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MedboardSponsor: Medboard: https://www.medboard.com/EuropePharmacist are distributors - French guide issued to educate them: https://medboard-public-assets.s3.amazonaws.com/Regulatory/9b892d08-611c-4326-a40e-750e0364df27.pdfTeam NBTeam NB position Paper - Reduced Scrutiny, Cost saving: https://www.team-nb.org/wp-content/uploads/2026/03/Team-NB-PositionPaper-MDR-IVDR-revision-impact-on-the-sector-20260302.pdfTeam-NB Demonstrate Safety and performance - For Combination of reagent and other equipment: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-PositionPaper-Demonstration-of-Safety-and-Performance-for-Combinatorial-Use-of-Devices-or-Equipment-V1-20260216.pdfTeam-NB- Letter on Cybersecurity - New Proposal again: https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdfTeam-NB - MDR Clinical & Tech File Training - Check the dates: https://medboard-public-assets.s3.amazonaws.com/Regulatory/442102-Leaflet-MDR-Clinical-Manufacturers-Training-20260528.pdf and https://www.team-nb.org/wp-content/uploads/2026/02/Leaflet-MDR-TD-Manufacturers-Training-20260429.pdfUKConsultation on recognizing CE mark - Should it be indefinitely: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devicesConsultation until: April 10, 2026 UK Reliance is ongoing - Draft proposal to recognize MDSAP and other: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devicesBookmark the MHRA contact page -*Whispering* If you want to Whistleblow, there is a contact Chuuut!!!: https://www.gov.uk/guidance/contact-mhraSolutionsEasyIFU: For eifu and Label - Test it for Free: https://easyifu.comSmarteye: for eQMS . Ask for a Demo: https://eqms-smarteye.com/RoWIMDRFReliance Playbook - With examples to apply: https://www.imdrf.org/sites/default/files/2026-02/IMDRF%20GRRP%20WG%20N89%20Reliance%20Playbook.pdfUSAFDA Cybersecurity documentation - Final Guidance: https://www.fda.gov/media/119933/downloadMalaysiaLaunch of the Innovative Pathway - Accelerate the development of your device: https://portal.mda.gov.my/index.php/announcement/1771-implementation-of-the-innovative-medical-device-review-pathway-by-medical-device-authority-ministry-of-health-malaysiaArgentinaSelf Declaration expended for Low-Risk devices - Themis platform to be used: https://www.argentina.gob.ar/noticias/entra-en-vigencia-el-nuevo-regimen-simplificado-para-la-habilitacion-de-establecimientos PodcastEpisode 376 - Defect Management in SaMD with Anindya Mookerjea: https://podcast.easymedicaldevice.com/376-2/Episode 377 - IEC 60601 4th edition with Leo Eisner: https://podcast.easymedicaldevice.com/377-2/Episode 378 - IMDRF & Regulatory Reliance with Stephanie Grassmann: https://podcast.easymedicaldevice.com/378-2/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
Why do so many MedTech products look brilliant on paper — yet still fail to get adopted in hospitals?A strong product alone is rarely enough to win hospital adoption. Even when the clinical idea is sound, devices often stall because they are hard to use in real workflows, lack an internal champion, or fail to show enough value to justify the cost. In this episode, Hakeem speaks with Dr. Torrie O'Daniel to unpack the three most common reasons promising MedTech products don't gain traction — and what founders can do differently to make real-world adoption far more likely.By listening, you'll:Learn the three most common reasons hospital teams do not adopt MedTech products that initially look promisingUnderstand how workflow fit, team-wide usability, and internal champions influence whether a device gets used consistentlyDiscover what founders need to prove clinically and economically to build momentum and justify adoptionPress play now to learn how to turn a promising MedTech product into one hospitals will actually use.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.
Ron Elliott, Director of Field Application Engineering at Digi International, spoke with Moshe Beauford of Technology Reseller News at the HIMSS Global Health Conference & Exhibition about the growing challenge of connecting legacy medical equipment to modern healthcare networks. Elliott explained that hospitals often rely on critical devices that were designed decades ago—equipment that still performs essential clinical functions but lacks modern network connectivity. Digi International focuses on bridging that gap by enabling healthcare organizations to securely connect legacy medical devices to contemporary IT infrastructures without requiring costly equipment replacement. Through specialized connectivity solutions and device networking technology, Digi allows hospitals to integrate older equipment with electronic health record systems, monitoring platforms, and broader healthcare IT environments. This approach helps healthcare providers extend the life of expensive medical equipment while still benefiting from modern data integration and management capabilities. Elliott noted that this challenge is widespread across healthcare systems where capital equipment can remain in service for many years. “Many hospitals have critical devices that still work perfectly well but weren't designed for today's connected environments,” he said, highlighting the importance of solutions that bring those devices into secure and manageable networks. As healthcare organizations continue to digitize clinical workflows and expand connected care, Digi International's technologies provide a pathway for modernizing infrastructure while protecting existing investments in medical equipment. Learn more about Digi International: https://www.digi.com/
Medical devices are a special segment of the IoT world where availability and patient safety are paramount. Tamil Mathi explains why many devices need to fail open -- the opposite of what traditional appsec approaches might initially think -- and what makes threat modeling these devices interesting and unique. He also covers how to get started in this space, from where to learn hardware hacking basics to reviewing firmware and moving up the stack to the application layer. Segment Resources: https://www.defconbiohackingvillage.org https://medium.com/@tamilmathimaddytamilthurai/securing-the-future-of-iot-with-trusted-execution-environments-tees-a-secure-scalable-and-1376f94e755c Visit https://www.securityweekly.com/asw for all the latest episodes! Show Notes: https://securityweekly.com/asw-373
