later-stage deals because they'd rather get a shorter time to exit.”Data that made the difference:Norris' insights from the HSBC Venture Healthcare Report let him advise startups fighting today's investment headwinds.Adopt a megaround mentality. “Series B has been extremely difficult,” Norris says. “[Raising] sub two million, that's one thing. But if you're looking to raise five million, it's almost better to raise twelve.”Find investors outside the mainstream. “Traditional venture investors don't want to write small checks.” Norris sees angel groups, innovation centers, and other small investors funding these early rounds.Explore acquisition exits, but be careful. “On the device side, most of the corporates have been pretty darn active,” Norris says. However, some litigate to block emerging competition, especially in the Dx/Tools sector. Norris' recommends researching potential acquirers before taking meetings.Download the HSBC Venture Healthcare Report for Norris' complete analysis, and watch the video below for insights into the Medical Device and Dx/Tools sectors, AI's role in MedTech, and more.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Andrew Holman, MD, CEO of Inmedix. Inmedix is commercializing CloudHRV, an FDA-cleared diagnostic that quantifies biological stress with clinical precision to guide treatment decisions in autoimmune disease and beyond.Andrew is a practicing rheumatologist in Seattle with 25 years of clinical and research experience. His discoveries linking autonomic dysfunction to autoimmune disease outcomes led to a $10 million patent sale to Boehringer Ingelheim. After a decade in retirement, he returned to found Inmedix and pioneer the field of immuno-autonomics — preparing the market for his technology years before launch.In this interview, Andrew shares how to build a category before commercializing a product, why clinical evidence creates competitive moats that money can't replicate, and how to raise capital from angel investors by understanding what they actually care about.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Andrew Holman.
If you are making it to the panel interview but still getting those automated "Thanks but no thanks" emails, you are likely making one of these 3 fatal mistakes.In this episode, we reveal why high-achievers like nurses, D1 athletes, and experienced VPs fail to break into Pharma and Medical Device sales. WHAT YOU WILL LEARN IN THIS EPISODE:- The "Immature Enthusiasm" Trap: Why being a "go-getter" isn't enough and the specific clinical research you MUST do before the first phone call.- The LinkedIn Strategy: Stop using LinkedIn like a digital resume. Learn the "20-Person Rule" and how to message hiring managers without being annoying.- The "Guard Down" Mistake: Why you are failing the field ride and peer interviews (and why you should never relax around potential colleagues).CHAPTERS (Jump to the section you need):0:00 - Intro: Why talented people get rejected01:50 - Mistake #1: You Didn't Do the Research (FDA, Clinical Trials, Competitors)04:44 - Immature Enthusiasm vs. Professional Readiness05:12 - Mistake #2: You Are Using LinkedIn Wrong (Stop asking to "Pick their brain")06:35 - The "20-Person" LinkedIn Strategy12:33 - Mistake #3: You Are Not Networking Correctly (The "Invisible" Applicant)13:43 - Warning: The "Guard Down" Trap with Peer Reps ABOUT MEDICAL SALES U: Medical Sales U is the premier training program for professionals looking to break into high-paying careers in Medical Device, Pharmaceutical, and Genetic Testing sales. We turn "outsiders" into top 1% candidates.CONNECT WITH US:Learn more about coaching and career support at medicalsalesu.com/#MedicalSales #PharmaceuticalSales #CareerAdvice #SalesInterview #MedicalSalesU #JobSearchTips #LinkedInStrategy
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
