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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.
Welcome back to Ditch the Lab Coat, the podcast where we break down the fascinating world of medicine with a blend of scientific skepticism and real-world insight. In today's episode, we dive deep into the mysteries of the vagus nerve—a nerve so ancient and essential, it's been called the “conductor” in the symphony of human physiology.Join host Dr. Mark Bonta as he sits down with Dr. Kevin Tracey, neurosurgeon, president and CEO of the Feinstein Institutes for Medical Research, and a pioneer in the world of bioelectronic medicine. Dr. Tracey's breakthrough research has shown us that the vagus nerve is far more than just a conduit for signals—it's a key player in managing inflammation, regulating our immune system, and maybe even shaping the future of medicine.In this conversation, you'll explore the mind-bending complexity of the nervous system, discover how cutting-edge science is redefining how we treat diseases like rheumatoid arthritis and long Covid, and learn how a tiny chip implanted in the neck might one day replace whole classes of immune-suppressing drugs. Dr. Tracey shares metaphors, straight talk about medical myths, and a vision for a future where reprogramming the body's reflexes could offer relief to millions.Get ready for a journey that's equal parts awe-inspiring and practical, as we unpack the true potential (and real-world considerations) of harnessing the vagus nerve's power. Whether you're a healthcare professional, a science nerd, or just someone searching for new answers, this episode invites you to see medicine in a whole new way. Resources : ( https://feinstein.northwell.edu/ )Episode HighlightsVagus Nerve Complexity Unveiled — We're only scratching the surface of understanding the vagus nerve's vast, intricate network and its essential bodily roles.Inflammation: Friend and Foe — Inflammation is vital short-term, but when uncontrolled, it's destructive and underlies many autoimmune and chronic diseases.Nervous-Immune System Interplay — The nervous and immune systems communicate reflexively, with nerves directly capable of controlling immune and inflammatory responses.Bioelectronic Treatments Emerge — Vagus nerve stimulation—via implanted chips—shows promise for conditions like rheumatoid arthritis without full-body immunosuppression risks.Individualized Nerve Fiber Functions — Each of the 200,000 vagus fibers controls specific functions, forming a body-wide symphony of precision responses.Not All Self-Help Fits — Lifestyle hacks can support vagus health, but serious disease often requires targeted nerve stimulation, not general wellness.Caution Against Online Misinformation — Vagus nerve advice online is often oversimplified or inaccurate; nuance and scientific backing are essential.Lifestyle Still Matters — Balanced diet, sleep, exercise, and community all help regulate vagus nerve tone and reduce chronic stress.Future Disease Applications Possible — Vagus stimulation may treat IBD, MS, and neurodegenerative or psychiatric conditions as research evolves.Episode Timestamps6:25 — Exploring Nervous System Complexity9:08 — Vagus Nerve Controls Inflammation11:05 — Vagus Nerve: Brain Signals Control Inflammation15:45 — Nervous System's Role in Immunity20:43 — Understanding Your Vagus Nerves23:25 — Vagus Nerve Health and Research25:12 — Vagus Nerve Stimulation Insights29:36 — Vagus Nerve Stimulator: Inflammation Therapy32:13 — Neurotransmitter Effects on Cytokine Production38:22 — Minimizing Nerve Damage in Surgery39:30 — Vagus Nerve Stimulation Benefits43:42 — Exploring Vagus Nerve Mysteries46:42 — Vagus Nerve Stimulation for Autoimmune Diseases50:52 — Cold Plunges & Bioelectrical Future DISCLAMER >>>>>> The Ditch Lab Coat podcast serves solely for general informational purposes and does not serve as a substitute for professional medical services such as medicine or nursing. It does not establish a doctor/patient relationship, and the use of information from the podcast or linked materials is at the user's own risk. The content does not aim to replace professional medical advice, diagnosis, or treatment, and users should promptly seek guidance from healthcare professionals for any medical conditions. >>>>>> The expressed opinions belong solely to the hosts and guests, and they do not necessarily reflect the views or opinions of the Hospitals, Clinics, Universities, or any other organization associated with the host or guests. Disclosures: Ditch The Lab Coat podcast is produced by (Podkind.co) and is independent of Dr. Bonta's teaching and research roles at McMaster University, Temerty Faculty of Medicine and Queens University.