When your MedTech launch has several weak points, how do you know which one to fix first before you waste 90 days improving the wrong thing?MedTech founders rarely fail because the device is poor. More often, they stall because they improve the wrong part of their launch first. When product, proof, pathway, and people all have room for improvement, deciding where to focus becomes critical. In this episode, Hakeem breaks down a practical decision rule that helps you identify the one move most likely to unlock real contracts and meaningful revenue.By listening, you'll:Learn why the lowest-scoring weakness is not always the first problem you should solveUnderstand how commercial conversations reveal whether proof, pathway, or people is the real revenue constraintUse a simple 90-day decision filter to prioritize the move most likely to accelerate traction this quarterPress play now to identify the one change that can move your MedTech launch closer to real contracts and meaningful revenueBook a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Massimiliano (Max) Colella, CEO of CMR Surgical.CMR Surgical is developing Versius, a surgical robot designed to make minimally invasive procedures more accessible across specialties.Max brings more than three decades of healthcare leadership experience spanning medtech and hospital systems. He previously held leadership roles at Johnson & Johnson and Smith & Nephew across Europe, Asia Pacific, and the Middle East, and later served as CEO of Evercare Group, a TPG portfolio company.In this interview, Max discusses how to prioritize capital allocation between platform development and product line expansion, when internal processes need restructuring, the importance of having the right culture, and why undertaking market research ahead of launching into a new market is crucial. He also shares his approach to hiring — and on maintaining clear board governance boundaries.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 Max Colella. KEY MOMENTS FROM THE INTERVIEW(03:08) - An overview of Max's background and the journey that led him to CMR Surgical (06:53) - Why Max chose surgical robotics — and how Versius is designed to differentiate from existing systems (16:18) - How Max restructured internal processes at CMR to eliminate large-company bureaucracy (21:09) - How market research reshaped CMR's U.S. strategy beyond ambulatory surgery centers (28:48) - Max's capital allocation philosophy: prioritize system performance and stability before expanding capabilities (32:19) - Max's take on Techmed and the future of robotics (36:36) - Why clearly defined roles between board and management are critical for governance (41:10) - Max's philosophy around hiring for mindset over skill
Arthur Spalding, TAMM Net, Inc., contract research organization, on FDA Approval, Clinical Trials, and Reimbursement for Medical Devices and Biotech (North Fulton Business Radio, Episode 944) On this episode of North Fulton Business Radio, host John Ray welcomes Arthur Spalding, President of TAMM Net, Inc., a boutique contract research organization that helps biomedical inventors and companies […]
Medical devices are a special segment of the IoT world where availability and patient safety are paramount. Tamil Mathi explains why many devices need to fail open -- the opposite of what traditional appsec approaches might initially think -- and what makes threat modeling these devices interesting and unique. He also covers how to get started in this space, from where to learn hardware hacking basics to reviewing firmware and moving up the stack to the application layer. Segment Resources: https://www.defconbiohackingvillage.org https://medium.com/@tamilmathimaddytamilthurai/securing-the-future-of-iot-with-trusted-execution-environments-tees-a-secure-scalable-and-1376f94e755c Show Notes: https://securityweekly.com/asw-373
Medical devices are a special segment of the IoT world where availability and patient safety are paramount. Tamil Mathi explains why many devices need to fail open -- the opposite of what traditional appsec approaches might initially think -- and what makes threat modeling these devices interesting and unique. He also covers how to get started in this space, from where to learn hardware hacking basics to reviewing firmware and moving up the stack to the application layer. Segment Resources: https://www.defconbiohackingvillage.org https://medium.com/@tamilmathimaddytamilthurai/securing-the-future-of-iot-with-trusted-execution-environments-tees-a-secure-scalable-and-1376f94e755c Visit https://www.securityweekly.com/asw for all the latest episodes! Show Notes: https://securityweekly.com/asw-373
On this episode of the SPOT Radio® podcast, Charlie Webb speaks with Malinda Elammari, who many in our industry know as the packaging princess. In this conversation, they explore together how sterile processing departments often favor different packaging methods, and how heat‑sealing pouches may be preferred over self‑sealing pouches in many facilities. Listen in on today's episode to hear the full discussion.About Malinda Elammari: As a certified Infection Preventionist with over two decades of experience in acute care, long-term care, public health, and professional sports, but most importantly being a wife, mother, sister, daughter, and friend, She has learned the importance of living the life you want while doing something you love.She is passionate about spreading the message of creating a safe environment for people, young and old, using infection prevention principles. I use evidence to support my recommendations while applying Her own experience, including some interesting stories, for application.Missy specialize in helping new Infection Preventionists develop an Infection Prevention Plan while managing their busy schedule. She also work with health departments, healthcare facilities (acute, post-acute, and long-term care), and sports teams to develop an Infection Prevention Program that promotes safety and excellence.Email me: https://crownpointconsult.com/Linkedin: malinda.elammari@gmail.com
Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-457
