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Medical technology is evolving faster than many manufacturers can adapt to, and falling behind can now happen in months rather than years. In this episode, Seth Rowan, Director of Business Development at Harmac Medical Products, discusses how AI, data integration, and digital transformation are reshaping medical device manufacturing. He explains why clean data is essential for successful AI adoption, how manufacturers can identify bottlenecks before they grow, and why companies need scalable manufacturing partnerships to bring single-use medical devices from design through commercialization. Tune in to learn how manufacturers can turn rapidly changing technology into practical solutions without losing sight of execution, quality, and scale. Resources: Connect with and follow Seth Rowan on LinkedIn. Follow Harmac Medical Products on LinkedIn and explore their website!
Behind Closed Doors: Male Victims Of Intimate Partner Violence Men make up nearly half of the victims of intimate partner violence, so why do so many survivor programs focus only on women? Our experts shed light on this frequently overlooked crisis, exploring the heavy realities of male victims of intimate partner violence and challenging the gender stereotypes that surround domestic abuse. Guests: Dr. Denise Hines, Elizabeth Shirley Enochs Endowed Professor of Social Work, George Mason University College of Public Health Aaron Ellis, survivor & advocate Host and producer: Kristen Farrah A World Of Silence Pt.2: Is Early Intervention Safe For Infant Hearing Loss? The FDA recently lowered the age criteria for children to receive cochlear implants to just seven months old, a shift that promises better developmental outcomes but leaves many parents deeply hesitant. Our experts this week demystifies the procedure – including why the actual surgical recovery might be far easier than families expect. Guests: Dr. Nancy Young, medical director of Audiology and Cochlear Implant Programs, The Ann & Robert H. Lurie Children's Hospital of Chicago, Lillian S. Wells professor in pediatric otolaryngology, Northwestern University Feinberg School of Medicine Doug and Eva Tweedy, parents Host: Greg Johnson Producer: Kristen Farrah Facebook: ingoodhealthpodX: @ ingoodhealthpodIG: @ingoodhealthpodYouTube: @ingoodhealthpodSpotify Apple Podcast In Good Health PodcastSubscribed to the newsletterFull ArchiveContact UsBecome an Affiliate Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
There are nearly one and a half million registered medical devices on the market in Australia. Now, you would think that life-saving treatments such as pacemakers, defibrillators and pain pumps would be subject to the same sorts of clinical trials as prescription drugs. Right?Today, investigative reporter Liam Mannix on which devices have attracted the most complaints, and the medical device under investigation by a coroner after a tragic case in a regional town in Victoria.Subscribe to The Age & SMH: https://subscribe.smh.com.au/See omnystudio.com/listener for privacy information.
There are nearly one and a half million registered medical devices on the market in Australia. Now, you would think that life-saving treatments such as pacemakers, defibrillators and pain pumps would be subject to the same sorts of clinical trials as prescription drugs. Right?Today, investigative reporter Liam Mannix on which devices have attracted the most complaints, and the medical device under investigation by a coroner after a tragic case in a regional town in Victoria.Subscribe to The Age & SMH: https://subscribe.smh.com.au/See omnystudio.com/listener for privacy information.
The FDA recently lowered the age criteria for children to receive cochlear implants to just seven months old, a shift that promises better developmental outcomes but leaves many parents deeply hesitant. Our experts this week demystifies the procedure – including why the actual surgical recovery might be far easier than families expect. Facebook: ingoodhealthpodX: @ ingoodhealthpodIG: @ingoodhealthpodYouTube: @ingoodhealthpodSpotify Apple Podcast In Good Health PodcastSubscribed to the newsletterFull ArchiveContact UsBecome an Affiliate Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-505
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For many medical device startups, obtaining FDA clearance seems like a clear, linear process.Identify a predicate device.Prepare your documentation.Submit your application.Wait for clearance.In reality, the journey is rarely that simple.In this episode of the Medical Device Made Easy Podcast, Joanna Nathan, CEO of Prana Surgical, shares her firsthand experience navigating the FDA clearance process and discusses the challenges that many startups only discover after they begin.Topics CoveredThe Reality Behind FDA ClearanceWhen do founders realize the process is more complex than expected?What would they do differently if they could start again?Predicate Devices and Substantial EquivalenceChoosing the right predicate device is one of the most important strategic decisions in a 510(k) submission.We discuss:Predicate device selectionIntended use considerationsTechnological characteristicsCommon misconceptions about substantial equivalenceBuilding a Product with the FDA in MindThe conversation explores how early regulatory decisions influence:Product developmentTesting strategyDocumentationRisk managementManufacturing planningWorking with the FDAHow valuable are Pre-Submission (Q-Sub) meetings?What questions should manufacturers ask?What mistakes should they avoid before engaging with the FDA?Lessons Every Startup Should KnowJoanna shares practical advice on:Unexpected FDA questionsCommon causes of delaysSoftware validationBiocompatibilityUsability studiesDocumentation preparationThe biggest misconceptions surrounding FDA clearanceKey TakeawayFDA clearance is much more than completing regulatory paperwork.Successful companies integrate regulatory thinking into product development from the very beginning.Making the right strategic decisions early can save significant time, reduce costs, and improve the likelihood of a successful FDA submission.Whether you're launching your first medical device or preparing your next regulatory submission, this episode provides practical insights to help you navigate the FDA clearance journey with greater confidence.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.LinkJoanna's LinkedIn: https://www.linkedin.com/in/joannacnathanPrana System: https://www.pranasurgical.com/prana-systemPrana Surgical's LinkedIn: https://www.linkedin.com/company/pranasurgicalSocial 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.
