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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 8.5 weeks, earning $105,502 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
Episode 313 hosts Dr Konstantin Frank (Aesthetic Doctor from Regensberg, Germany) In our ‘Masterclass Series' we host global experts to teach us about fillers, bio-stimulators, bio-remodellers, polynucleotides, exosomes and other products. (For toxin insights, check out our other mini-series, ‘The Tox Talks') In Chapter 9 we do something different by discussing the entire range of fillers made by Croma. We learn about who Croma are, get an understanding about their portfolio of products and what features to look out for when choosing a filler. 00:00 Introduction to Inside Aesthetics 00:46 Live from the Fresh Life Conference 01:08 Masterclass Series: Fillers Discussion 02:22 Introducing Dr. Konstantin Frank 03:44 Exploring the Aesthetic Industry in Europe 05:59 Dr. Konstantin's Background and Journey 10:05 Deep Dive into Croma Fillers 20:37 Manufacturing Insights and BDDE Discussion 27:30 Croma Fillers: Unique Selling Points 29:23 Differences in Syringe Design Between Europe and Australia 29:51 Colour Coding and Safety in Injectables 30:05 Regulatory Approvals and Quality Control 30:48 Medical Devices vs. Drugs: A Legal Perspective 31:28 Minimally Invasive Procedures and Safety 31:48 Using Croma Products: A Detailed Guide 34:21 Tips for Practitioners Using New Products 36:59 The Importance of Proper Training and Education 37:19 The Role of Anatomy in Successful Injections 47:08 The Impact of Social Media on Aesthetic Medicine 51:27 Global Perspectives on Aesthetic Practices 56:29 Concluding Thoughts and Future Episodes NEW - WATCH THIS EPISODE ON YOUTUBE NEW - OR WATCH THIS EPISODE ON SPOTIFY CHECK OUT OUR PATREON & GET A 7 DAY FREE TRIAL ACCESS THE IA OFFER MENTIONED IN THIS PODCAST (& use the discount code IA10) CLICK HERE IF YOU'RE A BRAND OR COMPANY & WANT TO WORK WITH US CLICK HERE TO APPLY TO BE A GUEST ON OUR PODCAST CONTACT US
Sales legend and trainer Steve Gielda—co-founder of Ignite Selling—joins Samuel to break down what truly drives performance in medical device, pharma, biotech, and diagnostics. Steve traces his path from selling 3M copiers out of a van to leading life-sciences consulting with Neil Rackham (of SPIN Selling) and building Ignite's simulation-based, gamified training that accelerates pipelines and product launches. We get tactical fast: how today's top reps think strategically, map real stakeholders (beyond the “friendly” contacts), and use smarter questions that challenge clinical and business assumptions—not just needs. Steve explains when SPIN still shines, where Challenger-style questions raise the bar, and why role-playing strategy is as critical as role-playing the call. For frontline managers, Steve lays out the playbook: coach early in the pipeline, ask more than you tell, know when to sell vs. when to coach, and—yes—let your reps fail on safe calls so they learn to win without you. We dive into work ethic vs. knowledge, turning average reps into top performers, and the signals that a high producer is (or isn't) ready for leadership. If you want practical frameworks to sharpen your questioning, focus your account strategy, and elevate your team's coaching culture, this episode delivers candid insights you can apply on your very next call. Connect with Steve: 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!
bersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals for evidence. In this article (based on the podcast episode), we explore: How to prepare cybersecurity documentation for audits and inspections Building post-market processes for vulnerability handling and reporting Linking cybersecurity with standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001…) Managing supplier and open-source component risks Implementing and maintaining an SBOM Key trends like the NIS2 Directive and the EU AI Act
The University of Galway is leading three new projects that aim to make medical treatments safer, faster and more effective after researchers secured the support of one of Europe's most prestigious funding programmes. The awards were made by the European Commission's Marie Sklodowska Curie Actions-Doctoral Network programme (MSCA DN), as part of Horizon Europe 2020. The programme supports researchers to become future leaders while investing in the University of Galway projects to improve lives and pave the way for better, more affordable healthcare. The network also provides training to make the researchers more creative, entrepreneurial and innovative, boosting their employability in the long term. One University of Galway project has an emphasis on sustainability and a move away from animal testing for brain disease; a second is looking at cardiovascular issues, specifically around improving heart stent durability and longevity; and a third seeks to advance equity, diversity and inclusion in clinical trials. Professor Fidelma Dunne, Director of the Institute for Clinical Trials at the University of Galway, said: "These projects show how research can make a real difference in people's lives. University of Galway is proud to be leading the way in creating smarter, safer, and more sustainable healthcare solutions." Professor Ted Vaughan, Interim Director of the Institute for Health Discovery and Innovation at the University of Galway, said: "These projects exemplify the mission of our new Institute - to accelerate fundamental and applied understanding of disease and enable disruptive solutions to health-based challenges. By combining cutting-edge science with collaborative training, we are not only advancing medical technologies but also shaping the next generation of research leaders. This investment from the European Commission underscores the importance of innovation that is ethical, inclusive, and focused on improving patient outcomes across society." The University of Galway projects funded by the Marie Sklodowska Curie Actions-Doctoral Network are: Dr Mihai Lomora leads the €4.2 million CerebroMachinesTrain Doctoral Network research project - Smarter Drug Delivery for Brain Diseases. Using advanced 3D brain models that mimic real brain tissue, the project will test tiny machines which are being developed to bring medicine exactly where it is needed. It avoids animal testing, making research faster, more ethical, and more accurate. Dr Lomora is a Lecturer and Principal Investigator in Bio(material) Chemistry at the University's School of Biological and Chemical Sciences in the College of Science and Engineering and a Funded Investigator at CÚRAM - the Research Ireland Centre for Medical Devices. This network project involves 14 partners from eight countries, including the US. Four PhD students will be supported through the project at the University of Galway. Dr William Ronan leads the €2.71 million MEDALLOY research project - Stronger, Safer Materials for Life-Saving Devices. It focuses on making materials used in minimally invasive medical devices - like stents and heart valve supports - stronger and longer lasting. Dr Ronan is a Lecturer and Principal Investigator in Biomedical Engineering at the University's College of Science and Engineering. The project includes partners from six countries - the US, Ireland, Italy, Germany, Czechia and Sweden. It will train nine PhD students, who will spend at least half of their time working directly in industry, earning hands-on skills ranging from material science to patient care. Dr Eimear Morrissey leads the €4.4 million EDICT research project - Advancing Equity, Diversity and Inclusion in Clinical Trials. It is a research and training network led by the Health Research Board-Trials Methodology Research Network, based at the University of Galway, which seeks to include older adults, ethnic minorities, people with disabilities, or those from lower-income backgrounds in clinica...