Send a textDaniel Gledhill is a seasoned manufacturing and engineering leader whose career bridges high-risk industrial operations and precision-driven medical device manufacturing. Daniel leads engineering teams responsible for multiple production areas supporting transcatheter heart valve delivery systems—products where quality, reliability, and patient safety are absolutely critical.Daniel's journey to medical devices began in heavy industry, where he worked as a process, chemical, and metallurgical engineer at Rio Tinto, including leadership roles at copper smelters overseeing sulfuric acid plants, powerhouses, and byproduct operations. These early roles shaped his systems-level thinking, comfort with complex processes, and respect for disciplined operations—skills that would later translate powerfully into regulated medical manufacturing environments.Over nearly ten years at Edwards Lifesciences, Daniel has progressed from manufacturing management into senior engineering leadership, guiding teams through scale-up, process improvement, cross-functional collaboration, and organizational change. His work sits at the intersection of engineering, manufacturing, quality, and leadership—where decisions directly impact both operational performance and patient outcomes.Daniel holds a Bachelor's degree in Chemical Engineering from the University of Utah, along with an MBA from the University of Utah's David Eccles School of Business. This combination of technical and business education informs his balanced approach to leadership—one that values data, people, and long-term system health over short-term wins.In this conversation, we explore what it really means to lead engineering teams in medical device manufacturing, how leadership expectations evolve as engineers move into management, and what lessons from heavy industry can sharpen execution in highly regulated, patient-critical environments.LINKS:Guest LinkedIn: https://www.linkedin.com/in/daniel-gledhill-a6155237/Guest website: https://www.edwards.com/ Aaron Moncur, hostDownload the Essential Guide to Designing Test Fixtures: https://pipelinemedialab.beehiiv.com/test-fixture 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 such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us Watch the show on YouTube: www.youtube.com/@TeamPipelineus
Many clinicians build Medical Devices that solve real clinical problems.They secure regulatory approval.They get positive feedback from early users.They even generate interest from hospitals or distributors.And yet… adoption stalls.Not because the product is poor — but because something critical in the launch is structurally weak.In this episode, we break down the four Ps that determine whether a MedTech product gets adopted or simply admired.This is not textbook marketing theory.It's the real-world framework that reveals exactly where your go-to-market strategy is breaking down.You'll discover:Why regulatory approval and engineering perfection don't guarantee adoptionThe difference between clinical enthusiasm and commercial proofWhy hospitals buy through processes — not passionThe hidden influence of decision-making units inside healthcare systemsWhy distributors and internal teams must align around the same commercial structureIf you're a clinician trying to turn a working prototype into a scalable Medical Device business, this framework will help you quickly identify the structural weakness slowing your launch.Because technically strong MedTech products rarely fail due to innovation.They fail when one of the four Ps breaks down.In the episode, we also walk through a quick self-audit so you can score your own launch and identify the single area that could unlock momentum in the next 90 days.Listen now and see where your go-to-market strategy might be exposed.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.
The global medical device regulatory environment is complex, often requiring manufacturers to repeat similar submissions and audits across multiple countries. This duplication slows innovation and delays patient access to life-saving technologies.To address this challenge, international regulators are increasingly collaborating through the International Medical Device Regulators Forum (IMDRF).In this podcast episode, Stephanie Grassmann (MedTechXperts) joins us to discuss how the concept of Regulatory Reliance is transforming global medical device approvals.What is IMDRF?The International Medical Device Regulators Forum (IMDRF) is a voluntary group of regulatory authorities working together to harmonize medical device regulations and reduce duplication across global markets.Members include major regulatory bodies such as:• United States (FDA)• European Union• Australia (TGA)• Brazil (ANVISA)• Canada (Health Canada)• China (NMPA)Their mission is to promote efficient regulation while maintaining high standards of safety and performance.Understanding Regulatory RelianceRegulatory reliance allows one authority to give significant weight to the work already performed by another trusted regulator.Instead of repeating full assessments, authorities can leverage existing evaluations, reducing regulatory burden while maintaining confidence in safety and effectiveness.Real-World Success StoriesSeveral regulators are already demonstrating the benefits of reliance mechanisms.Australia – TGAA Class III Mitral Valve Clip reached market access in just 20 working days after the regulator accepted evidence generated overseas.Argentina – ANMATDental instruments known as endodontic barbed broaches were approved in 9 working days using reliance pathways.Brazil – ANVISACompanies holding MDSAP certification may skip immediate on-site audits, saving both time and money during market entry.These examples show how regulatory cooperation can significantly accelerate approvals.The Role of MDSAPThe Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single regulatory audit recognized by multiple countries.This program plays a key role in enabling reliance between regulatory authorities and reducing redundant inspections.The European PerspectiveEurope has historically maintained a distinct regulatory framework under EU MDR and IVDR.However, recent proposals—including references to Articles 108a and 108b—suggest increasing collaboration with international frameworks such as IMDRF and MDSAP.While a single global approval system remains a long-term goal, reliance initiatives are already demonstrating that cooperation between regulators can improve efficiency without compromising safety.Looking AheadFor manufacturers and startups, embracing international regulatory frameworks early—such as MDSAP and IMDRF guidance—can significantly improve global market access strategies.As regulatory collaboration grows, the future of medical device approvals may become faster, more harmonized, and more patient-centered.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.LinkStephanie Grassmann Linkedin: https://www.linkedin.com/in/stephaniegrassmann-medtechxperts/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 powered by Podcastics, the easiest platform to create and publish your podcast.