On this episode of SPOT Radio, Charlie Webb, CPPL, breaks down five common mistakes medical device manufacturers make around equipment purchase, maintenance, and calibration. These gaps create significant process risk and are frequent root causes of failed seals in sterile barrier systems.Charlie draws on 30 years of experience in medical device packaging to explain how improper procurement choices, inconsistent maintenance schedules, and inadequate calibration practices undermine seal integrity and increase the likelihood of product recalls and patient risk. He outlines practical steps to tighten controls, improve documentation, and design validation protocols that reduce failure modes.Listen in for clear, actionable guidance on preventing seal failures, streamlining validation, and protecting patients from exposure to non‑sterile devices. Whether you manage packaging engineering, quality, or regulatory affairs, Charlie's insights will help your organisation avoid costly mistakes and strengthen your sterile barrier strategy.About Charlie Webb CPPL: Charlie Webb CPPL is the founder and President of Van der Stahl Scientific, a medical device packaging and testing machine provider and packaging testing and calibration laboratories.He is also a certified internal auditor and is the Quality Manager for Van der Stähl Scientific's demanding ISO/IEC 17025 Laboratory accreditation. Under Charlie's quality management system, his lab received the MSI Continuous Improvement Award. Charlie is a member of the IOPP Medical Device Packaging Technical Committee. He is a former co-PM in the Kiip group and voting ASTM F02 technical committee and has multiple granted and pending patents on medical device packaging machinery and pouch testers.His current patent-pending technologies include a medical device tray sealer that will integrate pouch testing within the packaging machine to provide 100% real-time seal testing. Also, in development is his patented HTIP system (human tissue isolation pouch) this disposable system is designed to help avoid packaging machine contamination.Charlie Webb CPPL Email: Charlie@vanderstahl.comwebsite: www.vanderstahl.com
Podcast: Error Code (LS 27 · TOP 10% what is this?)Episode: EP 76: Why Security Certs for New Medical Devices Might Just WorkPub date: 2025-11-26Get Podcast Transcript →powered by Listen411 - fast audio-to-text and summarizationDiversity in healthcare devices complicates segmentation, security controls, and zero-trust approaches. New certifications aim to help. Bob Lyle, CRO of Medcrypt, identifies how layered defenses, rigorous cybersecurity requirements for new devices, continuous monitoring, and dark-web credential surveillance can reduce risk.The podcast and artwork embedded on this page are from Robert Vamosi, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
In this episode of the Medical Sales Podcast, Samuel sits down with endoscopy leader and author Jon Alwinson to break down what makes GI and ASC sales one of the most predictable, high-impact spaces in medical devices while unpacking Jon's journey from failed entrepreneur to Stryker associate, rookie-of-the-year rep, and now ASC leader at Boston Scientific. Jon shares the systems that drive top-tier performance—true pre-call planning, zoning a territory with precision, and running each week with a focused attack list—while also exposing the pitfalls that hold reps back, from fear and negative self-talk to time-wasting habits and hiding in comfortable accounts. Samuel and Jon dive deep into identity, mindset, and mentorship, exploring how the best reps stay confident, stay disciplined, and stay out of their own heads. If you want a tactical, honest look at what it takes to thrive in medical sales and lead with excellence, this episode delivers it. Connect with Jon Alwinson: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How »
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Colby Holtshouse, President and CEO of May Health.May Health is developing a minimally invasive ovarian ablation therapy designed to restore ovulation in women with polycystic ovary syndrome (PCOS) and PCOS-related infertility.Before May Health, Colby served as Global Medtech Commercial Lead at Organon, overseeing the worldwide launch of the Jada System following Organon's acquisition of Alydia Health, where she held roles including COO, Interim CEO, and VP of Marketing. She has also held leadership positions at Pelvalon, AccessClosure, Medtronic, and Guidant.In this discussion, Colby shares why early clinical evidence should be built in focused layers rather than oversized, all-at-once trials. She explains how a small, deliberate early launch can reveal the workflow nuances and real-world expectations no study ever captures. And she outlines why founders should define the raise first — and how clarity, preparation, and a deep understanding of strategic partners can dramatically accelerate the fundraising process.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Colby Holtshouse.
