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On this episode of the SPOT Radio podcast, Charlie Webb CPPL speaks with Jeff Devich BSME, MBA about the Sterile Start™ program, together they break down why so many medical device manufacturers struggle with the complexity of the ISO 11607 framework and how gaps in understanding can lead to costly delays, failed validations, and audit findings. They share real world insights, practical strategies, and clear explanations that help teams strengthen their sterile packaging programs and avoid common pitfalls.About Jeff Devich BSME, MBAJeff's background includes serving as Director of Operations for a combination of device contract manufacturers. He has extensive experience in equipment and process validation within the MedTech industry. Jeff applies his mathematic and engineering expertise to for the Sterile Start™ program creating Design of Experiments and characterization reports for Van der Stähl Scientific sealers, helping customers understand how process parameters affect their specific products. Email me: jeffrey.devich@gmail.comLinkedIn: https://www.linkedin.com/in/jeffrey-devich-1b6b2788
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Karthik Ganesh, CEO of OnMed.OnMed is the healthcare technology company behind OnMed CareStation, a “Clinic-in-a-Box” designed to expand access to primary and urgent care. Before OnMed, Karthik served as CEO of EmpiRx Health, leading the company through rapid growth and a successful private equity transaction in 2021. Throughout his career, he's held leadership roles at QualCare, CareAllies, and Aetna, and advised healthcare organizations through Deloitte and EY.In this interview, Karthik discusses why hybrid care models still require a human touch, how enterprise healthcare buyers evaluate value propositions differently, why brand and culture should shape execution early, and how operating under constraints can sharpen innovation.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Karthik Ganesh, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:04) - Karthik's obsession with healthcare access, and the “broken doorway” problem behind OnMed (05:51) - How OnMed combines telemedicine and brick-and-mortar care into a “Clinic in a Box” (09:04) - The OnMed metrics that surprised Karthik most, including a 37% patient return rate, and the reasons behind the company's success (09:22) - What OnMed designed differently after realizing that patients approach healthcare with their guard up (15:27) - The pitfalls of B2C healthcare and how OnMed was built as a B2B company by intention (22:01) - How Karthik reshaped OnMed around clarity, structure, and high performers (30:23) - What “brand” actually means to Karthik (39:37) - How OnMed tailored its value proposition for payers, providers, employers, and universities (45:45) - Karthik's fundraising philosophy: constraints keep companies inventive
Heart of the Deal: The Insider's Guide to Medical Device Sales Success by Dr. Joseph DeAngelis, Kevin Matthews https://www.amazon.com/-/he/Heart-Deal-Insiders-Medical-Success/dp/B0FJB2R9KM Getheartofthedeal.com What if we told you there’s a sales career where rookies routinely earn more than seasoned lawyers and top performers make more than most doctors? You’d probably think we were selling you a get-rich-quick scheme. But we’re not. We’re talking about medical device sales. Global business consultant Dr. Joseph DeAngelis and medical device marketer Kevin Matthews have teamed up to introduce you to a high-stakes, high-reward world where mastering “Clinical Currency”–the unique blend of medical knowledge, sales savvy, and relationship capital that top performers leverage–will lead to unparalleled success. CV5Heart of the Deal offers the first-of-its-kind playbook for dominating the medical device sales landscape–whether you’re a newcomer looking to break in or a veteran aiming to join the seven-figure earners club.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Dr. Connie Lehman, founder and CEO of Clairity.Clairity is the first FDA-authorized AI platform that predicts a woman's five-year risk of developing breast cancer using only a routine screening mammogram.A physician scientist with over 300 peer-reviewed publications, Connie is a Professor of Radiology at Harvard Medical School and Breast Imaging Specialist at Massachusetts General Brigham (on leave). She holds an MD and PhD from Yale and was named to Forbes' 50 Over 50 Innovators and TIME 100 World's Most Influential Leaders in Health.In this interview, Connie discusses her experience translating academic research into a commercially viable startup, the massive undertaking of generating clinical evidence when you're creating a new category, and how Clairity is approaching adoption on two fronts: fitting into physician workflows and building access pathways for patients.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Connie Lehman, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:04) - The broken screening paradigm Connie saw in clinic — and the gap that became Clairity (05:09) - How Clairity rolls the clock back from detection to predicting risk in healthy women (07:31) - Why "more data is better" turned out to be wrong and how that shaped Clairity's product scope (21:57) - How physicians can translate grant-generating discipline into building a company (24:56) - What 18 months of pre-sub meetings revealed about navigating a de novo pathway (26:49) - Why Clairity validated its technology in over 250,000 mammograms when FDA required far less (34:43) - How Connie flipped the natural question from "how can doctors offer this?" to "how can women access it?" (43:47) - How relationships, not pitches, drove Clairity's $43M Series B
Send us Fan MailAmelia Howe is a biomedical engineer and R&D project manager whose career spans startups, research labs, and established medical device companies. She currently leads cross-functional development programs at COLTENE, where she coordinates teams across engineering, quality, regulatory, and manufacturing to bring new medical devices from concept to international launch.Amelia's journey into engineering began with a pivotal shift early in her academic career. While studying at The University of Akron, she transitioned from nursing to biomedical engineering after discovering the field through biomechanics research. Working in Dr. Brian Davis's lab, she contributed to innovative research on shear forces and biomechanics, helping analyze how human movement affects pressure and stress on the body.After graduating summa cum laude, Amelia joined Neuronoff, Inc. as its first employee. In the fast-moving startup environment, she wore nearly every hat imaginable—conducting research, developing prototypes, establishing quality systems, and contributing to core patents. She played a key role in the early development of the Injectrode neuromodulation technology while helping build the company's quality management system toward ISO 13485 compliance.Over time, Amelia gravitated toward project leadership, recognizing that even highly talented engineers need structured coordination to ensure complex products make it through development. She moved into project management roles, overseeing multiple technical programs simultaneously and aligning engineering, regulatory, and business teams around clear timelines and milestones.Today, in addition to her role at COLTENE, Amelia is launching Chrysalis Business Consulting, where she provides project management and business development support to medical device startups. With both an engineering background and an MBA from Quantic School of Business and Technology, she brings a rare perspective that blends technical depth with strategic business insight. LINKS:Amelia Howe LinkedIn: https://www.linkedin.com/in/ameliaehowe/Company website: https://www.linkedin.com/company/chrysalis-business-consulting-llc/Aaron Moncur, host Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus
Are you frustrated that your clinically sound medical devices aren't gaining traction in healthcare?In this episode, we challenge the notion that clinician agreement equates to adoption. You'll learn that adoption is a complex behavioral change that requires understanding multiple roles and barriers.By listening, you'll discover:The key barriers to adoption and how to address them effectively.The importance of tailoring your evidence story for different audiences.Actionable steps to create a behavior change plan for your medical device.Tune in now to transform your medical device strategy and enhance clinician adoption!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