In this episode, Etienne Nichols and Matt Stratton, Director and Principal Consultant at Coalition, delve into the dynamic and complex world of neurotechnology. They discuss the expansive definition of neurotech, the significant challenges in accelerating innovation—particularly concerning regulatory frameworks and cross-functional collaboration—and how a united industry voice can overcome these hurdles to bring life-changing devices to patients faster.Timestamps00:04 - Introduction to the episode and Matt Stratton02:21 - Matt Stratton's journey into neurotechnology and passion for acceleration04:30 - Defining neurotech beyond traditional boundaries07:11 - Major challenges preventing acceleration in neurotech10:16 - The internal and external barriers to collaboration13:40 - The "generalist vs. specialist" dilemma in neurotech expertise17:03 - Optimizing existing neurotech and the future of advanced neuroscience19:34 - What neurotech can learn from other medical device verticals22:50 - The complexity of the brain: "What is normal?"24:50 - Ethical considerations of neurotech advancements26:27 - Overcoming competitive intelligence in collaborative communities29:05 - Bridging the language gap between pharma and medical devices in neurotech31:40 - Matt Stratton's call to action for the neurotech community33:10 - Political challenges and maintaining focus on shared goalsStandout Quotes"I think the neurotech space is a bit broader than that because there are so many interrelated areas that are relying and using very similar technologies and ultimately aiming for the same patient groups...and will come across the same regulatory structures." — Matt StrattonMatt's expansive view highlights the interconnectedness of neurotech, emphasizing that a holistic approach to defining the field is crucial for effective collaboration and regulatory navigation."If what ties us together is greater than the soil we stand on, then yeah, we can remain standing together." — Etienne NicholsEtienne's profound statement underscores the power of shared purpose and patient-centric goals in transcending political and competitive barriers within the medical device industry.Top TakeawaysBroadening the Neurotech Definition: Neurotech extends beyond neuromodulation and BCIs to include neurodiagnostics, neuromonitoring, neurological drug delivery, and neurosurgical devices. This broader perspective fosters greater collaboration and addresses common regulatory and patient needs.Challenges in Acceleration: Key hurdles include complex regulatory environments, the need for increased collaboration among diverse experts (neuroscientists, biologists, engineers), and adapting to emerging technologies like AI.The Power of External Collaboration: Bringing together different industry players helps establish a unified voice for regulatory changes, benchmark best practices, and break down barriers to faster progress, especially as neurotech pushes ethical and technological boundaries.Learning from Other Verticals: While neurotech faces unique challenges, insights from established fields like orthopedics and CRM, particularly regarding rapid product development (e.g., "Moore's Law" in tech), offer valuable lessons for accelerating innovation.Navigating Complexity and Ethics: The brain's inherent complexity and the fluid concept of "normalcy" introduce unique challenges for neurotech. This includes addressing profound ethical considerations, such as the potential for enhanced human capabilities to exacerbate societal inequalities.Fostering Open Dialogue: Community platforms that focus on "mundane"
A new micro-credential course to encourage sustainability in the medtech, pharma and public sector in Ireland has been launched at University of Galway. The Green Labs initiative has been spearheaded since 2019 by Dr Una FitzGerald, Associate Professor of Biomedical Engineering in the School of Engineering and a Principal Investigator within CÚRAM, the Research Ireland Centre for Medical Devices. Green Labs develop medtech sustainability course The new 10-week microcredential programme is aimed at Ireland's extensive laboratory industry, including medtech and pharma, healthcare and science and the research sector and builds on the success and impact of the Green Labs initiative, which aims to reduce the environmental impact of laboratory practices. Dr Una FitzGerald said: "Once I took on board the considerable contribution that sustainable lab practices can make to global efforts to reduce GHGs and different kinds of waste, I felt compelled to act, because I supervise and teach many different cohorts of students. I feel I have a duty to do all possible to mitigate the climate and biodiversity crisis and feel fortunate that I am in a position to help. "As Ireland's medtech and pharma sectors continue to grow, so too does the responsibility to operate in an environmentally sustainable fashion. Laboratory testing is a crucial part of operations in these organisations, as well as for hospital and environmental testing - just think of how many lab tests are require to diagnose disease or to prove that the water you are drinking is safe. Medical device manufacturers also need lab tests to prove that implantable devices are sterile, and pharma companies use labs characterise the properties of drugs." The green labs journey commenced in 2019 with CÚRAM becoming the first laboratory in Europe certified as 'Green' by American non-profit, My Green Lab. Meeting this standard required raising awareness of the impact of lab work on the environment and prompted efforts to reduce plastic waste, energy and water usage and adopt green principles of synthetic and analytic chemistry. One fact learned was that a single ultra-low temperature freezer, used to store lab samples, uses as much energy as the average household. In 2020, Dr FitzGerald developed a course module for postgraduates on green lab principles and practice, which more than 170 students have taken to date, including online at universities in England, Scotland, Germany and Denmark. On Earth Day in 2022, Irish Green Labs (IGL) was launched by Dr Fitzgerald, in collaboration with Sustainable Energy Association of Ireland and Dublin City University to promote sustainable methods within public and private laboratories on the whole island of Ireland. The new online microcredential programme Green Labs Principles and Practice, will go further to address the lack of awareness of the impact that lab practices and behaviours have on the environment. Employees in corporate and public sector are being targeted through this course and the first 20 places are funded through Springboard. The first students enrol in September. Microcredential courses are short and accredited to meet the demands of learners, enterprise and organisations, created by Irish Universities Association (IUA) partner universities in consultation with industry and enterprise, under the MicroCreds project. Green Labs Principles and Practice will allow employees to examine how the organisation of, and practices in, scientific laboratories can be reformed to reduce their environmental footprint and be established on a more sustainable basis. The Irish Green Labs network is run on a voluntary basis, supporting more than 37 organisations within the public and private sectors, including all the higher education institutes, the Environmental Protection Agency, 10 hospitals and seven companies. Dr Fitzgerald's work in this area ultimately led to inclusion of sustainable lab practices in Taighde Eireann/Research Ireland's Climate...
