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Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Todd Usen, CEO of Adagio Medical.Adagio specializes in catheter-based ablation technologies for the treatment of cardiac arrhythmias, with a focus on ventricular tachycardia (VT). Todd has over three decades of leadership experience in the medical technology industry, with particular expertise in commercial strategy, operational performance, and business transformation. Before joining Adagio, Todd served as CEO of Minerva Surgical, a women's health company, and as CEO of Activ Surgical, a digital surgery startup. Todd has also served in executive positions at Olympus, United States Orthopedics, Smith and Nephew, and Boston Scientific.In this interview, Todd shares insights on making usability central to commercialization strategy, leveraging breakthrough designation beyond regulatory validation, and assembling effective boards by carefully selecting both investor and independent members who bring operational expertise.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Todd Usen.
■Learn how to turn user needs into clear, beginner-friendly test plans for Software as a Medical Device (SaMD). In this episode, we break down the essentials of SaMD validation—no PhD required! We cover: ►Why testing matters: Real-world examples of what can go wrong (and how to avoid it) ►From user needs to test cases: Simple “if-then” steps you can try today ►Who should test: Pros and cons of in-house vs. external testers ►eQMS basics: How to validate your electronic Quality Management System with minimal hassle ►Quick tips: The one thing you must do first, and the top beginner pitfall to avoid Whether you're a developer, QA engineer, or healthcare innovator, you'll walk away with practical strategies to ensure your medical software is safe, reliable, and compliant. Tune in and make your next SaMD project a success! ► Links from the Video ■Anindya Mookerjea: https://www.linkedin.com/in/anindyamookerjea ■S-Cube Technologies: https://eqms-smarteye.com/ ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice
Jennifer Jones, Chief Marketing Officer at TIDI Products, brings over 20 years of experience in the Medical Device industry, spanning a variety of sales and marketing roles. At her core, Jennifer is a marketer—but over the years, she's discovered her true passion lies in developing leaders. While many view leadership as a natural extension of technical expertise, she believes it is a distinct skill that requires intentional practice and consistent application. Today, leadership development is the cornerstone of her work. Jennifer leads a talented team of more than 50 professionals across product marketing, marketing communications, business development, and new product development. Her mission is to equip and empower leaders who will make a lasting impact in healthcare.To extend her reach, Jennifer launched a podcast—Virtual Leadership Coffee Chat with JJ—offering practical, actionable leadership advice. She believes that by getting to know your people, staying organized, listening to understand, asking before telling, and leading with humility, leaders can unlock limitless potential.Outside of work, Jennifer enjoys life with her husband of nearly 19 years and their 8-year-old son. She supports her husband's role as Music Director at their local church, cares for more than 100 plants, reads avidly, and builds elaborate Lego sets. Thank you for listening to "Can You Hear Me?". If you enjoyed our show, please consider subscribing and leaving a review on your favorite podcast platform.Stay connected with us:Follow us on LinkedIn!Follow our co-host Eileen Rochford on Linkedin!Follow our co-host Rob Johnson on Linkedin!
TÜV SÜD's Hannah Rounsville and Jessica Schmidt discuss practical strategies to extend device lifespan, improve reprocessing methods, and minimize waste—while maintaining patient safety and meeting regulatory requirements. They also share valuable insights into optimizing Instructions for Use (IFU) to incorporate resource-efficient practices that enhance device sustainability. By implementing these strategies, medical device manufacturers and healthcare facilities can achieve cost savings, ensure regulatory compliance, and promote environmental responsibility.Send us a message! Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram.
In this episode, host Sandy Vance sits down with Rob Stein of C2 Solutions, a division of Intellias, to explore how smart hospitals and connected device technology are reshaping the future of healthcare—both inside the hospital room and across rural communities.From defining what makes a hospital truly "smart" to navigating the challenges of interoperability and integration, this conversation offers a clear-eyed look at what it takes to go digital in healthcare today. Rob shares how Intellias is helping healthcare organizations modernize infrastructure, drive better patient outcomes, and expand care delivery beyond hospital walls.Whether you're a health IT leader, provider, or innovator looking to stay ahead of digital trends, this episode offers insights into the real-world challenges and opportunities of building smarter, more connected care systems.In this episode, they talk about:
Gemma started her career studying Mechanical Engineering at Cardiff University. She quickly discovered the world of Continuous Improvement and spent 20 years working to improve processes and systems within various manufacturing industries including Automotive, Pharmaceutical, Dairy, Cosmetics & Toiletries, Food, and Medical Devices. She has been a CI Manager numerous times and an Operations Manager running a factory of over 500 people.Gemma is hugely passionate about Improvement and developing people and processes. She gets such a kick out of coaching and facilitating, especially when she sees the lightbulb switch on in someone's head – when they solve a problem; when they realize they have the power to change; or when they get excited about all the improvements they could make.In 2019, Gemma left the world of employment to establish her own business, SPARK Improvement, aiming to switch on as many lightbulbs as possible. Her mission is to help organizations and individuals be the BEST they can be, by helping people SEE, helping people THINK, and helping people CHANGE.Gemma is based in Cheshire in the UK, working globally.Link to claim CME credit: https://www.surveymonkey.com/r/3DXCFW3CME credit is available for up to 3 years after the stated release dateContact CEOD@bmhcc.org if you have any questions about claiming credit.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Stuart Long, CEO of InfoBionic. InfoBionic's virtual cardiac telemetry platform, MoMe ARC®, brings together a tiered hospital-grade monitoring capability powered by advanced AI-enabled analysis for cardiac interventions.Stuart has over two decades of experience in the medical device and healthcare technology sectors, with a focus on driving rapid commercial growth. His leadership spans roles including CEO of Monarch Medical Systems, global chief marketing and sales officer at CapsuleTech, and executive positions at Philips Healthcare, Agfa HealthCare, AMICAS, and FUJIFILM USA. At CapsuleTech, he developed strategic initiatives that led to the company's acquisition by Qualcomm Life. In this interview, Stuart shares insights on combining debt and equity financing, hybrid commercial approaches, and positioning startups for acquisitions through adjacent market development — all while maintaining the persistence needed to survive the long game.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Stuart Long.