A medical device's intended use is not just a regulatory formality — it is the foundation of the entire product strategy.In this podcast episode, Monir El Azzouzi speaks with Karandeep Badwal about how intended use influences classification, clinical evaluation, risk management, labeling, and ultimately market access.The discussion explores why many companies underestimate the importance of intended use and how poorly written statements can create major downstream regulatory problems. From Software as a Medical Device (SaMD) to AI-driven products, the episode highlights real-world examples where unclear intended use created challenges during certification and compliance activities.The episode also provides practical guidance for manufacturers on:Defining a robust intended use statementAligning intended use with clinical evidence and risk managementAvoiding “labeling tricks” that may trigger regulatory scrutinyBuilding internal collaboration between regulatory, clinical, and product teamsThis is an essential discussion for MedTech startups, QA/RA professionals, and manufacturers navigating MDR, IVDR, FDA, or global regulatory pathways.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Linkkarandeepbadwal linkedin: https://www.linkedin.com/in/karandeepbadwal/qra-medical linkedin: https://www.linkedin.com/company/qra-medical/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Are you frustrated that clinically approved medical devices aren't gaining traction in healthcare?This episode dives deep into the gap between evidence and execution, revealing that it's often not the product, but the behavioral changes required for adoption that are overlooked. We challenge the common assumption that education alone will drive change.By listening, you'll discover:The key barriers to the adoption of medical devices in healthcare.How to approach behavior change for successful implementation.Strategies for improving clinician engagement.Tune in to discover how to turn your medical device into a success story in the healthcare market.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
In this kickoff episode of Project Medtech's “Five Things You Need To Know” miniseries, Duane Mancini is joined by Sean Thompson to break down the essentials of sterile medical device packaging compliance. Sean shares a practical, startup-friendly roadmap anchored in ISO 11607, starting with defining device inputs that drive packaging design decisions (sensitivities, geometry, sterilization method, scalability). He then walks through the four pillars—Make, Ship, Store, and Usability—covering sealing process validation, distribution simulation testing and feasibility testing, shelf-life strategy via accelerated and real-time aging, and the newer focus on usability and aseptic presentation. The episode highlights how missed packaging steps can create costly timeline and commercialization setbacks.Sean Thompson LinkedInPackaging Compliance Labs WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Antony Odell, co-founder and CEO of Echopoint Medical.Echopoint is a London-based UCL spinout developing iKOr, an optical microcatheter for coronary diagnostics.Antony brings over 30 years of medtech experience across Johnson & Johnson, Fresenius, and Stryker, before transitioning into startups as CEO of Tayside Flow Technologies and Tissue Regenix. He holds a BSc in Physiology and Biochemistry.In this interview, Antony discusses translating academic IP into a commercial device, choosing early clinical sites to balance speed and learning, managing non-dilutive funding as a long-term discipline, and outlines the most important responsibilities of an early-stage medtech CEO.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Antony Odell, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:06) - How Antony's career centered on translating clinical insights into commercial reality (05:54) - What Echopoint's iKOr does, and why 40% of cath lab patients leave without a diagnosis (12:13) - How Echopoint landed its first U.S. clinical site, and what that means for the company (13:48) - What to assess before spinning out an academic idea, and why clinician input is the first real test (20:14) - Why Echopoint chose Barts over typical sites for its first-in-human study (22:58) - How getting too close to one clinical site can lead to dangerous groupthink (30:54) - Why non-dilutive funding belongs on the board agenda permanently (39:54) - How CEOs should manage boards, control information flow, and avoid becoming a “glorified note-taker”
Are you frustrated with stagnant growth despite having an experienced distributor?This episode uncovers the common misconceptions surrounding long-term distributor relationships and highlights how reliance on these partnerships can lead to hidden underperformance. You'll learn why it's essential to reassess your distribution strategy for optimal success.By listening, you'll discover:The key criteria for selecting effective distributors in your marketHow to evaluate if your current distributor is truly the right fitActionable steps to boost underperformance and increase market growthTune in to transform your medical device strategy and unlock growth potential.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
Sponsor: Medboardhttps://www.medboard.com/ EuropeEUDAMED: It's Go Time -May 28th 2026 for New Products: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1860&qid=1720686388639 https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdfBrand new Notified Body Rules -Implementation regulation 2026/977https://eur-lex.europa.eu/eli/reg_impl/2026/977/ojhttps://www.medtecheurope.org/resource-library/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/EU MDR IVDR Simplification Proposal - 2 trackshttps://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2025/1023/COM_COM(2025)1023_EN.pdfEMA Breakthrough Medical Devices Pilot - Just launchedhttps://www.ema.europa.eu/en/news/new-pilot-support-development-breakthrough-medical-deviceshttps://www.ema.europa.eu/en/documents/presentation/presentation-breakthrough-medical-devices-pilot-information-sessio_en.pdfMIR form update - Update your files or links:https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en SwitzerlandSwissdamed device Registration - July 1st is cominghttps://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/produktregistrierung.htmlSwissmedic's 2026 PMS Focus Campaign - Class Iia, Iib and IIIhttps://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/info-ueberpruefung-dokumentation-zur-ueberwachung-nach-inverkehrbringen.htmlUKMHRA proposes indefinite CE Mark Recognition - Poll is closedhttps://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devicesNew UK Clinical Trials Framework -Live Since April 28thhttps://www.gov.uk/government/news/launch-of-clinical-trial-reformsNew MHRA fees + Faster Incident Reporting - Reminder to budget and update procedures.https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#feeshttps://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/vigilance-reporting-requirementsMHRA Medical Devices (Amendment) Regulations 2026 - Brand New, Your Input Neededhttps://www.gov.uk/government/news/mhra-invites-views-on-proposed-changes-to-medical-device-regulation EventsMedtech Summit - June 15-16, 2026 in Berlin, Germanyhttps://informaconnect.com/medtech-summitEuropean Medical Device Supplier Excellence Conference - June 9-11th, 2026 - Brussels, Belgiumhttps://medicaldevicesupplierexcellence.com/ InternationalUSA — FDA Launches - AI Platform HALO and Upgrades Elsa to 4.0https://www.fda.gov/news-events/press-announcements/fda-expands-ai-capabilities-and-completes-data-platform-consolidation Canada: Two changes happening — Mandatory Digital Submissions + New AI/ML Device Guidancehttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/mandatory-use-regulatory-enrolment-process-notice-to-industry.htmlhttps://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices/pre-market-guidance-machine-learning-enabled-medical-devices.pdf