In today's episode, we explore the evolving world of the Internet of Things (IoT), with a focus on its healthcare applications—IoHT (Internet of Health Things) and MIoT (Medical Internet of Things). These technologies are reshaping healthcare, personal safety, and connected care. The MIoT market is projected to grow from $93 billion in 2025 to $134 billion by 2029, while the smart hospital market may reach $148 billion. With 2.2 to 3.3 million connected medical devices already in use globally, the impact on patient monitoring, operational efficiency, and health equity is significant. While macro trends are important, we'll also highlight specific technologies making a difference every day.In past episodes, we've talked about challenges associated with an aging population and in today's episode we'll dial in and look to connect the dots with connected devices that are focused on sending medical alerts. As a quick highlight, 1 in 4 adults over 65 fall each year, which is a significant number considering that falls are the leading cause of injury-related death among adults age 65 and older. The Golden Hour is the critical first 60 minutes following an emergency event, when receiving treatment is believed to offer the greatest chances of survival.Here to talk about all of this and more is Chia-Lin Simmons, CEO of LogicMark. LogicMark provides a comprehensive platform of technology products and services that enable the Internet of Things (IoT). It provides technology products and services in healthcare communications and personal safety applications and services.Listen in with us as we discuss best practices for future-ready home health and the importance of inter-connected devices.Other insights range from how AI and ML are helping to transition from more reactive responses to more predictive responses with health-tech, to an introduction for the concept of “care villages” and how “connected data and devices” will start to virtually emulate the historical practices of multi-generational housing, to why game theory is emerging as a strategy in healthcare to balance between the various stakeholders and create winning scenarios as well as the best outcomes for patients.For more details visit TechLink Health on the web or connect with Chia-Lin on LinkedIn.This episode was hosted by Dr. Sarah Samaan.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we had a fascinating chat with Mary Lou Jepsen, founder and Chairman of Openwater, a medtech company developing breakthrough diagnostic and therapeutic wearables for cancer, stroke, mental illness, and beyond. Openwater is rethinking how medical devices are built — not as single-purpose machines, but as flexible platforms that function more like smartphones. A physicist and prolific inventor, Mary Lou holds nearly 300 patents and has launched over 50 products across VR, AR, holography, and consumer electronics. Previously, she led engineering at Intel, Facebook, and Google, taught at MIT, and now serves on the boards of Lear Corporation and Luminar Technologies. She has been named to Time magazine's list of the 100 most influential people. In this interview, Mary Lou explains why the traditional “one disease, one device” model falls short, and how her team is applying consumer electronics and open-source principles to develop scalable, software-driven tools. Backed by renowned investors including Khosla Ventures, Vitalik Buterin, and Esther Dyson, Openwater is aiming to make advanced care more accessible worldwide.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 Mary Lou Jepsen.
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/
In this episode, we chat with Sabrina Schoenborn, a mechanical engineer working at the intersection of medical design and emerging technology. From developing the world's first arthroscopic robot to her current work in quantum sensing at Q-CTRL. Sabrina shares her journey, the challenges of designing for healthcare, and how collaboration, simulation, and design thinking play a role in shaping real-world innovations.Share if you enjoy the episode; it helps us grow and bring more thoughtful conversations your way.
Dan Vukelich, President of the Association of Medical Device Reprocessors, has spent 25 years campaigning and working to encourage reuse and remanufacturing of ‘single use' medical devices, first in the USA and now in Europe and other countries. To give you a feel for the scale of this, in 2024, over 55 million single-use devices were reprocessed and reused across 17 countries in Asia-Pacific, Europe and North America. By doing that, hospitals saved the equivalent of over USD 450 million. The interest in reprocessing and reuse really took off during the pandemic, and since then, supply chain disruption has become more of an ongoing risk for hospitals. The Association of Medical Device Reprocessors (AMDR) was founded in 1999. It supports its members around regulation, legislation, and standard-setting, so hospitals and healthcare providers can increase quality, reduce cost, cut waste, lower emissions, and strengthen their supply chains. Dan explains what reprocessing includes and talks us through the categories of devices that are currently reprocessed and remanufactured. He describes how the medical sector has shifted from high-quality materials that could be easily sanitised and reused, to a situation where even very complex and expensive devices are designed to be disposed of after just one use, wasting finite and critical materials. We talk about the ethical and legal issues of reprocessing, and the role of regulations and standardization. Dan helps us understand the challenges for hospitals and how the shift to single-use has added a lot of extra costs to the health system and impacts all of us, either directly or as taxpayers. Dan also points to an important long-term trend, as more and more equipment manufacturers get involved, rather than pushing back on reuse.