Europe Notified Body survey report - 31 October 2024 - What is the main Surprise: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf The MIR form has been updated - Version 7.3.1 - Don't use previous versions: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en UK: UK MIR and FSCA - Change is in the AIR: https://www.gov.uk/government/publications/more-implementation/gb-mir-and-fsca-schema-implementation-guide UK MDR 2002 is dying - Long life to UK MDR 2025: https://www.legislation.gov.uk/ukdsi/2025/9780348269529 : Real-World Data or Clinical Trial or Both?- This is the question: https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions Training EU MDR Green Belt June 2025 - June 23rd, June 27th: https://school.easymedicaldevice.com/course/gb34/ eTraining on Vigilance and Audit preparation - Self-paced: https://school.easymedicaldevice.com/emd-course ROW USA Q-Sub update - New electronic template: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-q-submissions Brazil: SIUD or UDI in Brazil - Manual of Use in Portuguese: https://www.gov.br/anvisa/pt-br/assuntos/produtosparasaude/temas-em-destaque/arquivos/manual_siud_v01.pdf Saudi Arabia: Series of Webinar - June is a Busy month in Saudi Arabia: 16 June 2025 Companion Diagnostic Regulatory Requirements: https://www.sfda.gov.sa/en/workshop/3540492 17 June 2025 Saudi Unique Device Identification (SAUDI-DI): https://www.sfda.gov.sa/en/workshop/3540493 19 June 2025 Artificial Intelligence and Machine Learning: https://www.sfda.gov.sa/en/workshop/3540495 23 June 2025 Digital Health Medical Devices regulatory approach: https://www.sfda.gov.sa/en/workshop/3540496 24 June 2025 Medical Devices Risk Classification: https://www.sfda.gov.sa/en/workshop/3540497 Saudi In-house Devices - Not like EU: https://www.sfda.gov.sa/sites/default/files/2025-05/MDS-G022En.pdf Turkey: In Turkey, Economic Operators are Liable - Even after discontinuation or temporary stop of supply: https://titck.gov.tr/duyuru/tibbi-cihazlarin-tedarikinin-kesintiye-ugramasi-veya-durdurulmasi-sona-ermesi-durumunda-i-ktisadi-i-sletmecilerin-yukumlulukleri-hakkinda-duyuru-21052025113350 PODCAST: Podcast Nostalgia - What happened in May 2025 Episode 334 - What is the new UK Post-Market Surveillance Requirements? With Claire Dyson: https://podcast.easymedicaldevice.com/334-2/ Episode 335 - When is Regulatory Affairs needed during Design? With Aouda Ouzza: https://podcast.easymedicaldevice.com/335-2/ Episode 336 - is EHDS dangerous for Medical Device Manufacturers? With Cecile van der Heijden: https://podcast.easymedicaldevice.com/336-2/ Episode 337 - How Deepeye Medical overcame the AI Act? With Carmen Bellebna; https://podcast.easymedicaldevice.com/337-2/ Episode 338 - Trapped or Strategic? Changing Notified Bodies During MDR transition: https://podcast.easymedicaldevice.com/338-2/
Julio Martinez-Clark teamed up with his cardiologist brother and other doctors to help speed up the clinical trials part of the process. Julio's team at bioaccess® is moving medicine forward quicker by helping startups and researchers get the data from clinical trials in other countries. Advancements can now come to market quicker while also helping suffering people in countries that do not have the means to afford the proper medical care. This saves time, money, and people.Julio Martinez-Clark is the co-founder and CEO of bioaccess®. Julio believes Latin America is an untapped destination for Medtech clinical research. Since 2010, Julio has supported +100 Medtech in operationalizing successful clinical trials in several countries in Latin America. Julio was the chairman of the board of the Association for the Advancement of Clinical Research in Colombia (AVANZAR). Julio writes a column at Med Device Online, where his articles have been "Featured Editorials" on several occasions. Julio hosts the LATAM Medtech Leaders podcast, interviewing Medtech leaders who have succeeded in Latin America.Julio has a wealth of experience in various fields, including serving as an advisor to the CEO of Amavita Heart and Vascular Health™, the most extensive cardiovascular practice in South Florida, an advisor to government agencies in Colombia looking to position the country as a clinical trial destination, and a mentor to startups at Macondo Labs, a top incubator in Colombia.Learn more at www.bioaccessla.com and connect with Julio on Linkedin @juliomartinezclark Visit ConfidenceThroughHealth.com to find discounts to some of our favorite products.Follow me via All In Health and Wellness on Facebook or Instagram.Find my books on Amazon: No More Sugar Coating: Finding Your Happiness in a Crowded World and Confidence Through Health: Live the Healthy Lifestyle God DesignedProduction credit: Social Media Cowboys
What if clinical trials could save lives and launch your global medtech career? What happens when you combine cutting-edge medical devices, international clinical trials, and a relentless drive to create real-world impact? Meet Julio M. Clark — CEO of bioaccess® and host of the LatAm MedTech Leaders podcast — who turned a one-man regulatory operation into a pioneering contract research organization transforming healthcare across Latin America. In this episode of Neurocareers: Doing the Impossible!, we explore: How Latin America became a hub for first-in-human clinical trials The unique challenges and opportunities of medical device research in global markets Why AI is revolutionizing everything from informed consent to trial proposals Career pathways for biomedical engineers and clinicians in medtech startups The mindset needed to build impactful ventures from scratch — even after failure Julio shares the entrepreneurial journey behind bioaccess®, the future of medtech clinical trials, and how YOU can contribute to life-saving innovation—even if you're just starting out. Whether you're a neurotech enthusiast, aspiring clinical researcher, or global health innovator—this episode will inspire you to think bigger, act bolder, and, most importantly, choose the right table.
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastIf you think just applying is enough, it isn't. Everyone wants the six-figure med device job, but most people have no idea what it actually takes to get there. Learn the hard truths about breaking into the industry. Why most candidates fail, what top companies are really looking for, and how to become the kind of person they feel lucky to hire.Key TakeawaysUnderstand that medical device sales isn't like a regular job where you apply and get hired after a couple of interviews. You're going up against experienced professionals and even current reps who want a better gig.Make sure you show up like a professional. Being chill might work with your friends, but it won't land you a six-figure job talking to surgeons and execs. No jeans and T-shirts at interviews. No “lit” or “dog” in conversations.Knowing someone in the industry might get you an intro or a first-round interview, but it won't carry you through the whole process. You still have to earn it. Every company is different, and connections alone won't cut it.You've got to level up your mindset. Don't chase the six-figure job thinking money alone will solve everything. You need to become the kind of person who deserves that paycheck. Companies would feel lucky to hire you.Age doesn't matter as much as how prepared and professional you are. Maturity, attitude, and consistency are what win the job, not your resume alone.00:00 - Start01:12 - EXPECTATION #103:30 - EXPECTATION #205:15 - EXPECTATION #307:34 - EXPECTATION #4
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Shreya Mehta, co-founder and CEO of Zenflow.Zenflow is a medical device company focused on treating benign prostatic hyperplasia (BPH). A biomedical engineer, Shreya brings over 15 years of experience in medtech, including serving as a lead reviewer at the FDA, where she specialized in cardiovascular devices. Shreya co-founded Zenflow in 2014 out of the Stanford Biodesign Innovation Fellowship. The company was one of the first medical device startups backed by Y Combinator and also received early support from StartX and the UCSF Rosenman Institute at QB3.Shreya's experience at Zenflow reveals strategies for grounding innovation in patient needs, building productive FDA relationships, and leveraging accelerator programs to transform academic concepts into viable businesses.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Shreya Mehta.