This week on Pulse: Hot Topics, Louise and George look at what happens when digital health stops being a pilot and starts being a system decision — and why, again and again, the technology isn't the hard part.Portugal Buys AI Physiotherapy for an Entire Country — Portugal's National Health Service has contracted Sword Health to make AI-supported physiotherapy available to all 10 million citizens, free after a prescription, prompting the question: are governments shifting from buying AI software to buying AI-delivered healthcare?AI and Accountability: The First Complaints Land — The UK's first complaints about clinicians' inappropriate use of AI have reached professional regulators, arriving well before the evidence base and accountability frameworks are ready.95% of Health Apps Have No Verifiable Regulatory Approval — Rudolf Wagner's analysis found that of nearly 96,000 apps qualifying as Software as a Medical Device, 95% had no verifiable CE marking or FDA authorisation, leaving consumers with no easy way to know what they're actually using.Doctors Want Wearable Data, But Can't Use It — A new AMA(US) survey found 97% of physicians would review data from a patient's wearable, but no more than 6% have actually integrated it, blocked by missing standards, workflow fit, reimbursement and liability.Virtual Care Could Transform Residential Aged Care — Australian researchers found virtual care between aged care homes and GPs improves access and reduces unnecessary hospital visits, but is undermined by poor integration, unreliable networks and limited staff training — the technology works, the system around it doesn't.With Thanks to Datacom:Download the Executive Briefing Playbook LinkResources:Sword Health partners with Portugal's National Health Service LinkFirst complaints made over clinician use of AI, HSJ via Patient Safety Learning Hub LinkEnsuring the clinical impact of medical artificial intelligence, Andreoletti et al., Lancet Digital HealthLinkAnalysis of Software as a Medical Device (SaMD) Compliance in App Store Applications, Rudolf Wagner LinkDocs unable to harness wearables data, survey finds, Axios LinkVirtual care could benefit residential homes – study, Pulse+IT LinkVirtual care in residential aged care homes, Journal of Medical Internet ResearchLinkRecommendations:Clinicians – be part of the research into clinician use of AI, open globally LinkStandards Australia telehealth and virtual care standard LinkThere's An AI For That (TAAFT) newsletter LinkAge-Friendly Futures newsletter, George Gouzounis Link"Welcome to the Land of the Free" — World Cup song by Jason Stills LinkVisit Pulse+IT.news to subscribe to breaking digital news, weekly newsletters and a rich treasure trove of archival material. People in the know, get their news from Pulse+IT – Your leading voice in digital health news.Follow us on LinkedIn Louise | George | Pulse+ITFollow us on BlueSky Louise | George | Pulse+ITSend us your questions pulsepod@pulseit.newsProduction by Octopod Productions | Ivan Juric
What does it take to build healthcare technology that can make vital signs easier to capture, track, and use? In this episode of Entrepreneur Rx, host John Shufeldt sits down with Mitch Foster, founder and CEO of Mindset Medical, to discuss his career in healthcare, medical devices, robotics, and digital health. Mitch shares how his early work ethic and healthcare experience led him from orthopedic sales and executive leadership to building companies at the intersection of medicine and technology. The conversation explores Mitch's path through Merck, DeRoyal, Synthes, NuVasive, and Excelsius Surgical, the spine robotics company acquired by Globus Medical. Mitch reflects on lessons learned from mentors, physicians, strategic partners, and the experience of building and exiting a company before applying those lessons to Mindset Medical. The episode also looks at Mindset Medical's vision to turn the smartphone into a medical device. Mitch explains how the company evolved from digitizing patient intake to developing video-based vital sign technology, including FDA-cleared pulse rate and respiration rate tools, with a path toward non-contact blood pressure measurement. Beyond the technology, John and Mitch discuss telemedicine, rural healthcare, chronic disease management, entrepreneurship, resilience, founder traits, leadership under pressure, and building through pivots and setbacks. Mitch also shares advice for aspiring entrepreneurs: go for it, scenario plan, understand the sacrifice, and remember that time is the most valuable asset we have. About Mitch Foster: Mitch Foster is the founder and CEO of Mindset Medical and an experienced healthcare entrepreneur and medical device executive. His career spans pharmaceutical sales, orthopedics, spine robotics, digital health, and startup leadership. Before founding Mindset Medical, Mitch helped build Excelsius Surgical, a robotic spine surgery company acquired by Globus Medical. About Mindset Medical: Mindset Medical is developing technology designed to turn the smartphone into a medical device. The company's platform uses video-based technology to capture vital signs and support more accessible, data-driven care. With FDA clearances for pulse rate and respiration rate, Mindset Medical is working toward non-contact, non-calibrated blood pressure measurement and broader applications across telemedicine, rural healthcare, and chronic disease management. About Xcellerant Ventures: Xcellerant Ventures is a venture capital firm that invests in innovative companies across healthcare, technology, defense, and other emerging industries. Through multiple funds and investment vehicles, including the Jetstream Venture Fund, the firm partners with visionary founders, provides strategic guidance, and helps connect investors with opportunities in the private markets. About Jetstream Venture Fund: Jetstream Venture Fund is an interval fund managed by Xcellerant Ventures and Sweater Industries LLC, that seeks to provide investors access to early-stage, high-growth companies with flexible terms, lower minimums ($5,000), and no carried interest. Jetstream is one of the first funds of its kind, bringing venture-style investing opportunities to a wider professional audience. Back-end administration is provided by Sweater Ventures a ground-breaking turnkey fund management company. Disclosure for Jetstream: Investors should carefully consider the investment objectives, risks, charges, and expenses of the Fund before investing. The prospectus contains this and other information about the Fund and can be obtained by emailing or by visiting the. Please read the prospectus carefully before investing.
