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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 »
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/.
On today's Good Day Health Show - ON DEMAND…Host Doug Stephan and Dr. Ken Kronhaus of Lake Cardiology (352-735-1400) cover a number of topics affecting our health. First up, Doug and Dr. Ken begin with a medical success story with a new cancer vaccine, the importance of a strong immune system, and how we are inadvertently aging ourselves faster. Next, Doug and Dr. Ken address an increase in life expectancy, a study showing night owls have a higher risk of heart disease than early birds, and the state of public health (specifically where we're at with measles outbreaks. Moving on, Dr. Ken breaks down how weight-loss drugs are being shown to have a positive effect on heart-health when helping with weight loss. Continuing on with the discussion on heart-health and optimal cardiovascular awareness, Doug and Dr. Ken discuss what the numbers of blood pressure mean and why spikes happen at various times. Then, Doug and Dr. Ken address listener questions with a strong focus on the MIT Smart Pill, a biodegradable antenna that transmits a wireless signal from the stomach to confirm medication has been swallowed. Designed to improve adherence for high-risk patients, the pill uses zinc and cellulose materials to safely dissolve within a week, leaving only a tiny, non-biodegradable RFID chip that is naturally excreted. Website: GoodDayHealthrShow.com Social Media: @GoodDayNetworks
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
Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development.Key topics discussed include:Test Method Validation: definition, regulatory expectations, and when it is requiredFDA warning letters and the risks of non-compliant validation approachesCommon pitfalls and best practices for Test Method ValidationProcess Validation and Packaging ValidationThe role of statistics in MedTech, including sample size justificationRisk management linked to validation activitiesSupplier management, from sourcing components to audits and long-term supplier developmentSimon also explains how SIFO MEDICAL supports medical device manufacturers through consulting and online training focused on:Process validation and equipment qualificationTest Method Validation trainingISO 13485 and 21 CFR 820.30 complianceSupply chain development, including injection molding and cleanroom manufacturing environmentsThis episode is essential for quality managers, regulatory professionals, validation engineers, and MedTech manufacturers looking to strengthen compliance, avoid warning letters, and build robust validation strategies.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.
What does it take to bring medical devices to the market? It's a question lawyer Randy Prebula thinks about every day. Randy is a partner at a global law firm who specializes in the regulatory world of medical devices and technology. In this episode, he shares how he transitioned from a more than 20-year career as a scientist into the world of law and how that informs his legal work. He breaks down FDA's emergency use authorization, what qualifies as a device versus a drug, how products navigate FDA approval pathways, and why risk-benefit analysis drives every FDA decision. He also reflects on what it was like working in this field during the COVID-19 pandemic, helping to bring one of the first at home COVID-19 tests to market. Randy is a graduate of the Catholic University of America.This episode is hosted by Kyle McEntee.Mentioned in this episode:Colorado Law SchoolLearn more about Colorado LawLoyola Law SchoolLearn more about Loyola Law SchoolAccess LawHub today!
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/
Podcast: ICS Arabia PodcastEpisode: Medical Devices Exposed | 29Pub date: 2026-01-31Get Podcast Transcript →powered by Listen411 - fast audio-to-text and summarizationIn this episode , I'm joined by Alessio Rosas, an OT cybersecurity expert from Italy, to dive deep into the world of medical devices and the potential risks they face when exposed to the internet.The podcast and artwork embedded on this page are from ICS ARABIA PODCAST, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
Drop us a message!In this episode, Aigerim Mullen, Marketing Manager at Abbott, shares how her experience across clinical, academic, and commercial environments shapes her approach to healthcare and medical device marketing. We explore what strong marketing leadership looks like in a sector where patient outcomes, regulation, and innovation all intersect.Aigerim breaks down how to keep marketing genuinely patient-centred while still supporting commercial growth, and how to balance scientific credibility with clear, accessible communication that works for both clinicians and wider audiences.The conversation also looks ahead at the future of healthcare marketing, covering emerging challenges and opportunities for leaders navigating rapid technological and regulatory change.Plus, we're also speaking to Elena Nikiforova, Social Media Manager at Giraffe Social, to get her thoughts on using social listening to uncover sentiment, trends, and unmet needs… and how marketers can use these insights to build more empathetic, proactive brand strategies.Want to be featured on the pod? Drop us a voice note on Instagram at @GiraffeSM. About Giraffe Social's Social in 10 Podcast Giraffe Social is a multi-disciplined digital marketing agency specialising in social media marketing based on the South Coast of the United Kingdom. We work with a wide range of industries, spanning from Fintech and L&D, to Beauty and Retail. Social in 10 is a weekly podcast about all things digital marketing. We discuss all the things social media managers want to know, including the latest platform updates, emerging trends, campaign ideas, and best practices to help you stay ahead of the curve. Whether you're managing multiple clients or growing your brand in-house, each episode is packed with actionable insights… all delivered in under ten minutes. Hosted by the Giraffe Social team, this is your fast, fun, no-fluff guide to making sense of social. New episodes every week, so tune in and level up your marketing game!
