Any instrument, apparatus, implant, in vitro reagent, or similar or related article used for diagnostic and/or therapeutic purposes
POPULARITY
Categories
288 episodes with medical devices
173 episodes with medical devices
151 episodes with medical devices
146 episodes with medical devices
120 episodes with medical devices
88 episodes with medical devices
110 episodes with medical devices
49 episodes with medical devices
64 episodes with medical devices
82 episodes with medical devices
85 episodes with medical devices
71 episodes with medical devices
66 episodes with medical devices
60 episodes with medical devices
95 episodes with medical devices
77 episodes with medical devices
41 episodes with medical devices
32 episodes with medical devices
39 episodes with medical devices
36 episodes with medical devices
37 episodes with medical devices
56 episodes with medical devices
35 episodes with medical devices
28 episodes with medical devices
25 episodes with medical devices
17 episodes with medical devices
30 episodes with medical devices
18 episodes with medical devices
18 episodes with medical devices
11 episodes with medical devices
25 episodes with medical devices
14 episodes with medical devices
15 episodes with medical devices
15 episodes with medical devices
11 episodes with medical devices
11 episodes with medical devices
11 episodes with medical devices
25 episodes with medical devices
12 episodes with medical devices
11 episodes with medical devices
25 episodes with medical devices
11 episodes with medical devices
24 episodes with medical devices
7 episodes with medical devices
12 episodes with medical devices
14 episodes with medical devices
10 episodes with medical devices
6 episodes with medical devices
15 episodes with medical devices
6 episodes with medical devices
8 episodes with medical devices
12 episodes with medical devices
8 episodes with medical devices
5 episodes with medical devices
12 episodes with medical devices
6 episodes with medical devices
5 episodes with medical devices
10 episodes with medical devices
9 episodes with medical devices
4 episodes with medical devices
5 episodes with medical devices
4 episodes with medical devices
5 episodes with medical devices
10 episodes with medical devices
6 episodes with medical devices
8 episodes with medical devices
8 episodes with medical devices
6 episodes with medical devices
5 episodes with medical devices
4 episodes with medical devices
4 episodes with medical devices
5 episodes with medical devices
4 episodes with medical devices
3 episodes with medical devices
4 episodes with medical devices
9 episodes with medical devices
2 episodes with medical devices
3 episodes with medical devices
4 episodes with medical devices
7 episodes with medical devices
3 episodes with medical devices
4 episodes with medical devices
3 episodes with medical devices
4 episodes with medical devices
3 episodes with medical devices
4 episodes with medical devices
3 episodes with medical devices
11 episodes with medical devices
4 episodes with medical devices
6 episodes with medical devices
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/
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.
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
What if clinical trials could save lives and launch your global medtech career? What happens when you combine cutting-edge medical devices, international clinical trials, and a relentless drive to create real-world impact? Meet Julio M. Clark — CEO of bioaccess® and host of the LatAm MedTech Leaders podcast — who turned a one-man regulatory operation into a pioneering contract research organization transforming healthcare across Latin America. In this episode of Neurocareers: Doing the Impossible!, we explore: How Latin America became a hub for first-in-human clinical trials The unique challenges and opportunities of medical device research in global markets Why AI is revolutionizing everything from informed consent to trial proposals Career pathways for biomedical engineers and clinicians in medtech startups The mindset needed to build impactful ventures from scratch — even after failure Julio shares the entrepreneurial journey behind bioaccess®, the future of medtech clinical trials, and how YOU can contribute to life-saving innovation—even if you're just starting out. Whether you're a neurotech enthusiast, aspiring clinical researcher, or global health innovator—this episode will inspire you to think bigger, act bolder, and, most importantly, choose the right table.