Send us a textIn this episode of Healthcare Trailblazers, host Mendel sits down with Gabby Lawrence, Senior Director of Clinical Solutioning at TytoCare. TytoCare offers the Home Smart Clinic - for accessible, high-quality primary care from home, with no compromises, featuring artificial-intelligence-powered features to enable its telehealth platform to perform diagnostic capabilities. Gabby, an epidemiologist by background, explains how TytoCare's FDA-cleared handheld device with modular attachments transforms virtual healthcare by enabling comprehensive physical exams from home. The conversation covers TytoCare's evolution from urgent care applications into chronic disease management and primary care, their AI-powered wheeze detection capabilities, and strategic partnerships with major health systems like Atrium, Advocate, and Memorial Care. They explore the meaning behind "clinical solutioning" versus traditional clinical solutions, the challenges of B2B versus B2C models, and the company's vision for integrating GenAI to enhance physician capabilities while maintaining human oversight in patient care.
Hundreds of approved devices use artificial intelligence to help physicians diagnose patients faster and more accurately. Brooke & Associates is a legal and regulatory advisory firm that helps medical device makers get AI-powered devices through FDA pre-market approval.In Episode #40 of the MedTech Speed to Data podcast, Key Tech's Andy Rogers and Lei Zong speak with the firm's managing member, Jason Brooke, about the FDA's latest guidance to medical device developers for integrating AI into their products.Need to knowAI's role in MedTech — AI identifies otherwise undetectable data patterns that humans can apply in clinically meaningful ways.FDA's AI staffing surges — The agency accelerated hiring to develop internal AI applications and support pre-market reviews of new AI-powered devices.Radiological imaging leads the pack — More than half of 900+ FDA-approved AI-based products are in radiological imaging.Other fields are catching up — Cardiology and neurology applications are more recent entrants in AI-powered devices, but their numbers are growing.The nitty-grittyThe FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” in early 2025 to explain how it will address AI's adaptive nature in medical device regulation.“This guidance is really focused on a total product lifecycle approach,” Brooke explains.Good management practices govern traditional medical device development, so documenting the development process in pre-market submissions is not as critical. AI model development is different because the model can evolve once in service.“There's a level of information that's necessary in submissions for AI-based technologies that we haven't had to provide to the FDA before,” Brooke says. “They want a lot of information,” Brooke says. “That's an area I think may be problematic because a lot of that is somewhat trade secret.”AI-specific guidance touches almost every aspect of a company's submission, from risk assessment to labeling to cybersecurity. Brooke highlighted how the FDA's approach to AI data management could change development practices to ensure the independence of training and validation data sets. For example, companies must separate their clinical sites geographically and temporally.“This guidance gets into the weeds,” Brooke says. “It's important for companies to understand this if they're developing an AI-based product.”Data that made the difference:In addition to discussing the FDA's proposed AI regulations, Brooke discusses the challenges companies face in bringing AI-powered medical devices to market.“If you take away anything from this podcast,” Brooke says, “it's that there's a lot of burden associated with developing an AI-based medical device. If you don't need to, then I wouldn't recommend doing it.”Slow and steady wins the race. Do your homework, plan for the FDA review, and then engage the agency at the right time to get them on board.Thoroughly characterize your data sources. Devices like ECGs can vary by vendor, model, site location, patient, and many other factors. The FDA wants to know how this variability could affect the downstream AI model.Develop a strong clinical validation plan. The FDA will limit claims and require disclosures when a device that performs well overall underperforms among certain patient groups.
This episode focuses on writing for medical devices. Playing Sherlock Holmes, conducting usability studies, following regulations, working closely with the manufacturers and much more are all in a day's work when writing for devices. Listen to Trilogy's medical writing managers, Heidi Chapman and Laura Collada, and Senior Partner, Julia Forjanic Klapproth, discuss the similarities and differences between writing for devices and writing for drugs. Listen up!
Mariano Mattei is the Vice President of Cybersecurity and AI at Azzur Solutions, bringing over 30 years of expertise in cybersecurity, AI innovation, and software engineering. A Certified Chief Information Security Officer (CCISO), Mariano has led AI-driven transformations across Biotechnology, Pharmaceuticals, and Medical Device sectors, integrating AI into clinical trials, manufacturing automation, quality systems, and regulatory compliance frameworks (FDA 21 CFR Part 11, GAMP 5, GDPR, HIPAA). His work spans predictive analytics for risk management, AI-powered process optimization, anomaly detection in manufacturing, and regulatory AI governance. He recently graduated from Temple University's Master's Program in Cyber Defense and Information Assurance, and he's the author of "Data-Driven Cybersecurity – Proven Metrics for Reducing Cyber Risk"Listen NOW to discover, "The Secret to Taking A Secure Risk"
In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification. Who is Carmen Bellebna? Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye's QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment. 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. Link Carmen Bellebna LinkedIn: https://www.linkedin.com/in/men-be-a1828a81/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
What if your next business idea wasn't about making millions—but helping just one person? In this episode, Tom Livingston, CEO of Rampart IC, shares how a late-night phone call from a friend sparked the idea for a life-saving medical device—and how that simple act of service grew into a globally distributed, 8-figure company. From sketching concepts on a napkin to testing a prototype during a secret cabin weekend, Tom's journey is a masterclass in purpose-driven leadership, calculated risk, and building something that truly matters.Whether you're burning the midnight oil on your own big idea or still in the dreaming phase, this conversation is for you. Tom opens up about building the company while working full time, the coffee table pact that changed everything, and the power of building a team rooted in belief, not just ambition. This is a story of faith, uncertainty, and the quiet courage it takes to bet on what doesn't exist—yet.WILDFLOWER SHOWNOTES : shannaskidmore.com/tom-livingston-rampart-ic
In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. We will talk about the impact on Medical Device manufacturers but also on you as a human being as all this is about manipulation of data. Personal data or anonymized data. But can it be un-anonymized… Listen to this episode. Who is Cecile van der Heijden? Cécile van der Heijden is a senior legal expert at Axon Lawyers, a boutique law firm based in the Netherlands specialized in legal and regulatory affairs for the life sciences sector. With a strong focus on digital health, data protection, and medical device law, Cécile advises companies on navigating complex European regulations such as the MDR, GDPR, and the newly adopted European Health Data Space (EHDS) Regulation. She regularly supports clients developing AI, software as a medical device (SaMD), and connected technologies, helping them align innovation with compliance. Known for her practical approach, Cécile frequently speaks at conferences and publishes insights on digital health law across the EU. 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. Link Cecile van der Heijden LinkedIn Profile: https://www.linkedin.com/in/cevanderheijden/ Axon Lawyers website: https://www.axonlawyers.com/ EHDS: https://www.european-health-data-space.com/ Article EHDS: https://www.consilium.europa.eu/en/press/press-releases/2025/01/21/european-health-data-space-council-adopts-new-regulation-improving-cross-border-access-to-eu-health-data/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Dr. Arun Menawat, Chairman and CEO of Profound Medical. Profound is commercializing the TULSA-PRO system, an alternative approach to prostate cancer treatment that uses MRI-guided thermal ultrasound to target and eliminate cancerous tissue without surgical incisions. Before joining Profound in 2016, Arun served as the Chairman and CEO of Novadaq Technologies for 13 years, guiding the company from a startup to one of the fastest-growing, NASDAQ-listed medical technology businesses with a market cap exceeding one billion USD. Earlier in his career, Arun served as President of Cedara Software, a company that developed the industry's first medical imaging software platform. Today, it's part of IBM's Watson Health.In this interview, Arun shares insights on building credibility with physicians, the strategic approach to clinical trials that led to their recent Medicare reimbursement coverage, and his vision for transforming the future of surgery beyond prostate cancer.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Arun Menawat.