In this episode of Disruption/Interruption, KJ sits down with Oleg Kovalev, Chief Marketing Officer at Aspect Health, revealing how his company became the #1 women's hormonal health startup in the USA by disrupting traditional PCOS treatment. Discover how continuous glucose monitoring and lifestyle coaching are helping one in five women manage a condition that doctors have been treating wrong for decades—and how this medical innovation is driving explosive business growth. Four Key Takeaways: [4:21] PCOS affects 20% of women and is the #1 cause of infertility - Traditional medicine has underdiagnosed and undertreated PCOS for decades, leaving millions of women without proper answers or solutions beyond pills that mask symptoms. [8:33] Managing glucose levels can dramatically reduce PCOS symptoms - Simple lifestyle changes combined with continuous glucose monitoring help women see real-time correlations between their food choices and symptom improvement, leading to exceptional product retention. [17:24] Data-driven positioning beats gut feeling every time - Aspect Health grew 12x in nine months by systematically testing positioning through paid ads and user behavior metrics rather than relying on intuition or assumptions. [24:11] Ask what you should NOT be doing - Focus and intentionality come from eliminating tasks rather than adding them—the critical question every founder and marketer must answer to achieve breakthrough success. Quote of the Show (8:00):"When women go to doctor and they ask questions about PCOS, in most cases they don't get answers to their questions. Often they are given some standard protocol of taking some kind of pills." - Oleg Kovalev Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Oleg Kovalev LinkedIn: https://www.linkedin.com/in/alecko/Company Website: www.aspect-health.com How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.
Oral Arguments for the Court of Appeals for the Federal Circuit
International Medical Devices, Inc. v. Cornell
Oral Arguments for the Court of Appeals for the Federal Circuit
International Medical Devices, Inc. v. Cornell
You've done the hard part.You've secured regulatory approval. You've got two pilot sites running. You've even got distributor interest.But sales still aren't landing the way you expected.Now you've got 90 days. Limited runway. Board pressure building.And you can only prioritise one move.So what do you focus on?Do you activate the distributor and push for reach?Do you hire commercial support to build structure?Do you refine your messaging and economic case?Or do you double down somewhere else entirely?In this episode, we break down how clinician founders should prioritise when everything feels urgent — and why most MedTech businesses stall not because the product isn't strong, but because the commercial leverage isn't.You'll discover:Why regulatory approval is permission — not tractionThe difference between interest and evidence (and why only one protects your runway)The hidden risk of activating distributors too earlyWhy activity and progress are not the same thingThe decision framework that turns early traction into scalable momentumIf you're a clinician building a Medical Device and trying to simplify your go-to-market strategy, this episode will challenge how you think about traction, revenue and exporting.Because the difference between a working prototype and an international MedTech business isn't technical strength.It's commercial proof.Hit play and decide what you would prioritise — before you hear what we would do.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.
Holley Miller, founder and President of Grey Matter Marketing, is our guest on this episode of Let's Talk Medtech to discuss why it's so crucial to have the right message for your product.
The Cybercrime Magazine Podcast brings you daily cybercrime news on WCYB Digital Radio, the first and only 7x24x365 internet radio station devoted to cybersecurity. Stay updated on the latest cyberattacks, hacks, data breaches, and more with our host. Don't miss an episode, airing every half-hour on WCYB Digital Radio and daily on our podcast. Listen to today's news at https://soundcloud.com/cybercrimemagazine/sets/cybercrime-daily-news. Brought to you by our Partner, Evolution Equity Partners, an international venture capital investor partnering with exceptional entrepreneurs to develop market leading cyber-security and enterprise software companies. Learn more at https://evolutionequity.com
IEC 60601 has been central to medical electrical equipment safety for decades. From the prescriptive approach of the 2nd edition to the risk-based philosophy introduced in the 3rd edition, the standard has continuously evolved to address technological and regulatory complexity.Now, the upcoming 4th edition represents more than an amendment — it signals a structural transformation.This article explores:The Evolution of IEC 60601• Key shifts from the 2nd to the 3rd edition• Why risk management became central• What lessons shaped today's safety philosophyWhat the 4th Edition Brings• A major rewrite rather than incremental updates• The introduction of “atomic requirements”• Structural clarity for manufacturers, test labs, and regulators• Emerging technical considerations (digitalization, AI, cybersecurity, home use)Impact on Existing Devices• Will re-testing be required?• How to assess validity of existing test reports• Transition strategies with notified bodiesIntegration into Design & Documentation• Embedding IEC 60601 into risk management from day one• Required updates in risk files, EMC documentation, labeling, and usability engineering• Practical advice for SMEs with limited resourcesThe Future of IEC 60601• Greater harmonization with ISO 14971 and IEC 62304• Alignment with digital and AI regulatory frameworks• The long-term outlook for medical electrical safetyFor manufacturers, the message is clear:IEC 60601 is not just a testing standard — it is a design and risk management framework that must be integrated early and strategically.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.LinkLeo Linkedin: https://www.linkedin.com/in/leoeisnersafetyconsultants/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 powered by Podcastics, the easiest platform to create and publish your podcast.
Send a text message to the show!Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk. In this two-part episode, Omar Aimer, President of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.Tune in to find out:How reporting for medical devices differs from medicines and vaccinesHow AI may be used for predictive safety monitoringWhy regulatory and data harmonisation remains the key to improving medical device safetyWant to know more?Listen to the first part of the interview here.If you would like to learn more about the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.Founded in 2018, ISoP's Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.Got a story to share?We're always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!About UMCUppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
If you're a medtech company looking to take your innovation to the US and want some tips on US regulatory strategy, listen in as this podcast episode is for you.As part of MTPConnect's support for the Australian Government's Industry Growth Program, MTPConnect brought US regulatory expert Jeff Gibbs to Australia for a three-city tour for a seminar and workshop ‘Navigating FDA Pathways for Medical Devices'. Jeff is a Director at Hyman Phelps and McNamara – the largest law firm specialising in FDA issues, based in Washington DC, and brings his 40 years of expertise working with companies ranging from global manufacturers to start-ups.Jeff joins the podcast in Melbourne to discuss the device review process, the impact of recent changes at the agency under the new administration, how to get the most from your pre-submission, hot topics like cybersecurity, decision support software, biostatistics and clinical trial design and his top tips for success.