PodcastPodcast Nostalgia Episode 384: AI Medical Devices: What Notified Bodies Really Look for (Camille Petri): https://podcast.easymedicaldevice.com/384-2/Episode 385: The Fake QMS Problem: Why your ISO 13485 System will fail and Audit: https://podcast.easymedicaldevice.com/385-2/Episode 386: Life after CE Marking: Why AI Medical Devices Need Continuous Monitoring (Osman El-Kouban): https://podcast.easymedicaldevice.com/386-2/Episode 387: Master UDI-DI: The New Layer many Medtech Companies don't Understand (Hussam Mostafa): https://podcast.easymedicaldevice.com/387-2/Episode 388: Certifying LLM-Driven medical devices (Sandy Wright): https://podcast.easymedicaldevice.com/388-2/ Easy Medical DeviceConsulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/BOSS Program: Back Office ServiceseQMS: https://easymedicaldevice.com/smarteye-eqms/EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/Authorized Representative in EU, UK and SwitzerlandMarket access all over the world: https://easymedicaldevice.com/services/market-access/ This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Are you struggling to grow your medical device business while juggling the pressures of visibility and adoption?In this episode, we challenge common assumptions about growth strategies in healthcare. Many companies mistakenly believe that chasing patients through marketing is the fastest path to success, but this often leads to stalled growth and missed opportunities.By listening, you'll:Understand why meaningful partnerships outperform visibility in driving adoptionLearn how to assess the true value of your offering and its impact on customer retentionDiscover strategies to recalibrate your growth approach for sustainable successTune in now to uncover the secrets to building a thriving healthcare business by prioritizing value over noise.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Kurt Jacobus, co-founder and CEO of restor3d.restor3d provides patient-specific orthopedic implants using 3D printing and advanced software.Kurt has over two decades of experience in medtech entrepreneurship, including successful exits to Enovis and NuVasive. Prior to his career in medical devices, Kurt was a consultant at McKinsey & Company. He holds a PhD in Mechanical Engineering and is an Adjunct Professor at Georgia Tech. In this interview, Kurt discusses how restor3d used the FDA's 520(b) pathway to generate revenue and regulatory proof simultaneously, why self-regulating beyond FDA requirements makes submissions a competitive barrier, and how to approach investor relationships and board construction with long-term thinking.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Kurt Jacobus.KEY MOMENTS FROM THE INTERVIEW(03:21) - How Kurt went from wanting to build race cars to 20 years of orthopedic entrepreneurship (06:03) - How restor3d's patient-specific implants challenge the “8 sizes fit 8 billion people” model (15:36) - Why early-stage companies should “ring the cash register” as soon as possible (17:16) - How a 520(b) pathway helped restor3d generate revenue before full FDA clearance (31:48) - How restor3d treats every FDA submission like a PhD thesis and holds itself to standards beyond what regulators ask for (35:24) - What Kurt learned from restor3d's limited market release (40:03) - How Kurt raised is last$100M+ round, and why fundraising is really a networking game (45:13) - What makes a great board, and how the wrong one can quietly derail a company
In episode 247 of the Transition Drill Podcast, hear the journey of former Navy Corpsman Jason Brooks for veterans and first responders navigating the shift from service to health tech and agentic AI. Jason talks about the power of testing the waters during a career pivot, and what it takes to find your "North Star" after the uniform.Jason grew up in a intrigued by science and academic ambition, but his home life was far from stable. After his parents divorced, he spent his youth bouncing between New York and Pennsylvania, eventually finding himself on the streets and living in friends' homes during high school. Despite the chaos, Jason maintained a laser focus on his dream of becoming a doctor, inspired by his Uncle Walter. A tragic car accident at age 17, where he felt helpless as a friend passed away, solidified his "why" and shifted his focus toward medicine and service.Though he initially resisted the military, Jason eventually joined the Navy as a Corpsman. His time in service was defined by the same curiosity that led him to science as a child. He thrived in the medical field, but like many, he reached a point where he had to decide what came next. His transition wasn't a straight line. He describes a process of "dipping his toes" into various opportunities, moving through a career that eventually shifted from direct patient care to the tech and business side of healthcare.Today, Jason is a leader in the health tech space as the CEO of Innovo AI, proving that the skills learned in the field translate directly to the corporate boardroom. He's now a father of two, balancing his professional accomplishments with a commitment to his family and his roots. From working on seventh generation farms in the Hudson Valley to managing high-level healthcare operations, Jason's story is a testament to seizing the day. He shares how to handle the friction of a tumultuous transition and why you should never be afraid to take a chance on a new direction, even if it feels like starting over.CONNECT WITH THE PODCAST:Instagram: https://www.instagram.com/paulpantani/WEBSITE: https://www.transitiondrillpodcast.comLinkedIn: https://www.linkedin.com/in/paulpantani/SIGN-UP FOR THE NEWSLETTER:https://transitiondrillpodcast.com/home#aboutQUESTIONS OR COMMENTS:paul@transitiondrillpodcast.comSPONSORS:GRND CollectiveGet 15% off your purchaseLink: https://thegrndcollective.com/Promo Code: TRANSITION15Blue Line RoastingGet 10% off your purchaseLink: https://bluelineroasting.comPromocode: Transition10Frontline OpticsGet 10% off your purchaseLink: https://frontlineoptics.comPromocode: Transition10#transitiondrillpodcast #militarytransition #firstresponders
Unique Device Identification (UDI) has become a central element of medical device compliance worldwide.From EUDAMED in Europe to FDA databases in the United States, regulators increasingly rely on accurate UDI data to improve traceability and patient safety.But many manufacturers underestimate one important reality:
In just the past two months, Stryker, Intuitive Surgical, and Medtronic – three of the world's Top 100 Medical Device companies – have faced cyberattacks. Why are medtech companies becoming prime targets for hackers? What makes medical devices so vulnerable? And how is the FDA responding? In this episode of Let's Talk Medtech, Naomi Schwartz, VP of Regulatory Strategy at Medcrypt, breaks down: ✅ The anatomy of recent cyberattacks on leading medtech firms ✅ Why hackers are targeting the medical device industry ✅ What these breaches mean for patient safety and data security ✅ FDA's new cybersecurity requirements and what companies must do now
Have you ever wondered why your medical device fails to gain traction after regulatory approval? You're not alone.In this episode, we explore the critical difference between mere activity and a real commercial strategy. Many MedTech companies mistakenly believe regulatory approval guarantees demand, only to find themselves stalling without solid market plans.By listening, you'll:Learn how to develop a commercial strategy in parallel with regulatory processes.Understand the three key questions to answer before approval to ensure market readiness.Discover why engaging buyers early can facilitate smoother adoption of your medical device.Tune in now to transform your approach to go-to-market strategies and avoid costly missteps!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Alfred Griffin, co-founder and CEO of LightForce.LightForce is the developer of the world's first fully customized 3D-printed bracket system directly personalized for each patient's digital treatment plan.Alfred holds a DMD and PhD in Craniofacial Biology from the Medical University of South Carolina and completed his orthodontic residency at Harvard School of Dental Medicine, where he currently serves as faculty and the Board of Fellows. An ABO-certified practicing orthodontist, he continues to see patients every month while running the company.In this interview, Alfred shares how applying existing technology to an overlooked market can unlock a larger opportunity, how adoption friction is a design problem, and why scaling a new category requires treating operations as a core product investment.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Alfred Griffin.KEY MOMENTS FROM THE INTERVIEW(02:43) - How growing up in a family of dentists shaped Alfred's path into orthodontics (07:41) - How LightForce uses digital planning and 3D printing to create fully customized braces (08:48) - Why LightForce isn't a brilliant idea, but an obvious fix for the teen braces market that aligners missed (12:19) - How LightForce is like Google Maps for teeth, eliminating detours and removing inefficiencies (17:30) - How Alfred built LightForce around his clinical strengths and hired for experience to round out the gaps (30:56) - The 3-part secret to LightForce adoption by physicians (36:42) - How Alfred approaches fundraising, matching investors to the company's stage and needs (41:51) - About LightForce's digital factories and why they're the company's core moat