AI is reshaping the future of medical devices, but innovation brings complexity. In this episode of AI Issue Spotting, Scott Loughlin is joined by fellow Hogan Lovells Medical Device and Technology partners Michael Heyl and Jodi Scott to explore the challenges companies face as AI begins to monitor medical device performance, diagnose conditions, and even deliver patient care. From regulatory hurdles to liability risks, they discuss how medical device manufacturers can navigate this rapidly evolving space. With AI blurring the lines between traditional medical devices and new digital solutions, the discussion highlights what medical device businesses need to know to stay compliant and innovative.
Check out the TIES Sales Showdown at www.tx.ag/TIESVisit The Sales Lab at https://thesaleslab.org and check out all our guests' recommended readings at https://thesaleslab.org/reading-listTo listen to The Sales Lab Podcast on your favorite apps, visit https://thesaleslab.simplecast.com/ and select your preferred method of listening.Connect with us on Facebook at https://www.facebook.com/saleslabpodcastConnect with us on Linkedin at https://www.linkedin.com/company/thesaleslabSubscribe to The Sales Lab channel on YouTube at https://www.youtube.com/channel/UCp703YWbD3-KO73NXUTBI-Q
In part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC). This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and the regulatory logic that guides these transitions. The conversation highlights the importance of aligning regulatory strategy with business goals, and offers practical insights on leveraging real-world evidence, understanding the limits of FDA databases, and optimizing pre-submission meetings.Key Timestamps02:10 – Starting from a cleared 510(k): Do you need a new submission for OTC?06:45 – Implications of removing the healthcare provider from the equation12:00 – Risk management: Expanding risk profiles when lay users are involved18:15 – When a 510(k) becomes a De Novo or PMA22:50 – Usability testing and the risk of user error in OTC devices31:20 – Clinical investigations and good clinical practices (GCPs)36:00 – Real-world evidence vs. real-world data—what's usable?41:30 – Using Pre-Subs effectively and what “quality data” really means47:10 – Labeling, cleaning, and UDI for OTC products53:40 – OTC software and digital health—when is it a regulated device?01:00:00 – Summary: Aligning regulatory logic with common sense and business strategyQuotes“With an OTC device, we are taking the healthcare professional totally, completely, and utterly out of the loop.”– Mike DruesThis quote encapsulates the core regulatory challenge in moving a device to OTC: every element, from labeling to usability, must assume zero clinical supervision.“If the clinical trial won't tell you anything you don't already know from good real-world evidence, why spend the time and money?”– Mike DruesA powerful argument for using well-documented real-world evidence over unnecessary trials—provided the data truly meets evidentiary standards.Top TakeawaysLabel Expansion ≠ Shortcut: Moving from prescription to OTC usually requires a new submission—especially when removing the healthcare provider introduces new risks.Usability Testing Is Critical: OTC usability studies must go beyond IFU comprehension to include risk of misuse, poor device selection, and user decision-making.Real-World Evidence Can Help—If It's Clean: Real-world data isn't always usable. FDA will expect reproducibility, traceability, and strong justifications.Labeling & Design Must Assume No Clinical Oversight: Cleaning procedures, warnings, and directions must all be validated for home use and layperson comprehension.Use Pre-Subs Wisely: Especially for label expansions or gray-area digital health tools, pre-subs provide critical alignment with FDA and prevent costly errors.References & ResourcesEtienne Nichols on LinkedInFDA Guidance on Real-World Evidence for Regulatory Decision-MakingGreenlight Guru Webinar: What is and Isn't a Regulated Medical Device (feat. Mike Drues)FDA Guidance: Clinical Decision Support SoftwareMedTech 101: OTC vs Prescription DevicesAnalogy: Think of prescription vs. OTC devices like driving a manual vs. automatic car. Prescription devices assume a trained “driver” (the healthcare provider), while OTC devices must be intuitive and safe enough for anyone to “drive”...
As health care advances, our medical devices have to evolve to keep up, which means they have to be connected to networks and the wider internet in ways they never were before. Unfortunately, that also means they're prime targets for hackers who want to steal your information and cause chaos. The recent "Device Talks Boston" conference focused, in part, on how the industry needs to catch up and put stronger security in place for our medical devices. Trevor Slattery, Chief Technology Officer at Blue Goat Cyber in Scottsdale, Arizona attended the conference, and stepped away to talk with Nichole about solutions for this problem.
Send us a textJoin host Aaron Moncur as he sits down with Dr. Stuart Grant, a seasoned med tech innovator with over 25 years of experience at industry giants like Johnson & Johnson and DePuy. Dr. Grant shares his journey from design engineering to founding his own consultancy, offering invaluable insights into medical device development, regulatory challenges, and the future of medical technology.Main Topics:Career progression in medical device engineeringChallenges of starting a medical tech consultancyRegulatory differences across global marketsInnovation strategies in medical technologyAdvice for young engineersFuture trends in surgical robotics and AIAbout the guest: Dr. Stuart Grant is a seasoned expert in the MedTech industry with over 20 years of experience at major companies like Johnson & Johnson and DePuy Synthes. In 2023, he founded Archetype MedTech, a consultancy that helps medical device companies achieve market approval through innovation strategy, technical evaluations, and team training. He holds advanced innovation and project management degrees and is a Chartered Engineer with several medical device patents. In addition to his technical work, Stuart lectures on innovation history and is a visual artist. His international experience and multidisciplinary expertise make him a key advisor for MedTech startups and scale-ups.Links:Dr. Stuart Grant - LinkedIn Archetype MedTech Website The Idea Factory: Bell Labs and the Great Age of American InnovationExactly How Precision Engineers Created the Modern World
Gemma started her career studying Mechanical Engineering at Cardiff University. She quickly discovered the world of Continuous Improvement and spent 20 years working to improve processes and systems within various manufacturing industries including Automotive, Pharmaceutical, Dairy, Cosmetics & Toiletries, Food, and Medical Devices. She has been a CI Manager numerous times and an Operations Manager running a factory of over 500 people.Gemma is hugely passionate about Improvement and developing people and processes. She gets such a kick out of coaching and facilitating, especially when she sees the lightbulb switch on in someone's head – when they solve a problem; when they realize they have the power to change; or when they get excited about all the improvements they could make.In 2019, Gemma left the world of employment to establish her own business, SPARK Improvement, aiming to switch on as many lightbulbs as possible. Her mission is to help organizations and individuals be the BEST they can be, by helping people SEE, helping people THINK, and helping people CHANGE.Gemma is based in Cheshire in the UK, working globally.Link to claim CME credit: https://www.surveymonkey.com/r/3DXCFW3CME credit is available for up to 3 years after the stated release dateContact CEOD@bmhcc.org if you have any questions about claiming credit.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Claire Dixon, CEO of Neuraura.Neuraura is developing LoOop, an over-the-counter wearable that targets PCOS through low-frequency electrical stimulation.Claire brings over 25 years of international leadership experience to her role as co-founder and CEO of Neuraura. With a master's degree in engineering from Cambridge and an MBA from Harvard, she spent 15 years as a strategic consultant to capital-intensive businesses before transitioning to entrepreneurship. She was recently named among the “Top 200 Trailblazing Leaders in Women's Health and femtech” by Women of Wearables.In this interview, Claire shares insights on navigating regulatory pathways, designing for real user needs, and building strategic partnerships to bring innovative women's health solutions to market through a direct-to-consumer approach.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Claire Dixon.
