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Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-511
Send us Fan MailMichael Brooks is the founder and CEO of BayCath Medical, a Silicon Valley medical-device company specializing in the design, development, and contract manufacturing of catheter-based products. BayCath was created to give startups and fast-moving R&D teams a more collaborative manufacturing partner—one capable of supporting rapid prototyping, iterative development, pilot production, and smoother transfers into manufacturing. Michael launched BayCath after seeing catheter development lead times grow and watching delays interfere with customer timelines. His vision is to create an environment where engineers, physicians, and manufacturing specialists can work closely together, explore multiple solutions, and make informed design decisions without wasting valuable time or capital. Before becoming a founder, Michael held program management, engineering, and manufacturing roles throughout the medical-device industry. Across those positions, he gained experience in braided and coiled catheters, material selection, process development, design for manufacturing, validation, manufacturing transfers, fixture development, supplier management, and regulatory support. He also led high-priority customer programs, helped establish project-management processes, and coordinated complex work across technical, operational, and customer-facing teams. Michael earned his bachelor's degree in biomedical engineering from the University of California, Davis, along with a minor in technology management. His career has placed him at the intersection of hands-on engineering, customer communication, program leadership, and entrepreneurship—giving him a valuable perspective on what it takes to move medical-device ideas from early prototypes toward production and, ultimately, patient care. LINKS: Michael Brooks LinkedIn: https://www.linkedin.com/in/micbrooks10/ BayCath Website: https://www.baycath.com/ Innovation Week: https://www.baycath.com/workshops MedTech Bay Area Networking LinkedIn: https://www.linkedin.com/company/medtech-bay-area/ Aaron Moncur, host PDX 2026 is October 20-21 in Phoenix, AZ. Learn more and register at https://pdexpo.engineer/ 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
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-509
Having an ISO 13485 Quality Management System in place does not automatically mean that your quality processes are effective.A strong QMS should help an organization identify problems, evaluate their significance, capture information from the market, investigate systemic issues, and continuously improve.In this Easy Medical Device podcast collection, we examine several situations that can reveal whether a QMS is truly functioning—or simply looks good on paper.Understanding NC vs CAPAOne of the most misunderstood areas of quality management is determining when to open a Nonconformity and when to escalate an issue into a CAPA.Not every isolated problem requires a complete CAPA investigation. However, when an issue becomes recurring, systemic, significant, or potentially high-risk, a deeper investigation may be necessary.The objective isn't to create as many CAPAs as possible. It's to recognize the problems that genuinely require root cause investigation and corrective action.Why “We've Never Had a Complaint” Can Be DangerousZero complaints may sound like excellent news, but it can also raise an important question:Is your organization effectively capturing all sources of customer and post-market feedback?Potential complaints may appear through distributor communications, service reports, customer emails, returned products, training feedback, or other customer-facing channels.If this information isn't properly evaluated, the organization may miss important product performance or safety signals.The Fake QMS ProblemA Quality Management System can look excellent on paper.Procedures exist. Forms are available. CAPA processes are defined. Risk management documentation is complete.But if employees don't follow those processes in daily operations, the QMS can become disconnected from reality.That's the core of the “fake QMS” problem: the documented system and the way the company actually operates become two different systems.During an audit, this gap can quickly become visible.Building a QMS That Actually WorksAn effective QMS should be integrated into everyday operations rather than maintained only for certification or audits.Problems should be identified and evaluated appropriately. Customer feedback should feed into complaint handling and post-market activities. Significant and recurring issues should trigger investigation, and lessons learned should contribute to continuous improvement.Ultimately, the goal isn't to create a perfect-looking Quality Management System.The goal is to create a QMS that helps your organization consistently identify problems, manage risk, improve processes, and support the delivery of safe and effective medical devices.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.
From Non-Profit to Medical Device Sales in 60 Days with Shannon Donohue | Medical Sales UCan you land a 6-figure medical sales role without a background in B2B sales or healthcare? Yes—and today's guest proves exactly how to do it. In this episode of Medical Sales U, host Dave Sterrett sits down with Shannon Donohue, a former Non-Profit Director who pivoted her career into medical device sales and landed an Associate Sales Representative position at Baxter in under two months. If you are a non-profit worker, nurse, recent grad, or sales professional trying to break into the medical sales industry, Shannon's story shows you how to turn your past experience into your greatest asset. TIMESTAMPS:00:00 - Meet Shannon: Non-Profit to Capital Equipment Sales 01:30 - Shannon's "Why" & Leaving the Non-Profit World 06:57 - How Non-Sales Experience Translates to Medical Sales 09:15 - Making an Impact vs. Making Money (The Corporate Shift) 11:37 - Why Cold Applying Fails & How to Network 16:17 - The Brag Book Strategy That Got Attention 20:51 - Overcoming a Terrible Interview Practice Session 25:32 - The Baxter Interview: HireVue, RSMs & Mock Pitches 27:50 - Final Advice for Job SeekersReady to jumpstart your career in medical device or pharmaceutical sales?