AJ Reiter, Growth Director at Medcrypt, joins Pathmonk Presents to discuss their mission to secure medical devices for patient safety. Medcrypt provides cybersecurity solutions for top medical device manufacturers, focusing on surgical robotics and diabetes devices, ensuring FDA compliance and secure data transit. Reiter emphasizes the role of their website in guiding customer conversations and the importance of face-to-face engagements at industry events. Learn how Medcrypt's proactive approach and thought leadership help manufacturers expedite market entry while prioritizing patient safety and data integrity.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastGot the opportunity to sit down with Dr. Brian Blackwood and discuss what he looks for in his reps. Dr. Brian Blackwood is a board-certified orthopedic expert who specializes in joint replacement of the hip and knee, including Mako SmartRobotics™ joint replacement. With extensive training in the latest joint replacement and revision techniques, Dr. Blackwood is dedicated to providing the advanced orthopedic care his patients need to get back to an active lifestyle.In addition to being Boulder's first fellowship-trained hip and knee replacement specialist, Dr. Blackwood is a nationally renowned robotic-assisted total joint surgeon. By specializing in this minimally invasive technique, he is able to reduce pain, restore mobility, and promote a quick return to normal activities for patients suffering from joint pain. Dr. Blackwood is also a certified national educator for robotic-arm assisted surgery and has trained hundreds of other providers in this technique.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastGot the opportunity to sit down with Dr. Brian Blackwood and discuss what he looks for in his reps. Dr. Brian Blackwood is a board-certified orthopedic expert who specializes in joint replacement of the hip and knee, including Mako SmartRobotics™ joint replacement. With extensive training in the latest joint replacement and revision techniques, Dr. Blackwood is dedicated to providing the advanced orthopedic care his patients need to get back to an active lifestyle.In addition to being Boulder's first fellowship-trained hip and knee replacement specialist, Dr. Blackwood is a nationally renowned robotic-assisted total joint surgeon. By specializing in this minimally invasive technique, he is able to reduce pain, restore mobility, and promote a quick return to normal activities for patients suffering from joint pain. Dr. Blackwood is also a certified national educator for robotic-arm assisted surgery and has trained hundreds of other providers in this technique.
Podcast: Error Code (LS 27 · TOP 10% what is this?)Episode: EP70: Securing Medical Devices You Might Not Have Thought to SecurePub date: 2025-09-02Get Podcast Transcript →powered by Listen411 - fast audio-to-text and summarizationHealthcare organizations are prone to the same weaknesses that any other office or manufacturing site may have. Sonu Shankar, Chief Product Officer at Phosphorus Cybersecurity, explains how the devices you might not suspect might be the ones to bring down your organization if they're not secured. That includes the printer used to print patient wristbands.The podcast and artwork embedded on this page are from Robert Vamosi, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
Medboard EUROPE Guidance on the implementation of the Master UDI-DI - MDCG 2024-14 - rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf Updated - Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf There's a significant backlog: far more applications submitted than certificates issued, especially for IVDs. Time for certification: between 13 to 18 months on average Delay due to application missing critical information and refusal due to submission outside NB scope No transparency on capacity Germany new radiation protection regulation - Start July 1st, 2025: https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Strahlenschutz/_artikel.html?nn=986770If device emit radiation and need clinical investigation in germany: Include a radiation risk assessment in your clinical investigation dossier Coordinate with Radiation protection authorities Update investigator brochure and patient information Stricter Monitoring & Reporting Impact on Timelines So stricter documentation, more authorities involved and longer approval times UK MHRA launches Route B notification pilot Clinical trials regulations rollout: https://www.gov.uk/government/news/mhra-launches-route-b-notification-pilot-as-part-of-clinical-trials-regulations-rollout - https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device Switzerland New in Swissdamed - Medical Device registration with UDI Device Module: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-mepprodukte-moeglich.html 1 july-2026 Magazine Easy Medical Device Mag - Your QA RA Magazine: https://mailchi.mp/easymedicaldevice/emdmag1 Podcast: Best 40 Medical Device Podcast - Thanks: https://www.millionpodcasts.com/Medical-Device-podcasts/ REST OF THE WORLD SaMD and/or Artificial Intelligence on the spotlight - All countries want their regulation on it: USA: PCCP - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence SFDA: Workshop September 9th: https://www.sfda.gov.sa/en/workshop/4387139 TGA: Understanding regulation of software-based medical devices: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices#samd-and-ai-medical-device-compliance SAHPRA: Regulatory Requirements of AI/ML: https://www.sahpra.org.za/document/regulatory-requirements-of-artificial-intelligence-and-machine-learning-ai-ml-enabled-medical-devices/ Medical Device or Wellness device - Choose your side: https://www.sfda.gov.sa/sites/default/files/2025-08/MDS-G027.pdf
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Christopher Haig, co-founder and CEO of Efemoral Medical. Efemoral is developing bioresorbable scaffold technology for peripheral arterial disease. Chris has over 25 years of experience in cardiovascular devices, holding leadership roles at strategics including Guidant Corporation and Abbott Vascular, and driving growth at startups such as Calypso Medical and QT Vascular, where he built commercial infrastructure and launched multiple products ahead of its $55 million IPO.In this interview, Chris shares how bioresorbable scaffold technology found new life for peripheral arterial disease — and the lessons on matching tech to significant needs and choosing trial sites for lasting data.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 Christopher Haig.