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:
Medboard: https://www.medboard.com/ EUROPE new eIFU rules - Let's save some paper print: https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj https://health.ec.europa.eu/latest-updates/commission-simplifies-instructions-use-medical-devices-further-digitalise-healthcare-systems-2025-06-25_en EasyIFU.com MDR + IVDR + AI Act = MDCG 2025-6 - Any other legislation to add?: https://health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en?filename=mdcg_2025-6_en.pdf MDCG 2025-5: IVDR Performance Study - Masterclass to understand Performance Study: https://health.ec.europa.eu/document/download/f22f559b-dee5-43b4-9595-3ccdcca9f7ad_en?filename=mdcg_2025-5_en.pdf Team-NB. Software Qualification (IVDR) clarification - Translation of the MDCG 2019-11: https://www.team-nb.org/wp-content/uploads/2025/06/Team-NB-PositionPaper-Software-Qualification-under-the-IVDR-V2-20250627.pdf MDCG 2019-11: https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en?filename=mdcg_2019_11_en.pdf CECP: Mechanical Respiratory - Result is not good: https://health.ec.europa.eu/document/download/80f2432d-a9da-48ae-8ebb-0054b4922033_en?filename=cecp-2025-0000232089_opinion_en.pdf MDCG 2025-4 Software delivered with Online Platforms - Are your apps conform: https://health.ec.europa.eu/document/download/ec9b0f40-7f82-43a7-b833-ebd45b772eae_en?filename=mdcg_2025-4_en.pdf PROJECT NAME: COMBINE - Clinical Trials with Medicine and IVDs: https://ec.europa.eu/newsroom/sante/newsletter-archives/64447 https://health.ec.europa.eu/medical-devices-topics-interest/combined-studies/combine-project-1-pilot-all-one-coordinated-assessment_en UK UK PMS mandatory since June 16th, 2025 - Learning starts: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements#full-publication-update-history Press Release: https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain Periodic Safety Update Report: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur Example of reportable incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents MORE Guide update: https://assets.publishing.service.gov.uk/media/6847fc9c944a600f13bcb852/User_Reference_Guide___MORE_Incident_Submissions.pdf Document for implementation of Data: https://www.gov.uk/government/publications/documentation-for-implementation-of-data-requirements-under-the-new-post-marketing-surveillance-regulations ROW USA UDI for combination products - What are the rules?: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identifier-requirements-combination-productsConducting Remote Reg Assessment - SQuestion and Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers Transfer of Premarket Notification (510k) - Questions & Answers: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transfer-premarket-notification-510k-clearance-questions-and-answers CANADA Canada is cancelling all MDELs - Only if you don't confirm the Annual License Review: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/cancellation-non-compliance-annual-review-requirements-2025.html Saudi Arabia SFDA Webinar: Risk Management File - July 8th, 2025 10 AM Saudi Time: https://www.sfda.gov.sa/en/workshop/3868398 Podcast Episode 340 - Software as a Medical Device: Beginner's guide to Testing and Validation: https://podcast.easymedicaldevice.com/340-2/ Episode 341 - Notified Bodies raise concern on Risk Grading: https://podcast.easymedicaldevice.com/341-2/ Episode 342: From Zero to One: SaaS Founder's First Five Years: https://podcast.easymedicaldevice.com/342-2/
Logan, a distinguished leader in the medical sales industry, joins us to share her unconventional journey, from pre-med student to CEO in neuromonitoring, and later, to a hands-on role in spinal device sales. Her story is a powerful example of how diverse experiences can shape a well-rounded, impactful career in medtech. Logan offers key insights into the role of neuromonitoring in surgery, the risks of false positives, and the critical communication needed between OR teams. We explore the often-overlooked dynamics between neuromonitoring techs and device reps inside the OR. Logan pulls back the curtain on how strong reps build trust, stay composed under pressure, and keep patient care at the center, even when tensions rise. Her perspective reveals why emotional intelligence and accountability are non-negotiables for long-term success. Logan's transition from the C-suite back into the field brings a rare perspective on leadership and growth. She reflects on the humility and reward of working directly in surgical settings, the realities of financial motivation in healthcare, and the silos that still exist between clinical and commercial roles. Her take on leadership is clear, great managers must coach, delegate, and develop others if they want their teams to thrive. Whether you're in the OR, aiming for the executive suite, or somewhere in between, Logan's story is packed with insight, reflection, and hard-earned advice on how to grow a purpose-driven career in medical sales. Connect with Logan: 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!
In this episode of Let's Combinate, Archana shares her insights on the critical factors involved in designing clinical trials, from phase one safety profiling to pivotal phase three trials. She also discusses the importance of patient diversity, the ethical considerations in clinical research, and the future of clinical trials, including decentralized trials and the use of advanced technologies. The conversation highlights the intricate balance between maintaining rigorous scientific standards and adapting to new methodologies to enhance patient recruitment and data integrity. Time Stamps: 00:00 Welcome and Introduction 00:28 Understanding Clinical Trial Design 00:58 Phases of Clinical Trials 02:27 Oncology Trials and Patient Pathways 05:00 Protocol Design and Regulatory Considerations 08:40 Patient Preferences and Vendor Selection 18:53 Types of Clinical Trials 23:01 Understanding BA and BE Studies 24:39 Clinical Coordination of BA/BE Studies 25:15 Infrastructure and Emergency Management in Clinical Trials 26:19 Addressing Mistrust in Clinical Trials 29:54 Ensuring Diversity in Clinical Trials 32:41 The Rise of Decentralized Clinical Trials 39:06 Challenges and Solutions in Decentralized Trials 42:49 Technology and Regulation in Clinical Trials 47:28 Final Thoughts and Contact InformationArchana Sah is a Clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals including Tecentriq® in multiple indications and combinations, Alecensa®, Polivy®, Hemlibra®, Gazyva®, Pixuvri®. She has held various global positions within Biotech, Big pharma, CRO including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, and two Oncology biotech start up companies. She has also worked in healthcare technology as the Senior Vice President of Digital and Decentralized Solutions at Medable Inc. She is now an independent strategy consultant and Board Advisor and provides strategic advisory services to pharma, biotechs, digital healthtech software companies, venture firms in clinical development and operations as well as on leveraging innovative patient centered digital health technologies in a fit for purpose approach to improve diversity, access and efficiencies within the healthcare ecosystem. She has been honored as Top20 women in immuno oncology drug development and featured in PharmaFEATURES on Oncology drug development and Digital Health technology.She has routinely led several industry collaboration consortiums. She is the co-founding chair and member of Society for Clinical Research Sites Oncology Board and chaired the Annual Oncology Summits. She is a current Mentor for the CancerX Moonshot program dedicated to revolutionizing advancements in cancer care, clinical trials, patient support, biotech & pharma and drive integration of digital tools in oncology. She serves on the Leadership Council for Decentralized Trials and Research Alliance(DTRA) and as their Evidence/Publications Librarian. She also serves as an Advisor to American Cancer Society Cancer Action Network (ACS CAN) and is a reviewer for the international Journal of the American Cancer Society "Cancer". Invited advisor and keynote/speaker at several industry conferences.Contact: archana.sah@aspharmaadvisors.comSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Anthony Fernando, President and CEO of Asensus Surgical.Asensus is expanding the role of robotics in the OR with its performance-guided surgery platform — a digital-first, AI-enabled system designed to enhance precision and real-time decision-making. A mechanical engineer by training, Anthony has more than two decades of experience spanning medtech, robotics, and global operations. He joined Asensus in 2015 and previously served as Chief Operating Officer and Chief Technology Officer. Earlier in his career, Anthony held leadership roles at Stryker, Becton Dickinson, PerkinElmer, and Varian, where he focused on advancing automation and medical device innovation across international markets.In this interview, Anthony shares how the Durham, NC–based Asensus navigated uncharted regulatory territory for a first-of-its-kind technology and proactively made the case for acquisition — well before KARL STORZ came to the table.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 Anthony Fernando.