Recently I sat down with two true pioneers of the medical device industry — Gregory L. Peel and David “Dino” Harris Jr. — to talk about the book that's already inspiring the next generation of MedTech talent.Greg's new book, The Pivot Point, captures the stories of 16 African-American trailblazers who built careers in an industry almost no one knew existed when they started. Their stories of grit, door-knocking, resilience, and career pivots are pure gold for anyone in (or trying to break into) medical device sales.In this episode we talk about:• How pioneers navigated being the first in a territory• Why most people still don't know this industry exists• The Mayo Stand test — the real scoreboard for reps• The “door-knock theory” and why rejection is a skill• Why you must build multiple income streams• How a single career pivot can change an entire life trajectoryWhether you're a junior rep, a veteran leader, a transitioning athlete or veteran, or someone trying to break into medical sales — this conversation is a roadmap.RESOURCES
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Diversity in healthcare devices complicates segmentation, security controls, and zero-trust approaches. New certifications aim to help. Bob Lyle, CRO of Medcrypt, identifies how layered defenses, rigorous cybersecurity requirements for new devices, continuous monitoring, and dark-web credential surveillance can reduce risk.
Can you imagine a world in which a wearable device, like a smartwatch, could move your fingers to strum the guitar or play the drums? That kind of technology is part of the innovative research coming out of the Human-Computer Integration Lab at the University of Chicago, led by renowned computer scientist Pedro Lopes. His lab is developing a new generation of gadgets that use haptics (or tactile sensations like the buzz of your smartphone) to move your body, replicate your sense of smell and even make you feel things.In this episode, Lopes explores the potential of wearable devices to transform our future as well as brain-computer interfaces that are being developed by companies like Elon Musk's Neuralink that directly into the body. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
In this week's episode of Parallax, Dr Ankur Kalra welcomes Dr Courtney Maxey-Jones, Director of the Coronary Care Unit at Upstate University Hospital and a cardiac anesthesiologist intensivist by training. Dr Maxey-Jones co-founded and serves as Chief Operations Officer of GOMED, a not-for-profit organization transforming how we think about medical device waste and global healthcare equity. Dr Maxey-Jones shares the origin story of GOMED - born from witnessing the staggering waste generated in cardiac operating rooms, where expensive single-use devices are discarded due to expiration dates or changing surgeon preferences. Together with her partners, cardiac surgeon Dr Farhan Nadeem and physician assistant Connor Wasilnak, they recognized an extraordinary opportunity to make use of these waste items. Dr Kalra and Dr Maxey-Jones examine the ethical complexities of equipment reuse, the critical unmet needs for EP devices and cath lab equipment internationally, and GOMED's innovative partnership with Syracuse University biomedical engineering students to develop low-resource autoclaves. This episode reveals how observation of systemic waste evolved into a sustainable model for global cardiovascular care equity. Questions and comments can be sent to "podcast@radcliffe-group.com" and may be answered by Ankur in the next episode. Host: @AnkurKalraMD and produced by: @RadcliffeCardio Parallax is Ranked in the Top 100 Health Science Podcasts (#48) by Million Podcasts.
Today we're excited to welcome Navin Dewagan, the CEO of Boston-based Digital Health Solutions.Digital Health Solutions acts as the innovation partner for medical device and healthcare firms. Navin and his team help healthcare solution providers accelerate their medical products to market by leveraging years of domain expertise in IoT and cloud development, cybersecurity, mobile development and embedded software development for healthcare applications. Digital Health Solutions offers end-to-end software product expertise, from ideation to design & development, re-engineering, testing and verification & validation. Plus, with a range of services that's close to our heart at Qualio, the team offers comprehensive quality and compliance support to help customers meet the complex regulatory demands of standards like IEC 62304, ISO 13485 and ISO 14971. Qualio website:https://www.qualio.com/ Previous episodes:https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Wendy Mackenzie Pease, President of Rapport International, interviews Alain Tranchemontagne, CEO of Alleviate, whose 30+ years in medical devices spans start-ups to Fortune 50 organizations. He has led teams across 5 continents, has held commercial and general management positions, and brings significant global experience in the areas of product and market development. He shares practical, battle-tested ways to enter new markets, build culturally diverse sales engines, and lead with data (and humility) across continents. You'll learn how to: Build global demand the right way: Identify and activate credible KOLs, hire a local “anchor” leader, measure activity early, and make fast keep/replace decisions—while respecting culture and language on the ground. Run a 90-day turnaround playbook: Weeks 0–12 = listen widely (patients, clinicians, data), co-create objectives with the team, then double down on what works using “data density” (lots of signals to see real patterns). Go international without missteps: Sequence markets, map regulations and evidence needs, prioritize IP/trademarks, and treat translation as a regulated, technical task for pros—because “good enough” localization will bite you.