Design for Security from the Start: Making Medical Device Cybersecurity More ResilientMedTech innovation is revolutionizing healthcare but is also introducing new cyberattack vectors that can put manufacturers, hospitals, and patients at risk.In Episode 44 of the MedTech Speed to Data Podcast, Key Tech VP of Business Development Andy Rogers and Senior Computer Engineer Jamie Kendall discuss the FDA's latest cybersecurity guidance.Need to knowSmart, connected devices have greater risks — Medical devices are emerging vectors for bad actors targeting the healthcare industry.FDA's 2025 cybersecurity guidance update — The agency recommends risk-based development frameworks to make device cybersecurity more resilient.Clarifying “cyber devices” — The FDA's guidance applies to any medical device that runs software and could connect to the Internet.The nitty-gritty“Cybersecurity was always baked into our process,” Jaime explains. More specifically, Key Tech has adapted the TIR57 risk-based standard for managing medical device security to the new rules. “[The FDA's] 2023 guidance really laid the groundwork for our latest process. We've tweaked it slightly with the [latest update]. There are more explicit documentation requirements around vulnerability monitoring and more details on the software bill of materials (SBOMs).”Jamie goes on to describe how Key Tech's cybersecurity risk management plan informs product development. The security team starts by developing a threat model based on evaluations of data flows, data storage, and the cybersecurity activities protecting that data. “One of the first things that we always do is a threat model. This is a visual model of the system to show the elements of the device, where data is flowing, and where your trust boundaries are. This is a one-page, digestible visual that everyone can look at, assess, and go ‘yep, that makes sense' and then build your initial architecture and risk assessment based on that.”The security team documents the resulting security architectures using the FDA's recommended views:Global System View: Describes how software integrates with hardware and networks and the associated cybersecurity mitigations.Multi-Patient Harm View: Identifies mitigations for vulnerabilities or failures that could compromise multiple devices and harm multiple patients.Updateability/Patchability View: Summarizes the end-to-end process for distributing software updates and patches, especially if manufacturers do not control the entire path.Security Use Case View: Documents scenarios in which vulnerabilities can compromise the device's safety or effectiveness.“To give a sense of scale,” Jamie says, “this isn't one or two documents. It's a pretty large effort, and it's one of those things that you want to start early in your development process.”Data that made the difference:Throughout his conversation with Andy, Jamie shares some of the lessons Key Tech has learned about designing secure medical devices, including:Design for security from the beginning. Late changes are expensive, especially once in pre-production or after your FDA submission.Avoid cyber rabbit holes. Rather than addressing every possible threat, use data and risk to prioritize the real threats.Don't roll your own cybersecurity. Stick to standard practices, or you risk introducing unknown, novel vulnerabilities.Fully document your SBOMs. Standard libraries introduce layers of dependencies that you must understand. That's the only way to control your exposure to new vulnerabilities.Design devices that are truly safe. Cybersecurity risks are real. Don't treat compliance as a check box.Watch the whole conversation in the video below to learn more about designing for cybersecurity, the importance of third-party penetration testing, and more.