In this episode of the Medical Sales Podcast, host Samuel Adeyinka sits down with Alex Kinsel, a medical device rep specializing in noninvasive pain management within the VA system. Alex breaks down how his electrotherapy technology works, how it helps veterans reduce chronic pain, improve mobility, and reclaim their daily lives, and what it takes to sell into an integrated delivery network like the VA. From navigating bureaucracy and building clinician trust to educating patients and driving long term outcomes, Alex shares a transparent look at the hunter mindset required to win in this space. He also opens up about his personal journey into medical device sales, the impact of patient follow up, and why purpose driven selling is the key to lasting success in healthcare. Connect with Alex Kinsel: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How »
Pirouette Pharma CEO Conor Cullinane returns to Inside Startup Investing to share the company's progress since its last Wefunder raise—spanning FDA engagement, IND planning, and major steps toward scalable manufacturing. Pirouette is building a disc-shaped, push-button delivery system for injectable medications—aiming to turn the “violent, error-prone” experience of legacy auto-injectors into something closer to the Staples Easy Button: push once, and the device handles the rest. Chris and Conor discuss why intimidation and usability are major barriers in today's injection landscape, how Pirouette is approaching OTC naloxone via a combination-product regulatory pathway, what a pharmacokinetic study looks like, and why Pirouette is investing in manufacturing capacity to support both commercialization and pharma partnerships. Chapters 00:44 What Pirouette is building 03:42 Progress since last raise 06:26 FDA pathway explained 09:08 PK study + size/cost/timeline 13:07 Partnerships vs. standalone commercialization 16:15 Revenue timing + adoption expectations 20:12 Manufacturing scale plan 23:34 Founder “why” 26:07 Investor close
Podcast: Government Information Security Podcast (LS 27 · TOP 10% what is this?)Episode: The Danger of IT, OT, Medical Device Cyber Turf WarsPub date: 2026-02-23Get Podcast Transcript →powered by Listen411 - fast audio-to-text and summarizationWhat often appears to be turf wars between healthcare technology management, facilities OT staff, IT departments and security teams are often the result of unclear ownership and accountability for device security. And that presents safety risks to patients, says Mohamed Waqas, CTO of Armis.The podcast and artwork embedded on this page are from GovInfoSecurity.com, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Rick Bente, co-founder and CEO of Indomo.Indomo's flagship device, ClearPen, is an investigational at-home corticosteroid injection designed to treat inflammatory acne.Rick has over 20 years of experience as an engineer and operator across medtech and pharma, with leadership roles at Medtronic, Insulet, and YourBio, focused on drug delivery and combination products. He is an inventor on more than 50 patents and has generated over $150 million in investments.In this conversation, Rick discusses how Indomo translated an in-office dermatology procedure into at-home care, why usability had to be engineered rather than trained, how the company decided when to exit stealth mode, and how proof-based milestones shaped its fundraising.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 Rick Bente.
Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-440If you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 9.5 weeks, earning $113,760 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Do you actually have an export strategy or just international ambition?In this episode, Hakeem breaks down the five-step commercial system that turns export from a hopeful expansion into a revenue-driven growth plan. Because export rarely fails due to market difficulty, it fails due to lack of structure.If you're a clinician-founder building a Medical Device business, this episode will show you how to stop drifting between markets and start executing with clarity.Learn the 5-step framework to build a structured, revenue-led export systemDiscover how to prioritise markets using probability and potential (not attention and hype)Understand how to engineer distributor behaviour and adoption triggersHelping clinicians simplify their go-to-market strategy so they can stop guessing and turn their working prototypes into international MedTech businesses.Hit play now to build an export plan that survives commercial pressure.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.
In Software as a Medical Device (SaMD), defect management is far more than tracking bugs. It is a structured, risk-driven process that directly impacts patient safety, regulatory compliance, and product lifecycle control.This article (and podcast episode) explores both foundational and advanced perspectives on defect management in regulated software environments.We cover:Understanding Defects in SaMD• What defines a defect in a regulated context• How defect management differs from non-medical software• The relationship between defects, risk management, and ISO 14971Building a Compliant Defect Management Process• Essential documentation and tools• Severity and priority categorization• Handling defects discovered during validation or post-market• Differentiating between defects, change requests, and requirement gapsAdvanced & Real-World Scenarios• Managing safety-critical defects• When CAPA or vigilance reporting is required• Handling SOUP and third-party component issues• Ensuring traceability across versions and product variants• Agile defect management strategiesAudit Perspective & Common Pitfalls• Frequent gaps identified by regulators and notified bodies• How defect trend data supports CAPA and management review• Practical advice for startups implementing lightweight but compliant systemsWe also discuss how modern eQMS platforms (such as SmartEye) can help streamline documentation, automate traceability, and improve oversight without adding unnecessary bureaucracy.Defect management in SaMD is not about documentation — it's about maintaining control over risk and ensuring safe, effective software throughout its lifecycle.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.LinkSimon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/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 powered by Podcastics, the easiest platform to create and publish your podcast.