In this episode of Let's ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in combination products—a problem that continues to create confusion and regulatory risk even in 2025.Susan emphasizes the need for alignment on terminology and regulatory expectations, highlighting that true progress requires a science- and risk-based perspective. The discussion also covers how GMP requirements are interpreted differently in pharma versus medtech, the ongoing challenges of global harmonization, and why cohesive language is essential for compliance, inspection readiness, and effective product development.Episode Chapters00:00 Introduction and Welcome00:25 The Lexicon Problem in Drug-Device Combination Products01:01 Historical Efforts and Challenges02:12 Regulatory Frameworks and Definitions04:47 Industry and Regulatory Alignment Issues06:55 Science and Risk-Based Perspectives10:08 Terminology and Definitions in Practice14:05 Global Regulatory Differences17:22 Challenges in Harmonizing Standards23:13 Key Terms and Their Impact32:23 Conclusion and Contact InformationSusan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development. Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries. She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees. Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. Susan can be reached at sneadle@combinationprod.com Subhi 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.
We're at the ACPA Annual Meeting with returning guest and CozeeCoo founder and CEO Jennifer Stelmakh. Born from her real life frustrations with medical solutions and interventions, Jennifer created CozeeCoo, a thoughtfully designed surgical recovery vest that keeps little arms safe and healing cozy while finally replacing stiff elbow restraints. Jennifer shares how the energy and collaboration at ACPA fuel her passion for innovation and community impact. Tune in as she reveals new CozeeCoo updates, what she's learned on her entrepreneurial journey, and why the annual meeting remains critical to transforming support for cleft families everywhere. Links and Resources: Patreon Subscription Tiers for Exclusive Content Our Forever Smiles Merch Store NC Cleft Mom FB Group Our Forever Smiles FB Group ______________________________________________________________________________ Today's sponsor is sienna dawn media Integrated Marketing Agency sienna dawn media is more than just a marketing agency—they are your partners in progress. Their mission is simple — to alleviate marketing bandwidth, allowing creative business owners to focus on what they set out to do: create. sienna dawn media empowers creatives to thrive without the burden of managing their own social media and marketing campaigns. So, if you're ready to set sail toward new horizons, let sienna dawn media chart the course and steer your business toward success. Visit siennadawnmedia.com.
Healthcare organizations are prone to the same weaknesses that any other office or manufacturing site may have. Sonu Shankar, Chief Product Officer at Phosphorus Cybersecurity, explains how the devices you might not suspect might be the ones to bring down your organization if they're not secured. That includes the printer used to print patient wristbands.
Company president Scott Zeitzer and COO Justin Bantuelle join host Michael Roberts to share insights on building digital ecosystems around medical devices. You'll learn what factors to consider, how to prioritize needs, and the importance of getting customer feedback every step of the way. Hosted on Acast. See acast.com/privacy for more information.
Digital Health Talks - Changemakers Focused on Fixing Healthcare
Welcome to today's episode where we have the distinct privilege of speaking with Lisa Suennen, Managing Partner of American Heart Association Ventures, who was just featured in Forbes 50 Over 50 and we couldn't be more thrilled to congratulate her on this well-deserved recognition! This honor celebrates Lisa's extraordinary impact as a true powerhouse in healthcare innovation and venture capital. With over 35 years of experience at the intersection of healthcare, technology, and investment, Lisa brings an unparalleled perspective on how we can transform healthcare delivery and outcomes. At American Heart Association Ventures, she leads a multi-fund platform that's investing in the future of healthcare across the entire spectrum—from cutting-edge medical technologies to addressing critical social determinants of health.Her career has spanned multiple dimensions of the healthcare ecosystem:Venture Capital Leadership: From her current role at AHA Ventures to previous General Partner positions at Manatt Ventures, Psilos Group, and GE Ventures, where she led the healthcare fund and served on the overall Investment CommitteeEntrepreneurial Success: Co-founded and served as CEO of CSweetener, a healthcare leadership development company that was successfully acquired by HLTH FoundationStrategic Advisory Roles: Chairs the Scientific Advisory Board of NASA's Translational Research Institute for Space Health and serves on the International Investment Committee of the ANDHealth Digital Health FundThought Leadership: Author of the widely-read Venture Valkyrie blog, internationally recognized speaker, and faculty member at UC Berkeley's Haas School of BusinessIndustry Recognition: Fellow of the prestigious Aspen Institute's Health Innovators FellowshipLisa Suennen, Managing Partner, American Heart Association VenturesMegan Antonelli, Founder & CEO, HealthIMPACT Live
When we think of medical devices and how they're built, 3D printing isn't necessarily the first thing that comes to mind. But Boston Micro Fabrication is at the cutting edge of an exciting development in how life-saving devices are prototyped and created. With the news that the FDA is pivoting away from animal testing towards 3D organoids, and with the growing need to produce miniature, intricate and high-quality devices at speed, BMF's nanometer-precise microArch 3D printing technology is opening the door to new possibilities - allowing the rapid production of equipment like stents, endoscopes, and even needles. A BMF-built catheter recently featured in a nature.com scientific report, delivering 183x higher drug concentrations for liver cancer treatment than would otherwise have been possible.We were thrilled to talk to the CEO of BMF, John Kawola, about the company's exciting work. Qualio website:https://www.qualio.com/ Previous episodes:https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastTired of hearing it's “impossible” to break in at six figures? Jacob shares the truth behind high-paying entry roles in medical device sales and why most reps are giving you bad advice. If you're aiming for a $100K+ starting salary, this episode gives you the mindset, strategy, and real-world insight to make it happen—no fluff, no excuses.00:00 - Start01:05 - When It's OK To Get Hired Under 100K04:15 - Do Your Research12:56 - Be Strategic16:27 - Expand The Expectations18:45 - Overall Advice
Dean's Chat hosts, Drs. Jensen and Richey, welcome Dr. Laura Brinker to the podcast! Laura Brinker, DPM, was previously a Vice President of Clinical Affairs at Paragon 28, where she drove innovation in foot and ankle surgical solutions. She now has a consulting firm to address advancements of medical devices, regulatory compliance, and clinical trials. With a background in Mechanical Engineering from Purdue and a DPM from Temple University, she completed her residency at the University of Louisville/Jewish Hospital. Dr. Brinker has combined private practice experience, clinical research, and engineering expertise to advance podiatric surgery and medical device development. Enjoy this entrepreneurial discussion with a young leader in our profession!