Can you break into Medical Device Sales without a background in sales?In this episode, Vidhi Patel shares the exact roadmap she used to transition from a Biology major and Clinical Researcher to an On-Site Specialist at Stryker, and finally landing her dream role in Breast & Skeletal Health Sales at Hologic.If you've been told you "don't have enough experience" or you've been stuck in a clinical role wanting to pivot to the business side, this interview is for you. Vidhi and I break down the tactical tools—from 30-60-90 Day Plans to the "About Me" PDF—that make a candidate undeniable to hiring managers.In this video, you will learn:Why the "On-Site Specialist" role is the best backdoor into sales.How to use LinkedIn to get noticed by top-tier recruiters.The secret to the "About Me" page that builds instant rapport with surgeons.Why you should let your company pay for your MBA (and why you don't need it to get hired).How to handle the grueling Stryker/Hologic interview process and the Gallup test.TIMESTAMPS:0:00 - Intro: Meet Vidhi Patel2:15 - Why Ohio State? (The OSU Connection)4:10 - From Clinical Research to Stryker On-Site6:45 - The Reality of the OR: Managing 3 Different Shifts9:30 - How LinkedIn and Networking Landed the Interview12:00 - Working with External Recruiters: What You Need to Know14:50 - The 30-60-90 Day Plan: Don't Just Copy/Paste!17:30 - The "About Me" PDF: The Secret Weapon for Rapport21:00 - Soft Skills: Reading the Room vs. Following a Script23:15 - Why Hologic? (A Personal Connection to Breast Cancer)25:30 - National Parks & Work-Life Balance in Med Sales29:00 - MBA vs. Experience: Which one matters more?31:30 - Advice for those stuck: "You just need one YES."Connect with Vidhi Patel:LinkedIn: https://www.linkedin.com/in/vidhipat/
Send us Fan MailRyan Schoonmaker has spent roughly two decades in medical device product development, building a career around solving hard engineering problems in high-stakes environments. Today he is the founder of Tight Line Solutions, where he works with growth-stage product development teams to reduce chaos, improve execution, and build the kind of systems that make technical organizations more efficient and predictable. His messaging consistently emphasizes that innovation is not just about ideas, but about disciplined execution, sound principles, and the ability to lead teams through complexity. Before launching Tight Line Solutions in late 2025, Ryan served as Director of Mechanical Engineering at Beta Bionics. Prior to that, he held senior R&D leadership positions at BD and spent more than seven years at Dexcom, progressing from Staff Mechanical Engineer to Director of Mechanical R&D. His background also includes product development work at Safety Syringes and Helbling Precision Engineering, where he worked on drug delivery systems, insulin-related devices, infusion sets, and other life science technologies. That combination of consulting, hands-on engineering, and executive leadership gives him a rare view across the full arc of product development.One of the most compelling parts of Ryan's story is that his work has touched products with enormous real-world impact. In his own words, helping bring the Dexcom G6 and G7 to market reinforced the lesson that meaningful innovation requires structure, rigor, and strong execution. Public patent records also show his name on multiple Dexcom-related design patents, reflecting direct involvement in device development. He pairs that technical depth with a strong focus on team culture, communication, and breaking large problems into manageable pieces—exactly the kind of perspective that resonates with engineers trying to grow into stronger technical leaders. Ryan also brings a strong academic foundation in mechanical engineering, with a B.S. from the University of Maryland and an M.S. from Tufts University, where his thesis focused on vibrotactile feedback in minimally invasive surgery. That blend of technical depth, medical device experience, and leadership philosophy should make for a rich conversation on product development, risk mitigation, engineering culture, and what it takes to build products that truly matter. LINKS:Guest LinkedIn: https://www.linkedin.com/in/ryan-schoonmaker-59048411/Guest website: https://www.linkedin.com/company/tight-line-solutions/Aaron Moncur, host Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus
Join Ed Parcaut as he sits down with Téa Phillips, inventor and founder of MetaFlex Glove, for an inspiring discussion on creativity, resilience, and the realities of building a mission-driven startup. In this episode, Téa Phillips shares her journey from growing up in a family of tinkerers and makers to developing a Class 1 medical device designed to help people with hand pain and mobility challenges. Together, Ed Parcaut and Téa Phillips dive into: The early inspirations from her inventor father and entrepreneurial grandparents Real-world challenges of launching an innovative medical product How MetaFlex Glove addresses issues like arthritis, carpal tunnel, and sports injuries The ups and downs of entrepreneurship: manufacturing hurdles, FDA regulations, hiring lessons, and fundraising Why building something meaningful is worth every struggle Whether you're an aspiring entrepreneur or interested in the power of purposeful invention, this episode offers practical insights and a dose of motivation. Learn more about MetaFlex Glove at metaflexglove.com and connect with Téa on LinkedIn or Instagram. *Contact Ed Parcaut:** -
The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.Now, Europe is introducing an additional layer: Master UDI-DI — adding both structure and complexity to the system.Understanding the UDI StructureTo fully understand Master UDI-DI, it's important to distinguish between the different levels:• UDI-DI → Identifies a specific device• Basic UDI-DI → Groups devices with the same intended purpose and characteristics• Master UDI-DI → Applies to highly individualized devices with specific design parametersThis new layer aims to better manage products with high variability.Why Master UDI-DI Was IntroducedFor certain devices — such as spectacle frames, lenses, and other customizable products — the number of variations can become overwhelming.Master UDI-DI helps:• Reduce the number of identifiers required• Improve traceability• Simplify product grouping• Enhance recall efficiencyKey BenefitsDespite its complexity, Master UDI-DI brings several advantages:✔ Better organization of device data✔ Improved market surveillance✔ Faster identification during recalls✔ Stronger protection against counterfeit productsChallenges for ManufacturersHowever, the implementation is not without challenges:• Increased data requirements• Risk of incorrect UDI assignment• Need for cross-functional coordination• Integration with EUDAMEDAs highlighted in the discussion, errors in UDI can be costly — including recalls and data inconsistencies.Timeline and UrgencyWhile the labeling deadline is set for November 2028, manufacturers should not wait.EUDAMED requirements are already active, and preparation takes time.
