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This episode features Steven Martin, Chief Technology Officer at TRIMEDX, who shares how health systems can move beyond AI hype to achieve measurable results in medical device management. He discusses the importance of quick ROI, strong governance, and responsible innovation to optimize operations, reduce risk, and align technology with each organization's unique care philosophy.This episode is sponsored by TRIMEDX.
US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, the uncertainty can be alarming. In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers. You'll learn: Which FDA activities continue, and which are suspended How submissions like 510(k), PMA, and De Novo are impacted What happens to clinical trials, recalls, and ongoing investigations Whether this situation has happened before and how long it could last How companies can prepare and what contingency actions to take
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA's Office of Combination Products (OCP). Mark takes us on a deep dive into the history of how combination products have been regulated in the U.S., starting with the Safe Medical Devices Act of 1990 and how the process evolved into the formation of OCP in 2002.We explore questions such as: What challenges did industry and the FDA face in the early days of combination products? How did the “Request for Designation” process come about, and how is regulatory identity determined? What is the “Primary Mode of Action” (PMOA) rule and why does it matter? How do user fees, cross-center coordination, and post-market regulations shape how combination products get to market and are monitored? Mark also highlights current regulatory gapssuch as cross-labeling and site registration issues that continue to impact developers.Whether you're working in med-tech, pharma, or regulatory affairs, this episode offers historical perspective, technical insights, and strategic take-aways for navigating the combination-product space. Tune in for a candid conversation with one of the leading figures in this field.Timestamps:00:00 Introduction & Guest Welcome00:35 Historical Background of Combination Products03:05 Creation of Office of Combination Products (OCP)04:29 Early Challenges and Developments04:54 MDUFA, PDUFA, User Fee Programs & Legislative Impact14:24 Defining Primary Mode of Action (PMOA)18:35 OCP's Role & Responsibilities26:49 Industry Adoption & Challenges38:48 Regulatory Gaps & Future Directions46:00 Conclusion & Contact InformationContact & Resources:Connect with Mark Kramer on LinkedIn or via email at Mark.Kramer@greenleafhealth.comMark Kramer is Principal of the Medical Devices & Combination Products regulatory practice at Eliquent Life Sciences (formerly Greenleaf Health). He has more than 35 years experience at FDA and in regulated industry. At FDA, he established and directed the Office of Combination Products and was a scientific reviewer and later supervisor of the premarket review of devices in a variety of medical discipline areas. Following his FDA career, he served as Regulatory Affairs Executive and Chief Regulatory Strategist at GE Healthcare and then as an independent regulatory consultant for over 10 years before joining Greenleaf. Mark served as a board member of the Regulatory Affairs Professionals Society (RAPS) and in 2021, he was awarded the RAPS Founders Award, the profession's highest honor, recognizing exemplary regulatory professionals who have shaped regulatory policy and practice and have made a positive impact on the profession.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
Sai Ranjith is a quality engineer with over eight years of experience in the medical device industry. He specializes in regulatory compliance, risk management, and product lifestyle quality. In addition to his technical work, Sai has a Six Sigma green belt and is a certified ISO 13485:2016 Medical Device Auditor. He actively contributes to the quality community through ASQ, serving as the program chair for the Granite State Chapter and an active member of the ASQ Quality Management Division. Sponsored by: MAESTRO: The first all-digital, fully connected CMM built for the future.