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastAlready in med device sales but stuck below six figures or feeling like you've plateaued? In this episode, Jacob challenges the industry norms and lays out exactly how reps are landing roles at $100K, $130K, even $160K+ from day one. Whether you're in an associate role or already closing deals, this is your blueprint to move up faster, earn more, and position yourself for high-leverage opportunities.00:00 - Start01:06 - When It's OK To Get Hired Under 100K04:16 - Do Your Research12:20 - Be Strategic15:51 - Expand The Expectations18:09 - Overall Advice
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Howard Rosen, co-Founder and CEO of Evident Vascular, a company developing an AI-powered intravascular ultrasound (IVUS) platform to improve vascular imaging and intervention. Before co-founding Evident, Howard held senior leadership roles at Intact Vascular and Vesper Medical, guiding both companies through successful acquisitions by Philips. He also served in executive roles at Haemonetics and BG Medicine, and spent over two decades at Boston Scientific, where he held a range of leadership positions across the peripheral and cardiovascular franchises.In this interview, Howard shares why launching right — not fast — is the key to success in medtech. He breaks down how Evident built early momentum by investing in deep market validation, engaging KOLs as true collaborators, and resisting scope creep at every turn. Howard also unpacks the company's deliberate regulatory strategy, using early FDA engagement as a tool to de-risk development. On the fundraising front, he explains why board composition matters more than valuation, and why strategic acquirers respond best to credibility, not cold outreach.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 Howard Rosen.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastWhat's the real difference between people who break into medical device sales at $60K and those who land $160K jobs straight out the gate? In this episode, Jacob unpacks what separates average from elite. From mindset to coachability to who you're listening to. If you're tired of feeling stuck or settling for less, this episode is your wake-up call.00:00 - Start01:33 - What Is Average03:48 - Develop A Healthy Circle Of People06:42 - Being Coachable09:50 - Invest In Yourself11:38 - Don't Do It All Alone14:29 - Average Thoughts vs Top Performer Thoughts
Managing Software Updates in Medical Devices: Best Practices & Pitfalls In the world of medical devices, software updates are never just technical tweaks—they directly impact patient safety, regulatory compliance, and product reliability. Managing these updates correctly is a challenge many manufacturers face, especially with evolving standards like ISO 13485 and IEC 62304. In this episode of our podcast, we dive into the critical aspects of software update management for medical devices: Versioning strategies – How to classify bug fixes, minor updates, and major releases, and the role of semantic versioning in regulated environments. Documentation & traceability – Why proper version control and documentation are essential for audits and compliance. Communication with stakeholders – Best practices for release notes, change logs, and informing users, regulators, and internal teams. Common pitfalls – Mistakes that lead to compliance risks and how to avoid them. Pro tips & resources – Actionable recommendations to strengthen your update and versioning strategy. Whether you are a software engineer, QA/RA professional, or regulatory affairs manager, this episode will give you practical tools and insights to build a robust, compliant, and audit-ready update process.
In this episode of the Medical Sales Podcast, Samuel Adeyinka sits down with Gina Torres, a nurse-turned-medical device sales professional at Johnson & Johnson, to unpack what it really takes to thrive in one of the most competitive fields in healthcare: peripheral vascular and coronary sales. Gina shares her inspiring journey from working multiple nursing jobs to consolidating her career into one life-changing role in medical device sales. She reveals how she broke into the industry, why she chose Shockwave's groundbreaking intravascular lithotripsy technology, and what makes the clinical specialist role such a powerful entry point for both clinicians and driven non-clinicians. From balancing 5 a.m. case starts to late-night procedures, Gina gives a behind-the-scenes look at the unpredictable but rewarding life of a vascular rep. She also breaks down the income potential, the skills that truly separate top performers, and why grit, empathy, and the ability to “get comfortable being uncomfortable” matter more than a clinical background. Whether you're a nurse considering the leap, a bachelor's graduate wondering if you can compete, or an aspiring sales rep curious about cardiovascular devices, this conversation delivers raw insights, career strategies, and real talk about success in medical sales. Connect with Gina: 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!
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down withTracy MacNeal, President and CEO of Materna Medical. Materna is developing two devices addressing different aspects of pelvic health: Ellora, aimed at preventing childbirth injuries during delivery, and Milli, designed to treat vaginismus, a pelvic floor condition that makes intercourse painful or impossible.Tracy is a healthcare executive and engineer with over 25 years of experience in medical devices, digital health, and women's health, including six successful transactions. In addition to heading Materna, Tracy serves on the AdvaMed Board and leads its Women's Health Equity Initiative, and was previously President of Diagnostics and Digital Health at Ximedica.In this interview, Tracy shares how clinical data enabled Materna to bridge B2B and B2C channels, and why clarity of focus is essential when commercialization paths diverge. Tracy also outlines what it takes to build in undefined markets, from aligning KOLs to publishing foundational definitions, and offers a candid perspective on what investors really want: clear financial returns, backed by a founder they trust to deliver when things go sideways.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 Tracy MacNeal.