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-508
A growing gap between device complexity and organizational knowledge is turning service reliability into an enterprise‑level risk for regulated industries. In this episode, Ryan Makely, Senior Director of CALID Service at Bruker Scientific, breaks down how fragmented documentation, rapid loss of expert judgment, and inconsistent field diagnoses undermine both operational performance and any future AI‑enabled support capability — in conversation with Emerj's Marilie Fouché. Leaders will hear practical themes around building structured knowledge foundations, reducing repeat‑visit failure cycles, and preparing service teams for scalable AI adoption. This episode is sponsored by Aquant. Learn more about how Emerj drives pipeline for other AI brands - download our media kit at emerj.com/AD1
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-508
Quality and regulatory compliance are fundamental to bringing safe and effective medical devices to market. As regulations continue to evolve and technologies become more complex, manufacturers must adopt a proactive approach to quality throughout the entire product lifecycle.This podcast collection explores key topics shaping today's medical device industry, including the FDA's transition to the Quality Management System Regulation (QMSR), effective validation and supplier management strategies, and structured approaches to managing software defects in Software as a Medical Device (SaMD).Together, these discussions highlight how strong quality systems extend beyond documentation. They emphasize the importance of risk-based thinking, supplier oversight, software quality, and continuous improvement to ensure compliance while protecting patients.Whether you're working in Quality Assurance, Regulatory Affairs, Engineering, or Product Development, these conversations offer practical insights to help strengthen your Quality Management System and prepare for the evolving regulatory landscape.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.
Content Note: This episode contains open conversations about chronic pain, trauma, medication, addiction, suicidal thoughts, and medical gaslighting. These experiences are shared with honesty, hope, and the intention of helping others feel less alone. Please listen gently and take the space you need.In this raw and inspiring episode, Lyndsay Soprano sits down with fellow CRPS warrior, executive coach, and author Alesia Briggs to share the realities of living with chronic pain—and the strength it takes to keep choosing hope.Together, they share the realities of living with chronic pain, fighting to be believed, navigating difficult diagnoses, and learning to advocate for themselves in a healthcare system that doesn't always have the answers. Alesia opens up about her journey through CRPS, the challenges of medication, spinal cord stimulation, and the unexpected moments that changed the course of her healing.Throughout the conversation, Lyndsay and Alesia explore the importance of finding the right medical team, protecting your energy, setting boundaries, and leaning on the people who continue to show up when life feels impossible. They remind us that healing isn't about pretending everything is okay—it's about adapting, asking questions, and refusing to let pain write the ending of your story.This episode is raw, validating, and filled with hope for anyone navigating chronic illness, trauma, or the uncertainty of an invisible condition. Because even on the hardest days, there is always another page waiting to be written.Episode Highlights:(00:00) Introduction to Lyndsay and Alicia Briggs(04:04) Alesia's early struggles with diagnosis and medication(07:00) The dangers of medication side effects and mental health(09:52) Alesia's experience with hallucinations and medication risks(12:58) The importance of mental health support and therapy(17:02) Managing energy and workplace communication(20:45) Sharing health issues at work and building trust(27:01) The journey with spinal cord stimulators(34:01) Alesia's story of pregnancy and nerve rewiring(40:13) Hope, resilience, and community support(43:07) Closing thoughts and resourcesFollow Alesia Briggs Online Here:Website: www.coachbriggs.comInstagram: @coach.briggsLinkedIn: Alesia BriggsBook: Finding the Off Switch: There is Another PageSubscribe on YouTube | Merch Shop is OPEN!! | COMING SOON: The Pain Hub - A Women's Healing Community. Subscribe Now!Unfiltered convos. Dark humor. Real healing. This is where pain meets purpose — and you're not doing it alone.++Want to be a guest on Giving Pain Purpose with Lyndsay Soprano? Send her a message on PodMatch, here: Be a Guest on The Show
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with David Veino, President and CEO of Neuros Medical.Neuros is commercializing the FDA-approved Altius Direct Electrical Nerve Stimulation System for chronic post-amputation pain.Before Neuros, David held senior commercial leadership roles at Cardiovascular Systems (CSI) and Stryker, and helped grow CSI's coronary and peripheral business from approximately $50 million to more than $250 million in annual revenue while leading key amputation-prevention initiatives. He also serves as a private equity advisor with Sectoral Asset Management. In this interview, David discusses how commercialization begins by mapping the patient journey upstream, what it takes to generate gold-standard clinical evidence for a novel therapy, how investors assess scalable medtech businesses, and how to build an investor pitch that earns the next meeting. 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 David Veino, 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(03:02) - David's 30-year medtech journey from cardiovascular devices to leading Neuros (04:38) - How Neuros is treating chronic post-amputation pain with on-demand neuromodulation (11:08) - Why Neuros completely changed its strategy halfway through the pivotal trial (15:36) - Why commercialization starts with referral pathways, not end-users (18:09) - How prosthetists became one of Neuros' most important referral sources (26:11) - What it takes to generate gold-standard clinical evidence for a first-of-its-kind therapy (37:41) - Building an investor pitch that earns the next meeting (41:42) - What gets David excited enough to invest in a medtech company