In-utero procedures can yield better long-term outcomes for the baby. However, fetal surgery relies on instruments developed for other disciplines. An early-stage startup in Maryland is developing in-utero instruments to improve outcomes for both fetus and mother.Fetal Therapy Technologies CEO Selena Shirkin joins Key Tech's Andy Rogers for Episode 42 of the MedTech Speed to Data podcast to discuss startup innovation in fetal surgery.Need to knowFetal surgeries carry risks — In addition to uterine damage complicating future pregnancies, 40% of surgeries have a risk of preterm birth.Few specialized tools are used — In the field's forty-year history, the FDA has only approved the Karl Storz Fetoscope for use in fetal surgeries.Off-label device use is widespread — Equipment borrowed from adjacent fields like laparoscopy and neurosurgery weren't indicated for use in the uterus.The nitty-grittyShirkin and Chief Technology Officer Eric McAlexander founded Fetal Therapy Technologies as students in Johns Hopkins University's biomedical engineering graduate program. While shadowing surgeons, they saw how off-label instruments complicated procedures.“I watched a surgeon using a grasper and suture,” Shirkin recalled. “The suture was falling out of the grasper because they didn't fit. It took time in the surgery to make sure that didn't occur.”Observations like these led the team to wonder why the field lacked optimized tools. “As biomedical engineers,” Shirkin says, “we asked ourselves what if we created those purpose-built instruments that actually make these procedures safer?”They quickly ran into the commercial limits of a market as small as fetal surgery. With only one device FDA-approved for in-uterine procedures, surgeons have no choice but to use devices off-label. So Fetal Therapy Technologies is flipping the script by leveraging the broader applications of an instrument designed for fetal surgeries.“In a way, our company solves two problems at once,” Shirkin says. “A company that creates a fetal innovation [that] also raises a much broader market of general microsurgery.”Their first product is a uterine port. “Similar to laparoscopic surgeries,” Shirkin explains, “that involves inserting a port through the abdomen into the uterus. [The new] port is designed to leverage the elastic properties of the uterine environment to make entry safer than the current clinical standard.”For broader commercialization, they aim to demonstrate equivalence to predicate devices and qualify as a 510(k) Class II device following benchtop and animal studies. Approval for fetal surgeries is a longer journey, but the company can build on its data before entering human trials.Data that made the difference:Shirkin offered insights for other students considering an entrepreneurial future in MedTech.Leverage university resources. “We work incredibly closely with the Johns Hopkins Center for Fetal Therapy,” Shirkin says. We've also gotten opportunities from Johns Hopkins Technology Ventures.”Build a network of advisors. “We are supported by a very broad variety of clinical, technical, and business mentors across the Johns Hopkins ecosystem and beyond.”Tap into local funding sources. “There's a lot of collegiate business plan competitions that we've been very successful [raising] non-dilutive funds that way. There are also state-level grants. We just received a Baltimore Innovation Initiative grant.”
Podcast: The Industrial Security Podcast (LS 35 · TOP 3% what is this?)Episode: Medical Device Cybersecurity Is Tricky [The Industrial Security Podcast]Pub date: 2025-10-28Get Podcast Transcript →powered by Listen411 - fast audio-to-text and summarizationYes the device has to be safe to use on patients, and yes it has to produce its results reliably, but patient / data confidentiality is also really important. Naomi Schwartz of Medcrypt joins us to explore the multi-faceted world of medical device cybersecurity - from MRI's to blood sugar testers.The podcast and artwork embedded on this page are from PI Media, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
Yes the device has to be safe to use on patients, and yes it has to produce its results reliably, but patient / data confidentiality is also really important. Naomi Schwartz of Medcrypt joins us to explore the multi-faceted world of medical device cybersecurity - from MRI's to blood sugar testers.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
The following article of the Health industry is: “Mexico Cancels Drugs, Medical Devices Tender. What's Next?” by Juan Luis Serrano Leets, Partner Life Science, Garrigues.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Kate Dilligan, CEO of Cooler Heads.Cooler Heads is a commercial-stage company addressing a problem affecting many chemotherapy patients undergoing treatment for solid tumors: hair loss and the loss of privacy that comes with it. The company's FDA-cleared medical device, Amma, makes scalp cooling accessible by fitting into infusion center workflows rather than disrupting them.Kate brings an unconventional background to medtech — from political fundraising to developing classified software for the U.S. government. As a solo female founder who had never worked in hardware, she started Cooler Heads in 2018 after her own experience with breast cancer. By mid-2025, the company had raised $11 million in Series A funding and placed devices across 27 states, with most accounts having never offered scalp cooling before.In this interview, Kate shares how to design for health system adoption by solving workflow problems first, why saying “no” to scope creep protects your first-generation product, and how political fundraising tactics translate directly to building investor relationships in medtech.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 Kate Dilligan.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Young Juhn, CEO of Wellysis.Wellysis is the Samsung spinout behind S-Patch, a lightweight wearable that enables long-term ECG monitoring without the discomfort of established cardiac monitoring devices.Young has spent more than two decades bridging hospital and home-based care — from his early career at Johnson & Johnson, to more than a decade at Kaiser Permanente, to leading healthcare innovation at Samsung before spinning out Wellysis in 2019.In this interview, Young shares why patient interviews should shape product design, how regulatory clearance is just the starting point for global commercialization, and why building a medical foundation before branching into consumer markets is critical for lasting 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 Young Juhn.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
The barriers to market entry for medical devices -- everything from hearing aids to MRI machines -- here and abroad are significant. Some researchers suggest that more than 95 percent of proposed medical device innovations fail to launch. Host Llewellyn King and Co-host Adam Clayton Powell III talk to Alex Gorrie, founder and CEO of London-based Dromeda.ai.