In this thought-provoking episode of SPOT Radio, host Charlie Webb, CPPL, sits down with sustainability advocate Samantha Smith to explore the critical intersection of healthcare and environmental responsibility. Together, they unpack the growing urgency to make hospitals and clinics more sustainable—without compromising patient care or regulatory compliance. They also dive into the cultural and institutional hurdles that often slow progress, and how a possible shift towards a data-driven decision-making can open new possibilities for long-term impact.If you've ever wondered how medical facilities can reduce their environmental footprint while maintaining safety and sterility, this episode will leave you inspired—and armed with insights to make a difference.About Samantha Smith: DIRECTOR, SUSTAINABILITY AND PRODUCT STEWARDSHIPSenior MedTech leader in Sustainability, ESG, and Product Stewardship, shaping corporate strategy, securing executive alignment, and delivering measurable business and environmental impact. Selected by Medtronic's Executive Leadership Team to build and scale the first R&D function focused on Sustainability, securing $4M+ in funding. Defined and reported to investors Medtronic's first external-facing Sustainability Product and Packaging goals. Trusted voice in MedTech Sustainability, representing the company in key industry and customer forums.CAREER HIGHLIGHTSSustainability Strategy & External Reporting: Secured $4M+ in executive-approved funding to build Medtronic's first R&D function focused on Sustainability and defined external product and packaging ESG goals reported to investors, embedding ESG into product innovation and driving investor confidence.Cost Savings & Risk Mitigation: Negotiated $100M+ in Master Supply Agreements for packaging, delivering 5% year-over-year cost savings and protecting Medtronic from COVID-related supply chain price surges, saving $10M+.Operational Excellence & Circularity:Integrated circularity and eco-design criteria into Medtronic's New Product Development process, advancing FY30 sustainability commitmentsSamantha Smith Email: samanthakeeneysmith@gmail.comLinkedin: linkedin.com/in/samanthakeeneysmith
MD+DI Senior Editor Amanda Pedersen breaks down the most significant mid-year trends shaping the medical device industry in this insightful episode of Let's Talk Medtech. Get her expert analysis on market developments, regulatory changes, and emerging technologies that are transforming healthcare innovation.Whether you're a medical device professional, healthcare provider, or industry investor, this episode delivers valuable insights to help you navigate the evolving medtech landscape. Subscribe for regular updates on industry news, expert interviews, and in-depth analysis of the technologies revolutionizing patient care.
What's in the air your device is giving off? When it comes to medical devices, even invisible emissions like volatile organic compounds (VOCs) can pose very real risks. In this episode, we break down ISO 18562, the standard guiding the evaluation of gas pathway emissions in medical devices, and how it plays a vital role in protecting patient health. Whether you're developing ventilators, anesthesia systems, or breathing circuits, tune in to learn how to ensure compliance, minimize emissions, and safeguard users from the inside out.Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.
The FDA has begun urging manufacturers to treat cybersecurity risk management as a material business concern. Hal Porter, Director of Consulting Services, Clearwater, speaks with Allyson Maur, Associate, McGuireWoods, about the implications of the FDA's growing focus on cybersecurity as a core component of medical device safety and financial risk and what that shift means for legal, compliance, and risk professionals. They discuss how manufacturers and providers should navigate these expectations, how legal teams can prepare for regulatory scrutiny, and how cyber risk in the device ecosystem is quickly becoming a board-level issue. Sponsored by Clearwater.Watch this episode: https://www.youtube.com/watch?v=3Y9R5kwRqeULearn more about Clearwater: https://clearwatersecurity.com/ Essential Legal Updates, Now in Audio AHLA's popular Health Law Daily email newsletter is now a daily podcast, exclusively for AHLA Premium 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/.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastMost people are using LinkedIn the wrong way and it's costing them interviews. 5 simple strategies that will help you actually land phone calls, build real connections, and get your foot in the door in medical device sales. Whether you're sending cold messages or hopping on unexpected phone calls, these tips will change your approach and improve your results.00:00 - Start01:21 - TIP 1 - Finding Connections04:20 - TIP 2 - Sending The First Message07:53 - TIP 3 - Do Not Over-Share08:38 - TIP 4 - Follow Up12:35 - TIP 5 - Prepare Questions15:49 - Free Gift
Send us a textIn this Tech Tuesday episode, Dr. Donna Brezinski, founder and CEO of Little Sparrows Technologies, joins the show to talk about the BiliHut — a portable, high-intensity phototherapy device designed to treat neonatal jaundice with both clinical effectiveness and practical usability in mind.A neonatologist by training, Dr. Brezinski explains how her clinical experiences led to the development of the BiliHut, which delivers uniform phototherapy across the baby's body while solving key issues like positioning errors, thermal regulation, and access for breastfeeding. Unlike traditional overhead lights or fiber-optic pads, the BiliHut is engineered for both hospital and home use, with versions adaptable to low-resource settings and unreliable power grids.The conversation covers the physics behind its design, recent clinical data on treatment time, and deployment strategies from rural U.S. areas to clinics in Mongolia and Burundi. Dr. Brezinski also outlines how clinicians and families in the U.S. can access the device through durable medical equipment providers, visiting nurse agencies, or hospital DME programs.More information about the BiliHut and its availability can be found at littlesparrowstech.com. Support the showAs always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below. Enjoy!