In this episode of Disruption/Interruption, KJ sits down with Gennadi Seko, founder and CEO of Oxilight, who is revolutionizing wound care diagnostics by transforming smartphones into powerful medical imaging devices. Gennadi shares his personal journey from Bay Street finance to medical physics, driven by his grandmother's diabetic foot amputation. He discusses how his company is disrupting the medical device industry by making diagnostic technology portable, affordable, and accessible—moving critical wound care assessments from expensive hospital labs to patients' homes. This conversation explores the intersection of deep tech innovation, healthcare accessibility, and the power of multimodal diagnostics in saving lives and limbs. Four Key Takeaways [26:19] Multimodality is the Game Changer - Instead of multiple expensive single-purpose devices sitting on shelves, combining three technologies (multispectral imaging, fluorescence imaging, and thermal imaging) into one $200 smartphone attachment provides a 360-degree view of wound health and dramatically improves diagnostic specificity. [9:29] The Diabetes Crisis is Escalating - 27% of seniors (65+) in the United States have diabetes, and the disease is now affecting people as young as 25. Diabetic foot complications account for 80% of all non-traumatic amputations, making early detection critical. [21:44] Mobility Saves Lives and Money - Moving diagnostic technology to patients' homes solves the compliance problem and enables early intervention. Preventing one amputation saves healthcare systems 10x in costs while dramatically improving patient quality of life. [14:50] Physiological Imaging Beats Anatomical Measurement - Traditional wound measurement with rulers only tracks size over time, requiring multiple visits. Physiological imaging provides immediate prognostic information from a single snapshot, identifying whether a wound will heal normally or requires intervention. Quote of the Show (23:27): “I don't want to improve hospital healthcare. I want to improve healthcare in general." - Gennadi Seko Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Gennadi Seko: LinkedIn: https://www.linkedin.com/in/gennadisaiko/Company Website: https://oxilight.ca How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.
In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance under the NMPA.The conversation explores why Western companies often underestimate China's regulatory expectations — particularly when assuming EU or U.S. approvals, ISO standards, or FDA clearances will translate directly. Elaine explains how China requires demonstration of safety and effectiveness against applicable local standards primarily GB (national standards) and YY (medical device industry standards) including both mandatory and recommended variants (e.g., GB vs GB/T, YY vs YY/T).The episode dives into China's local type testing model and the role of Product Technical Requirements (PTRs) in defining test methods, parameters, accessories, and applicable standards for registration.Elaine also outlines how China's quality system expectations align to China Medical Device GMP rather than ISO 13485 including major GMP updates taking effect in November 2026 and discusses implications for foreign manufacturers.Additional discussion topics include China agents and authorized representatives, clinical evaluation expectations, post-market reporting requirements, and how China's device classification system can influence regulatory strategy.⏱️ Timestamps00:00 Welcome + Meet Elaine (MedTech Chopsticks)00:38 Why China Is Different: Local Standards vs EU/US Assumptions03:35 GB & YY Standards Explained (National vs Industry Standards)05:07 Local Type Testing & PTRs: Building China Product Technical Requirements06:52 China GMP Updates: Key Differences vs ISO 1348512:42 China Agent vs EU Authorized Rep: Roles & Responsibilities15:19 Choosing Local Test Labs: NMPA-Designated Testing Considerations18:42 Planning Early: Standards Gaps, Clinical Evaluation & PMS Risks24:43 China Certification & Device Classification Changes (Class I/II/III)28:38 Where to Find Elaine + ClosingSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Shaun Bagai, CEO of RenovoRx. The company is developing targeted oncology therapies and is currently commercializing RenovoCath, which is focused on pancreatic cancer. Before joining RenovoRx in 2014, Shaun spent over a decade in the cardiovascular space, including leading global market development at HeartFlow and helping establish the European renal denervation market at Ardian, which Medtronic acquired for approximately $1 billion. He began his career in clinical research and device sales at TransVascular and Medtronic. In this interview, Shaun discusses how testing markets with minimal infrastructure reveals what leads to commercial success, why clinical trial enrollment benefits from sales discipline, and what founders should understand about going public when traditional capital isn't available.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 Shaun Bagai.