Send us a textMedicaid covers nearly 90 million Americans, but coverage doesn't always equal health.What if the real driver of outcomes isn't the doctor's office or an app, but the communityitself?In this episode of CareTalk Executive Features, WiderCircle co-founder and CEO Darin Buxbaum joins David Williams to share how peer-led circles and community engagement are improving health outcomes, boosting member trust, and delivering value for health plans.
Intricon specializes in designing, molding, and assembling some of the smallest and smartest components in the medical device industry. Our guest, Jay Tavakolian, Operations Program Director at Intricon, shares insights into the precision, scalability, and innovation behind building micro medical devices that serve critical applications in surgical navigation, wearables, diagnostics, and therapeutic technologies. The conversation dives into the opportunities and challenges of working at the micro scale—from molding and tooling to advanced automation and 3D manufacturing techniques. Discover how Intricon enhances production capacity while minimizing risk, ensuring that every device meets the highest medical standards.Sponsored By:
This episode tackles the often-overlooked but critical topic of medical device reimbursement. Host Etienne Nichols speaks with Haley King, co-founder and CEO of Paxos Health, about why this process is just as vital as FDA approval for a device's commercial success. They explore the journey a medical device takes, highlighting the distinction between FDA approval and securing reimbursement from payers.Haley explains the three key pillars of reimbursement: coding, coverage, and payment. She delves into the complexities of CPT codes and the significant difference between a temporary Category 3 code and the gold-standard Category 1. The discussion also covers the immense challenges medical device companies face, including the lengthy timeline—sometimes years—to secure payer coverage, which can be a make-or-break factor for startups. The conversation wraps up with a look at how artificial intelligence is beginning to streamline the cumbersome, manual process of patient access and appeals.Key Timestamps1:45 - The initial challenge of making coverage match medical need.3:30 - The three-part reimbursement pathway: coding, coverage, and payment.5:50 - Navigating CPT codes and the difference between Category 1 and Category 3.10:15 - Common challenges for medical device companies seeking payer coverage.13:20 - The multi-year timeline to achieve Medicare coverage for innovative devices.15:00 - Advice for regulatory and quality professionals on speeding up reimbursement.20:10 - How AI is currently being used in patient access and reimbursement.24:45 - Debating the accuracy of AI and its role in replacing human expertise.Quotes"A lot of times patients are not going to be able to pay out of pocket for expensive medical treatments, and a lot of times providers are not going to be able to write off those treatments on their side. So somebody needs to pay for this. And that's usually the health insurance companies..." — Haley King"I think that for this sort of a use case [AI], you're always going to want some human in the loop... AI has the potential to be super, super powerful in this space, but I think you're always going to want to have human experts involved." — Haley KingTakeawaysIntegrate reimbursement strategy early: Unlike FDA approval, which focuses on safety and efficacy, payers also demand evidence of a device's clinical and economic value. Medical device companies, particularly startups, should integrate reimbursement planning into their pitch decks and product development timelines from the outset.Recognize the two-step process: FDA approval is not a golden ticket to reimbursement. Companies must understand the subsequent and often lengthy process of securing coding, coverage, and payment from payers like CMS and private insurance companies, which can take several years.Enhance clinical trials for payers: Regulatory and quality professionals can speed up the reimbursement process by designing clinical trials that not only meet FDA requirements but also generate robust data to prove a device's clinical and economic value. This may involve including additional endpoints to justify the cost.Harness AI for efficiency, not replacement: AI is a powerful tool for automating the tedious parts of reimbursement, such as sifting through patient records and payer policies. However, it should be viewed as a way to enhance, not replace, the work of human experts who can handle complex edge cases and appeals.Be aware of coding complexities: The distinction...