Are you letting the fear of failure prevent your medical device from thriving in the market?This episode reveals how the conventional wisdom around failing can actually stifle innovation. Embracing failure is not just an option; it's a necessity for growth in the healthcare sector. By listening, you'll:Learn to view failure as a stepping stone to successUnderstand the role of failure in fostering resilienceDiscover how to encourage your team to innovate without fearTune in to revolutionize your approach to failure and open new paths for success in your medical device journey.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
בפרק הזה אני מארחת את איה פטרבורג, שותפה מייסדת בקרן S Capital (יחד עם חיים סדגר). איה היא אישה שהקריירה שלה רצופה בפיבוטים אמיצים – מעריכת דין, דרך הובלת פיתוח עסקי בסטארטאפים, ועד להפיכתה לאחת המשקיעות הבולטות והמוערכות בישראל. השיחה שלנו, שהתחילה על כוס קפה עוד לפני שלחצנו Record, צללה מהר מאוד אל מאחורי הקלעים של קבלת החלטות בעולם ההשקעות, אבל התמקדה בעיקר באדם שמאחורי היזם. דיברנו על הכוח של אינטואיציה, על החשיבות הקריטית של ענווה, ולמה בחירת משקיע היא לפעמים החלטה גורלית יותר מבחירת שותף. מנזיר בודהיסטי למבחן ה"נעים לי": כוחה של אינטואיציה השיחה שלנו התחילה באחד הסיפורים המרתקים שאיה שיתפה, אשר החזיר אותנו לגיל 20, לטיול בדהרמסאלה שבהודו. מתוך מאות נזירים, משהו במבט ובאנרגיה משך אותה לגשת דווקא לנזיר אחד ספציפי ולבקש ללמוד ממנו על בודהיזם. לימים התברר שזהו המתורגמן האישי של הדלאי למה וראש הספרייה הלאומית. היכולת הזו "לזהות" אנשים, את הזיק בעיניים ואת הפוטנציאל, מלווה אותה עד היום כשהיא פוגשת יזמים. אנחנו מדברות על "מבחן ה-נעים לי" ועל Fit בין אנשים. איה מחדדת ש"נעים לי" לא אומר לחפש את האדם ה"נחמד" ביותר, אלא לבחון את ההתאמה האמיתית (Fit) לדרך משותפת. זה אומר לשים יד על הבטן ולשאול: האם נעים לי בסיטואציה הזאת מול האדם הזה? האם נצליח להחזיק מרחב משותף ולנהל שיחה מכבדת גם כשיהיו מחלוקות ומורכבויות בהמשך הדרך? היכולת הזו להקשיב לבטן היא קריטית. איה, וגם שותפה חיים סדגר, מאמינים שאינטואיציה אינה מנותקת מדאטה, אלא היא רצפטור שקולט המון נתונים מהסביבה ועוזר לנו להרגיש עם מי נוכל לכבוש את העולם. ענווה ככלי עבודה וחוסן מנטלי ערך בולט שאיה אימצה מהבודהיזם ורלוונטי כל כך לעולמנו הוא ענווה. היא מזכירה ליזמים (וגם למשקיעים!) לא לחטוא בחטא היוהרה. גם כשמגייסים סכום עתק או רושמים הצלחה מסחררת, המציאות יכולה להשתנות ברגע. לכן, כשהיא בוחנת השקעה, היא לא מתאהבת במוצר – הרי הוא כנראה ישתנה. היא מסתכלת על החוסן הנפשי של היזם, על הגמישות המחשבתית שלו, ועל היכולת שלו לעמוד נחוש גם מול "כיתת יורים" של השוק או של משקיעים ותיקים. לשחק במגרש שבו אתם מנצחים: Founder-Market Fit איה מודה בכנות מרעננת: "אני אוהבת לנצח". מתוך התפיסה הזו, היא מייעצת ליזמים לבחור בקפידה את המגרש שבו הם פועלים. היא משתפת סיפור על יזם סדרתי ומוצלח שרצה להקים חברת Medical Device מתוך רצון "לעשות טוב". איה וצוות הקרן שכנעו אותו לוותר על הרעיון, פשוט כי לא היה לו שם Founder-Market Fit. המסר כאן חזק: ההצלחה הכי גדולה מגיעה כשאנחנו מייצרים לעצמנו מגרש שמותאם בדיוק לחוזקות, לניסיון ולייחודיות שלנו, ולא מנסים להתחרות במקומות שלא מדויקים לנו רק כי הם נשמעים נכון. אל תסתנוורו מסיבובי ענק: משקיע זה "חתונה קתולית" בתקופה שבה אנחנו שומעים על סבבי סיד מפלצתיים מקרנות אמריקאיות, איה עושה קצת סדר, במיוחד עבור יזמים בתחילת דרכם. היא מזכירה שלא כל הנוצץ זהב, וקרן ענקית היא לא תמיד השותף הנכון לכל חברה. התובנה הכואבת אך החשובה שלה היא שמשותפים - קשה ככל שזה יהיה - אפשר להיפרד. אבל ממשקיע – אי אפשר להיפטר. הוא נשאר איתכם ב-Cap Table לכל הדרך. לכן, היא מפצירה ביזמים להשקיע זמן, לעשות רפרנסים ולבחור את המשקיעים שלהם באותה רמת קפדנות שבה בוחרים שותף לחיים. מסר לסיום: לייצר את המציאות של עצמך את תפיסת העולם היזמית שלה, איה שאבה במידה רבה מאביה ז"ל. כילד שאהב לצייר קומיקס, ציוריו נגנבו ופורסמו בעיתון ללא מתן קרדיט. במקום לשקוע בקורבנות או באכזבה, הוא פשוט החליט להקים עיתון משלו כדי שיהיה לו איפה לפרסם את יצירותיו. הסיפור הזה הוא תמצית היזמות והמסע האנושי בעיניה של איה – היכולת לקחת את הקושי, לא לוותר, ולייצר במו ידינו את המציאות ואת המגרש שבו נוכל לצמוח ולהשפיע.
Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-488Ken RealiLinkedin: https://www.linkedin.com/in/kenreali/Reali Family Vineyard: https://www.realifamilyvineyard.com/
Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-488Ken RealiLinkedin: https://www.linkedin.com/in/kenreali/Reali Family Vineyard: https://www.realifamilyvineyard.com/
Are you frustrated by slow adoption rates of your medical device? You're not alone.This episode challenges common assumptions about clinician feedback and market readiness. You'll learn how to dig deeper into feedback to uncover real challenges that hinder adoption.By listening, you'll discover:The true barriers to adoption for your medical deviceThe importance of asking specific questions to gain clarityHow to simplify the introduction of your product for greater clinician acceptanceTune in to discover actionable strategies to enhance your medical device's market presence and adoption rate.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
What does it really take to succeed in medical device sales in New York City?In this episode of the Chase MedSearch Podcast, host Jordan Chase sits down with Tyler Nader, a Medical Device Sales Leader and former NYC Territory Rep who built dominant businesses across Manhattan, the Bronx, Brooklyn, and Queens. New York is different. It's dense. It's political. It's hyper-competitive. And it's home to some of the most prestigious academic hospitals and Level 1 trauma centers in the world — including Columbia, Cornell, Mount Sinai, NYU, Montefiore, and Northwell.Tyler shares what it's really like to:• Sell into Level 1 trauma centers at 22 years old• Navigate hospital politics and institutional hierarchies• Handle logistics in the most demanding healthcare market in America• Launch a new therapy from zero to nearly $2 million in two years• Exceed quota 11 consecutive quarters• Become the #1 rep nationally (and globally)• Build physician trust in elite academic institutions• Compete in a market where “there are 100 of them to one of you”• Transition from top producer to hiring managerHe also talks candidly about imposter syndrome, getting kicked out of ORs (operating rooms), working 365 days straight in trauma, and why New York reps are built differently.This episode is a masterclass for:• Medical device sales reps looking to break into competitive markets• Startup MedTech companies launching new therapies• Hiring managers evaluating territory-building talent• Reps who want to understand how to build true physician credibilityIf you can make it in New York City, you really can make it anywhere.RESOURCES:https://www.linkedin.com/in/tyler-nader-24bba6b1/
Growing up, Valencia Koomson wasn't supposed to be the one playing with the electronic set - that was her brother's Christmas present. She played with it anyway, and now she runs a lab at Tufts University focused on designing precision biosensors. She's turned that expertise toward addressing a long-overlooked problem in medical technology: pulse oximeters that work less reliably for patients with darker skin.In this episode, she explains what it actually takes to engineer a more inclusive pulse oximeter and she shares how she's navigating the complexities of commercialising a new medical device.You'll learn:- Why pulse oximeters tend to be less accurate on patients with darker skin tones- The engineering principles Koomson is using to redesign the device from the ground up- How she thinks about bridging the gap between lab innovation and real-world impact---*** Help us shape the future of Made For Us! Take our 4-minute listener survey for the chance to win a $25 Amazon Gift Card and get instant access to our curated reading list of every book ever recommended on the show: https://forms.gle/pNyrCooa23oYsaVk7---About Valencia KoomsonValencia Koomson holds the position of Associate Professor in the Department of Electrical and Computer Engineering at Tufts University with a secondary appointment at the Department of Computer Science and Tisch College of Civic Life. She is the founding director of the Advanced Integrated Circuits & Systems Lab at Tufts with a research focus on medical device innovation, global health technology, and health equity advocacy. Dr. Koomson completed B.S. and M.Eng. degrees in electrical engineering and computer science at MIT. She was awarded the George C. Marshall scholarship to pursue post-graduate studies at the University of Cambridge where she received the M.Phil. and Ph.D. degrees in electrical engineering. Dr. Koomson has authored over 60 publications, book chapters, and patents. She was awarded the Dr. Martin Luther King Jr. Visiting Professorship at MIT in 2021.Follow Valencia Koomson on LinkedIn: https://www.linkedin.com/in/profkoomson/Learn more about the Advanced Integrated Circuits and Systems Lab at Tufts: https://engineering.tufts.edu/ece/koomson---Other episodes you might like:The pulse oximeter problem: a trusted medical device comes under the spotlightHow to design a fairer healthcare system---Connect with Made for Us- Show notes and transcripts: https://made-for-us.captivate.fm/- LinkedIn: https://www.linkedin.com/company/madeforuspodcast- Instagram: https://www.instagram.com/madeforuspodcast- Newsletter: https://madeforuspodcast.beehiiv.com/
Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it is only the beginning.In this episode, Osman El-Koubani shares insights into the post-market realities of AI as a Medical Device (SaMD) and what manufacturers must do to remain compliant over time.CE Certification Is Not the Finish LineMany companies assume that once their device is certified, the main regulatory burden is over.In reality, Post-Market Surveillance (PMS) becomes critical — especially for AI systems that can evolve or degrade in real-world conditions.Relaxing after certification can lead to:• Loss of control over performance• Undetected risks• Regulatory non-complianceAI in the Real World: Performance DriftAI models often behave differently once exposed to real-world data. This phenomenon, known as performance drift, can reduce accuracy and reliability over time.Manufacturers must implement continuous monitoring strategies, including:• Real-world data (RWD) collection• Performance tracking• Feedback loops for improvementUpdating AI Devices: What Is Allowed?Updating AI systems introduces regulatory complexity.Key questions include:• What qualifies as a significant change?• Does retraining require re-certification?• How should updates be documented and justified?Manufacturers often struggle with these decisions, leading to compliance risks.PCCP: Enabling Controlled EvolutionThe concept of a Predetermined Change Control Plan (PCCP) allows manufacturers to define in advance how an AI system can evolve.While this concept is gaining traction globally, its implementation in Europe is still evolving and requires careful regulatory consideration.Building a Mature AI PMS SystemA robust post-market system for AI devices should include:• Continuous performance monitoring• Risk management integration• Clear documentation of updates• Strong governance of data and modelsWho is Osman El-KoubaniDr Osman El-Koubani is a doctor and clinical researcher. With nearly a decade of experience at the intersection of healthcare, digital innovation, and AI, he has developed and implemented NHS digital solutions and advised multiple software and AI medical device startups. At Scarlet, Osman works as a Clinical Engineer and AI/ML expert, leading clinical evaluation, risk management, and usability for AI-driven medical devices, while also helping SaMD and AIaMD manufacturers navigate certification and maintain compliance through transparent, practical, and safety-focused regulatory processes.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkScarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=trueSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.