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-507
Cybersecurity has become one of the biggest challenges facing medical device innovators, and it's about much more than protecting data. In this episode of Project Medtech's mini series, cybersecurity expert Christopher Gates breaks down the first five essential principles every medtech company should understand, from designing secure devices from day one to navigating FDA expectations and staying ahead of evolving threats powered by AI and quantum computing. Whether you're building your first device or scaling an established company, this conversation is packed with practical insights to help you strengthen your cybersecurity strategy and bring safer technologies to market.Christopher Gates LinkedInarsMedSecurity WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Vijit Sabnis, co-founder and CEO of Adaptyx Biosciences.Adaptyx is a Stanford spinout developing wearable technology for continuous molecular monitoring.Over the past 20 years, Vijit has worked at the intersection of deep technology as an inventor, founder, and investor. Before Adaptyx, he was a Partner at Khosla Ventures and co-founded Solar Junction to commercialize high-efficiency solar cell technology. He holds a Ph.D. in Electrical Engineering from Stanford.In this interview, Vijit discusses how to recognize when a scientific idea is worth building a company around, how to build startup-style learning cycles when spinning technology out of academia, and designing products that are easy for clinicians and consumers to adopt. 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 Vijit Sabnis, 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(03:17) - Vijit's path from Stanford, solar energy, and venture capital to building Adaptyx (07:25) - How Adaptyx is trying to do for hormones what continuous glucose monitors did for diabetes (13:50) - The signals Vijit looked for before founding Adaptyx (25:35) - How Adaptyx turned academic research into startup-speed learning cycles (32:15) - Why cortisol became the company's first clinical application (36:26) - How Adaptyx is designing new molecular data to fit existing clinical workflows (42:12) - Why new consumer health platforms opened new paths to commercialization (47:24) - Fundraising in an era of shorter attention spans
The Signal Relief Patch – Powerful, reusable relief A drug-free wellness patch that works with your body's own signals to calm everyday discomfort. https://SignalRelief.com/MelK Disclaimer: Signal Relief is a Health and Wellness product. The Product is not a Medical Device and is not intended to diagnose, treat, cure, mitigate, or prevent any disease or medical condition. Use the Product only as directed. Consult a physician before use if you have diabetes, circulatory problems, chronic pain, skin conditions, nerve disorders, any other medical condition, or any implantable devices. Do not use if pregnant. CLIENT REVIEWS ★★★★★ Miracle It really works. Amazing product. – Ralph C. ★★★★★ Extremely grateful for Signal Relief Purchased my first patch to give it a try. Having back issues for years finally found something that has worked is such a blessing. – Kerin H. ★★★★★ A real miracle!! Got this for my dad who has been suffering for years… It's amazing how much better he gets around now! This patch hasn't just changed my dads life. It's changed my family's life. We all have so much more joy not seeing dad hurt anymore!! – Joshua B. ★★★★★ It works! A friend purchased one for me. It worked so well I purchased another one. As someone said, "I don't know why it works, but it does". – Karen C. ★★★★★ Finally relief I am now able to have relief when standing, walking, driving, climbing stairs, and sleeping. I put the patch in different areas of my lower back-where it is needed. – Patricia Learn more about Signal Relief: https://SignalRelief.com/MelK
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-506
Breaking into medical device sales—or landing your next opportunity—has never been more competitive.In this episode of the Chase MedSearch Podcast, Jordan Chase sits down with recruiter Jay Waggoner to share three decades of hiring experience and discuss what separates candidates who consistently receive offers from those who never make it past the interview.Whether you're trying to break into medical device sales, advance your career, or simply understand how top MedTech companies evaluate talent, this conversation is packed with practical, real-world advice from professionals who interview thousands of candidates.In this episode, you'll learn:How to stand out in today's competitive medical device job marketThe biggest mistakes candidates make during interviewsWhat hiring managers actually look for beyond the résuméHow networking can accelerate your careerThe habits and characteristics shared by top-performing sales professionalsAdvice for recent graduates, experienced reps, and career changersWith more than 30 years of executive recruiting experience and thousands of successful placements, Jordan shares lessons learned from helping many of the industry's leading medical device companies build high-performing commercial teams.Whether your goal is your first medical device sales role or your next leadership opportunity, this episode will help you approach your job search with greater confidence and a clearer strategy.Connect with Chase MedSearch