In this conversation, I talk with Jason Scherer, the CEO and founder of VitaTek, to learn about the innovative approach his company takes in the medical device manufacturing industry. He shares insights on the challenges faced with bringing medical devices to market, the importance of technology in reducing healthcare costs, and the experiences of innovators in the field. The discussion also touches on the future of robotic surgery and AI, as well as the investment risks associated with medical device development. We hope you enjoy the show! Godspeed. ~ James 00:00 Introduction to Vita Tech Group 02:22 The Stages of Medical Device Manufacturing 05:14 Challenges in Medical Device Development 08:21 Innovative Solutions in Medical Device Production 11:01 The Impact of Technology on Healthcare Costs 13:58 Future of Robotic Surgery and AI 16:31 Navigating the Medical Device Market 18:54 The Role of Innovators in Medical Devices 21:45 Investment and Risk in Medical Device Development 24:25 Conclusion and Future Outlook
Jacques the Party Scientist is Bringing Joy to the WorldJacques The Party Scientist ditched his career in pharmacology to, among other things, develop the Joy Bootcamp, the first joy-based leadership retreat. We chatted about his corporate life in Medical Devices (something we have in common), his transition to self-employment, and the ways in which he uses speaking to spread his message of joy.To learn more about the Party Scientist and Jacques, visit https://thepartyscientist.com/__TEACH THE GEEK (http://teachthegeek.com) Prefer video? Visit http://youtube.teachthegeek.comGet Public Speaking Tips for STEM Professionals at http://teachthegeek.com/tips
Medboard Europe TToo much Incomplete Tech File - Let's explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf 2025/1920 on Master UDI-DI - Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920 Borderline manual Update - New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf red blood cell additive solutions containing adenine dual action cream with menthol and capsaicin Lactose tablets for vaginal use microabrasion dental stain removers medical examination table covers Mobile sterile air system EU asks your feedback on EU MDR and IVDR - Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en Switzerland Swissdamed Technical Documentation - XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf UK UK PMS guidance for Report - Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report Magazine Issue 1: Sept/Oct 2025 - Next one will come November 2025: https://easymedicaldevice.com/emd-mag/ Events Medtech Conf events - Be listed on the MAP: https://medtechconf.com/events-map-2/ EasyIFU Free trial for eIFU with EASYIFU - Compliant EU 2025/1234: https://easyifu.com ROW US FDA Computer System Assurance - SOP offered on the show notes: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0 Malaysia affiliate member of MDSAP - What does it change?: https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist Egypt guidance to import your devices - Medical Devices, Accessories, IVD: All type of devices: https://edaegypt.gov.eg/media/lafopofx/1-regulatory-guideline-of-issuance-of-import-approvals-of-all-types-of-medical-devices_gd.pdf Medical Equipment and Accessories: https://edaegypt.gov.eg/media/fltnd1qc/4-regulatory-guideline-of-issuing-import-approvals-for-medical-equipment-and-their-accessories_gd.pdf IVD: https://edaegypt.gov.eg/media/e2rf4qg5/2-regulatory-guideline-of-the-procedures-and-rules-of-obtaining-import-approvals-for-iaboratory-and-diagnostic-equipment-gd.pdf Podcast Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/ Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/ Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/ Easy Medical Device Service Support for Consulting (QA RA projects) Support for Authorized Representative and Market Access Integration to an eQMS 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
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Josh Vose, CEO of Tulavi Therapeutics.Tulavi is advancing hydrogel-based implants like the allay Hydrogel Cap, which is designed to optimize nerve injury recovery and reduce the risk of neuroma formation.Josh is a physician, engineer, and entrepreneur with more than 20 years of experience in medical devices. He has held leadership roles at Medtronic following its acquisition of PEAK Surgical and drove growth at startups including SIA Health, which he led through commercialization and acquisition by Integra LifeSciences.In this interview, Josh shares why defining the clinical problem with absolute clarity is the foundation of medtech success, and how leaning into the harder regulatory path can create lasting moats.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 Josh Vose.
Pharmac believes it makes sense to leave the day-to-day stuff to Health NZ. The Associate Health Minister and Minister Simeon Brown have jointly announced the national agency and drug-buyer can both procure medical devices. Pharmac will focus on more-technical equipment —due to its level of clinical input and assessment— and Health NZ on bulk-buying standard items. Pharmac Chair Paula Bennett told Mike Hosking it clears up uncertainty around who does what. LISTEN ABOVE See omnystudio.com/listener for privacy information.