Have you ever wondered what it's really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I sit down with Adam Isaac, an industry expert who made the leap from engineering student to successful entrepreneur in the MedTech world. Adam's journey is a masterclass in career transformation. Without prior experience in Regulatory Affairs & Quality Assurance (RAQA), he navigated the complex world of compliance and built a thriving consultancy business — all without traditional advertising. What you'll discover in this episode:
A medical sales rep blows the whistle on an alleged kickback scheme where he says a company bribed staff at a Veterans Affairs hospital to buy unnecessary medical devices at taxpayer expense, and use them in medically unnecessary procedures on veterans. The company and doctors dispute the allegations and deny any wrongdoing.Order Sharyl's new bestselling book: “Follow the $cience.” Subscribe to my two podcasts: “The Sharyl Attkisson Podcast” and “Full Measure After Hours.” Leave a review, subscribe and share with your friends! Support independent journalism by visiting the new Sharyl Attkisson store.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
In this episode, we speak with Sarah Gebauer MD anesthesiologist and RAND Senior Researcher, who discusses the critical questions facing healthcare professionals as AI becomes integrated into clinical practice. She's the author of "Machine Learning for MDs" newsletter and published research on physician attitudes toward AI including the BMJ Evidence-Based Medicine article Survey of US physicians' attitudes and knowledge of AI. Her company Validara Health works on evaluation frameworks for healthcare AI implementation. Physicians have been using AI for EKG interpretation for decades without fully understanding the algorithms, highlighting that transparency should focus on appropriate usage rather than complete technical knowledge. Most current AI tools operate as Software as a Service rather than regulated Medical Devices, while the FDA struggles to keep pace with rapid AI development. Despite their challenging history with EHR implementation, physicians show strong interest in learning about AI when they believe it will help patients. The medical liability landscape remains uncertain until legal precedents are established through jury awards, making documentation of clinical decision-making crucial when using AI as additional information alongside other clinical data. Traditional machine learning evaluation metrics often fail to predict real-world clinical performance, where workflow integration and clinician experience prove more important than laboratory results. For professional development, busy physicians benefit most from resources that push information directly to them, such as newsletters and targeted social media follows, rather than formal courses requiring active searching. Some places to follow along with AI in healthcare: Machine Learning for MDs newsletter TLDR AI newsletter a16z healthcare If you enjoy the show, please leave a ⭐⭐⭐⭐⭐ rating on Apple or a
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Joanna Nathan, CEO and co-founder of Prana Surgical — a startup developing image-guided surgical platforms for precision oncology. Joanna's career spans translational research at Texas Heart Institute, product development at Saranas, and portfolio management at Mercury Fund and Johnson & Johnson's Center for Device Innovation. She mentors founders through her not-for-profit organization Enventure and teaches entrepreneurship at Rice University's Jones School of Business.In this interview, Joanna shares her framework for evaluating which medtech ideas merit pursuit, revealing three critical signals every founder should look for: clinical urgency that requires no convincing, favorable asymmetry between value and technical risk, and optimal market timing. Joanna also demonstrates how systematic grant applications and strategic resource allocation can extend runway while building investor credibility, and addresses the unique psychological challenges of building life-critical devices.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 Joanna Nathan.
Leaving medication in a hot car for extended periods of time can make them less effective or potentially dangerous.
VALUE FOR VALUE Thank you to the Bowl After Bowl Episode 397 Producers: ChadF, Kevin S, cottongin, harvhat, boostein berge, cbrooklyn, Boolysteed, makeheroism, ericpp Play games SUNDAY with Hyper SpaceOut at 6 p.m. Central SirSpencer & Lavish join SirSeatSitter for ABS N' A 6-PACK FRIDAY August 8 @ 4 p.m. Central Tune in to Oystein Berge's Mutton, Mead & Music: The Hundredth Addition featuring DuhLaurien & Mary-Kate Ultra as special guests Check out the latest entry on The Great Unthinking Intro/Outro: EVA - 失望した GET FREE STICKERS! Send a self-addressed envelope to PO Box 410514 Kansas City, MO 64141 FIRST TIME I EVER... Tonight, Bowlers called in to talk about the first time they ever learned a song to play. Next week, we want to hear about the First Time YOU Ever listened to a cassette. TOP THREE 33 33 more Palestinians killed in Israeli airstrikes in war-torn Gaza (Anadolu Ajansi) Ben-Gvir's visit to Jerusalem holy site sparks tensions as Israeli fire kills 33 seeking aid (The Associated Press) Maui brush fire burns 33 acres (Maui Now) 'Pepsi Girl' turns 33: August 2 (Oregon Live) SiriusXM reports drop to 33 million paid subscribers, strength in podcasting (Hollywood Reporter) BEHIND THE CURTAIN The Board of Immigration Appeals ruled people fighting removal after being convicted on state drug charges have the burden of proving the state statute is broader than federal law to avoid deportation DEA promotes article linking weed to depression, suicidal ideation (Get Smart About Drugs) Trump signs executive order targeting funding for safe consumption sites (White House) ScottsMiracle-Gro CEO speaks to Trump about legalization (Fox BUsiness) Glass House Brand provides updates to ICE raid (Globe Newswire) Minnesota dispensaries open without inventory (FOX) 150 New York pot shops could be shut down (Fox) Texas DA Sarah Stogner smokes joint live on TikTok to protest THC-ban legislation (LinkedIn) German Federal Institute for Drugs and Medical Devices issues first-ever approval for compassionate use of psilocybin in the European Union (Open PR) METAL MOMENT Tonight, DuhLaurien brings THEM TEETH. with Gods and Monster Trucks Please send moving karma to the great and powerful RevCyberTrucker! ON-CHAIN, OFF-CHAIN, COCAINE, SHITSTAIN Clark Moody Dashboard Tornado Cash jury still deliberating (Bitcoin Magazine) SEC's Peirce defends transaction privacy as Tornado Cash verdict looms (CoinTelegraph) Man who lost 8K Bitcoin now worth $900 million wants to tokenize entire in bid to assert claim on dumped fortune (Yahoo Finance) KC Bitcoiners' coffee meetup at Maps at 8:30 a.m. FRIDAY FUCK IT, DUDE. LET'S GO BOWLING! Radioactive wasp nests found at SC Cold War-era US nuclear bomb site (KTLA) Bat flies into woman's mouth in Arizona, costs nearly $21k in medical bills (NBC) Dildo thrown on court during final moments of WNBA game (New York Post) Denmark zoo asks people to donate small pets as food for captive predators (AP) Parents given deceased son's brain by funeral homes, lawsuit alleges (AP) Matt Rife, Elton Castee buy Warren Occult Museum (FOX) Brazilian woman found dead with 26 iPhones glued to her body (Dangerous Minds) Archaeologists keep finding massive shoes at an ancient Roman fort - and they have no idea why they're so big (Smithsonian Magazine) Seattle Kraken's mascot attracts bear (Twitter) How Goose the water monitor lizard was caught 2 weeks after escaping Massachusetts home (NBC)
In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanger Ali of BSI to unpack the evolving landscape of cybersecurity in medical devices. Together, they explore the latest FDA and EU guidance, the growing expectations for connected device security, and the top gaps companies face when bringing products to market. From threat modeling and SBOMs to legacy device challenges and global regulatory alignment, this episode offers practical insights for MedTech developers navigating today's complex cybersecurity requirements. Whether you're launching a new device or updating an existing one, this conversation is packed with actionable advice to help you stay secure and compliant.