Learn more on how to break into medical device sales: https://click.newtomedicaldevicesales.com/yt-506
Many medical device startups assume they're audit ready because they have documented procedures, completed templates, and a Quality Management System in place.However, successful audits require much more than organized documentation.In this episode of the Medical Device Made Easy Podcast, we welcome Chiratana Pot from Enlil to discuss what true audit readiness looks like and why continuous compliance is far more effective than preparing only when an audit is scheduled.What You'll LearnWhat Is an Audit Really?Many organizations view audits as exercises designed to uncover mistakes.In reality, audits evaluate whether your Quality Management System is implemented effectively and consistently—not simply whether procedures exist.Compliance vs. Audit ReadinessBeing compliant and being audit ready are not always the same.The discussion explores how companies can move beyond documentation and demonstrate that their processes are actively followed throughout the organization.Common Startup MistakesDrawing from experience working with MedTech startups, Chiratana shares the most frequent challenges organizations encounter before their first audit, including assumptions that often lead to unexpected findings.Why Traceability MattersOne of the central themes of the episode is traceability.We examine how effective traceability connects requirements, risks, design decisions, verification activities, and documentation—making change management more efficient and strengthening overall compliance.How Enlil Supports Connected DevelopmentThe conversation concludes with an overview of Enlil's approach to connected development, explaining why integrating quality into product development from the beginning helps organizations maintain continuous audit readiness rather than relying on last-minute preparation.Key TakeawayAudit readiness is not a checklist completed before an inspection.It's the result of building a culture where quality, traceability, and compliance are embedded into everyday work.For MedTech startups, developing this mindset early can simplify audits, improve product quality, and create a stronger foundation for long-term regulatory success.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.Who is Chiratana (CP) Pot? Chiratana (CP) Pot is Senior Director of Product at Enlil, a cloud-native, AI-driven development traceability platform built for medical device and life sciences organizations. Enlil connects quality, regulatory, R&D, manufacturing, and operations teams through a unified system of record, enabling traceability, auditability, and regulatory readiness across the product lifecycle. CP works with MedTech organizations to strengthen design controls and audit readiness. He is a frequent contributor on topics including design controls, lifecycle traceability, and regulatory readiness, helping organizations move beyond documentation compliance to evidence-based product development.LinkChiratana's linkedin: https://www.linkedin.com/in/chiratana-pot/Website: https://enlil.com/Enlil's LinkedIn: https://www.linkedin.com/company/enlil-inc/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 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!
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Bob Paulson, President and CEO of Sonex Health. Sonex's UltraGuideCTR device is a minimally invasive technology that enables ultrasound-guided carpal tunnel release procedures to be performed outside the surgical suite using local anesthesia, expanding patient access and reducing the cost of care.Before joining Sonex, Bob led multiple venture-backed medical device companies through commercialization, including NxThera, acquired by Boston Scientific, Restore Medical, acquired by Medtronic, and VentureMed Group. Earlier in his career, he held senior leadership roles at Medtronic, Advanced Bionics, and Endocardial Solutions, which was acquired by St. Jude Medical.In this interview, Bob explains how to build a reimbursement strategy before your first clinical study, drive physician adoption when introducing a new care pathway, and raise capital aligned with value inflection points. 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 Bob Paulson, 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(03:19) - Bob's path from Medtronic to multiple medtech exits before joining Sonex (05:38) - Why 80% of eligible carpal tunnel patients avoid surgery — and how Sonex is changing that (11:11) - The reimbursement challenge that reshaped Sonex's clinical evidence strategy (19:07) - Reimbursement is a three-leg process: FDA, CPT, and payer coverage (22:07) - Reverse engineering your company from the exit you're trying to achieve (29:35) - How Sonex helped surgeons move carpal tunnel procedures out of the OR (39:06) - Sonex's "pitcher-catcher" approach to physician and patient adoption (41:59) - Bob's framework for choosing investors who can finance the entire journey, not just the next round
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.
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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.
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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.
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.
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