A Kiwi start up has been going gangbusters across the ditch. Medsalv remanufactures single-use medical products, cleaning and disinfecting them so they can be safely reused. After eight years in business, their products have been approved by Pharmac for use in New Zealand. CEO Oliver Hunt told Mike Hosking it's been done in America for a while, but they're really bringing it to the rest of the world, Australia and New Zealand in particular, now. The range of products they can remanufacture is pretty substantial, he says, and they can clean products up to 14 times at a significantly lower cost than the original products. LISTEN ABOVE See omnystudio.com/listener for privacy information.
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
Send us a textIn this episode of the Being an Engineer podcast, host Aaron Moncur interviews Katie Karmelek, a mechanical engineer and co-founder of Chamfr. Katie shares her journey from engineering to entrepreneurship, discussing her passion for medical device innovation and how Chamfr is revolutionizing component sourcing for medical device engineers.Main Topics:Katie's engineering background and family influencesThe founding of Chamfr and its mission to accelerate medical device developmentChallenges of creating an online marketplace for medical componentsPersonal experiences that highlight the importance of medical device innovationAdvice for young engineers and entrepreneursAbout the guest: Katie Karmelek is a mechanical engineer and entrepreneur with nearly 20 years of experience in the medical device industry. She is the co-founder of Chamfr, an online marketplace that simplifies sourcing components and tools for medical device development by connecting engineers with qualified suppliers.Before launching Chamfr in 2017, Katie held roles in product development and business management at companies like Olympus, Vention Medical, and TDC Medical. She also founded Karmelek Engineering, Inc., applying her technical expertise to further innovation in the field.Katie holds both a Bachelor's and Master's degree in Mechanical Engineering from Northeastern University. She is committed to mentoring young engineers and frequently shares insights on materials and design trends through the Chamfr blog.Links:Katie Karmelek LinkedInChamfr - Website Click here to learn more about simulation solutions from Simutech Group.
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 - Start02:26 - Who Is Rachel Littleton?08:16 - Biggest Stressors In First 6 Months As A Rep10:05 - Moving To The UK17:26 - UK Healthcare vs US Healthcare21:30 - How Different Is The Medical Sales Field In The UK vs US26:35 - Being Passionate In What You Do28:43 - Rachel's Advice For Those Interested In Medical Device Sales30:14 - Rachel's Advice To New Reps
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we had a really engaging conversation with James (Jim) Corbett, CEO of AVITA Medical.AVITA Medical's RECELL system uses Spray-On Skin Cell technology to accelerate healing for patients with severe burns and wounds. Jim brings nearly 40 years of medical device leadership experience to AVITA Medical. His career spans global commercial and operational roles, including President of Boston Scientific and General Manager of Scimed Life Systems. Jim has served as CEO of six companies, including three publicly traded entities — Microtherapeutics, ev3, and Alphatec Spine — as well as CathWorks, Home Diagnostics, and Vertos Medical.In this interview, Jim shares lessons from a career spanning global medtech leadership positions — including the importance of hands-on fundraising, adapting sales strategies as products mature, and how generating clinical evidence beyond FDA requirements serves commercial adoption.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 Jim Corbett.
In this episode I sit down with Mike Denzer, a mechanical engineer, inventor, and trusted leader in the combination product space. We talk about the power of networking not just as a tool for finding your next job, but as a foundation for building a meaningful and resilient career in pharma and medtech.Mike shares what it's like to develop life-changing devices like Amgen's Auto Click autoinjector, how he built credibility across R&D and regulatory teams, and why asking good questions and being generous with your time pays off more than any formal title. If you've ever struggled to balance technical depth with approachability or you're trying to navigate CROs, design controls, or cross-functional chaos, I hope you enjoy this conversation! ⏱️ Timestamps00:00 Welcome and introduction00:56 Why networking matters01:57 Life-changing moments in engineering09:45 Challenges and innovations in autoinjectors14:47 CROs, sponsors, and collaboration18:22 Mike's favorite projects and final thoughtsAbout Mike Denzer:Mike Denzer is a mechanical engineer, inventor, and combination product leader with over 20 years of experience in drug delivery system development. He's held leadership roles at companies like Amgen, Teva, Bristol Myers Squibb, and Kymanox, and is credited as an inventor on five U.S. patents related to autoinjector platforms and delivery technology.He's the founder of Combo Products LLC, where he now consults on combination product design, human factors strategy, and technical development. Mike is widely respected for his collaborative style and clear communication across engineering, clinical, regulatory, and quality functions.Contact Mike: mdenzer@comboproductsllc.comSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.