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastIf you think just applying is enough, it isn't. Everyone wants the six-figure med device job, but most people have no idea what it actually takes to get there. Learn the hard truths about breaking into the industry. Why most candidates fail, what top companies are really looking for, and how to become the kind of person they feel lucky to hire.Key TakeawaysUnderstand that medical device sales isn't like a regular job where you apply and get hired after a couple of interviews. You're going up against experienced professionals and even current reps who want a better gig.Make sure you show up like a professional. Being chill might work with your friends, but it won't land you a six-figure job talking to surgeons and execs. No jeans and T-shirts at interviews. No “lit” or “dog” in conversations.Knowing someone in the industry might get you an intro or a first-round interview, but it won't carry you through the whole process. You still have to earn it. Every company is different, and connections alone won't cut it.You've got to level up your mindset. Don't chase the six-figure job thinking money alone will solve everything. You need to become the kind of person who deserves that paycheck. Companies would feel lucky to hire you.Age doesn't matter as much as how prepared and professional you are. Maturity, attitude, and consistency are what win the job, not your resume alone.00:00 - Start01:12 - EXPECTATION #103:30 - EXPECTATION #205:15 - EXPECTATION #307:34 - EXPECTATION #4
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Shreya Mehta, co-founder and CEO of Zenflow.Zenflow is a medical device company focused on treating benign prostatic hyperplasia (BPH). A biomedical engineer, Shreya brings over 15 years of experience in medtech, including serving as a lead reviewer at the FDA, where she specialized in cardiovascular devices. Shreya co-founded Zenflow in 2014 out of the Stanford Biodesign Innovation Fellowship. The company was one of the first medical device startups backed by Y Combinator and also received early support from StartX and the UCSF Rosenman Institute at QB3.Shreya's experience at Zenflow reveals strategies for grounding innovation in patient needs, building productive FDA relationships, and leveraging accelerator programs to transform academic concepts into viable businesses.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Shreya Mehta.
Send us a textIn this episode of Healthcare Trailblazers, host Mendel sits down with Gabby Lawrence, Senior Director of Clinical Solutioning at TytoCare. TytoCare offers the Home Smart Clinic - for accessible, high-quality primary care from home, with no compromises, featuring artificial-intelligence-powered features to enable its telehealth platform to perform diagnostic capabilities. Gabby, an epidemiologist by background, explains how TytoCare's FDA-cleared handheld device with modular attachments transforms virtual healthcare by enabling comprehensive physical exams from home. The conversation covers TytoCare's evolution from urgent care applications into chronic disease management and primary care, their AI-powered wheeze detection capabilities, and strategic partnerships with major health systems like Atrium, Advocate, and Memorial Care. They explore the meaning behind "clinical solutioning" versus traditional clinical solutions, the challenges of B2B versus B2C models, and the company's vision for integrating GenAI to enhance physician capabilities while maintaining human oversight in patient care.
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!
Hundreds of approved devices use artificial intelligence to help physicians diagnose patients faster and more accurately. Brooke & Associates is a legal and regulatory advisory firm that helps medical device makers get AI-powered devices through FDA pre-market approval.In Episode #40 of the MedTech Speed to Data podcast, Key Tech's Andy Rogers and Lei Zong speak with the firm's managing member, Jason Brooke, about the FDA's latest guidance to medical device developers for integrating AI into their products.Need to knowAI's role in MedTech — AI identifies otherwise undetectable data patterns that humans can apply in clinically meaningful ways.FDA's AI staffing surges — The agency accelerated hiring to develop internal AI applications and support pre-market reviews of new AI-powered devices.Radiological imaging leads the pack — More than half of 900+ FDA-approved AI-based products are in radiological imaging.Other fields are catching up — Cardiology and neurology applications are more recent entrants in AI-powered devices, but their numbers are growing.The nitty-grittyThe FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” in early 2025 to explain how it will address AI's adaptive nature in medical device regulation.“This guidance is really focused on a total product lifecycle approach,” Brooke explains.Good management practices govern traditional medical device development, so documenting the development process in pre-market submissions is not as critical. AI model development is different because the model can evolve once in service.“There's a level of information that's necessary in submissions for AI-based technologies that we haven't had to provide to the FDA before,” Brooke says. “They want a lot of information,” Brooke says. “That's an area I think may be problematic because a lot of that is somewhat trade secret.”AI-specific guidance touches almost every aspect of a company's submission, from risk assessment to labeling to cybersecurity. Brooke highlighted how the FDA's approach to AI data management could change development practices to ensure the independence of training and validation data sets. For example, companies must separate their clinical sites geographically and temporally.“This guidance gets into the weeds,” Brooke says. “It's important for companies to understand this if they're developing an AI-based product.”Data that made the difference:In addition to discussing the FDA's proposed AI regulations, Brooke discusses the challenges companies face in bringing AI-powered medical devices to market.“If you take away anything from this podcast,” Brooke says, “it's that there's a lot of burden associated with developing an AI-based medical device. If you don't need to, then I wouldn't recommend doing it.”Slow and steady wins the race. Do your homework, plan for the FDA review, and then engage the agency at the right time to get them on board.Thoroughly characterize your data sources. Devices like ECGs can vary by vendor, model, site location, patient, and many other factors. The FDA wants to know how this variability could affect the downstream AI model.Develop a strong clinical validation plan. The FDA will limit claims and require disclosures when a device that performs well overall underperforms among certain patient groups.