For decades, medical device manufacturers in the US relied on 21 CFR 820 (QSR) — a system known for being procedural and checklist-oriented.But starting February 2nd, 2026, FDA will implement QMSR, changing not only the regulation structure but also the inspection philosophy.QMSR does not eliminate Part 820. Instead, FDA is amending it to incorporate ISO 13485:2016 by reference, bringing the US closer to the global quality language used across Europe, Canada, Japan, and beyond.Why FDA is doing thisFDA's move is driven by three key goals:Harmonization (reduce duplicated systems and audits)Modern quality thinking (move from “procedures” to “system effectiveness and risk”)Inspection efficiency (more end-to-end audits)What inspections may look like under QMSRInstead of jumping between SOPs, inspections may follow real flows like:Complaint → Risk Management → CAPA → Design Change → Supplier ImpactThe focus becomes traceability, consistency, and risk-based justification.What companies should do nowTo be QMSR-ready, companies should:Build an ISO 13485-style process mapMake risk visible everywhere, not only in product developmentImprove CAPA triage and effectiveness checksStrengthen design controls (especially software development & V&V)Train teams on the new “why/how” inspection styleWho 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.
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 leave patients vulnerable. 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:What defines a medical device and how prevalent they are in our societyWhy device safety monitoring is different from medicines and vaccines, and where current surveillance still falls shortHow global initiatives aim to strengthen safety monitoring standardsWant to know more? If you would like to learn more on 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”. Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.
Hardware security is not a new problem, but it is rapidly expanding in both consumer and medical domains due to hyperconnectivity. Medical devices and counterfeit medicines represent a fundamental security challenge. In particular, although counterfeit medicines are not a new issue,the problem continues to worsen as counterfeiting practices become increasingly sophisticated. The counterfeiting of biomedical products poses a serious threat to patient safety, public health, and economic stability in both developed and developing countries, and many current countermeasures remain vulnerable because they provide limited security. In this talk, we will share our work on biomedical hardware security with a focus on pharmaceutical products. We present cyber-physical biomedical security technologies that encode dosage information and authentication into edible biomaterials, enabling serialization, track-and-trace, and authentication at the dosage level. This approach empowers patients to play an active role in combating counterfeit medicines. About the speaker: Young Kim is a professor in the Weldon School of Biomedical Engineering and holds the titles of University Faculty Scholar and Showalter Faculty Scholar at Purdue University. His research centers on co-creating hardware(devices) and software (models) for large-scale societal and healthcare applications. His lab develops hybrid machine learning by combining data analytics with models grounded in optical spectroscopy and light-matter interactions to move beyond big-data, compute-intensive AI and leverage engineers' domain expertise. His work spans optical imaging and spectroscopy, mesoscopic physics, meta materials, cancer research, hardware security, and global health,unified by machine learning and data analytics. His research has been funded by a diverse range of agencies, including NIH, CDC, VA, AFOSR, USAID and Gates Foundation. His primary applications are in global health and rural community health, which address large-scale societal and healthcare challenges in mutually reinforcing ways.
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.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Marina Pavlovic Rivas, co-founder & CEO of Eli Health.The company is focused on making hormone data accessible in real time through its saliva-based testing system that delivers results through a mobile app. A data scientist by training, Marina previously founded Gradiant AI, a machine learning company that was acquired in 2019. In this interview, Marina discusses how to evaluate form factor options without locking into a design too early, what beta testing reveals that years of lab work can't, and how existing consumer spending patterns influence positioning and pricing strategies. She also shares how regulatory considerations shaped product decisions from the outset and why building in-house proved more efficient than outsourcing when external partners said the company's goals were impossible.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 Marina Pavlovic Rivas.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Greg Walters, co-founder & CEO of Excision Medical. Excision is developing a leaflet modification system to enable lifetime management of aortic stenosis.Greg has almost 40 years of experience in cardiovascular devices, holding leadership roles at Kensey Nash Corporation where he led the development of Angio-Seal and several endovascular programs. He later co-founded Essential Medical, which was acquired by Teleflex in 2018, and is an inventor on more than 75 U.S. and European patents.In this interview, Greg discusses why early-stage teams should build to learn rather than to impress, using functional prototypes to generate real feedback and fundraising momentum. He outlines how disciplined safety work — not perfection — defines first-in-human readiness, and what makes a pre-revenue company attractive to strategic acquirers. 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 Greg Walters.