SPONSORMedboard: https://www.medboard.com/EUROPE New Harmonization Standards - Implementing Decision 2026/193: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193Neurosurgical implantsEN ISO 14155:2020 on clinical investigationsEN ISO 18562 series on Biocompatibility for Breathing gas pathways Germany: Transition from DMIDS to EUDAMED - March 19, 2026:https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770EUDAMED mandatory by May 28th, 2026 High-Level Conference on Medical Devices - March 16th, 2026 - Brussels:https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_enThe conference will feature three breakout sessions focusing on:Enhanced predictability for conformity assessments: combining certainty with flexibilityClinical evidence at EU level to support the regulatory framework: the key role of Expert PanelsBreakthrough technologies for better care: turning guidance into realityTeam-NB: Letter on Cybersecurity - MDR and IVDR proposal draft version:https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdfSwitzerlandSwissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf Swissdamed Webinar - May 28th, 2026:https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.htmlUKUK to exempt Health Institution - Not a priority for nowhttps://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devicesTrainingTeam-NB: Training on MDR technical Documentation - For manufacturers on April 19th, 2026:https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/EasyIFUCreate eIFU and Labels easily - Compliance to EU MDR/IVDR:Https://easyifu.comRoWNorth AmericaFDA: General Wellness devices - Guidance by the FDA:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devicesFDA: Cybersecurity in Medical Devices - QMS and Pre-market submission:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarketAPACMalaysia: Electronic Certificates issued by MDA - For FSC, Manufacturing Certificates and Export Certificateshttps://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysiaIndia: Import of IVD - Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3DAfricaEgypt: Database for Product Registration -Online Electronic Service: https://eservicesdata.edaegypt.gov.eg/MedicalDevicesMiddle EastSaudi Arabia: SFDA inspection of QMS requirements - Process that would be followed:https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdfPodcastEpisode 372 - How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/Episode 373 - QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/Episode 374 - Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/ServicesConsulting support: info@easymedicaldevice.comAuthorized Representative: EO@easymedicaldevice.comSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
Krystal and Saagar discuss Trump demanding high housing prices, Olympic athletes attack USA, AI medical device backlash, Trump admin whitewashes Sudan. Nathaniel Raymond: https://x.com/nattyray11?lang=enTo become a Breaking Points Premium Member and watch/listen to the show AD FREE, uncut and 1 hour early visit: www.breakingpoints.comMerch Store: https://shop.breakingpoints.com/See omnystudio.com/listener for privacy information.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Justin Zenanko, co-founder & CEO of SynerFuse.SynerFuse is developing the e-TLIF procedure, which combines spinal fusion with neuromodulation by placing leads directly at exposed nerves during surgery.A certified public accountant and serial entrepreneur, Justin previously served as CFO and senior vice president of corporate development at Recombinetics, where he led fundraising efforts totaling $68 million.In this interview, Justin discusses approaching FDA interactions as negotiations, validating procedures with off-the-shelf components before investing in custom devices, and structuring private raises through investment banks to preserve control while delaying institutional venture capital.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 Justin Zenanko.
Christine Moundas, Health Care and Data Partner at Ropes & Gray LLP and Co-Head of the firm's Digital Health Initiative, discusses the new landscape of state consumer privacy laws and how life sciences and medical device companies can comply with these new requirements. Sponsored by Ropes & Gray.Watch this episode: https://www.youtube.com/watch?v=wGUy4Bs72t4Learn more about Ropes & Gray: https://www.ropesgray.com/enEssential Legal Updates, Now in Audio AHLA's popular Health Law Daily email newsletter is now a daily podcast, exclusively for AHLA Comprehensive members. Get all your health law news from the major media outlets on this podcast! To subscribe and add this private podcast feed to your podcast app, go to americanhealthlaw.org/dailypodcast. Stay At the Forefront of Health Legal Education Learn more about AHLA and the educational resources available to the health law community at https://www.americanhealthlaw.org/.
How do top sales leaders stay on top in 2026? Seasoned National Sales Director Kristy McCracken shares her secrets.About This EpisodeIn this episode of Medical Sales U, I sit down with Kristy McCracken, a veteran leader in medical devices and biologics. From managing multi-million dollar revenues to leading national teams at companies like Essity and Merck, Kristy knows what it takes to win.We dive deep into:The "Always Learning" Mindset: Why high-level executives are returning to the basics to stay competitive.Modern Networking: How to use LinkedIn and AI to find common ground with hiring managers today.Leadership & Coaching: Kristy shares a powerful story of how she coached an underperforming rep back to success.The Future of Med-Tech: Balancing high-tech AI tools with the "human touch" that closes deals.Whether you are trying to break into medical sales or you're a seasoned pro looking to reinvent your role, Kristy's insights on persistence and "sharpening the saw" are essential listening. Key Moments (Timestamps)00:00 – Introduction: The greatest winners never stop learning.02:15 – Kristy's journey: 20 years in Pharma and Medical Devices.04:30 – Why even National Sales Directors need a "Professional Community."07:45 – Breaking in vs. Leveling up: What has changed in 2026?11:10 – Leadership Deep Dive: Coaching a rep through a PIP (Performance Improvement Plan).15:30 – Networking Secrets: How Kristy landed her latest role using Dave's strategies.19:20 – The Human Element: Asking the "follow-up" question.23:10 – Advice for the next generation of medical sales leaders.Resources & LinksConnect with Kristy McCracken: https://www.linkedin.com/in/kristy-mccracken/READY TO BREAK INTO MEDICAL SALES? We help professionals transition into top-tier medical sales roles: medicalsalesu.com/Kristy mentioned that "Persistence is Key." What is the biggest rejection you've faced in your career, and how did you bounce back? Let us know in the comments!If you found value in this talk, please: SUBSCRIBE for more interviews with industry leaders. LIKE this video to help other medical sales professionals find us. HIT THE BELL so you never miss a coaching session.#MedicalSales #Leadership #CareerGrowth #SalesCoaching #MedTech #MedicalSalesU #Networking2026