Mariano Mattei is the Vice President of Cybersecurity and AI at Azzur Solutions, bringing over 30 years of expertise in cybersecurity, AI innovation, and software engineering. A Certified Chief Information Security Officer (CCISO), Mariano has led AI-driven transformations across Biotechnology, Pharmaceuticals, and Medical Device sectors, integrating AI into clinical trials, manufacturing automation, quality systems, and regulatory compliance frameworks (FDA 21 CFR Part 11, GAMP 5, GDPR, HIPAA). His work spans predictive analytics for risk management, AI-powered process optimization, anomaly detection in manufacturing, and regulatory AI governance. He recently graduated from Temple University's Master's Program in Cyber Defense and Information Assurance, and he's the author of "Data-Driven Cybersecurity – Proven Metrics for Reducing Cyber Risk"Listen NOW to discover, "The Secret to Taking A Secure Risk"
In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification. Who is Carmen Bellebna? Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye's QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Carmen Bellebna LinkedIn: https://www.linkedin.com/in/men-be-a1828a81/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
What if your next business idea wasn't about making millions—but helping just one person? In this episode, Tom Livingston, CEO of Rampart IC, shares how a late-night phone call from a friend sparked the idea for a life-saving medical device—and how that simple act of service grew into a globally distributed, 8-figure company. From sketching concepts on a napkin to testing a prototype during a secret cabin weekend, Tom's journey is a masterclass in purpose-driven leadership, calculated risk, and building something that truly matters.Whether you're burning the midnight oil on your own big idea or still in the dreaming phase, this conversation is for you. Tom opens up about building the company while working full time, the coffee table pact that changed everything, and the power of building a team rooted in belief, not just ambition. This is a story of faith, uncertainty, and the quiet courage it takes to bet on what doesn't exist—yet.WILDFLOWER SHOWNOTES : shannaskidmore.com/tom-livingston-rampart-ic
In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. We will talk about the impact on Medical Device manufacturers but also on you as a human being as all this is about manipulation of data. Personal data or anonymized data. But can it be un-anonymized… Listen to this episode. Who is Cecile van der Heijden? Cécile van der Heijden is a senior legal expert at Axon Lawyers, a boutique law firm based in the Netherlands specialized in legal and regulatory affairs for the life sciences sector. With a strong focus on digital health, data protection, and medical device law, Cécile advises companies on navigating complex European regulations such as the MDR, GDPR, and the newly adopted European Health Data Space (EHDS) Regulation. She regularly supports clients developing AI, software as a medical device (SaMD), and connected technologies, helping them align innovation with compliance. Known for her practical approach, Cécile frequently speaks at conferences and publishes insights on digital health law across the EU. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Cecile van der Heijden LinkedIn Profile: https://www.linkedin.com/in/cevanderheijden/ Axon Lawyers website: https://www.axonlawyers.com/ EHDS: https://www.european-health-data-space.com/ Article EHDS: https://www.consilium.europa.eu/en/press/press-releases/2025/01/21/european-health-data-space-council-adopts-new-regulation-improving-cross-border-access-to-eu-health-data/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Dr. Arun Menawat, Chairman and CEO of Profound Medical. Profound is commercializing the TULSA-PRO system, an alternative approach to prostate cancer treatment that uses MRI-guided thermal ultrasound to target and eliminate cancerous tissue without surgical incisions. Before joining Profound in 2016, Arun served as the Chairman and CEO of Novadaq Technologies for 13 years, guiding the company from a startup to one of the fastest-growing, NASDAQ-listed medical technology businesses with a market cap exceeding one billion USD. Earlier in his career, Arun served as President of Cedara Software, a company that developed the industry's first medical imaging software platform. Today, it's part of IBM's Watson Health.In this interview, Arun shares insights on building credibility with physicians, the strategic approach to clinical trials that led to their recent Medicare reimbursement coverage, and his vision for transforming the future of surgery beyond prostate cancer.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Arun Menawat.