A World Of Silence: Navigating Infant Hearing Loss & Cochlear Implants The ability to listen is the very first skill we develop in the womb, and it's crucial for cognitive growth. Thankfully, infants born with hearing loss have a few options to keep their development on track. Our experts this week explore the science of pediatric audiology, how to make an early diagnosis, and the cochlear implant journey. Guests: Dr. Nancy Young, medical director of Audiology and Cochlear Implant Programs, The Ann & Robert H. Lurie Children's Hospital of Chicago, Lillian S. Wells professor in pediatric otolaryngology, Northwestern University Feinberg School of Medicine Eva Tweedy, parent Doug Tweedy, parent Chronic Disease Is Threatening Your Vision – Here's How To Prevent It Millions of people are currently facing vision loss, and so many more are at risk due to a rise in chronic illnesses. Our experts reveal how common conditions like diabetes threaten our sight, and how proper management can stop this preventable damage in its tracks. Guests: Jeff Todd, president & CEO, Prevent Blindness Dr. Paul Chan, chair, Department of Ophthalmology & Visual Sciences, University of Illinois Chicago, board member, Prevent Blindness Facebook: ingoodhealthpodX: @ ingoodhealthpodIG: @ingoodhealthpodYouTube: @ingoodhealthpodSpotify Apple Podcast In Good Health PodcastSubscribed to the newsletterFull ArchiveContact UsBecome an Affiliate Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
A World Of Silence: Navigating Infant Hearing Loss & Cochlear Implants The ability to listen is the very first skill we develop in the womb, and it's crucial for cognitive growth. Thankfully, infants born with hearing loss have a few options to keep their development on track. Our experts this week explore the science of pediatric audiology, how to make an early diagnosis, and the cochlear implant journey. Guests: Dr. Nancy Young, medical director of Audiology and Cochlear Implant Programs, The Ann & Robert H. Lurie Children's Hospital of Chicago, Lillian S. Wells professor in pediatric otolaryngology, Northwestern University Feinberg School of Medicine Eva Tweedy, parent; Doug Tweedy, parent Host and Producer: Kristen Farrah Facebook: ingoodhealthpodX: @ ingoodhealthpodIG: @ingoodhealthpodYouTube: @ingoodhealthpodSpotify Apple Podcast In Good Health PodcastSubscribed to the newsletterFull ArchiveContact UsBecome an Affiliate Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-504
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For many medical device companies, a successful audit is seen as the ultimate proof that their Quality Management System is performing well.Few or no findings.Positive feedback from auditors.Management celebrates.But does passing an audit really mean your QMS is healthy?In this episode of the Medical Device Made Easy Podcast, we explore why the answer is often no.Audits Are Samples—Not Complete EvaluationsWhether it's an ISO 13485 audit, a Notified Body assessment, an FDA inspection, or an internal audit, auditors can only review a small sample of your quality system.They cannot examine every complaint, every supplier, every design decision, or every production batch.A successful audit demonstrates compliance with the sampled evidence—but it does not guarantee that every aspect of the system is functioning effectively.The "Audit Mode" ProblemMany organizations unintentionally enter "Audit Mode" before inspections.Training records are updated.CAPAs are closed.Procedures are revised.Management reviews suddenly take place.While preparation is important, organizations should ask themselves:Are we improving our QMS—or simply preparing for an audit?Culture Matters More Than FindingsSome of the most significant quality risks rarely appear during an audit.Examples include:Employees afraid to report mistakesPoor communication between departmentsWeak supplier relationshipsDesign decisions that are never challengedInformal workarounds that bypass documented proceduresThese issues can remain invisible during a short audit while gradually increasing organizational risk.Measuring the Real Health of Your QMSInstead of focusing only on audit findings, management should monitor indicators such as:Complaint investigation timelinesCAPA closure performanceSupplier management effectivenessRisk management updatesCross-functional communicationNear-miss reportingContinuous improvement initiativesThese metrics often provide a far more accurate picture of QMS maturity than the number of audit findings alone.Final ThoughtPassing an audit is an important achievement and deserves recognition.However, organizations should never confuse regulatory compliance with operational excellence.A healthy Quality Management System is not built to impress auditors.It is built to consistently deliver safe, effective, and compliant medical devices while continuously improving every day—even when no auditor is watching.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.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.
Medical technology is moving quickly, and the companies that succeed will be the ones that stay connected, think strategically, and solve the right problems. In this live episode from DeviceTalks Boston, Etienne Nichols, MedTech Guru at Greenlight Guru and host of the Global Medical Device Podcast, discusses the major shifts shaping the medical device industry. He shares insights on global regulatory harmonization, tougher funding conditions, the growing role of AI, and why data strategy matters more than ever. Etienne also explains why companies need to understand their true user population, challenge assumptions in product development, and prepare for a future where medical devices work together as connected systems. Tune in to learn how medical device companies can navigate change, use data more strategically, and build solutions that better serve users and the broader healthcare ecosystem! Resources: Connect with and follow Etienne Nichols on LinkedIn. Follow Greenlight Guru on LinkedIn and explore their website. Listen to the Global Medical Device Podcast here.