This episode offers a "biocompatibility brief" with guest Marina Daineko, a MedTech expert and chemist specializing in biological evaluations. Marina shares her perspective on the critical role of chemistry and critical thinking in assessing the safety of medical devices. The discussion highlights the need to look beyond simple pass/fail tests and delve into the nuances of raw data analysis, material composition, and manufacturing processes to uncover potential risks.Marina emphasizes that biocompatibility is not an isolated task but must be fully integrated into a company's quality management system (QMS). She explores the connection between biological safety and key QMS processes such as change management, post-market surveillance, and CAPA. The conversation also touches on the shift from a reactive to a proactive mindset in the industry, driven by new regulations like the latest revision of ISO 10993-1.Using real-world examples, Marina illustrates the importance of considering long-term patient exposure and cumulative effects. She provides clear explanations of complex concepts like the difference between extractables and leachables. Her advice to MedTech professionals is to always be curious, ask questions, and prioritize communication across all teams to ensure the safety and efficacy of medical devices.Key Timestamps01:37 - Importance of a Biological Evaluation Plan and in-depth data analysis03:48 - The need for critical thinking in biocompatibility, highlighted by the silver ion example06:03 - How a chemistry background informs a deeper understanding of materials08:06 - Real-world examples of biocompatibility risks from the Netflix documentary, The Bleeding Edge11:20 - Discussion on cumulative effects and long-term exposure to materials12:56 - Applying a risk-based approach beyond standard tables15:39 - The difference between extractables and leachables18:18 - Integrating biocompatibility into the QMS (change management, CAPA, post-market surveillance)22:01 - The shift from reactive to proactive biocompatibility approaches23:55 - How to explain complex biocompatibility concepts to non-technical teamsQuotes"Biocompatibility is not a bubble. It must be integrated into the quality management system." - Marina Daineko"Don't be shy and ask the questions. Stay curious... and communicate." - Marina DainekoTakeawaysGo Beyond the Checklist: A biological evaluation plan and critical thinking are essential. Don't rely solely on standard pass/fail tests; analyze raw data and question unexpected results, as seen in the silver ion example.Assess Cumulative Risk: For long-term or implanted devices, consider the cumulative effect of chemicals that may leach from the device over time. Proactive risk management should account for this long-term exposure.Integrate Biocompatibility into the QMS: Biocompatibility should not be treated as a standalone task. It must be integrated with core QMS processes like change management, CAPA, and post-market surveillance to ensure continuous device safety throughout its lifecycle.Communicate Across Teams: Effective communication is paramount. Technical biocompatibility information must be translated for different teams—from regulatory and quality to marketing and sales—by highlighting the impact on deadlines, compliance, and patient safety.ReferencesNetflix Documentary, The Bleeding Edge: A documentary that exposes systemic flaws and risks within the medical device industry, featuring the case of the Essure device.ISO 10993-1: The international standard for the biological evaluation of medical devices, which is undergoing revisions to emphasize a lifecycle-based approach to safety.Etienne Nichols' LinkedIn: For more...
John Golden's Linkedin: https://www.linkedin.com/in/goldenjohn/Vital Neuro Linkedin: https://www.linkedin.com/company/vital-neuroChris Hoyd's Linkedin: https://www.linkedin.com/in/chrishoyd/ John Golden is the CEO of Vital Neuro. He has considerable experience in operational and technology leadership, and led the successful exit from EXOS, a previous company he founded and built, prior to joining Vital Neuro 7 years ago. John has spent his career dedicated to making high quality complex technologies into simple consumer products that people can use, and uses the Vital Neuro technology himself 3-4 times per day to stay on top of his game. John has led the company through the clinical development all the way to reality as a consumer facing product, with a guiding principle that neurofeedback technology should be as easy to use as regular headphones. Product in Healthtech is community for healthtech product leaders, by product leaders. For more information, and to sign up for our free webinars, visit www.productinhealthtech.com.
Sheila Buswell is the CEO and Co-Founder of Buswell Biomedical, a veteran of the US Army, and the author of Is This Seat For Me? Overcoming Imposter Syndrome in Everyday Life and Business. In her book, Sheila shares her personal experiences overcoming sexism in engineering and tech and dealing with impostor syndrome, as well the stories of a diverse group of accomplished individuals who struggled with self-doubt but found ways to overcome it. She hopes to help others who feel limited by their beliefs experience more freedom and realize they are enough.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Greg Lipschitz, CEO of Firefly Neuroscience. Firefly's FDA-510(k) cleared Brain Network Analytics (BNA™) technology objectively measures brain function through EEG analysis. With a proprietary database spanning twelve cognitive disorders, the company serves both clinical practitioners and pharmaceutical partners.Greg brings extensive experience in private equity, investment banking, capital markets, and finance to his leadership role. As Managing Director of Old Stone Advisors and former Vice President of Lazer Capital, Greg has advised on over $1 billion in transactions. He is a Chartered Financial Analyst.In this interview, Greg shares insights on strategic fundraising approaches, platform prioritization decisions, and building commercial momentum in healthcare through direct sales and customer feedback loops.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 Greg Lipschitz.
Everything You Need to Know About EU Regulation 2025/1234 and the Future of eIFU for Medical Devices On July 16, 2025, a pivotal regulatory update—EU 2025/1234—comes into effect, expanding the use of electronic Instructions for Use (eIFU) to a much broader range of medical devices and accessories. Unlike previous regulations that limited eIFU to implantables or certain fixed devices, this amendment now authorizes the use of eIFU for all professional-use medical devices, including those covered by transitional provisions and even non-medical products listed under Annex XVI. This shift marks a turning point in the digitization of compliance documentation in the medical device industry. In this video, we walk you through the full impact of the new regulation, as well as the operational benefits and responsibilities that come with adopting eIFU.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Maulik Nanavaty, CEO of Anumana. Anumana, an AI-driven health technology company focused on cardiovascular care, is taking a pragmatic approach to scaling AI in medicine.Maulik is a seasoned healthcare executive with over 30 years of global experience in the medical device industry. He spent 18 years at Boston Scientific, where he led its $1B+ Neuromodulation division and served as President of Boston Scientific Japan. Prior to that, he held leadership positions at Baxter. Known for driving innovation in implantable and artificial intelligence (AI)-powered technologies, Maulik also serves on the board of Rani Therapeutics.In this interview, Maulik shares why building a strong risk-benefit case and designing around real-world clinician needs are key to adoption. With data from over 20 million patients and a focus on transparency, Anumana is reshaping how AI reaches the point of care.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 Maulik Nanavaty.