AI is reshaping the future of medical devices, but innovation brings complexity. In this episode of AI Issue Spotting, Scott Loughlin is joined by fellow Hogan Lovells Medical Device and Technology partners Michael Heyl and Jodi Scott to explore the challenges companies face as AI begins to monitor medical device performance, diagnose conditions, and even deliver patient care. From regulatory hurdles to liability risks, they discuss how medical device manufacturers can navigate this rapidly evolving space. With AI blurring the lines between traditional medical devices and new digital solutions, the discussion highlights what medical device businesses need to know to stay compliant and innovative.
Check out the TIES Sales Showdown at www.tx.ag/TIESVisit The Sales Lab at https://thesaleslab.org and check out all our guests' recommended readings at https://thesaleslab.org/reading-listTo listen to The Sales Lab Podcast on your favorite apps, visit https://thesaleslab.simplecast.com/ and select your preferred method of listening.Connect with us on Facebook at https://www.facebook.com/saleslabpodcastConnect with us on Linkedin at https://www.linkedin.com/company/thesaleslabSubscribe to The Sales Lab channel on YouTube at https://www.youtube.com/channel/UCp703YWbD3-KO73NXUTBI-Q
Send us a textJoin host Aaron Moncur as he sits down with Dr. Stuart Grant, a seasoned med tech innovator with over 25 years of experience at industry giants like Johnson & Johnson and DePuy. Dr. Grant shares his journey from design engineering to founding his own consultancy, offering invaluable insights into medical device development, regulatory challenges, and the future of medical technology.Main Topics:Career progression in medical device engineeringChallenges of starting a medical tech consultancyRegulatory differences across global marketsInnovation strategies in medical technologyAdvice for young engineersFuture trends in surgical robotics and AIAbout the guest: Dr. Stuart Grant is a seasoned expert in the MedTech industry with over 20 years of experience at major companies like Johnson & Johnson and DePuy Synthes. In 2023, he founded Archetype MedTech, a consultancy that helps medical device companies achieve market approval through innovation strategy, technical evaluations, and team training. He holds advanced innovation and project management degrees and is a Chartered Engineer with several medical device patents. In addition to his technical work, Stuart lectures on innovation history and is a visual artist. His international experience and multidisciplinary expertise make him a key advisor for MedTech startups and scale-ups.Links:Dr. Stuart Grant - LinkedIn Archetype MedTech Website The Idea Factory: Bell Labs and the Great Age of American InnovationExactly How Precision Engineers Created the Modern World
Gemma started her career studying Mechanical Engineering at Cardiff University. She quickly discovered the world of Continuous Improvement and spent 20 years working to improve processes and systems within various manufacturing industries including Automotive, Pharmaceutical, Dairy, Cosmetics & Toiletries, Food, and Medical Devices. She has been a CI Manager numerous times and an Operations Manager running a factory of over 500 people.Gemma is hugely passionate about Improvement and developing people and processes. She gets such a kick out of coaching and facilitating, especially when she sees the lightbulb switch on in someone's head – when they solve a problem; when they realize they have the power to change; or when they get excited about all the improvements they could make.In 2019, Gemma left the world of employment to establish her own business, SPARK Improvement, aiming to switch on as many lightbulbs as possible. Her mission is to help organizations and individuals be the BEST they can be, by helping people SEE, helping people THINK, and helping people CHANGE.Gemma is based in Cheshire in the UK, working globally.Link to claim CME credit: https://www.surveymonkey.com/r/3DXCFW3CME credit is available for up to 3 years after the stated release dateContact CEOD@bmhcc.org if you have any questions about claiming credit.