Regulation gets you approved. A go-to-market strategy gets you adopted.The question is: are you spending more time preparing your medical device for approval than preparing it for commercial success?Many clinician founders believe launching a medical device starts with regulation, manufacturing, or raising investment. But by the time you're thinking about those things, many of the decisions that determine commercial success have already been made. In this episode, Hakeem shares a practical seven-step framework to help you validate the problem, build the right evidence, develop a go-to-market strategy, and create the foundations for successful commercialisation and future expansion into export markets.Listeners will discover:The seven stages every clinician should complete before commercialising and exporting a medical deviceWhy validating the problem, evidence, and go-to-market strategy matters more than rushing to launchHow to identify the biggest commercial constraint holding your MedTech business back and prioritise the next step towards adoption, sales, and international growthPlay this episode now to benchmark your progress against the seven-step framework and discover the next step that will help you commercialise, export, and grow your medical device business with confidence.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 Dr. Sudhir Srivastava, founder, chairman, and CEO of SS Innovations (Nasdaq: SSII). The company's SSi Mantra surgical robotic system supports a variety of surgical robotic procedures, including cardiac surgery. Sudhir brings more than three decades of experience in minimally invasive and robotic cardiac interventions, having served as Director of Robotic Cardiac Surgery at the University of Chicago and founder of the International College of Robotic Surgery. A pioneer in the field, Sudhir has performed more than 1,400 robotic procedures, including over 750 beating-heart totally endoscopic coronary artery bypass (TECAB) surgeries.In this interview, Sudhir discusses what it takes to democratize robotic surgery beyond affordability, how SS Innovations built teleproctoring, telesurgery, and the supporting infrastructure for its robotic platform, and his milestone-based approach to financing a capital-intensive medtech company. 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 Sudhir Srivastava, 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(03:01) - Sudhir's journey from performing the world's first beating-heart robotic bypass to founding SS Innovations (07:14) - The 22-year-old patient who became the catalyst for Sudhir's affordable robotic surgery platform (08:59) - Building Mantra 3 from the ground up in just five months (12:14) - Inside the engineering process that eliminated months of costly iteration (16:20) - The question that shaped SS Innovations: "How do you democratize access?" (27:10) - From one office to performing 24 telesurgeries in 12 hours across India (29:29) - How a mobile training bus became part of Sudhir's answer to make robotic surgery accessible (33:49) - Lessons from commercializing a surgical robotics platform across developing markets (39:43) - Starting with just $5 million: Sudhir's milestone-based approach to fundraising
SponsorMedboard: https://www.medboard.com/EuropeWell-Established Technologies - Publication of the Delegated act: https://ec.europa.eu/newsroom/sante/newsletter-archives/770132 Delegated acts:Class III and implantables: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451Class Iib implantables: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359In line with the Administrative Simplification Agenda COMBINE Phase 2 - Increase of Scope : https://ec.europa.eu/newsroom/sante/newsletter-archives/76937Incease of Scope:Eligibility for multinational investigational medicinal product (IMP) clinical trials combined with:Performance studies of IVDs or companion diagnostics requiring authorisationClinical investigations of medical devices requiring authorisation Combined studies with Advanced Therapy Medicinal Products (ATMPs) possibleOptions for single or separate sponsorsProcedure for substantial modifications in combined studies authorised in the pilot to be launched later in phase 2Exploration of single protocols and joint documents Austria: FSC deficiencies - Most issues identified: https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale/common-deficienciesSSCP, Upload you should! - MDCG 2026-4 released: https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg_2026-4_en.pdfStart Date October 2026, Due date February 2027 Harmonized Standard update - A full list was disclosed: https://eur-lex.europa.eu/eli/dec_impl/2026/1231/ojMDCG 2021-5 Rev 1 EU REP Symbol -Should you continue to use EC REP? https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_mdcg_2021_5_appendix_en.pdfDuring the transition time, within a staggered approach for the implementation, it is acceptable to use one or both symbols ‘EC REP' and ‘EU REP' on different levels of packaging, as well Team-NB- Micro Small Entreprise - Discount imposed https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-Micro-Small-Entreprise-Initiatives-V1-20260616.pdfUKUpdate of UK Borderline Guide - Remove of antimicrobial substances as Medical Devices: https://www.gov.uk/government/publications/borderlines-with-medical-devicesThe line: 'Alcohol-only pre-injection swabs and wipes are considered to be medical devices as are those containing anti-microbial substances such as chlorhexidine, cetrimide or iodine.' has been changed to this: Alcohol-only pre-injection swabs and wipes are considered to be medical devices.SwitzerlandSwissdamed: RegistrationNew option: M2M and Master UDI-DI: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/neu-online-editor-m2m-produktregistierung-master-udi.htmlSwissdamed UDI User guide: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_841e_hb_swissdamed_user_guide_udi_devices_module.pdf.download.pdf/BW630_40_841e_HB_swissdamed_User_Guide_UDI_Devices_Module.pdfMedtech Conf: Medtechconf.comPodcastEpisode 393 - Best of „AI CE marking“: https://podcast.easymedicaldevice.com/393-2/Episode 394 - NC vs CAPA: Are You Opening the Wrong Records?: https://podcast.easymedicaldevice.com/394-2/Episode 395 - “We've Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices: https://podcast.easymedicaldevice.com/395-2/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/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.
Resources:Million Dollar Flip FlopsFollow Us on Insta Ready to transform your business and your life while making a difference? Grab your copy of *Million Dollar Flip Flops*—the ultimate guide to creating a life and business that feels just as good as it looks. And here's the best part: 100% of the proceeds go directly to our foundation, Send a Student Leader Abroad, with a goal of sending 1,000,000 deserving kids on life-changing trips around the world.As a thank you for your support, we're offering exclusive bonuses available only for our podcast listeners. These bonuses are packed with extra tools and resources to help you implement the principles from the book faster and more effectively.Don't miss this opportunity to gain invaluable insights, impact a young leader's life, and be a part of something bigger. Click the link, order your copy, and claim your listener-only bonuses today! Together, let's change lives—one trip at a time.www.MillionDollarFlipFlops.com/book**P.S.** Every book you buy gets us one step closer to sending 1,000,000 kids on life-changing adventures. Let's make it happen!