In this episode, host Etienne Nichols sits down with Jose Bohorquez and Mohamad Foustok from CyberMed to dissect the complex world of Software as a Medical Device (SaMD) and cybersecurity. They emphasize that SaMD is first and foremost a medical device and should be treated as such from the very beginning of the development process. The conversation highlights the most common mistakes companies make, like treating security as an afterthought and jumping straight into coding without a solid architectural plan.Mohamad Foustok introduces the concept of "zero trust" and the critical importance of designing for security across the entire product lifecycle, from initial concept to post-market surveillance. The discussion clarifies that cybersecurity is not limited to network-connected devices but applies to any medical device with a software function, regardless of its connectivity. They also touch on the historical context of FDA guidance, noting a significant shift in recent years that has raised the regulatory bar and put a greater emphasis on robust cybersecurity documentation.The guests provide actionable advice for MedTech professionals, stressing the value of a balanced approach that integrates security and functionality from day one. They explain that a well-thought-out process, though seemingly slower at the outset, ultimately saves time and resources by preventing costly and time-consuming redesigns later on. This episode serves as a vital guide for anyone looking to build a secure and compliant medical device in today's evolving regulatory landscape.Key Timestamps[01:50] Common pitfalls in developing SaMD, including overlooking regulatory guidance like IEC 62304.[03:20] The critical mistake of treating cybersecurity as an afterthought in product development.[05:00] Who cybersecurity applies to beyond software, including patients, manufacturers, and supply chains.[06:30] The FDA's stance on cybersecurity for any device with a software function, even if not network-connected.[08:00] A discussion on "reasonable assurance of cybersecurity" and what it means for manufacturers.[10:00] The "zero trust" principle and why you should never assume a network is secure.[14:00] How hospitals and other stakeholders are demanding more rigorous cybersecurity standards.[15:40] The ideal process for a "security-first" development lifecycle.[21:00] Why rushing development without a proper architecture can lead to significant delays and cost overruns.[23:00] A brief history of FDA's cybersecurity guidance and the major shift in 2023.Quotes"Software as a medical device ultimately is a medical device, and so you want to be developing it from the get-go with that mindset." — Jose Bohorquez"Security can't be an afterthought. You have to consider security at the inception of your approach to a product." — Mohamed FustokTakeawaysA "Security-First" Mindset is Essential: Integrate cybersecurity from the initial architectural phase of your project. This proactive approach saves significant time and money by avoiding costly redesigns and delays later in the development process or after an FDA submission.Cybersecurity is for All Software-Driven Devices: Don't assume that only cloud-connected devices need cybersecurity documentation. The FDA requires documentation for any device with a software function, including embedded systems and programmable logic, even if it's not connected to a network.Regulatory Compliance is a Process, Not a...
Prashant Yadav joins Tommy to talk about what does this mean for our healthcare system?
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comToday we have the pleasure of having Mr. James Watkins who went from being an Associate Sales Rep all the way a former Vice President at Medtronic. He goes into his journey on how he was able to break in and the journey it took to make it to VP
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comToday we have the pleasure of having Mr. James Watkins who went from being an Associate Sales Rep all the way a former Vice President at Medtronic. He goes into his journey on how he was able to break in and the journey it took to make it to VP
In this episode of the Medical Sales Podcast, Samuel Adeyinka sits down with Kat Hurd, medical device sales coach and former Fortune 500 leader with 15 years of experience. From athletic training to rep of the year, to VP-level leadership and now founder of her own coaching business, Kat's journey is proof that you don't need a biology degree to thrive—you need grit, process, and the right mindset. Kat shares the pivotal moment that led her to leave corporate leadership and launch her coaching business, why so many reps fail without a clear sales process, and the three biggest gaps she sees holding reps back: lack of process, lack of ownership, and inconsistent follow-through. She also unpacks the truth about work ethic, limiting beliefs, and how managers can spot red flags before making a bad hire. Whether you're trying to break into med device, hit President's Club, or grow into leadership, this episode is packed with real-world strategies from someone who's been a top rep, a respected leader, and now a coach guiding the next generation of sales professionals. Connect with Kat Hurd: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today!
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Ahmed Elmouelhi, CEO of TRiCares. TRiCares is developing Topaz, the first purpose-built transcatheter tricuspid valve replacement system — a technology designed specifically for the right side of the heart, where complex anatomy has made durable solutions elusive.Ahmed is a 20-year medtech veteran with leadership experience across electrophysiology, men's health, neuromodulation, and structural heart. Before joining TRiCares, he helped build multiple businesses at AtriCure and held key roles at Medtronic during the early days of TAVR. He also serves as Chairman of the American Heart Association in Minnesota.In this interview, Ahmed shares why adoption — not added complexity — is the ultimate measure of medtech innovation, how a small group of physician champions can accelerate clinical studies faster than internal resources alone, and why treating your board like collaborators in the “sandbox” leads to stronger partnerships and better outcomes.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 Ahmed Elmouelhi.