Send us a textBob Hankins brings over 20 years of dedicated experience in the medical-device industry, spanning engineering leadership, product development, process improvement and strategic technical oversight. As Director of Engineering at TE Connectivity, he leads a global team of engineers and scientists focused on designing, developing and delivering innovative customer-centric medical device solutions—particularly complex machined, extruded and laser-cut components. In this role he ensures design for manufacturing and quality within ISO 13485-compliant systems, marrying deep technical understanding with regulatory-driven manufacturing discipline.Before his current role Bob led Research & Product Development Engineering at Nordson Medical and has held key leadership positions at several medical-device companies, including overseeing product development platforms, multi-site engineering operations, manufacturing automation and system launches. Throughout his career he has honed core competencies in manufacturing process improvement, continuous improvement (including Six Sigma/Lean methodologies), design for manufacturing/assembly, regulatory compliance (ISO 13485, ISO 14971, FDA), and product R&D for the health-care market.Bob's academic background includes a Bachelor of Science in Mechanical Engineering from the University of California, Irvine, and an Executive MBA from the Drucker School at Claremont Graduate University. This combination of technical and business education supports his ability to lead engineering organizations in bridging innovation with operational execution, customer development and quality.In this episode we'll dive into how Bob thinks about leading engineering teams in the regulated medical-device space, how he drives design and process improvements globally, how he balances innovation with manufacturing rigor, and what advice he has for engineers growing into leadership roles in healthcare technology. We'll also explore his views on what the next wave of medical-device manufacturing and design looks like—and how engineering leaders can foster a culture of excellence, empowerment and impact. LINKS:Guest LinkedIn: https://www.linkedin.com/in/rthankins/Guest website: https://www.te.com/en/home.html Aaron Moncur, hostThe Wave is a place for engineers to actively learn, share ideas, and engage with people doing similar work. Learn more at thewave.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 such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us Watch the show on YouTube: www.youtube.com/@TeamPipelineus
Discusses key takeaways from the U.S. Food and Drug Administration's revised Clinical Decision Support Software and General Wellness Product guidance documents. Our guests today are Christina Kuhn and Olivia Dworkin from the law firm Covington. Christina advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products. Olivia minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. Additional resources: FDA's Clinical Decision Support Software guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software FDA's General Wellness: Policy for Low Risk Devices guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices 5 Key Takeaways from FDA's Revised Clinical Decision Support (CDS) Software Guidance: https://www.cov.com/news-and-insights/insights/2026/01/5-key-takeaways-from-fdas-revised-clinical-decision-support-cds-software-guidance FDA Issues Revised Guidance on General Wellness Products: https://www.cov.com/en/news-and-insights/insights/2026/01/fda-issues-revised-guidance-on-general-wellness-products Covington Digital Health Blog and Resources: https://www.cov.com/en/practices-and-industries/industries/digital-health CITI Program's Essentials of Software as a Medical Device and Clinical Decision Support Systems: https://about.citiprogram.org/course/essentials-of-software-as-a-medical-device-clinical-decision-support-systems/ CITI Program's course catalog: https://about.citiprogram.org/course-catalog
Some of the biggest advances in women's health start with a simple question: why hasn't this been fixed yet? In this episode of BackTable OBGYN, Dr. Tess Kim, a minimally invasive gynecologic surgeon at Massachusetts General Hospital and the founder of Fruits of Labor, a women's health medical device innovation company, joins host Dr. Amy Park. --- SYNPOSIS Dr. Kim's educational journey began with medical school at Emory, followed by residency at Beth Israel Deaconess Hospital, and fellowship training at MGH. She discusses the founding of Fruits of Labor, which began with the Perry Peach—a warm compress device designed to reduce severe perineal tearing during childbirth and now acquired by Medicines360. Dr. Kim also talks about her creative process, the importance of addressing historically neglected areas in women's health, and the potential impact of her new project, Mellomallows, which aims to reduce discomfort during gynecological procedures such as IUD placement. The conversation concludes with a discussion of the challenges and opportunities in women's health innovation, the significance of supportive networks, and the role of passion and commitment in driving meaningful change. --- TIMESTAMPS 00:00 - Introduction02:03 - The Birth of PeriPeach: Addressing Severe Tearing06:51 - New Medical Devices: Mellomallows08:41 - The Creation and Mechanism of PeriPeach 11:11 - Company Development: Mentorship and Resources17:37 - Pitching Practice and Experience 19:26 - Project Funding and Working with Medicines36021:51 - Advice for Aspiring Innovators23:52 - Concerns About AI in Healthcare26:48 - Innovations in Women's Health29:06 - Challenges in Academic Medicine32:01 - The Importance of Female Innovators34:00 - Forming a Startup in Women's Health36:10 - Parting Advice for Future Innovators37:37 - The Future of Women's Health Innovations40:10 - Conclusion --- RESOURCES Fruits of Labor website:https://www.fruitsoflabormed.com/home PeriPeach website:https://www.peripeach.com/
A newly minted Doctor calls to talk about earning their PhD in medical devices, how they managed to end up in the middle of a red panda escape, and the small surprises that come with moving to the U.S. He and Geth talk about finishing a PhD when the future feels up in the air, the uneasy role of AI in health care, and why practicing tiny rebellions can help you show up when it really matters. Come see Beautiful Anonymous live! Head to punchup.live/chrisgethard for tickets to our upcoming shows. Sign up for Beautiful/Anonymous+ to get ad free episodes and access to exclusive audio including 5 Random Questions with this week's caller. Leave us a voicemail at (973) 306-4676 Head to Talkiatry.com/beautiful and complete the short assessment to get matched with an in‐network psychiatrist in just a few minutes. Refresh your winter wardrobe with Quince. Go to Quince.com/beautiful for free shipping on your order and 365-day returns. Now available in Canada, too. Right now, when you spend $1,000 on Upwork Business Plus, you'll get $500 in credit. Go to Upwork.com/save now and claim the offer before 1/31/2026. Get 20% off your DeleteMe plan when you go to joindeleteme.com/ BEAUTIFUL and use promo code BEAUTIFUL at checkout.
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