WBSRocks: Business Growth with ERP and Digital Transformation
Send us Fan MailThe medical device industry encompasses a diverse range of business models, including consumable manufacturers, distributors, capital equipment providers, and service-focused organizations, each with distinct operational and regulatory requirements. Consequently, selecting the right ERP system involves far more than evaluating feature lists. Organizations must assess how effectively an ERP platform supports their manufacturing processes, quality management initiatives, traceability requirements, compliance obligations, and long-term growth objectives. In this video, we examine the leading medical device ERP systems in 2026 and explore how different solutions address the industry's unique operational, financial, and regulatory challenges, helping organizations identify the best fit for their specific business model and strategic goals.In this episode, our host Sam Gupta discusses the top medical device ERP systems in 2026. He also discusses several variables that influence the rankings of these ERP systems. Finally, he shares the pros and cons of each ERP system.Video: https://www.youtube.com/watch?v=eqE_43prs0kRead: https://www.elevatiq.com/post/top-medical-device-erp-systems/Questions for Panelists?
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Aditya Rajagopal, co-founder and CEO of Esperto Medical.Esperto is a Caltech spin-out utilizing compressed sensing technology with ultrasound to continuously and non-invasively measure blood pressure.Before Esperto, Aditya co-founded ChromaCode, a molecular diagnostics company, and was a researcher at Google[x], where he worked on novel medical imaging methods. Aditya also serves as part-time faculty at Caltech and USC, and holds BS, MS, and PhD degrees in Electrical Engineering from Caltech. In this interview, Aditya discusses why great science doesn't necessarily make great companies, what it takes to win as a fast-follower in medtech, and how to sequence a platform technology without spreading resources too thin.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 Aditya Rajagopal, 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(02:44) - Aditya's journey from Caltech and Google to tackling one of medicine's hardest engineering problems at Esperto (05:17) - How Esperto is trying to solve a 50-year-old problem: continuous blood pressure monitoring without an arterial catheter (07:17) - Why Esperto was okay with being a fast-follower in an established market instead of creating a new one (16:12) - "Great science doesn't necessarily make great companies" and other lessons Aditya learned at ChromaCode (24:02) - Three hurdles every medical device must clear before clinicians will actually adopt it (27:44) - How Aditya determines whether a technical problem actually has a "there there" (37:51) - Esperto's pitch strategy and how it raised from a position of strength (43:18) - What first-time founders often misunderstand about how venture capital actually works
Want to Break Into Medical Device Sales. Learn More Here: https://click.newtomedicaldevicesales.com/yt-502
Want to Break Into Medical Device Sales. Learn More Here: https://click.newtomedicaldevicesales.com/yt-502
At first glance, hearing "We've never had a complaint" sounds like excellent news.No customer dissatisfaction.No product issues.No safety concerns.But for Quality and Regulatory professionals, this statement should trigger an entirely different question:How do you know?What Is a Complaint?Many organizations believe a complaint only exists when a customer submits an official complaint form or explicitly uses the word "complaint."Regulators take a much broader view.A complaint may include:Unexpected device performanceProduct malfunctionsCustomer dissatisfactionUsability issuesDistributor observationsTechnical support interactionsReturned productsAny information suggesting the device may not meet requirementsComplaints Are Often HiddenPotential complaint signals can be found in:Customer emailsDistributor communicationsService reportsSales team discussionsTraining sessionsSocial media commentsTechnical support ticketsIf these sources are ignored, valuable post-market information is lost.Why Zero Complaints Can Be a Red FlagImagine a company with:5,000 devices on the marketProducts sold in 20 countriesDaily clinical useAnd yet...No complaintsNo usability observationsNo customer questionsNo returned devicesExperienced auditors may not celebrate.Instead, they may question whether the complaint handling process is effective enough to capture real-world information.Complaint Handling Impacts the Entire Quality SystemWeak complaint collection doesn't only affect one procedure.It directly influences:Clinical Evaluation Reports (CER)Post-Market Surveillance (PMS)PMCF activitiesPSUR preparationBenefit-Risk assessmentsState-of-the-art reviewsIf complaint data is incomplete, clinical evidence may also be incomplete.Five Practical RecommendationsDefine complaints broadly.Review every customer-facing information source.Create a structured complaint screening process.Trend data regularly to identify recurring issues.Periodically challenge your system by asking:"Would an auditor agree that we've identified every potential complaint?"Final ThoughtThe next time someone proudly says,"We've never had a complaint,"don't celebrate immediately.Ask instead,"How do we know?"Because in medical devices, the absence of complaints is not always evidence that everything is working perfectly.Sometimes, it's evidence that nobody is looking.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.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.