Is your medical device vision actually helping you grow - or silently holding you back?If you're a clinician founder with a working prototype but struggling to scale or export your medical device, the problem likely isn't your product — it's your vision. In this episode, Hakeem Adebiyi breaks down why most healthcare innovations stall commercially and how to fix it using a proven, clinician-friendly framework.Here's what you'll learn:Why your current vision might be too generic — and how that's stalling your commercial growthThe DAMP framework: a 4-step system to pressure test your vision for direction, alignment, motivation, and peopleA practical on-the-go exercise to sharpen your vision and guide real business decisions immediately
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Moving more than 19,000 patient cardiac devices across 15 locations to a cloud-based management platform was a big lift that improved clinical administration and patient care, says Amy Tucker of Advocate Health's Sanger Heart & Vascular Institute.
Medboard: https://www.medboard.com/EuropeEMD Mag Issue 3 - For QA RA people: https://easymedicaldevice.com/emd-mag/EU to simplify MDR and IVDR - Proposal ongoing: https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf - https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_25_3078/QANDA_25_3078_EN.pdf - https://ec.europa.eu/commission/presscorner/api/files/attachment/882087/FACTSHEET%20medical%20devices%20final%20(1).pdfTeam NB Position Paper on Annex VII - Not agreeing all EU Proposal: https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216.pdfMDCG 2025-9 Learn Breakthrough Devices BtX - Guidance for innovative products: https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdfInfographic: https://www.linkedin.com/posts/melazzouzi_medtech-mdr-ivdr-activity-7414590943179202560-jbxH?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuIMDCG 2025-10 on PMS - Learn how to do it with this guidance: https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdfNotified Body Malta Conformity Assessment - 52nd Notified Body for MDR: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=SIMS_INPUT_282916&filter=notificationStatusId:1 ServicesEasyIFU - Manage your eIFU and Labels: https://easyifu.com SwitzerlandSwissdamed registration deadline - July 1st 2026: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/frist-produktregistrierung-in-swissdamed.html - https://swissdamed-webinar.ch/#E402A0UKMHRA Price changing -: More cost for manufacturers: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees RoWFDA: How to use Real World Evidence - Guidance Document offered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devicesAustralia: Preparing for UDI and AusUDID - Checklist for preparation available: https://www.tga.gov.au/sites/default/files/2025-12/preparing-for-udi-in-australia-checklist_0.pdf PodcastPodcast Nostalgia - What was discussed lastly: Episode 367 - From Engineer to Clinical Evaluation Expert - Florian Tolkmitt: https://podcast.easymedicaldevice.com/367-2/Episode 368 - Simplifying EU MDR IVDR with Adam Isaacs Rae: https://podcast.easymedicaldevice.com/368-2/Episode 369 - Last Podcast of the Year: https://podcast.easymedicaldevice.com/369-2/Episode 370 - Verification & Validation with Aaron Joseph: https://podcast.easymedicaldevice.com/370-2/
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Jaeson Bang, Founder & CEO of Future Cardia. Future Cardia is developing a subcutaneous heart-failure monitoring platform designed to capture both electrical and mechanical cardiac signals through a simple office-based procedure.Jaeson brings more than two decades of experience building implantable cardiac technologies across Medtronic, CVRx, EBR Systems, and Abiomed. Drawing on that background, he questioned industry assumptions around miniaturization and invasive workflows — and built a device that prioritizes performance, durability, and clinical practicality instead.In this interview, Jaeson shares how challenging a core constraint unlocked a faster development path, why deep domain expertise matters more than thrift in regulated markets, and how raising capital outside traditional VC can preserve leverage and buy time.If you'd rather read than listen, here's a link to the full interview with Jaeson Bang.