In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we'll let you know when and why you should involve them earlier. Listen to this episode. Who is Aouda Ouzzaa? Aouda Ouzzaa brings over 16 years of expertise in Regulatory Affairs (RA) and Quality Assurance (QA), supporting the entire product lifecycle—from development to post-market surveillance. She has successfully led projects across pharmaceuticals, biologics, medical devices (EU MDR), cosmetics, and Software as a Medical Device (SaMD). Her global regulatory knowledge spans EMA, FDA, GCC, and Rest of World (ROW) markets. Aouda has hands-on experience preparing IND, BLA submissions, and securing orphan drug designations. As a certified GMP and GDP auditor, Aouda has worked closely with cross-functional teams to ensure compliance with international standards while optimizing regulatory interactions. Her methodical approach and deep understanding of complex regulatory environments make her a strategic asset for organizations navigating global compliance challenges. Whether you're developing a new drug, launching a medical device, or scaling a digital health solution, Aouda Ouzzaa brings the insight and precision needed to achieve regulatory success. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Aouda Ouzza LinkedIn Profile: linkedin.com/in/aouda-ouzzaa-51877a32 SmartQARA website: https://smartqara.com/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs). This episode unpacks how intended users, environments, and risk tolerances shape device categorization, and why usability testing is far more complex than many realize. Whether you're developing a consumer health product or preparing a label expansion strategy, this is a must-listen for your regulatory roadmap.Key Timestamps[03:05] – What defines an OTC vs. prescription medical device?[06:45] – Market size of OTC devices and major product categories10:00 – Label expansion: moving from Rx to OTC status13:22 – The role of intended use environment in OTC classifications20:40 – Examples of devices in each FDA class that are OTC26:30 – Prescription devices used in home settings vs. true OTC31:15 – Characteristics that qualify devices for OTC status37:55 – Self-diagnosis, self-selection, and patient usability challenges43:00 – “Reasonably foreseeable misuse” and how to interpret guidance49:05 – Do you design for the lowest common denominator?56:10 – Representing diverse user populations in usability testing1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies1:08:15 – FDA's perspective on device safety: OTC vs. RxQuotes“The best regulatory professionals don't just know the rules—they know the exceptions.”Dr. Mike Drues reminds us that exceptional regulatory strategy lies in understanding nuance, especially in OTC classifications where edge cases can redefine categories.“Just because a device is used at home doesn't mean it's over the counter.”This insight challenges a common industry assumption, underscoring the importance of carefully defining intended use and environment early in development.Key TakeawaysOTC ≠ Low Risk by Default – Many Class II and even rare Class III devices can be OTC; it's more about intended user, use environment, and risk mitigation than class alone.Label Expansion Requires Strategy – Transitioning a device from prescription to OTC isn't just about removing a doctor's role—it may involve new usability studies, labeling changes, and potentially a 510(k) or de novo submission.Understand the "Intended Use Environment" – FDA doesn't just care about where the device is used, but how those environmental parameters (like light, humidity, and user training) affect safe operation.Usability Testing Must Reflect Real Users – For OTC devices, human factors validation must account for diverse educational backgrounds, not just ideal users.Don't Rely on Labels Alone – Whether or not users read (or understand) instructions must be tested, not assumed. Intuitive design is critical for OTC success.References & ResourcesEtienne Nichols on LinkedInGreenlight Guru Medical Device Classification Webinar with Mike Drues (for explanation on device classes)FDA Guidance: “Factors to Consider When Making Benefit-Risk Determinations in Medical Device...
Roadmap for Medical Device Startups Hello, this is Hall T. Martin with the Startup Funding Espresso -- your daily shot of startup funding and investing. The path for a medical device startup is clearly defined. In building a medical device startup or diligencing one, consider this roadmap. Market requirements -- establish the current state of the market, including size, needs, and current solutions. Product requirements -- define the requirements a medical device product must have to be successful with customers. Clinical unit -- a prototype that is used to run initial clinical tests. Preclinical validation -- initial test results with the clinical unit. First in human test -- clinical trials with human subjects. Clinical validation -- in human clinical test results. CE Mark -- regulatory approval to sell a product in Europe. First European orders -- initial sales of the product in Europe 510 K clearance -- regulatory approval to sell the clinical device in the US. First US orders -- initial sales of the product in the US. Break even -- sales equal operating costs. Growth then scale -- sales continue to grow. In reviewing a medical device startup, it's important to know the steps ahead and plan your fundraising for it. Thank you for joining us for the Startup Funding Espresso where we help startups and investors connect for funding. Let's go startup something today. _______________________________________________________ For more episodes from Investor Connect, please visit the site at: Check out our other podcasts here: For Investors check out: For Startups check out: For eGuides check out: For upcoming Events, check out For Feedback please contact info@tencapital.group Please , share, and leave a review. Music courtesy of .
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastWhy your resume isn't the make-or-break factor in landing a job, common mistakes people make with resumes, why relationships matter more than the perfect resume, how to show growth and numbers on your resume even if you're not in sales, creative ways nurses and clinical specialists can showcase their skills, how to avoid overloading your resume with too much information, why clarity and simplicity beat long resumes, what sales managers are actually looking for when scanning resumes, the importance of emotional intelligence for younger candidates, and how building relationships beats obsessing over your resumeKey Takeaways:It's not just about the resume. You need to focus on relationship building to stand out.Numbers and percentages showing growth are critical, even if you're not coming from a sales background.You don't need a flashy or overly detailed resume. Clarity and relevance win every time.Nurses, PTs, and clinical backgrounds can show value by highlighting efficiency, patient outcomes, or communication skills.Keep each role on your resume to 2-4 strong points max. Don't overload it with every task you ever did.For clinical specialist roles, patient-facing skills matter more than showing sales numbers.Stop blaming your resume. If you were truly that strong of a candidate, you'd be moving forward regardless.