Are you frustrated by the slow uptake of your medical device in export markets?In this episode, we challenge the common belief that distributors are solely responsible for market uptake. You'll learn why the slow adoption of your product is often not about activity, but rather about how demand is generated and responded to.By listening, you'll discover:The true constraints holding back your medical device's successHow to ask the right question about demand generationInsights on how to rethink your export strategy for better resultsTune in to uncover insights that can help you transform your go to market strategy for your medical device.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
Are you tired of guessing your way through MedTech exporting decisions?This episode shows why many MedTech companies stumble when they don't have a structured approach to diagnose their issues.By listening, you'll discover:A structured framework for confident decision-making in medtech expansionHow to Identify key constraints that hinder your growth and adoption ratesHow to effectively evaluate feedback without making premature changes Tune in to gain the confidence and structure needed for successful exporting in the medical device field.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
Many medical device companies believe they have a compliant Quality Management System (QMS).On paper, everything looks perfect:• Procedures are written• Forms are available• Risk management is documented• CAPA systems are definedBut during an audit, everything falls apart.What Is a “Fake QMS”?A fake QMS is not necessarily incorrect — it is simply not implemented in reality.Employees may not understand it.Processes may not be followed.Evidence may not exist.In short:
Podcast: ICS Arabia PodcastEpisode: HaHacking Health: Unveiling vulnerabilities in Wearable Medical DevicesPub date: 2026-04-12Get Podcast Transcript →powered by Listen411 - fast audio-to-text and summarizationIn this episode we're joined by Mohammad AlHussan from Kuwait. We dive into the world of wearable medical devices, discussing how attacks like DoS and MITM can target devices such as insulin pumps.The podcast and artwork embedded on this page are from ICS ARABIA PODCAST, 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 Stéphan Toupin to unpack one of the boldest transitions in medical sales, from a successful pharmaceutical career into the riskier but far more flexible world of medical device distribution and entrepreneurship. Stéphan shares why he willingly took a major pay cut to leave pharma, how freedom mattered more to him than salary, and what it really looked like to build something of his own from the ground up after divorce, major life change, and a move from Canada to the United States. He explains the key differences between pharma and med device, why distribution can offer unlimited upside for the right person, and what people misunderstand about the U.S. medical device market. He also breaks down how his company now helps foreign medical device manufacturers enter the U.S. by supporting everything from strategy and importing to warehousing, distribution, and commercialization. This is a must listen for anyone curious about entrepreneurship in med device, the distributor path, and what it truly takes to bet on yourself. Connect with Stéphan Toupin: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How »
Are you confident in your distributor's transparency? This episode may change that view.In this episode, we're uncovering a critical mistake in medical device distribution that could leave you vulnerable. Many clinicians mistakenly believe regular chats with distributors are enough for a solid partnership, but that's often not the case.By listening, you'll discover:How transparency impacts your distribution strategyThe essential questions to ask during distributor meetingsActionable tips on creating effective contingency plansTune in now to ensure your medical device distribution isn't a risky gamble.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
From $50k to $115k: How a Ministry Director Broke into Medical Sales (and Survived a Major Setback)Can you pivot from a nonprofit background to a six-figure medical device sales role? Kevin Maher did—but it wasn't a straight line. From landing a dream $115,000 offer at AstraZeneca to having it rescinded over a driving record error, this is the raw, unfiltered truth about the medical sales journey.In this episode of Medical Sales U, Kevin Maher and I dive deep into the grit, the "corporate game," and the exact steps needed to land a role at top companies like Applied Medical.What You'll Learn in This Episode:The "Panera Strategy": How Kevin hunted down a hiring manager in real life.Transferable Skills: Why ministry, teaching, and coaching are "secret weapons" for sales.The Driving Record Warning: The $115k mistake you MUST avoid before you apply.The "Corporate Game": How to balance radical authenticity with professional wisdom.Clinical Interviewing: A look inside the Applied Medical vNOTES procedure test.Timestamps:0:00 - Introduction: Kevin's transition from Young Life to Med Sales.04:20 - The skill set: Why "Area Directors" make great Territory Managers.08:15 - Networking 101: Finding an AstraZeneca manager at Panera Bread.16:30 - The $115k Offer: Doubling a salary overnight.18:45 - DISASTER: Why the offer was rescinded (and how to fix your record).22:10 - The Grind: Delivering bulletins and taking calls from the car.27:50 - Learning from Rejection: Failing the Boston Scientific final round.31:15 - The "Corporate Game": When to be authentic vs. when to be wise.36:40 - Success at Applied Medical: The vNOTES clinical interview.41:20 - Final Advice: Perseverance and the future of Medical Sales.Connect with Us:Follow Kevin Maher on LinkedIn: https://www.linkedin.com/in/kevinmaher1/About Medical Sales U:We help high-performers—teachers, nurses, and professionals—break into the medical device and pharmaceutical sales industry through expert coaching and a proven community of winners. We help professionals transition into top-tier medical sales roles: medicalsalesu.com/#MedicalSales #CareerPivot #MedicalDeviceSales #AstraZeneca #JobInterviewTips #SalesCareer #MedicalSales
Artificial Intelligence is rapidly transforming the medical device industry, enabling smarter diagnostics, predictive analytics, and personalized healthcare solutions. However, with this innovation comes increased regulatory complexity.In this episode, Camille Petri shares insights into how Notified Bodies assess AI-based medical devices and what manufacturers need to prepare for successful certification.Are AI Devices More Difficult to Certify?Compared to traditional software, AI-based medical devices introduce additional layers of complexity. These include data dependency, algorithm behavior, and potential variability in performance.Notified Bodies are therefore placing greater emphasis on transparency, traceability, and robustness.Data: The Foundation of AI CertificationOne of the most critical elements in AI certification is the quality of data.Manufacturers must clearly document:• Training datasets• Validation datasets• Test datasetsCommon deficiencies include poor dataset representativeness, lack of traceability, and insufficient justification of data selection.Clinical Evaluation for AIClinical evaluation for AI devices differs from traditional approaches.Regulators may accept retrospective data in some cases, but increasingly expect strong clinical evidence demonstrating real-world performance.The challenge lies in proving that the AI system performs consistently across different populations and use cases.Risk Management in AIAI introduces new types of risks, including:• Algorithm bias• Performance drift over time• Lack of explainabilityManufacturers must integrate these risks into their risk management process, in line with ISO 14971.Performance, Validation & Continuous LearningA key question for regulators is how to manage AI systems that evolve over time.Notified Bodies often differentiate between:• Locked algorithms (fixed behavior)• Continuous learning systems (adaptive models)Each approach has different regulatory implications, particularly regarding validation and post-market monitoring.Key TakeawayAI in MedTech offers tremendous opportunities, but certification requires a strong foundation in data, clinical evidence, and risk management.Understanding what Notified Bodies expect early in development can significantly improve your chances of a successful submission.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkCamille Petri Linkedin: https://www.linkedin.com/in/camillepetri/Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=trueSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
Are you frustrated by low adoption rates despite enthusiastic feedback from clinicians?This episode dives into the misconception that clinical enthusiasm translates to commercial success. We discuss how understanding your decision-making unit is crucial for effective stakeholder engagement.By listening, you'll discover:How to map out your decision-making unit effectivelyThe true decision-makers who influence adoptionActionable strategies to address objections directlyTune in now to uncover crucial strategies that could save your medical device launch.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.