Former top medical device rep, Andrew Norden, joins Jordan to reveal the financial pitfalls most reps don't see coming — from job-change 401(k) rollovers to employer-stock risk, emergency funds, insurance gaps, and planning for retirement in a volatile industry. After 20 years in medical device and now a wealth advisor, Andrew offers practical, real-world guidance to help reps protect their income, build security, and create a long-term financial plan they can trust.RESOURCES
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Kaitlin Maier, co-founder and CEO of Reia. Reia has developed a self-managed pessary — a collapsible device that empowers women to treat pelvic organ prolapse comfortably and independently. A mechanical engineering graduate of Dartmouth, Kaitlin previously worked at Sherpa Technology Group, developing patent strategies for leading life science and technology firms. In this conversation, Kaitlin shares how she and her co-founders turned a student project into an FDA-cleared product using resource constraints as a design advantage. She explains how to turn FDA feedback into forward momentum, why running an NIH-funded randomized controlled trial (RCT) strengthened both credibility and confidence, and how non-dilutive funding can buy the time and control founders need to build on their own terms.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Kaitlin Maier.
Antoine Pivron, Vice President of Health Solutions in the B2B division at Withings, highlights the clinical-grade connected devices that are changing the remote patient monitoring market. The equipment and AI-enhanced tools are designed to focus on personalized patient engagement and retention, ultimately leading to improved health outcomes. The data made available identifies trends over time, allowing for intervention when necessary, and is presented in a form that emphasizes prevention rather than reaction. Antoine explains, "We are very well known for our connected devices, especially the weight scales. So we were the first company back in 2009 to develop a connected weight scale, and now we are the leader in this field, mainly in Europe and in the US. So I think we might have the broadest ecosystem of connected devices to be honest, on the market. So we have weight scales, but we also have blood pressure monitors, activity trackers with smart watches. We also have urine analyzers that we're going to launch next week, actually. We really do have a huge range of products that can be used at home to remotely monitor patients." "They're actually analyzing the trends over weeks, months, and they have an intervention when there is something that is not going in the right direction. So it's more about managing alerts if needed. For instance, in chronic heart failure, most remote patient monitoring programs, doctors manage alerts only. And for obesity care, it might be like coaches or nutritionists having a one-time a week or a one-time a month video call with the patient, and they're just managing the trends. So it's not about being in constant alert, it's about having more data to help them make the right decision." #Withings #DigitalHealth #RemoteMonitoring #ConnectedDevices #MedTech withings.com Download the transcript here
Antoine Pivron, Vice President of Health Solutions in the B2B division at Withings, highlights the clinical-grade connected devices that are changing the remote patient monitoring market. The equipment and AI-enhanced tools are designed to focus on personalized patient engagement and retention, ultimately leading to improved health outcomes. The data made available identifies trends over time, allowing for intervention when necessary, and is presented in a form that emphasizes prevention rather than reaction. Antoine explains, "We are very well known for our connected devices, especially the weight scales. So we were the first company back in 2009 to develop a connected weight scale, and now we are the leader in this field, mainly in Europe and in the US. So I think we might have the broadest ecosystem of connected devices to be honest, on the market. So we have weight scales, but we also have blood pressure monitors, activity trackers with smart watches. We also have urine analyzers that we're going to launch next week, actually. We really do have a huge range of products that can be used at home to remotely monitor patients." "They're actually analyzing the trends over weeks, months, and they have an intervention when there is something that is not going in the right direction. So it's more about managing alerts if needed. For instance, in chronic heart failure, most remote patient monitoring programs, doctors manage alerts only. And for obesity care, it might be like coaches or nutritionists having a one-time a week or a one-time a month video call with the patient, and they're just managing the trends. So it's not about being in constant alert, it's about having more data to help them make the right decision." #Withings #DigitalHealth #RemoteMonitoring #ConnectedDevices #MedTech withings.com Listen to the podcast here
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Somer Baburek, CEO and co-founder of Hera Biotech. Hera is developing AI-driven tissue diagnostics for conditions that disproportionately affect women, including endometriosis and cervical cancer.Before launching Hera, Somer spent nearly a decade in venture capital, where she evaluated early-stage medtech startups and learned what separates the survivors from the rest.In this conversation, Somer explains how Hera designed global clinical pathways that balance cost and credibility, why boutique CROs can outperform big names, and how a pre-commercial startup completed three strategic acquisitions using equity and brand trust rather than cash.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Somer Baburek.