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastKendy Elmore is the founder of The Lobby Medical Sales Network, a nationwide online community that connects reps through networking, mentorship, and career growth opportunities. He talks about building community, staying consistent when no one's watching, and why the relationships you build today might unlock doors years down the line. If you're thinking long game in this industry, Kendy's story will change how you approach the process.Key TakeawaysYour dream role probably won't show up in month one. Stay consistent with your outreach, your networking, and your mindset, even when no one is responding.The more reps you put in now, the more leverage you'll have later. Opportunities open up when preparation and timing collide.Don't just connect, contribute. Add value when you network. Show up with something helpful or interesting, not just a pitch.Invest in relationships without expecting something in return. The people who remember you are the ones you didn't try to sell to right away.Build your own brand while you're job hunting. Whether it's content, conversations, or just showing up authentically, your name should mean something before you walk into an interview.The Lobby Medical Sales Network can be a solution for reps who feel stuck trying to network alone. It gives you direct access to a supportive community, real conversations, and connections that actually lead somewhere.00:00 - Start02:09 - Who Is Kendy Elmore10:13 - Founding The Lobby Medical Sales Network16:41 - What Is The Lobby Medical Sales Network20:12 - Benefits Of The Lobby vs LinkedIn32:36 - Kendy's Advice To Newcomers In Medical Device Sales35:03 - Follow Kendy & The Lobby Medical Sales Network
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastKendy Elmore is the founder of The Lobby Medical Sales Network, a nationwide online community that connects reps through networking, mentorship, and career growth opportunities. He talks about building community, staying consistent when no one's watching, and why the relationships you build today might unlock doors years down the line. If you're thinking long game in this industry, Kendy's story will change how you approach the process.Key TakeawaysYour dream role probably won't show up in month one. Stay consistent with your outreach, your networking, and your mindset, even when no one is responding.The more reps you put in now, the more leverage you'll have later. Opportunities open up when preparation and timing collide.Don't just connect, contribute. Add value when you network. Show up with something helpful or interesting, not just a pitch.Invest in relationships without expecting something in return. The people who remember you are the ones you didn't try to sell to right away.Build your own brand while you're job hunting. Whether it's content, conversations, or just showing up authentically, your name should mean something before you walk into an interview.The Lobby Medical Sales Network can be a solution for reps who feel stuck trying to network alone. It gives you direct access to a supportive community, real conversations, and connections that actually lead somewhere.00:00 - Start02:09 - Who Is Kendy Elmore10:13 - Founding The Lobby Medical Sales Network16:42 - What Is The Lobby Medical Sales Network20:12 - Benefits Of The Lobby vs LinkedIn32:36 - Kendy's Advice To Newcomers In Medical Device Sales35:04 - Follow Kendy & The Lobby Medical Sales Network
This week, Michelle reflects on 19 years in medical device sales — and shares the powerful mindset shifts that helped her thrive in a high-pressure, fast-paced, often male-dominated industry. Whether you're in healthcare sales, medical device, pharma, or any high-performance career, this episode offers essential tools to help you reduce burnout, trust yourself more, and do more of what actually matters. Inside this episode: The real truth about long-term success in medical sales Why self-trust is your greatest asset How perfectionism and people-pleasing keep you playing small A neuroscience-backed look at how to retrain your brain for success The difference between burnout and boundaries Why we need more women in sales leadership — and how you can rise without sacrificing your wellbeing Plus, Michelle shares her favorite energy alignment practices, including breathwork, identity-based habits, and redefining what self-care really means.
Professors Daniel Carpenter and Timo Minssen explore evolving pharma and medical device regulation, including the role of clinical trials, while Microsoft applied scientist Chad Atalla shares where AI governance stakeholders might find inspiration in the fields.Show notes: https://www.microsoft.com/en-us/research/podcast/ai-testing-and-evaluation-learnings-from-pharmaceuticals-and-medical-devices/
Before we get started with today's show, we want to take a moment to dedicate this episode to someone very special. Emma, Sharon's granddaughter and the daughter of today's guest co-host Michelle, was born prematurely and spent her short life in the NICU. She passed away just three days after she was born. Today's episode is released on Emma's birthday and we're honored to share it in her memory. Our guest today is a mother and former labor and delivery nurse who has become an incredible entrepreneur. Ashley Crafton joins us to share the incredible story behind her startup, Galena Innovations, and the development of the Hannah Cervical Cup, a device designed to help prevent spontaneous preterm birth. Here's some of what you'll hear in this episode:
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastShe broke into medical device sales, moved across the world, and now she's navigating the UK healthcare system. Rachel Littleton shares what it's like selling medical devices in London as an American, the steep learning curves she faced, and what no one tells you about the first year in the industry. This is for the person curious about what it takes to leap into a new career and a new country.Key Takeaways:Network with intention by reaching out to actual reps and hiring managers on LinkedIn, not just clicking apply.Expect to feel overwhelmed in your first year. It's normal, and pushing through it is part of the process.Treat every person in the clinic like they matter, because they do. Secretaries and MAs can be your biggest allies.Focus on helping patients first; the money will follow when your purpose is in the right place.If you ever get a chance to work abroad, go for it. You'll grow professionally and personally in ways you can't imagine.00:00 - Start02:24 - Who Is Rachel Littleton?08:14 - Biggest Stressors In First 6 Months As A Rep10:03 - Moving To The UK17:24 - UK Healthcare vs US Healthcare21:28 - How Different Is The Medical Sales Field In The UK vs US26:33 - Being Passionate In What You Do28:41 - Rachel's Advice For Those Interested In Medical Device Sales30:12 - Rachel's Advice To New Reps
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