Episode 389: Mid-Year Reset for Women in Medical Device Six months down, six to go — and if you're in medical device or field-based sales, I'm willing to bet the first half of this year felt productive on paper and quietly exhausting underneath. Not because you're doing something wrong. Because the job you're actually doing is bigger than the one on your job description. In this episode, we're naming that invisible weight, explaining what it's doing in your nervous system, and giving you a concrete reset you can use before your next hard meeting. What You'll Learn ✨ Why the exhaustion you feel by mid-year isn't random — and what's actually causing it neurologically ✨ The biology of burnout explained simply: your amygdala, your prefrontal cortex, and why "just relax" has never worked for anyone ✨ How cognitive reappraisal (a CBT tool) literally rewires your brain's stress response over time ✨ Why your gut instincts are pattern recognition — and why trusting them is a performance strategy, not woo ✨ A 3-step, 5-minute reset practice you can use in real time ✨ A journal prompt for the second half of the year that will change how you carry the load The Big Takeaway The load you've been carrying is real. The relationship labor, the emotional labor, the constant low hum of being the calm, capable one in every room — none of that shows up on the quota sheet. But the way your nervous system responds to it? That part you actually have leverage over. This one hits all four pillars of the RISE Method — Resilient Mindset, Inner Energy, Success Strategy, and Empowered Self-Trust — because a mid-year reset isn't a one-time fix. It's the rewrite. Ready to go deeper? Join the weekly newsletter at michellebourquecoaching.com/newsletter
Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-sessionFinished medical devices can create a lot of surprises when they are added to combination product kits.A needle, vial adapter, filter, or transfer device may already be sterile, cleared, qualified, and sold at massive scale.But already on the market does not automatically mean ready for your combination product.In this episode, I talk through the challenges of selecting finished medical devices for combination product kits and the three lifecycle moments that usually determine whether qualification goes smoothly or turns into a late-stage problem.We cover:* Why “already approved” does not mean combination-product ready* Why you inherit the supplier's design, QMS, packaging, validation, change control, and outsourcing decisions* What to think about before supplier selection* How to set expectations during supplier selection* Why structured qualification matters* How PPAP concepts like process flow, PFMEA, control plans, inspections, sampling, and validation evidence can helpThe main point: A commercially available device may be qualified for someone else's intended use. Your job is to determine whether it is qualified for yours.Chapters:00:00 Device Selection Stakes02:05 Common Supplier Myths03:54 Inheriting the Device QMS04:53 Three Crucial Moments05:51 Before Selection: Intended Use07:21 Packaging, Markets, and Risk Flags08:55 During Selection: Set Expectations10:33 Qualification: Use a Structured PPAP Approach14:12 Wrap Up and Next StepsSubhi Saadeh is the Founder and Principal at Let's Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics.Let's Combinate helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across drug and device domains.#CombinationProducts #MedicalDevices #PharmaQuality #SupplierQuality #DrugDeviceCombinationProducts #PPAP #QualitySystems
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Eric Kau, co-founder and CEO of Climatic.Climatic is commercializing L Max, a daily inhaled system that proactively supports lung function.Before Climatic, Eric served as COO of Seed Health and was part of the foundational team at Chewy. Earlier in his career, Eric held growth and operational leadership roles across consumer, wellness, and e-commerce businesses, including Amazon, BoxyCharm, Target, and Best Buy. In this interview, Eric discusses what it takes to build a consumer category that doesn't yet exist, how Climatic approached clinical validation and consumer education simultaneously, and how early user behavior helped identify the company's strongest initial customer cohorts.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 Eric Kau, 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(02:49) - Eric's path through Amazon, Chewy, Seed, and the consumer health experiences that led to Climatic (05:49) - Why Climatic is treating lung health like hydration, sleep, or nutrition (11:47) - How Climatic rapidly iterated on formulas, delivery systems, and prototypes to launch a product for a new category in under 2 years (14:56) - Climatic's approach to product design, which is built around gym bags, vanities, and existing wellness routines (19:59) - How early users shaped both Climatic's clinical strategy and its go-to-market focus on endurance athletes and biohackers (23:56) - Why Climatic spent more time teaching consumers about lung health than selling the product itself (34:07) - What investors needed to believe before funding a category that didn't yet exist (40:27) - How Climatic built a 15,000-person waitlist through Strava run clubs instead of paid ads
One of the most common sources of confusion in medical device Quality Management Systems is knowing when to open a Nonconformity (NC) and when to initiate a Corrective and Preventive Action (CAPA).Some organizations turn every issue into a CAPA, while others rarely open one at all. Both extremes can create challenges during audits and may indicate an immature quality system.In this episode of the Medical Device Made Easy Podcast, we explain the fundamental differences between NCs and CAPAs and explore real-life situations to help quality professionals make better decisions.A Nonconformity simply indicates that a requirement has not been met. A CAPA, however, is a structured process designed to investigate and eliminate the root cause of significant, recurring, or systemic issues.Through multiple scenarios, we discuss:When an isolated event should remain a simple NC.How trends and recurring problems justify CAPAs.Why a single event can trigger a CAPA when patient safety is involved.Whether a CAPA always requires a Nonconformity first.Alternative sources of CAPAs, including complaints, audits, PMS activities, PSUR reviews, PMCF activities, and management reviews.How auditors evaluate the maturity of a CAPA system.The three questions every quality professional should ask before deciding between an NC and a CAPA.The objective is not to open more CAPAs, nor to avoid them. The objective is to open the right CAPAs, based on risk, recurrence, and impact.Understanding this distinction is essential for building a robust and effective quality management system that supports compliance, patient safety, and continuous improvement.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.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.
Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate certification requirements and maintain safety and performance throughout the entire product lifecycle.In two podcast episodes featuring Sandy Wright and Osman El-Koubani, we explore the journey from certifying LLM-driven medical devices to managing them after CE marking.Certifying LLM-Driven Medical DevicesLarge Language Models such as ChatGPT, Gemini, and Claude introduce new regulatory challenges. Unlike traditional software, these systems raise questions around predictability, validation, traceability, supplier management, and model updates.Topics discussed include:What defines an LLM-driven medical deviceClinical evaluation strategiesDemonstrating clinical benefitUsing commercial AI modelsSupplier controls and external dependenciesSignificant changes and model updatesLife After CE MarkingObtaining CE certification is not the end of the journey.AI medical devices require continuous monitoring once they reach the market.Manufacturers must address:Performance drift in real-world settingsCollection and analysis of real-world dataAI retraining and change managementPredetermined Change Control Plans (PCCPs)Post-Market Surveillance (PMS)Continuous safety and performance evaluationAI Devices Require a Lifecycle ApproachAI systems are dynamic technologies. Success depends not only on achieving certification, but also on maintaining control over performance, updates, and clinical safety throughout the product lifecycle.As regulations continue to evolve, manufacturers must combine robust development practices with proactive post-market monitoring to ensure long-term compliance and patient safety.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.LinkSandy LinkedIn: https://www.linkedin.com/in/wrightsandy/Osman Linkedin: https://www.linkedin.com/in/osman-kan/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 hosted by Podcastics, the easiest platform to create and publish your podcast.