Today's guest is Dr. Ankur Sharma, Head of Medical Affairs for Medical Devices and Digital Radiology at Bayer. Dr. Sharma joins Emerj Editorial Director Matthew DeMello to explore the complex intersection of AI, medical devices, and data governance in healthcare. Dr. Sharma outlines the key challenges that healthcare institutions face in adopting AI tools, including data privacy, system interoperability, and regulatory uncertainty. He also clarifies the distinction between regulated predictive models and unregulated generative tools, as well as how each fits into current clinical workflows. The conversation explores the evolving roles of the FDA and EU AI Act, the potential for AI to bridge clinical research and patient care, and the need for new reimbursement models to support digital innovation. This episode is sponsored by Medable. Learn how brands work with Emerj and other Emerj Media options at emerj.com/ad1. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the ‘AI in Business' podcast!
Epinephrine auto-injectors, first developed in the 1970s, are the most common emergency treatments for anaphylaxis, often deadly allergic reactions. The limitations of liquid epinephrine and the device's decades-old technology have kept these life-saving devices out of patients' hands. Austin-based startup Windgap Medical, Inc. plans to break these barriers with a more convenient, shelf-stable alternative.In Episode 41 of the MedTech Speed to Data podcast Key Tech's Andy Rogers and Thomas James sit down with Windgap's co-founder and Chief Business Officer, Brent Buchine, to discuss the data-driven development of the company's life-saving technology.Need to know· Epinephrine auto-injectors are big business — A $1.3 billion market at Windgap's founding, sales of epinephrine auto-injectors exceeded $3.1 billion in 2024.· Few eligible patients get these life-saving devices — Only 52% of American food allergy patients ever receive prescriptions, and epinephrine auto-injectors are only available in 32% of the world's 195 countries.· Traditional auto-injectors are relatively large and inconvenient — Only 55% of patients with prescriptions report having immediate access to their auto-injectors.· Liquid epinephrine is thermally unstable — Doses lose their effectiveness with prolonged heat exposure, forcing patients to refill their prescriptions more frequently.The nitty-grittyBuchine and his co-founders saw an opportunity to make epinephrine delivery more convenient and accessible. “We developed a freeze-dried version of epinephrine to make it more stable and double, if not triple, the shelf life,” Buchine explains.However, lyophilization introduces an extra step in the treatment process. The dried epinephrine must be rehydrated and mixed in a solution before injection.“If you have a rescue product for emergency use, you have to get it very quickly,” Buchine says. “With modest training, you need to make sure people know how to use the product because their life is at risk if it doesn't work.”Windgap's ANDI® platform is a small, highly portable single-dose auto-injector, Buchine explains. “Simply twisting the cap automatically rehydrates that dose in a couple of seconds — no shaking, no swirling required. It's ready to inject by pressing the device next to the injection site.”Windgap and its pharmaceutical clients are still in the commercialization phase, but the company is already looking at the future of complex injectables.“We see that, fundamentally, formulation pipelines are getting more and more challenging,” Buchine says. “You have multiple injections, you have mixing, you have high viscosity/high volume. The conventional options out there are not as suitable anymore. We're solving those problems specifically because we think there's an opportunity to be best in class in that area.”Data that made the difference:Developing combination products is a multi-stakeholder problem. “It's drug, it's device, it's patient, it's prescriber, it's payer. You've got to think about all of those stakeholders along your development.”Get in front of stakeholders to understand the problem. “We did a lot of surveys and uncovered the opportunity. Patients weren't getting prescriptions filled or weren't even going to the doctor to get prescriptions. It was that segment that we spent a lot of time talking to.”Listen to your customers. “We'll talk to pharmaceutical companies [and ask] what are some of the biggest challenges you're facing in your pipeline? And then you just listen. Over time, you look for that recurring theme. That's what really drove our product strategy.”Use data to convince investors. “There was a vastly underserved market. Our ability to communicate that to investors and help them understand the opportunity of taking [at the time] a $1.3 billion business to something substantially above that.”
Navigating Clinical Trials for Medical Device Startups: Insights from Julio Martinez-Clark of bioaccess®In this episode of The Thoughtful Entrepreneur, host Josh Elledge sits down with Julio Martinez-Clark, Founder and CEO of bioaccess®, to explore the challenges medical device startups face in navigating early-phase clinical trials. Julio draws on his extensive experience to explain how bioaccess® is helping companies conduct trials in Latin America as a strategic alternative to the U.S., offering startups an efficient and cost-effective way to progress. The conversation dives into the intricacies of regulatory compliance, data quality, and patient recruitment, offering critical insights for innovators looking to accelerate their time to market.Overcoming the Challenges of Medical Device Clinical TrialsJulio Martinez-Clark explains the complex journey from medical device innovation to market. He highlights that medical device development is often capital-intensive and time-consuming, with startups typically relying on grants in the early stages before needing millions to fund animal studies, human trials, and regulatory submissions. One of the biggest challenges that startups face is meeting investor expectations for rapid progress and clear milestones, particularly with the ultimate goal of acquisition by large players such as Medtronic or Johnson & Johnson.The U.S. clinical trial process, while rigorous, is also costly, and the lengthy approval timelines add pressure for startups already constrained by limited resources. Julio stresses that many medical device innovators underestimate the amount of time it takes to secure funding, develop products, and get approval from the FDA. He also shares how crucial it is for companies to factor in the regulatory strategies and financial resources needed to navigate these challenges without facing setbacks.To overcome these challenges, startups should build long-term financial plans and strategies, preparing for what can be a long and resource-heavy journey. This proactive approach, combined with a solid regulatory strategy, ensures that startups remain on track and avoid costly delays.About Julio Martinez-ClarkJulio Martinez-Clark is the Founder and CEO of bioaccess®, a company dedicated to helping medical device startups navigate the early stages of clinical trials and regulatory approval. With years of experience in the medical device and healthcare innovation sectors, Julio provides strategic insights into accelerating time to market and achieving regulatory compliance for cutting-edge medical technologies.About bioaccess®bioaccess® is a leading contract research organization (CRO) focused on supporting medical device startups through early-phase clinical trials, particularly in Latin America. Offering a more affordable and faster approach to clinical trials, bioaccess® helps startups overcome high costs and lengthy timelines associated with U.S.-based trials while ensuring adherence to global regulatory standards and high data quality.Links Mentioned in This Episodebioaccess® WebsiteJulio Martinez-Clark on LinkedInKey Episode HighlightsThe Fractional Legal Team...