Got a question or comment? Message us here!Healthcare security isn't just about networks anymore. In this episode, we dive into the complex world of connected medical devices, the challenges of securing them, and why organizations need a more holistic approach to cybersecurity.Support the showWatch full episodes at youtube.com/@aliascybersecurity.Listen on Apple Podcasts, Spotify and anywhere you get your podcasts.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Laura Yecies, CEO of Osteoboost.Osteoboost is the first FDA-cleared drug-free prescription treatment for osteopenia in postmenopausal women.Laura brings over 30 years of experience across technology, digital health, and medical innovation, with a focus on overlooked gaps in women's health. She previously served as CEO of SugarSync (acquired by J2 Global), Catchsold (sold to Apple), and Neurosync, a neurotechnology company. In this interview, Laura discusses why choosing a Class II prescription path creates a regulatory moat, how designing for daily comfort and a frictionless experience drives commercialization, and how channeling early patient demand turned a waitlist into a launch strategy.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Laura Yecies.KEY MOMENTS FROM THE INTERVIEW(02:49) - An overview of Laura's background and her transition from consumer tech to medtech (04:53) - The problem Osteoboost is solving — and why bone health remains a massive unmet need (08:31) - How Osteoboost designed its device with the consumer experience in mind (15:44) - Why Osteoboost chose a Class II regulatory pathway over an easier path (19:50) - How to design clinical trials that reflect real-world use and drive patient compliance (25:01) - How early demand and a waitlist validated strong consumer pull before full commercialization (28:48) - Why Laura believed the problem wasn't demand — it was lack of options (33:57) - How patients can become a powerful “sales force” in healthcare (38:20) - Why shifting consumer behavior is making self-pay more viable — with reimbursement coming later
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Send us Fan MailMustafa Poonawala is a globally recognized leader in medical device and diagnostics innovation, known for his ability to translate strategy into execution across R&D, clinical operations, and portfolio management. Over a career spanning more than two decades, he has built and led world-class engineering and program teams, guided products from early development through regulatory approval, and driven large-scale organizational transformation in highly regulated environments.Currently, Mustafa is the CEO of DynaMill Research, a specialized Clinical Research Organization focused on helping diagnostics companies dramatically reduce cycle times and improve cost predictability. DynaMill's approach blends agile program management, end-to-end digital clinical workflows, predictive enrollment strategies, and deep partnerships with multi-site clinical networks. The goal is simple but ambitious: help diagnostic innovations reach patients faster without sacrificing rigor or quality.In parallel, Mustafa is Managing Partner at Steps Program Management, where he has spent nearly a decade advising organizations on agile transformation, PMO maturity, and portfolio optimization—particularly within medical device R&D. His work emphasizes lean, value-driven processes, difficult prioritization, and delivery predictability, all grounded in real-world execution rather than theory.Previously, Mustafa held senior leadership roles at BD, Hospira, OBS Medical, and Boston Scientific. His experience spans implantable and disposable devices, complex electromechanical systems, software and cybersecurity for safety-critical systems, and large-scale diagnostics portfolios exceeding billions of dollars in revenue. With a PhD in Software Engineering focused on safety-critical systems, Mustafa brings a rare blend of deep technical rigor, business acumen, and servant leadership to every challenge he tackles.LINKS:Guest LinkedIn: https://www.linkedin.com/in/mustafapGuest website: https://dynamillcro.comAaron Moncur, host Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus
In this episode, we challenge the common assumption that clinicians are the sole influencers in MedTech. You'll learn about the various stakeholders who play a critical role in product adoption, ensuring you don't waste time on unproductive strategies.In this episode you'll discover:How to spot hidden decision makers in the healthcare landscapeThe critical role of stakeholders in successful medical device adoptionActionable strategies to tie your product to broader pain points for effective salesAre you still convinced that doctors are the primary decision-makers for your medical device adoption?Tune in now to discover how shifting your focus can lead to faster revenue and successful adoption!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.
Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-473
Are you frustrated with the next steps after creating a MedTech prototype?In this episode, we tackle the confusing crossroads of funding versus clinical trials. Most founders believe progress hinges on either building more or raising money, but we'll challenge that notion with actionable insights.By listening, you'll:Learn to define the core assumption that is crucial for your successDiscover the fastest ways to validate your prototype without excessive spendingUnderstand why complexity can be a distraction from achieving your goalsTune in now to redefine your strategy and accelerate your MedTech journey!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.
As healthcare organizations respond to the cyberattack on Stryker, the focus is shifting from what happened to how decisions are made in the moment. Gist Healthcare Podcast host J. Carlisle Larsen speaks with Phil Englert of Health-ISAC about navigating uncertainty during an incident, how these events shape perceptions of medical device risk, and what it takes for organizations to coordinate under pressure. You can listen to the first half of the conversation here. Hosted on Acast. See acast.com/privacy for more information.
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