The Advantage of Rapid Prototyping in Wearable MedTech DevelopmentModern cancer treatments are getting better at targeting specific forms of cancer. However, this improved effectiveness often introduces lethal side effects. Skribe Medical is developing wearable technologies to help oncologists monitor and manage these side effects and ultimately improve cancer survivability.In Episode 45 of the MedTech Speed to Data podcast, Key Tech's Andy Rogers has a conversation with Ryan Neely, Skribe Medical's CEO and co-founder, about the startup's approach to rapid prototyping, clinical trials, and wearable technology.Need to knowCancer treatment can be lethal — The most effective drugs often come with black box warnings of harmful and lethal side effects.600,000 US patients are at risk of cardiotoxicity — Toxic drugs damage the heart, leading to complications like arrhythmia and heart failure.Managing cardiotoxicity can delay cancer treatments — Oncologists must now schedule patients for third-party ECG testing, which takes time and delays treatment.The nitty-grittySkribe Medical is developing a wearable ultrasound sensor that detects cardiotoxicity signals for use in oncology clinics. “We have a patch that can be worn to detect cardiotoxicity and really streamline monitoring of heart health,” Neely says. “Rather than an oncologist sending a patient to get a cardiac ultrasound, which could take weeks, the patch can just be placed above the heart for about five minutes. We record a bunch of different signals, pass them through an AI model, and then we can give them either a thumbs up or a thumbs down.”Neely goes on to explain how the in-clinic wearable approach delivers benefits beyond better patient outcomes. “The first device that we're building is intended to be used in the clinic by a nurse or a medical assistant. By the time the doctor is there, you've got your answer.”Designing a wearable device rather than an implant created several advantages for Skribe Medical during its early development. “In a regulated industry like medical devices,” Neely explains, “it's like a little bit of a chicken and egg where people say, ‘we'd like to see some clinical validation' and you're thinking, ‘Well, I don't have a million dollars to fund that.' In a non-invasive device, any opportunity that you can have to test, even if it's this big, bulky thing, you can get some data.”Skribe Medical's technology can extend to other aspects of oncology, including peripartum cardiomyopathy, a rare form of heart failure arising towards the end of a pregnancy. Long-term, Neely envisions building the longitudinal training data needed for predictive monitoring. “What we'd like to do is be able to say, ‘two weeks from now there might be an issue' so you can do something today that prevents any drop [in injection fraction] at all.”Data that made the difference:Skribe Medical's three founders built first prototype at home. They used their home electronics and 3D printing labs to rapidly prototype the first functional sensors.Rapid wearable development delivered data quickly, first by testing themselves and then through clinical testing.Skribe Medical conducted the first clinical tests at an ECG lab where, with consent, the wearable collected patient data for comparison with the patient's ECG results.Having clinical data so early in the process encouraged investors. Last year's pre-seed round raised $1.6 million from angels and VCs to support the next phase of device development and trials.Listen to Andy's conversation with Neely to hear more about Skribe Medical's journey, development process, and the advantages of wearable medical technology.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Kara Egan, founder and CEO of Teal Health.Teal Health is the company behind the first FDA-authorized at-home cervical cancer screening wand.Before founding Teal, Kara worked in healthcare and software investing at .406 Ventures and Emergence Capital, and held product and marketing roles at Zendesk and Stitch Labs. In this interview, Kara discusses building support and follow-up into at-home screening, how Teal expanded its comparative clinical study to support broader market adoption, and how healthcare incentives, reimbursement, and institutional trust shape new care models.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 Kara Egan, 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(02:49) - Kara's background in health technology investing and software that shaped Teal's consumer-first approach (05:14) - How Teal turned the traditional Pap smear into the first FDA-authorized at-home screening product (07:30) - Turning at-home testing, telehealth, and clinician follow-up into a single care experience (13:48) - Raising Teal's first $1M with mockups and consumer-grade design (22:17) - Teal's comparative study that matched physician-collected screening with 96% sensitivity (23:40) - How asking women what they actually wanted changed Teal's view of the market opportunity (32:05) - “Take off the healthcare hat” — Kara's framework for fundraising, incentives, and commercialization (41:48) - What investors actually care about beyond the company's mission
Highlights from their conversation include: Keith Smith's Journey into Manufacturing and Industrial Engineering (0:49) Overview of Vonco Products as a Medical Device Contract Manufacturer (1:53) Single Use Fluid Bags, Horizontal Services, and Turnkey Offering (2:06) Being “Freaks About Leaks” and the Liqui Lock Guarantee (4:16) RF Welding vs Heat Seal Welding for Different Polymers (5:39) The Spark Program and On-Site Rapid Prototyping with Customers (7:03) Enter Lock Innovation for Enteral Feeding and Customer Adoption (8:21) Geopolitical Shocks, Iran Conflict, and Plastic Supply Volatility (9:32) Reshoring, Near Shoring, and Rethinking Global Supply Chains (12:18) COVID, Panic Buying, and Stockpiling Risk in Medical Devices (14:34) Automation Priorities, Staffing Challenges, and Failed Experiments (17:01) Diversification Strategy, Customer Mix, and Supply Chain Resilience (19:28) Parting Thoughts and Takeaways (20:46) Dynamo Ventures is a venture firm backing founders upgrading the physical economy. As intelligence moves into critical infrastructure and technology collides with physics, industry is entering a new era of transformation - the industrial renaissance. Born from the dirt and grit of supply chains and shaped by operations, not spreadsheets, Dynamo focuses on the complex realities of building in the real world. We invest in companies transforming infrastructure, manufacturing, logistics, transportation, and the systems that power global commerce. Dynamo works closely with founders who combine ambition with a bias to action, bringing a builder mindset to venture capital through deep operational insight, systematic pressure-testing and hands-on partnership. Our purpose is simple: to back the relentless shaping the industrial renaissance. Learn more at www.dynamo.vc. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Sponsor Medboard Medboard: https://www.medboard.com/EUROPEEurope Starts Regulating the Regulators - Implementing Regulation (EU) 2026/977: https://eur-lex.europa.eu/eli/reg_impl/2026/977/ojEUDAMED is mandatory - Panic is raising: https://health.ec.europa.eu/medical-devices-eudamed/overview_enGermany: https://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte/DMIDS-anleitung-anzeigepflichtige-mp-ivd.pdf?__blob=publicationFileBelgium: https://www.famhp.be/en/news/eudamed_clarifications_regarding_obligations_from_28_may_2026Portugal: https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/13092901AI Medical Devices - Timeline changed for AI ACT: https://www.consilium.europa.eu/en/press/press-releases/2026/05/07/artificial-intelligence-council-and-parliament-agree-to-simplify-and-streamline-rules/Germany guidance: https://www.bundesnetzagentur.de/DE/Fachthemen/Digitales/KI/5_Innovationen/_DL/Roadmap_Pilot.pdf?__blob=publicationFile&v=5Spain new HTA - Royal Decree 415/2026: https://www.boe.es/boe/dias/2026/05/29/pdfs/BOE-A-2026-11587.pdfDenmark on languages - Reminder that there are requirements to follow: https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/UKMHRA regulatory advice meetings - Pay and ask what you want: https://www.gov.uk/guidance/medical-devices-ask-for-a-regulatory-advice-meeting-from-the-mhraEasy Medical Device solutionsEasyIFU - electronic Instruction for Use: https://easyifu.comSmarteye - electronic Quality Management System: https://eqms-smarteye.com/Rest of the WorldFDA reinforce Human Factors expectations - This is not nice to have: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissionsSaudi Arabia bundling criteria - More products in a single application: https://www.sfda.gov.sa/sites/default/files/2026-05/MDS-G28.pdfPodcastPodcast Nostalgia - Re-listen latest podcast episodes:Episode 390 - How can a proper intended use save your device with Kanrandeep Badwal: https://podcast.easymedicaldevice.com/390-2/Episode 391 - Feedback after 3 months of the new FDA QMSR is in place with Mathangi Srinivasan: https://podcast.easymedicaldevice.com/391-2/ 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/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.
This episode was brought to you by Mouser, our go-to source for electronics parts for any hobby or prototype. Click HERE to see how 3D metal printing is making custom medical implants stronger, better fitting, and tailored to every patient. Become a founding reader of our newsletter: http://read.thenextbyte.com/ As always, you can find these and other interesting & impactful engineering articles on Wevolver.com.
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
Tariffs, consolidation, and inflation are transforming medical device manufacturing. Wipfli's Cara Walton discusses how these industry trends are reshaping production processes and what medtech companies can do to stay ahead.
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.
The FDA's new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality System Regulation (QSR) framework that had been in place for nearly 30 years.Three months later, the reality is becoming clear for many manufacturers:QMSR is far more than a simple regulatory update.It represents a complete transformation in how the FDA expects companies to manage quality, risk, design controls, manufacturing, supplier oversight, and post-market surveillance.From Siloed Quality to Lifecycle ThinkingUnder the old QSR framework, companies often treated quality activities separately:Design controlsCAPAManufacturingSupplier managementPost-market surveillanceQMSR changes this mindset entirely.FDA now expects manufacturers to demonstrate integrated, risk-based quality management across the entire product lifecycle.This means:Design changes must connect to manufacturing validationSupplier issues must feed into risk managementPost-market surveillance must proactively identify trendsManagement reviews must show real decision-makingWhy Many Companies Were Not ReadyA major misconception across the industry was believing that ISO 13485 certification automatically meant QMSR readiness.But manufacturers are now discovering major gaps:Incomplete Design History Files (DHF)Weak risk integrationPoor documentation traceabilityReactive PMS systemsLimited management review evidenceFDA inspections are already reflecting these expectations.Inspectors are requesting:Internal audit reportsSupplier audit documentationManagement review recordsRisk-based decision evidenceThis level of transparency is new for many organizations.Real-World Challenges Manufacturers Are FacingOne of the biggest pain points is DHF restructuring.Companies with years of design changes are now being forced to reconstruct the logic behind historical decisions and organize fragmented information into a coherent, risk-based structure.Another major shift is Post-Market Surveillance.QMSR pushes manufacturers from reactive complaint handling toward proactive monitoring of known high-risk failure modes using trend analysis, registries, and real-world data.Management review processes are also under greater scrutiny.FDA now expects leadership teams to demonstrate how quality data drives actual strategic decisions.Best Practices for QMSR TransitionManufacturers preparing for QMSR should focus on:1. Cross-functional collaborationBreak down silos between QA, RA, Manufacturing, Design, and Supply Chain.2. Documentation mappingIdentify where critical design logic and risk decisions currently exist.3. Continuous risk managementImplement ongoing cross-functional risk review meetings.4. Stronger internal auditsMove beyond checklist auditing toward analytical risk-focused auditing.5. Meaningful management reviewsUse management review meetings to demonstrate active leadership involvement in quality decisions.Final ThoughtsQMSR is fundamentally changing the FDA's expectations.Companies that adapt early will build stronger systems, improve product quality, and reduce regulatory risk.Companies that delay may face:FDA 483 observationsWarning LettersProduct launch delaysIncreased remediation costsThe transition to QMSR is not simply a compliance project.It is a complete redesign of how medical device companies manage quality.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.LinkMathangi Srinivasan linkedin: https://www.linkedin.com/in/mathangiks/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.
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.
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.
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