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastJacob talks with Charles Studer, a former nurse who transitioned into medical device sales with one of the largest med device companies in the world. They discuss going from nursing to sales, overcoming fear of change, finding fulfillment outside of traditional healthcare roles, why nurses make great clinical specialists, relocating for career goals, choosing the right med device path based on personality, the difference between associate and clinical roles, and why you're not throwing your degree away by changing directions.Key Takeaways:Your healthcare background isn't wasted when you move into medical device sales. It's actually what gives you an edge if you know how to use it.If you're feeling unfulfilled, stuck, or like you were meant for more than clocking in and out, it's okay to explore a different path.You don't need to go back to school or rack up more debt to make a meaningful career change. You just need a strategy and support.The clinical specialist route is perfect for people who still want patient interaction but want more autonomy and variety in their day.Fear is normal when you make a career jump, but being uncomfortable is part of what makes you grow and hit new levels.Find a mentor, and surround yourself with people who get it. Don't let coworkers or friends hold you back with their own fear or judgment.Success in this field isn't just about credentials. It's about doing the work, staying consistent, listening, and being coachable.00:00 - Start02:03 - Who Is Charles Studer04:56 - What Motivated You To Make The Change To Medical Device Sales10:51 - What Made You Not Want To Stay In The State You Were Hired For13:45 - What Made Take The Leap To Actually Leave Nursing17:43 - Choosing Clinical Specialist Instead Of Associate Sales Rep21:25 - Advice To A Nurse Interested In Medical Device Sales
In this episode of Let's Combinate, host Subhi Saadeh is joined by Kirk Petyo, Managing Partner at Talent Factory Medical and founder of Talent Factory Recruiting. If you're a bioengineering student, recent grad, or early-career professional trying to break into medical devices, biotech, or pharma—this one's for you.With extensive experience recruiting for regulated industries like aerospace, medical devices, and pharmaceuticals, Kirk offers grounded, actionable insights for early-career professionals and hiring managers alike.This episode covers how to craft a strong resume, the importance of knowing your career “why,” how to stand out to recruiters, and why onshoring and shifting regulatory trends matter for the next generation of talent in life sciences.Timestamps00:00 – Welcome and Guest Introduction 00:35 – Kirk's Career Journey and Advice 02:18 – Navigating Early Career Challenges 03:12 – Building a Strong Resume and Networking 04:38 – The Importance of Specificity in Job Applications 08:56 – Recruitment Insights and Industry Trends 12:05 – Personal Experiences and Lessons Learned 18:49 – Advice for Upcoming Graduates 23:18 – The Importance of Passion in Job Interviews 24:00 – Evaluating Candidates Beyond Experience 24:58 – Personal Stories and Career Choices 30:55 – Bioengineering vs. Mechanical Engineering 41:34 – Industry Trends and Onshoring 44:18 – Entry-Level Opportunities and Recruitment About Kirk PetyoKirk Petyo is the Managing Partner at Talent Factory Medical and founder of Talent Factory Recruiting. He has spent his career recruiting top talent in highly regulated industries like aerospace, medical devices, biotech, and pharma. Known for his ability to bridge business needs with real human connections, Kirk helps companies grow stronger teams—and helps candidates navigate complex career decisions with clarity and purpose.About the Host Subhi Saadeh is a Quality Professional and host of Let's ComBinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.
Dive deep into the complex world of medical device supply chains with supply chain executive Simon Hinds. This comprehensive episode of the OnTrack Podcast explores the unique challenges of bringing life sciences products from development to market, including regulatory compliance, global sourcing strategies, and risk management in an increasingly complex geopolitical landscape. From tier-one to tier-three supplier relationships to the critical importance of traceability in medical manufacturing, Simon shares real-world insights on how companies navigate everything from tariff risks to pandemic-induced disruptions. Learn about the stark differences between pharmaceutical supply chains and other industries like automotive and consumer electronics, and discover why medical device companies face uniquely high barriers to entry when implementing global assembly strategies.