Whether you've already gained height or are planning your procedure, figuring out how to explain it to friends, family, or coworkers can be tricky. In this livestream, we'll break down real strategies patients use - from full honesty to creative cover stories - and help you decide what story fits your journey best.________Audio Podcast: will be posted within 24-48hrs after the stream endsTimestamps: Chapters00:00 Intro to Limb Lengthening Surgery and Patient Experiences07:44 Updates from Patients: Progress and Challenges16:55 What to Tell Others About Surgery27:35 Exploring Limb Lengthening Options30:03 Personal Experiences with Lengthening Surgeries33:01 The Controversy Surrounding Height Surgery35:59 Navigating Social Perceptions of Height40:02 Understanding the Psychological Aspects of Height Surgery42:59 The Role of Proportions in Height Perception45:59 Addressing Concerns and Risks of Limb Lengthening51:58 The Stigma and Misunderstandings of Height Surgery54:09 Personal Experiences with Pain and Support55:54 Sharing Personal Stories and Family Support56:19 Surgical Procedures and Costs57:17 Updates on Medical Devices and Market Trends59:20 Industry Pricing and Patient Awareness01:01:40 Technical Difficulties and Community Interaction01:05:06 Financing Options for Surgery01:09:40 Outro________
In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. You have maybe heard recently the UK MHRA saying that there should be a new requirement to perform Post-Marketing Surveillance for Medical Devices in the UK. So what this means? Who is impacted? How to comply? Listen to this episode. Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body offering ISO 13485, MDSAP and CE conformity assessment to medical device manufacturers. She is involved in DQS's application to become a UK Approved Body and offer UKCA conformity assessment. In parallel, she interacts with DQS's international team developing accessible content to support manufacturers with the regulatory pathways and transitions. 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. - Links from the Video Claire Dyson LinkedIn: Claire Dyson | LinkedIn Blogs – 3 part series on U vs UK PMS UK PMS Regulations: Overview & Key Requirements for Medical Device Safety UK Medical Device Vigilance – Part 2: Vigilance & Reporting Requirements UK PMS vs EU MDR – Key Differences & Impact on CE-Marked Medical Devices Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass. They unpack the roles, regulations, and realities of medical device development in a heavily regulated space. From defining what actually counts as a medical device to navigating FDA classifications and global regulations, the trio offers practical insights, industry analogies, and personal war stories that make this episode as entertaining as it is educational. Whether you're in R&D, marketing, clinical, or quality, this is the episode to bookmark and share with every new hire.Key Timestamps02:20 – What counts as a medical device? Intended use and labeling06:48 – Differentiating roles: Quality, Regulatory, Clinical, R&D, and Marketing15:40 – Understanding regulatory bodies: FDA, EU MDR, Health Canada, and more20:15 – FDA Classifications: Class I, II, III, and what determines risk26:00 – Standards to know: ISO 13485, 14971, 14155, 21 CFR Part 82033:05 – FDA pathways: 510(k), De Novo, PMA – when and why they apply41:55 – The design control matrix explained (User Needs through Validation)49:00 – Reverse engineering design controls: pitfalls and best practices55:30 – Clinical trials vs. preclinical studies: When each is required1:00:45 – Manufacturing & supplier controls: operations meets compliance1:04:15 – Final advice for MedTech newcomers: Read the regs and know the problemQuotes“Just because you don't call it a medical device doesn't mean the FDA agrees with you.” – Sarah AdamsThis quote highlights a key regulatory pitfall: your marketing claims, not just your label, determine if the FDA considers your product a medical device.“A 510(k) is like someone checking your wristband at the door—you're cleared to go in. A PMA? That's a locked door and you need full approval to enter.” – Chris RushA memorable analogy that demystifies the difference between FDA clearance and approval pathways.Top TakeawaysLabeling + Intended Use = Regulatory TriggerWhether it's software or a simple tool, if your product makes medical claims or supports medical decision-making, it may fall under FDA or other international regulatory oversight.Regulatory Pathways Are Tied to Risk and NoveltyKnow the difference between a 510(k), De Novo, and PMA. Class II “me-too” devices may avoid clinical trials, while Class III and novel devices usually require significant evidence.Understand Design Controls EarlyReverse-engineering documentation late in development is risky and inefficient. Start early with user needs and build forward through the five pillars: inputs, outputs, verification, and validation.Cross-functional Understanding Prevents Compliance GapsMarketing, clinical, and R&D all influence regulatory standing. Even social media likes can trigger off-label scrutiny—every department needs to understand their regulatory impact.Reading Regulations Is Not OptionalA strong regulatory foundation is key to faster development, better audits, and smoother market access. Resources like 21 CFR Part 820 and ISO 13485 are surprisingly readable and essential.References & ResourcesEtienne Nichols on LinkedInChris Rush on LinkedIn
From Burnout to Boundaries: The Mindset Shift That Helps You Thrive If you've ever said, “I just need to get through this week…” — this episode is for you, my high-achieving friend. Burnout isn't just exhaustion — it's often hidden behind achievement. In this episode, I'm pulling back the curtain on:
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Vicky Demas, CEO of identifeye HEALTH (formerly Tesseract Health), who's leading the company's efforts to democratize access to retinal imaging. Using advanced algorithms and automated systems, identifeye's technology captures and analyzes retinal images to detect early signs of disease.Before joining identifeye HEALTH, Vicky led new product development at GRAIL, supporting the creation of the company's multi-cancer early detection test (Galleri). She was also a founding member of Google Life Sciences (later Verily) within Google [x], where she led teams focused on diagnostics, medical devices, and translational laboratory science. An engineer and scientist, Vicky holds over 20 patents and has authored numerous scientific publications across multiple disciplines.In this interview, Vicky challenges founders to consider: Are you building a diagnostic solution that can scale globally or a product limited to specialized healthcare settings? She also discusses why understanding real-world implementation challenges early can prevent costly missteps later.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Vicky Demas.
In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career professionals. The tips include: publishing early to build visibility, understanding how industry regulations and processes work, developing interdisciplinary skills, and finding mentors for guidance. Subhi emphasizes the importance of learning for its own sake and seeking out diverse experiences to enhance one's career prospects in the highly regulated field of bioengineering.00:00 Introduction and Purpose of the Episode00:36 Tip 1: Start Publishing Early04:26 Tip 2: Learn How Industry Really Works06:14 Tip 3: Build Skills Across Disciplines09:00 Tip 4: Find Mentors and Network12:08 Conclusion and RecapSubhi Saadeh is a Quality Professional and host of 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.