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastWhy your resume isn't the make-or-break factor in landing a job, common mistakes people make with resumes, why relationships matter more than the perfect resume, how to show growth and numbers on your resume even if you're not in sales, creative ways nurses and clinical specialists can showcase their skills, how to avoid overloading your resume with too much information, why clarity and simplicity beat long resumes, what sales managers are actually looking for when scanning resumes, the importance of emotional intelligence for younger candidates, and how building relationships beats obsessing over your resumeKey Takeaways:It's not just about the resume. You need to focus on relationship building to stand out.Numbers and percentages showing growth are critical, even if you're not coming from a sales background.You don't need a flashy or overly detailed resume. Clarity and relevance win every time.Nurses, PTs, and clinical backgrounds can show value by highlighting efficiency, patient outcomes, or communication skills.Keep each role on your resume to 2-4 strong points max. Don't overload it with every task you ever did.For clinical specialist roles, patient-facing skills matter more than showing sales numbers.Stop blaming your resume. If you were truly that strong of a candidate, you'd be moving forward regardless.
In this episode, I sit down with my dear friend and Flowpresso founder, Desiree De Spong, for a deep dive into the lymphatic system—and why it's the secret key to modern health. We explore how Flowpresso evolved from a wild idea to a game-changing class 2 medical device, how mechanical compression mimics the body's own fluid dynamics, and why heat, pressure, and vibration can completely reset your nervous system.We unravel the myths around cancer and lymphatic drainage, discuss why chronic stress is the true pandemic, and celebrate the simple acts of grounding, breathing, and reconnecting to your body's natural rhythms. This conversation is rich with gems for anyone looking to heal faster, age gracefully, and thrive in a world that often pulls us away from ourselves.HIGHLIGHTS[02:59] - Why Desiree created Flowpresso: solving for scarcity in lymphatic care[06:54] - Debunking the myth: does lymphatic drainage spread cancer?[11:57] - How Flowpresso's compression system mirrors true lymphatic flow[14:05] - The magic of overlap: why bladder design matters for real drainage[17:18] - Why we push fluid to the heart: the importance of the terminus[19:18] - How gentle heat enhances lymphatic, vascular, and cellular health[21:33] - The FlowVibe tool: facial lymphatics made simple and effective[28:51] - Why daily lymphatic support is essential in today's toxic world[35:38] - Chronic stress: the biggest driver of disease you might be missing[41:45] - Measurable change: shifting fluid from extracellular to intracellular[45:56] - How lymphatic drainage supports wound healing and post-surgical recovery[49:47] - Physical therapy, athletic performance, and the future of healing[53:35] - Why Flowpresso became an FDA Class 2 Medical Device[57:43] - Trauma, memory, and why holding space matters in healing sessionsCONNECT WITH DESIREE DE SPONG + FLOWPRESSOWebsite: https://flowpressousa.com/Instagram: https://www.instagram.com/flowpresso/UPGRADE YOUR WELLNESSBeam Minerals: http://beamminerals.com/beautifullybroken(Use Code: BEAUTIFULLYBROKEN for Discount)Silver Biotics Wound Healing Gel: https://bit.ly/3JnxyDD (30% off)(Use Code: BEAUTIFULLYBROKEN for Discount)StemRegen: https://www.stemregen.co/products/stemregen?_ef_transaction_id=&oid=1&affid=52Code: beautifullybrokenLightPathLED https://lightpathled.pxf.io/c/3438432/2059835/25794Code: beautifullybroken CONNECT WITH FREDDIE Check out my website and store: (http://www.beautifullybroken.world) Instagram: (https://www.instagram.com/beautifullybroken.world/) YouTube: (https://www.youtube.com/@BeautifullyBrokenWorld)
© 2020-2025 Ivy Podcast Discovery LLC