Guests:Dr Mihai Lomora, Scientist with CÚRAM, the Research Ireland Centre for Medical Devices based at the University of GalwayDr Jessamyn Fairfield from the School of Natural Sciences at the University of GalwayDr Fergus McAuliffe, Head of Research Engagement and Impact at Trinity College Dublin
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 9.5 weeks, earning $113,760 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
University of Phoenix confirms a massive data breach affecting almost 3.5 million current and former students, staff, and partners after attackers exploited a zero-day in Oracle E-Business Suite. We break down the implications for identity theft risk and breach response. Next, Andre explains why most existing medical devices would fail the FDA's new cybersecurity standards and how healthcare organizations can manage legacy device risk in critical environments. Finally, Bryan breaks down a cloud breach spree that hit 50 global organizations because multi-factor authentication wasn't enforced. Learn why MFA is no longer optional and how basic security failures lead to major breaches. Tune in for expert insights, practical advice, and what every IT leader needs to know today.
How do you go from being the Ohio State University mascot to an ICU Nurse, and finally to a top-tier Pharmaceutical Sales Rep at Pfizer in just 11 weeks?In this episode of Medical Sales U, I sit down with Corey Stewart to break down his incredible career transition.- The "Hospital Cafeteria" Interview: The insane story of how Corey interviewed for Pfizer while his wife was in labor (and still crushed it).- The STAR Method: Watch a live roleplay of how to answer the "Tell me about a time..." question using courage and clinical experience.- Salary Negotiation: Full transparency on the numbers. See how Corey negotiated a $112k offer up to a $158k total first-year package.-Networking Strategy: Why reaching out to the team is more important than reaching out to the manager.If you are a nurse, teacher, or athlete looking to break into Medical Device or Pharma Sales, this will give you some insight.CHAPTERS0:00 - Intro: Meeting Brutus Buckeye & The "Expert of One" Mindset2:15 - Why Leave Nursing? Burnout, Family, and Income8:45 - The Strategy: Networking with Peers vs. Hiring Managers15:30 - Master Class: Using the STAR Method in Interviews (Live Example)24:10 - The "Courage" Story: Challenging a Surgeon in the ICU32:45 - Must See: Interviewing for Pfizer While His Wife was in Labor!40:20 - The "Re-Close": How to Tell Them You Got the Job45:50 - Money Talk: Negotiating Base Salary, Commission, & Relocation ($158k Total)52:10 - Final Advice: Betting on YourselfWANT TO BREAK INTO MEDICAL SALES? Ready to leave the bedside or the classroom and start a 6-figure career? Apply to Medical Sales U today: medicalsalesu.com/ABOUT THE GUEST: Corey Stewart is a former Ohio State "Brutus" mascot, a Cardiovascular ICU Nurse, and now a Pharmaceutical Sales Representative at Pfizer. He successfully transitioned into the industry in just 11 weeks using the Medical Sales U coaching program.#MedicalSales #Pfizer #NurseToSales #SalaryNegotiation #OhioState #BrutusBuckeye #PharmaSales #CareerTransition #InterviewTips #DaveSterrett #MedicalSalesUDisclaimer: The views expressed in this video are those of the speakers and do not necessarily reflect the official policy or position of any other agency, organization, employer, or company.