MedBoard EU Joint clinical assessment procedure - EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086 Team-NB position paper on Companion diagnostics - Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf MDR and IVDR put at risk transplantation - Donor Screening and SoHo preparation: https://www.edqm.eu/documents/52006/162284/PA-PH-TO%20%2824%29%2018%20%E2%80%93%20Risks%20to%20safety%20and%20quality%20in%20donor%20screening%20and%20SoHO%20preparations%20due%20to%20poor%20implementation%20of%20the%20MDR%20and%20IVDR%20%E2%80%93%20CD-P-TO%20Position%20paper%20%E2%80%93%20October%202025.pdf/51d5efb2-4611-13ad-76a0-b5710b371248 Dedicated proportionate regulatory pathway for Niche fields Article 5(5.g) requirements to the highest risk categories (Health institutions to create documentation for the products) Update of MDCG guidance on In-house devices to better reflect the operational reality. Off-label use and RUO are not falling on Article 5.5 so grey zone. Team-NB proposal for MDR & IVDR - 5 topics on the agenda: https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/ Early dialogue: Use of this to talk to Notified Bodies Article 61.10 & WET: Update for more clarity. Narrow the scope. Digitalisation: Machine readable documents, AI to support simulations to reduce Animal testing. Coding for MD and IVD Designation and recertification: For Notified Bodies Breakthrough: Coordinated pathway with challenge to generate Clinical Data. Notified Bodies Count - S New comers for MDR and IVDR: SGS Fimko oy (IVDR 19): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1016921 ICIM S.P.A. (MDR 51) : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43747&filter=notificationStatusId:1 Notice (MDR): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1020121 Standards New Harmonized Standards - Clothing and sterilisers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502078 Biocompatibility ISO TS 23485: https://www.linkedin.com/posts/melazzouzi_iso13485-iso-medicaldevice-activity-7393773266689228801-d7LM?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI UK Reliance with US FDA - Harmonization is ongoing: https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai Service eIFU with free access -Test it and let us know : https://Easyifu.com eQMS for a structured Quality Management System - Get your demo: https://eqms-smarteye.com/ Magazine eMagazine . EMD Mag Free- Are Notified Bodies still the right model: https://easymedicaldevice.com/emd-mag/ ROW US FDA: Pre-RFD -:Combination product: https://www.fda.gov/media/189466/download US FDA: QMSR guidelines -: How to create a QMS: https://www.fda.gov/media/189345/download PODCAST Podcast review - What happened in October 2025 Episode 357 - Highlights from La Rentrée du DM 2025: https://podcast.easymedicaldevice.com/357-2/ Episode 358 - Clinical Evidence under EU MDR - Why so many dossier fail (And how to fix it): https://podcast.easymedicaldevice.com/358-2/ Episode 359 - Real World Evidence - How to use it right for FDA and EU: https://podcast.easymedicaldevice.com/359-2/ Episode 360: US Government Shutdown - What FDA can still be doing? Rob Packard: https://podcast.easymedicaldevice.com/360-2/ Episode 361 - Automatisation of your QA RA Job with AI - Hatem Rabeh: https://podcast.easymedicaldevice.com/361-2/
This episode features Steven Martin, Chief Technology Officer at TRIMEDX, who shares how health systems can move beyond AI hype to achieve measurable results in medical device management. He discusses the importance of quick ROI, strong governance, and responsible innovation to optimize operations, reduce risk, and align technology with each organization's unique care philosophy.This episode is sponsored by TRIMEDX.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
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