In the past on the podcast, we've explored health-tech and medical devices leveraging next-generation technologies to improve outcomes, including innovations in heart health, neuro-tech, and deep tech like AI and Machine Learning. While advancements like Brain Computing Interfaces show promise, we're not there yet. Today's devices and technologies focus on enhancing quality of life now, while innovators pave the way for the future.In today's episode we discuss devices and technologies shaping the present and future for individuals with mobility challenges, a growing societal issue as aging demographics rise in developed countries. With 500-700 million people globally affected by mobility issues—such as fall risks, fatigue when walking, or difficulty transitioning from sitting to standing—these trends carry significant economic, healthcare, and workforce impacts. How can addressing mobility issues make a difference?Listen in with us as we discuss all of this and more with Rick Sherak, an Air Force Veteran and seasoned Executive Leader in the Medical Devices, Biotech, and Diagnostics Space who is currently the CEO of Exokinetics, a mobility technology company dedicated to revolutionary advancements in the mobility industry and the continued development of life-changing products to help restore the full range of movement, independence, and a healthier lifestyle for those who struggle with diminished mobility. Invented by Hall-of-Fame and Oscar winning Steadicam creator Garrett Brown and partners, the Zeen®, Exokinetic's core offering, is a state-of-the-art upright walking mobility device designed for those who are at risk of falling, tire easily when walking, and want to move from sitting to standing independently without assistance.Other insights range from how innovations showcased in the movie Rocky ultimately played a role in shaping the future of health and wellness, to best practices for establishing relationships with the US Department of Veteran Affairs, to how mobility is one of the core pillars as we enter the Age of Longevity.For more details visit TechLink Health on the web or connect with Rick on LinkedIn.This episode was hosted by Dr. Sarah Samaan.The episode points to several references with links below:
In this episode, I sit down with my dear friend and Flowpresso founder, Desiree De Spong, for a deep dive into the lymphatic system—and why it's the secret key to modern health. We explore how Flowpresso evolved from a wild idea to a game-changing class 2 medical device, how mechanical compression mimics the body's own fluid dynamics, and why heat, pressure, and vibration can completely reset your nervous system.We unravel the myths around cancer and lymphatic drainage, discuss why chronic stress is the true pandemic, and celebrate the simple acts of grounding, breathing, and reconnecting to your body's natural rhythms. This conversation is rich with gems for anyone looking to heal faster, age gracefully, and thrive in a world that often pulls us away from ourselves.HIGHLIGHTS[02:59] - Why Desiree created Flowpresso: solving for scarcity in lymphatic care[06:54] - Debunking the myth: does lymphatic drainage spread cancer?[11:57] - How Flowpresso's compression system mirrors true lymphatic flow[14:05] - The magic of overlap: why bladder design matters for real drainage[17:18] - Why we push fluid to the heart: the importance of the terminus[19:18] - How gentle heat enhances lymphatic, vascular, and cellular health[21:33] - The FlowVibe tool: facial lymphatics made simple and effective[28:51] - Why daily lymphatic support is essential in today's toxic world[35:38] - Chronic stress: the biggest driver of disease you might be missing[41:45] - Measurable change: shifting fluid from extracellular to intracellular[45:56] - How lymphatic drainage supports wound healing and post-surgical recovery[49:47] - Physical therapy, athletic performance, and the future of healing[53:35] - Why Flowpresso became an FDA Class 2 Medical Device[57:43] - Trauma, memory, and why holding space matters in healing sessionsCONNECT WITH DESIREE DE SPONG + FLOWPRESSOWebsite: https://flowpressousa.com/Instagram: https://www.instagram.com/flowpresso/UPGRADE YOUR WELLNESSBeam Minerals: http://beamminerals.com/beautifullybroken(Use Code: BEAUTIFULLYBROKEN for Discount)Silver Biotics Wound Healing Gel: https://bit.ly/3JnxyDD (30% off)(Use Code: BEAUTIFULLYBROKEN for Discount)StemRegen: https://www.stemregen.co/products/stemregen?_ef_transaction_id=&oid=1&affid=52Code: beautifullybrokenLightPathLED https://lightpathled.pxf.io/c/3438432/2059835/25794Code: beautifullybroken CONNECT WITH FREDDIE Check out my website and store: (http://www.beautifullybroken.world) Instagram: (https://www.instagram.com/beautifullybroken.world/) YouTube: (https://www.youtube.com/@BeautifullyBrokenWorld)
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comVeteran-turned-medical device rep Edward Dix joins the show to share his story of breaking into orthopedics, transitioning to diagnostics, and launching RepPrep.ai. An AI-powered pre-call tool for sales reps. Topics include military-to-sales transitions, trauma and ortho grind, rep relocation, growing territories, how diagnostics differ from ortho, how RepPrep works, real-life impact on patients, and putting reps first in tech.Key Takeaways
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.comVeteran-turned-medical device rep Edward Dix joins the show to share his story of breaking into orthopedics, transitioning to diagnostics, and launching RepPrep.ai. An AI-powered pre-call tool for sales reps. Topics include military-to-sales transitions, trauma and ortho grind, rep relocation, growing territories, how diagnostics differ from ortho, how RepPrep works, real-life impact on patients, and putting reps first in tech.Key Takeaways
In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. You will see in this episode that some elements will be similar to registration in EU or US but you will also see a lot of differences. We will also talk about cost for the registration and you will see how this is affordable. Who is Adam Isaacs Rae? Chartered quality professional with a Master's Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management. 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. Link Adam Isaacs Rae LinkedIn: https://www.linkedin.com/in/adam-isaacs-rae/ https://theotherconsultants.substack.com/p/register-your-medical-device-in-malaysia Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets. From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep shares real-world insights for MedTech companies developing their global market strategies. Learn why early planning for reimbursement is just as crucial as regulatory approval, and how future-proofing your strategy against political and economic changes can safeguard your device's success.Key Timestamps:00:00 – Intro and Sponsor Message (Greenlight Guru Quality)02:30 – Why Reimbursement Must Be Considered Early07:15 – US Reimbursement System: Medicare, Medicaid, and Private Insurers13:10 – EU Reimbursement: Challenges with Fragmented National Systems17:45 – Asian Market Differences: Japan, China, and South Korea23:20 – The Importance of a Reimbursement Expert28:05 – Navigating Political Changes in Global MedTech Markets33:30 – Special Challenges for AI and Software as a Medical Device40:00 – Direct-to-Consumer vs. Prescription Strategies46:20 – Integrating Real-World Evidence and Post-Market Surveillance52:00 – How Management Reviews Can Align Business and Quality Goals01:03:10 – Pros and Cons: US vs. EU Reimbursement Models01:18:20 – Final Takeaways and Closing ThoughtsStandout Quotes:"Reimbursement isn't just the final step after regulatory approval — it is a core business strategy."Why it matters: Many companies fail by not building reimbursement into their earliest development and design decisions."You can have the most innovative medical device in the world, but without a reimbursement pathway, you won't have a viable business."Why it matters: Innovation alone isn't enough; financial strategy is crucial to survival and growth.Top Takeaways:Start with reimbursement in mind: Align your product claims, indications, and market strategies with potential reimbursement pathways early.Tailor by region: US, EU, and Asian markets all have distinct reimbursement landscapes — success in one doesn't guarantee success in another.Hire jurisdiction-specific experts: Use consultants experienced in your target markets to avoid costly mistakes.Leverage post-market surveillance: Integrate real-world evidence gathering into your QMS and management reviews to support reimbursement claims.Build strategic flexibility: Political and regulatory landscapes shift — maintain backup jurisdictions and alternative market strategies.References:Etienne Nichols on LinkedInGreenlight Guru Quality Management SystemMedtech Podcast hosted by Karandeep Singh BadwalMedTech 101 Section:What is "Reimbursement" in MedTech?Reimbursement refers to how a company gets paid for a medical device after it's cleared for use. This usually involves navigating government programs (like Medicare) or private insurance, and it determines how easily hospitals, clinics, or individuals can buy and use a product.Simple Analogy: Think of it like getting a movie produced: regulatory clearance is getting your movie rated, but reimbursement is making sure theaters agree to pay you to...