We talk with Matt Trentini, Principal Software Engineer at Planet Innovation, about using MicroPython for professional embedded development—including medical devices. Matt shares how he was drawn back to embedded development after becoming jaded with traditional C-based workflows, and explains why MicroPython's interactive REPL and rapid development cycle have become game-changers for his team.We explore the practical realities of using an interpreted language on microcontrollers: how Planet Innovation uses it for Class B medical devices, what the performance trade-offs actually look like, and how features like the Unix port enable robust testing. Matt walks us through deployment considerations, explains how to integrate C code when needed, and shares compelling stories about real-time client demos that would be impossible in C++.Whether you're skeptical about high-level languages in embedded systems or curious about alternatives to traditional development workflows, this conversation offers a grounded, engineering-focused look at what MicroPython can—and can't—do in production environments.Key Topics[03:30] Matt's background and why he left embedded development before MicroPython brought him back[08:45] What MicroPython is: a complete re-implementation of Python for microcontrollers with REPL, filesystem, and machine module[13:20] How Planet Innovation introduced MicroPython through an OpenMV vision processing project[17:15] The game-changing power of the REPL for interactive hardware development and testing[21:40] Running MicroPython code on x86 for testing, and the mock machine library approach[26:30] Python library compatibility: what works, what doesn't, and memory considerations[29:50] Integrating C and C++ code through extension modules for performance-critical sections[33:10] Performance realities: 10-100x slower in interpreter, but can always drop to C speed when needed[37:45] Tooling: MPRemote, the magical mount feature, and development workflow[42:20] When NOT to use MicroPython: cost-sensitive high-volume products and resource constraints[45:30] Using MicroPython in Class B medical devices and safety-critical applications[49:15] Garbage collection: simple, predictable, and controllable—can be disabled when needed[52:40] Real-time client demo story: modifying state machines during a call and showing results immediately[56:20] Deployment: frozen code, disabling REPL and filesystem, and OTA considerations[01:01:30] Common mistakes: logic errors and inadvertent allocations rather than memory corruption[01:05:45] Threading, AsyncIO, and the Global Interpreter Lock across different ports[01:08:20] State machine frameworks: StateChart, Yasme, and PyTransitions[01:11:40] Junior developer productivity: faster onboarding compared to C/C++ embedded development[01:15:10] Getting started: board bring-up as an ideal first use case for MicroPython[01:17:50] Hardware-in-the-loop testing as a low-risk way to try MicroPythonNotable Quotes"It's hard to overstate how game changing the REPL is. Particularly as an embedded engineer, once you see that you can interactively talk to a peripheral, you can generate your own I2C, squirt it across and see what the peripheral does with it—suddenly driver development has just become easy to experiment with." — Matt Trentini"My trite answer is that MicroPython is slow—10 to 100 times slower than C in the interpreter. But my flip side answer is that it can always be made as fast as C because you can always drop into C to write things." — Matt Trentini"There was a moment in a recent project where we were discussing the workflow of a state machine with the client, and while we were on a call, another engineer was actually making changes to MicroPython code. Literally a couple minutes after we'd been hashing out the details, they showed the changes in the state machine using the REPL. The client was blown away—in 25 years of development, I have never had that kind of turnaround in C and C++." — Matt Trentini"If you want to make a good friend of your electronics engineers, give them a build of MicroPython that can run on their custom board. In the past, they would typically be waiting for weeks or sometimes months before a software resource could be assigned. Now I can turn around a MicroPython build in a day or two, and they can test I2C, GPIOs, and UARTs themselves." — Matt Trentini"The irony is that the people who have embedded C knowledge are actually the people that can benefit the most from MicroPython. It's like having a superpower—you understand what MicroPython is doing in the background, you know you're just effectively writing a lot less code." — Matt TrentiniResources MentionedMicroPython Official Site - The official MicroPython project website with documentation and downloadsOpenMV - Computer vision project using MicroPython for camera-based applicationsMPRemote - Tool for interacting with MicroPython devices, including the magical mount featurePlanet Innovation - Medical device consultancy using MicroPython in production devicesStateChart - State machine library compatible with Python and MicroPythonYasme - Yet another state machine library developed at Planet InnovationPyTransitions - Popular Python state machine library being ported to MicroPythonCircuitPython - Adafruit's fork of MicroPython with additional features and CPython compatibility focus You can find Jeff at https://jeffgable.com.You can find Luca at https://luca.engineer.Want to join the agile Embedded Slack? Click hereAre you looking for embedded-focused trainings? Head to https://agileembedded.academy/Ryan Torvik and Luca have started the Embedded AI podcast, check it out at https://embeddedaipodcast.com/