Many MedTech companies focus heavily on FDA clearance but overlook a critical layer of U.S. market entry: state-level compliance. In this episode, Etienne Nichols speaks with Adam Steadman, CEO of MDD Options, to unpack the real-world challenges that derail commercialization after regulatory approval. From navigating state-specific registration, sales tax laws, and distribution logistics to choosing between direct and distributor-based strategies, Adam shares hard-earned insights for avoiding the "second valley of death" post-clearance. Whether you're a domestic startup or an international company entering the U.S., this episode arms you with a tactical understanding of compliance landmines and scalable go-to-market strategies.Key Timestamps00:02 – Intro: The real MedTech “valley of death” after FDA clearance04:45 – Why U.S. state-level registration is misunderstood and overlooked08:15 – State-level definitions of medical devices and why they differ11:20 – Strategic go-to-market options: Distribution vs. Direct17:00 – How regulations vary drastically by state (CA, TX, etc.)21:50 – The real risks of noncompliance: lawsuits, bad PR, and due diligence failures26:15 – Why distribution agreements can stall your growth (and how to avoid it)34:30 – Sales tax & use tax: The hidden compliance trap39:10 – Logistics, warehousing, and long-term liabilities in contracts44:55 – Overlooked pitfalls: Secretary of State filings and income tax in 36+ states51:15 – Software as a Medical Device (SaMD): U.S. compliance still applies55:30 – Selling to the U.S. government vs. private sector buyers59:20 – Veterinary devices and why they still need regulatory controls1:03:10 – What a winning go-to-market strategy actually looks like1:10:25 – Adam's final advice to MedTech startups (foreign and domestic)Standout Quotes"You're not entering one country—you're entering 50 states and D.C. Each with its own rules, definitions, and tax laws."—Adam Steadman explains why U.S. MedTech entry requires a state-by-state strategy, especially for international companies."None of the strategics want your warehouse management system—they want your product, your sales, and your proof of market fit."—Steadman on why building non-core infrastructure slows down commercialization and valuation.Top 5 TakeawaysFDA Clearance ≠ Market Readiness – State-level registrations, sales tax laws, and pharmacy board definitions often delay or block commercialization.Distribution Isn't Always a Shortcut – National distributors may have misaligned incentives and can lock you into exclusivity that hinders growth.Sales Tax is a Regulatory Minefield – 46 states require separate sales tax registration, exemptions tracking, and monthly filings—even if you're tax-exempt.Beware of Long-Term Contracts – Logistics and distribution contracts often lock companies into rigid terms that prevent pivots or acquisitions.Speed to Market Is Strategic – Getting to market fast is often the difference between becoming #1 or #3—and #3 often gets nothing.MedTech 101What Is “Nexus” and Why It Matters for Sales Tax?“Nexus” refers to the minimum level of economic activity that triggers tax obligations in a given state. For example, selling $100,000 of devices or 200 transactions may establish nexus, requiring you to register for sales tax. Unlike VAT in Europe, U.S. sales tax laws are state-specific, making this a major compliance hurdle for MedTech companies.References & Resources
Inside INdiana Business Radio for the afternoon of June 16, 2025. A Michigan-based medical device manufacturer details plans for a $70 million facility in Warsaw. Plus, the Indiana Pacers are working to keep up with "overwhelming" demand for merchandise. Get the latest business news from throughout the state at InsideINdianaBusiness.com.
TestTalks | Automation Awesomeness | Helping YOU Succeed with Test Automation
In today's show, we're diving deep into the highly specialized world of software testing for medical devices. Our guest, Priyank Soni, brings over 20 years of experience and a wealth of knowledge from the front lines of medical innovation, think cardiac mapping, lab automation, and infusion pumps. Not only is Priyank a recognized authority in embedded systems, AI, and machine learning, but he's also a master at transforming manual QA processes into scalable, cloud-based automated frameworks. Join host Joe Colantonio as he and Priyank unravel the unique challenges of testing in a heavily regulated, high-risk environment where safety, compliance, and innovation must work hand-in-hand. You'll gain practical insights into navigating stringent standards like ISO 13485, managing risk in legacy systems, and balancing Agile development with rigorous verification requirements. Plus, Priyank shares the real impact of AI and automation in medical device testing—and what the future might hold for testers in this rapidly evolving field. Whether you're a seasoned QA pro or just curious about what it takes to deliver safe, compliant software in healthcare, you won't want to miss this episode! Take the first step towards transforming your and our community's future. Check out our done-for-you services awareness and lead generation demand packages, and let's explore the awesome possibilities together now https://testguild.com/mediakit
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastMindset Course: https://jacob-mclaughlin.mykajabi.com/offers/JbXC3NYf/checkout Mindset as the biggest success factor, overcoming negative self-talk, dealing with haters and rejection, fake timelines and unnecessary pressure, the reality of breaking into the industry, how to handle anxiety during the process, importance of internal language and beliefs, building resilience, defining what success actually looks like, raising your standards and your circle, creating a mindset worth $150k+, staying consistent even when it's hardKey Takeaways:The way you talk to yourself matters way more than you think. If you're constantly putting yourself down, you're slowing yourself downYou're going to get rejected or ignored, and sometimes people are just plain rude. Don't take it personallyStop stressing over made-up deadlines; breaking in doesn't have to happen in three weeks or elseIt's supposed to be hard. Most people quit when it gets tough, so keep pushing and you'll stand outYou don't get paid $150K just for applying—you've got to show up like someone who's worth that kind of moneyWho you hang around makes a huge difference. If your circle doesn't want more, it'll hold you back00:00 - The #1 Indicator For Success In Medical Device Sales01:09 - 1. Negative Self Talk03:32 - 2. Haters06:42 - 3. Planting Timelines08:15 - 4. The Actual Reality08:56 - 5. Accept The HARD10:14 - Be Happy. Healthy. Wealthy
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
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.
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"
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
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