How One Leader Came Out of Retirement to Transform Home Healthcare Jasper Freeman, Director of National Accounts at SC Pharmaceuticals, didn't just return to medical sales—he came back with a mission to change it. In this episode, Jasper shares how he helped launch Ferosix, a revolutionary heart failure treatment designed to keep patients out of the hospital and improve care at home. But that's just the beginning. We dive into: The untold story of Pharmacy Benefit Managers (PBMs) and their massive influence over drug pricing and access Why the insurance-sales-patient triangle is the key battleground in healthcare innovation What the U.S. can learn from other countries about lowering costs and improving care Bold reform ideas—from slashing med school tuition to rethinking drug distribution This is a rare, behind-the-scenes look at the business of healthcare, guided by someone who's lived it at the highest levels. If you're in medical sales—or trying to break in—this episode is a masterclass on what's next and how to lead the change. Connect with Jasper: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today!
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastBreaking into medical device sales, networking for success, finding mentorship, investing in yourself, handling career transitions, balancing work and family, the power of perseverance, personal growth, and lessons from sports and life experiences.Key Takeaways1️⃣ Invest in Yourself – If you're serious about breaking into medical device sales, be willing to invest time and resources into learning and networking.2️⃣ Build Strong Relationships – Networking is key. Focus on building authentic connections instead of just asking for favors.3️⃣ Stay Resilient & Patient – The process can be long and challenging, but success comes to those who stay consistent and persistent.4️⃣ Adopt a Growth Mindset – Always be willing to learn and improve. Every rejection is a lesson that can help you get better.5️⃣ Act Like the Person You Want to Become – Whether it's how you prepare, how you show up, or how you perform, start acting like the high-level rep you aspire to be.00:00 - Start01:07 - Intro02:25 - Who Is Greg Neil06:15 - Managing Blockbuster Was My Cap09:07 - Move Into Banking12:59 - Moving Out Of Banking18:26 - Finding The Program27:28 - Beginnings Of The First Interviews38:37 - How Did Know Medical Device Sales Was The Career For You41:32 - Greg's Advice To Break Into Medical Device Sales
In this episode of Nurse Converse, Shenell Thompkins is joined by Tiffany Cannon, who shares her powerful story of living with a Left Ventricular Assist Device (LVAD). At just 28, Tiffany experienced heart failure during pregnancy, leading to an emergency C-section and the life-changing decision to receive an LVAD. She opens up about the emotional toll, her return to nursing, and how her dual perspective as both a patient and nurse fuels her passion for advocacy, empathy, and patient empowerment. Tiffany's journey is one of resilience and hope, proving that heart disease is not the end—but a new beginning. >>One Nurse's Journey with LVAD (Left Ventricular Assistive Device)Jump Ahead to Listen: [02:17] Tiffany's journey to heart failure.[05:53] Heart failure diagnosis after childbirth.[09:23] Divine intervention in medical decisions.[13:25] Gratitude through life changes.[21:00] Bridging patient-nurse connection.[22:49] Advocacy and patient awareness.[26:18] Heart disease is not a death sentence.[29:09] Supporting nurses in their careers.Connect with Shenell on social media:Instagram: allonenurse_shenell TikTok: all_one_nurseFor more information, full transcript and videos visit Nurse.org/podcastJoin our newsletter at nurse.org/joinInstagram: @nurse_orgTikTok: @nurse.orgFacebook: @nurse.orgYouTube: Nurse.org
Breaking into the medical device market is more complex than just having an innovative product. The real challenge lies in understanding and navigating the intricate business landscape of healthcare. That's why we're diving into the crucial aspects of medical device commercialization, uncovering the common misconceptions that many innovators face, such as the idea that a great product will automatically find its market. In this week's episode, sponsored by Physician Growth Accelerator, we sat down with Chris Hanna, founder and CEO of Walnut Hill Medical, who brings his extensive experience in guiding medical device companies through the commercialization process in the United States. Chris sheds light on the importance of aligning product development with market needs, crafting effective business strategies, and partnering strategically with healthcare providers. We discuss the critical elements that determine whether a medical device will succeed or falter in the competitive healthcare market. What we discuss in the episode: The importance of viewing healthcare as a business and understanding its financial dynamics Strategies for medical device companies to effectively commercialize their innovations The role of comprehensive business planning in securing investment and market entry Insights into the collaboration between engineers, healthcare professionals, and business developers to ensure product viability The impact of regulatory and reimbursement challenges on the commercial success of medical devices Resources from this episode: Get the free MedTech Talk Tracks for Action Physician Growth Accelerator Walnut Hill Medical Social Media: Connect with Chris on LinkedIn Connect with Zed on LinkedIn
WBSRocks: Business Growth with ERP and Digital Transformation
Send us a textWhen evaluating the top ERP systems for the medical device industry, it's essential to recognize the wide range of business models that fall within this sector, from biotech startups to large-scale manufacturers of capital equipment and consumables. This ranking focuses strictly on the ERP solutions themselves—independent of the companies behind them—and considers their applicability across organizations of all sizes. Since ERP requirements differ significantly depending on a company's scale, regulatory obligations, and operational focus, the commentary accompanying each system is critical in helping businesses determine fit. For example, a biotech firm may prioritize robust compliance and research support, while a consumables manufacturer might seek high-efficiency production and traceability. As such, a top-ranked ERP solution may not be universally ideal, but rather excels in particular areas like scalability, automation, or compliance. Choosing the right system involves aligning these strengths with your specific business needs, ensuring the ERP not only supports current operations but is also capable of adapting to future growth and industry demands.In this episode, our host Sam Gupta discusses the top 10 medical device ERP systems in 2025. He also discusses several variables that influence the rankings of these medical device ERP systems. Finally, he shares the pros and cons of each medical device ERP system.Background Soundtrack: Away From You – Mauro SommFor more information on growth strategies for SMBs using ERP and digital transformation, visit our community at wbs. rocks or elevatiq.com. To ensure that you never miss an episode of the WBS podcast, subscribe on your favorite podcasting platform.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comBreaking into medical device sales with a sales background, the truth about B2B experience, understanding the hiring process, making your resume stand out, interview challenges and how to overcome them, learning to sell to surgeons, why confidence alone isn't enough, how to position yourself against the competition, and strategies to speed up the hiring process.Key Takeaways:1️⃣ If you have sales experience but aren't getting hired, it's not just your resume—it's how you position yourself. Make sure you're showing how your experience translates into medical device sales.2️⃣ Hiring managers invest heavily in new hires. They want the best candidate, not just someone with experience. Show them why you are the best fit.3️⃣ Just listing numbers on your resume isn't enough. Use percentages to demonstrate real growth and impact to catch hiring managers' attention.4️⃣ Stop focusing on what you did and start talking about what you're doing now to break into medical sales. Employers want to see proactive effort.5️⃣ Being coachable is more important than being experienced. If you keep hitting a wall, it's time to rethink your approach and be open to learning.00:00 - 01:02 - Intro04:11 - Show Numbers With Growth Whitin Your Resume08:03 - Relate Your Previous Experience To Medical Device Sales11:12 - Keep Your Ego In Check18:34 - Be Open To Continue Learning
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