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 9.5 weeks, earning $113,760 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026.The episode reflects on a full year of continuous content creation, including:Weekly podcast episodes covering global medical device regulationsIncreased focus on artificial intelligence and its impact on QA/RA rolesEducational initiatives such as EMD Mag, designed to make complex regulatory topics more accessibleDevelopment of digital tools like EasyIFU, labeling automation, and eQMS solutionsExpansion of consulting, back-office services, and international presenceThe discussion also addresses upcoming challenges:Increasing pressure on Notified BodiesRisks for late MDR/IVDR transitionsThe importance of anticipation and regulatory strategy for new and existing manufacturersMore than a recap, this episode is a strategic pause — an opportunity to reflect, learn, and prepare for the years ahead in a rapidly evolving medtech regulatory environment.Who is Monir El Azzouzi?Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice
Start making $150k - $200k+ in your first year of medical sales. Stop chasing crowded "old school" roles like Orthopedics and Spine. The real money—and the life-saving innovation—is in Oncology and Specialty Pharma. Today, I reveal the exact blueprint to reinvent your career and break into the most lucrative sector of healthcare. Whether you're a nurse, a teacher, or stuck in a "middle-class mindset," this episode breaks down why your background doesn't matter. Only your preparation does.I share my personal journey from a non-profit minister making $70k to a high-level oncology rep, and explain why "casual advice" from friends will get you rejected. If you want to master the interview, crush your clinical knowledge, and build a 6-figure life, this is the masterclass you need.WHAT YOU WILL LEARN IN THIS EPISODE:- The "Gold Rush" Shift: Why you should ignore Orthopedics and focus entirely on Oncology, Diagnostics, and Genetic Testing.- The 3 Essential Mindset Shifts: How to move from "winging it" to becoming an obsessively prepared candidate.- Real Success Stories: How Kanika (immigrant to Dallas), Sydney (nurse), and others went from zero experience to $200k roles.- The "Ride-Along" Trap: Why you need a brutal coach, not a nice mentor.- The HEART Framework: The 5 character traits (Humility, Energy, Active Listening, Resilience, Trust) that hiring managers look for.- Confidence vs. Arrogance: How to show "grit" without sounding like a jerk.- Daily Habits of Top 1% Earners: The 5 AM club, the "20 LinkedIn adds" rule, and why your degree (MBA) has a lower ROI than coaching.- The Michael Jordan Rule: Why even the greatest of all time hired coaches for their specific weaknesses.TIMESTAMPS00:00 - Introduction: The Program Focus (Oncology vs. Orthopedics)01:34 - Dave's Story: Reinventing Career from Ministry to Medical Sales03:44 - Success Stories: How Nurses & Immigrants Got Hired (Kanika, Sydney)06:47 - Mindset Shift #1: Be Coachable (Why Friends Can't Help You)09:20 - Mastering Virtual Interviews (Lighting, Camera & Background)10:32 - Mindset Shift #2: Be Curious (Understanding Clinical Trials & FDA)12:32 - Salary Reality: Device Associate ($80k) vs. Oncology ($155k+)13:55 - Mindset Shift #3: Collaboration (Working with MSLs & Nurse Navigators)16:28 - Confidence vs. Arrogance (The "Grit" Trap)18:02 - The H.E.A.R.T. Framework (Humility, Energy, Listening, Resilience, Trust)19:00 - Daily Habits: 5 AM Wake-ups, LinkedIn Strategy & Handling Rejection20:00 - The"Middle Class Mindset" Trap: Why Degrees Have Low ROI22:25 - Using AI for Resumes Without Sounding Like a Robot25:55 - The "Why": Patient Outcomes & Life-Extending Impact29:35 - The 3 Questions You Must Ask Yourself31:01 - The Michael Jordan Analogy: Why Even the Best Hire Coaches.ABOUT MEDICAL SALES U: Medical Sales U is the premier training program for professionals looking to break into high-paying careers in Medical Device, Pharmaceutical, and Genetic Testing sales. We turn "outsiders" into top 1% candidates.CONNECT WITH US: Learn more about coaching and career support at medicalsalesu.com/#MedicalSales #OncologySales #CareerPivot #SalesCoaching #HighIncomeSkills #DaveSterrett #MedicalSalesYou #InterviewTips #SalesJobs #PharmaceuticalSales
Send us a textThis episode is a rerun.Rob Donley has a deep understanding of how engineering works. Kicking off his engineering career from a young age building RC cars and model rockets, he has provided design and leadership capabilities for many companies over the years, and brings to the table not just the ability to design something, but to understand the many facets that accompany development of a new product such as manufacturing, supply chain, financial strategy, and project management. Download the Essential Guide to Designing Test Fixtures: https://pipelinemedialab.beehiiv.com/test-fixtureAbout Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community. The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us
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