This episode with Stuart Grant of Archetype MedTech demystifies the "front end of innovation," a critical yet often overlooked phase of medical device development. Stuart, a seasoned MedTech veteran with over two decades of experience at Johnson & Johnson, shares insights from his doctoral research on this topic. He breaks down the process, defining the front end as the crucial period between applied science and new product development, where teams identify unmet clinical needs and shape a product concept. This conversation offers a clear roadmap for balancing creativity with structure, using the Design Council's Double Diamond model and Stuart's 10 key insights for observing user behavior.Stuart Grant's discussion on the front end of innovation highlights the importance of deeply understanding the user and the environment in which a device will be used. He introduces a number of tools and techniques, such as the Pugh Matrix and the NVivo software, to help teams transition from a broad exploration of ideas to a focused, viable product concept. Stuart explains that while the front end may seem "fuzzy," it can be a systematic process that uncovers the true clinical and market needs that will determine a product's success. He emphasizes that the most successful devices aren't just incrementally better, but are born from a deep understanding of customer insights.This episode is an essential guide for anyone involved in MedTech innovation, from academic researchers to seasoned engineers. Stuart's insights challenge the conventional reliance on key opinion leaders and provide a framework for a more holistic, user-centric approach. He outlines how to identify and interpret subtle user behaviors, from workarounds and unconventional uses to unspoken frustrations, all of which are critical for developing a truly impactful and user-friendly medical device. Whether you're at the very beginning of a project or looking to improve your current innovation process, this episode provides actionable strategies to bridge the gap between a great idea and a marketable product.Key Timestamps(2:00) Defining the "Front End": Stuart explains what the front end of innovation is and why its name has evolved from the "fuzzy front end."(8:00) The Double Diamond Model: An explanation of the UK Design Council's Double Diamond, illustrating the divergent and convergent phases of problem-solving.(12:30) Common Pitfalls: Discussing the three critical questions to answer: Is there a market (viability)? Is the technology possible (feasibility)? Do users want it (desirability)?(15:00) Balancing Creativity and Structure: The roles of different team members and how to manage the creative (divergent) and critical (convergent) phases of innovation.(21:00) 10 Ways to Find User Insights: Stuart breaks down the specific techniques and red flags to look for when observing users, including workarounds, affordances, and areas of disjuncture.(26:00) The Problem with KOLs: Why relying solely on key opinion leaders can be a mistake and the importance of observing a wider range of users.(30:00) Triggers of Use: How unconventional uses of a device can reveal new product opportunities.Standout Quotes"A craftsman will build you exactly what you ask for. An artist will build you what you didn't know you need." - Etienne Nichols"You don't just do what the customer says because that could lead to a terrible product." - Stuart GrantTakeawaysObservation is Key: Go beyond interviews. The most valuable insights come from observing users in their natural environment,...
In this episode of Dare to Disrupt, host Ryan Newman speaks with Robert Chisena, co-founder and CTO of Amplitude Vascular Systems (AVS). AVS is a medical device company focused on safely and effectively treating severely calcified arterial disease. Robert shares his journey from growing up on Long Island in a family of physicians, to discovering his passion for research and entrepreneurship at Penn State, to co-founding an innovative medical device startup.Robert reflects on formative experiences at Penn State, including joining the Schreyer Honors College, diving into biomedical engineering research, and participating in Invent Penn State's first cohort of the Summer Founders Program. He then traces how his graduate work at the University of Michigan—collaborating closely with physicians—led to the development of AVS's intravascular lithotripsy technology, a novel approach to restoring blood flow in hardened arteries.Along the way, Robert discusses the challenges of taking research from lab to market, securing venture capital, and convincing physicians of a new device's safety and efficacy.Later in the episode, Penn State Ph.D. Candidate Marzia Momin joins the conversation. Marzia is working on a neuro-tech startup developing personalized, 3D-printed neural implants for neurological disorders, with applications in therapy and brain-computer interfaces. Marzia recently participated in both the Invent Penn State NSF I-Corps regional short course program and the NSF I-Corps National Teams program. She asks Robert about how to build the best startup team, raising funding as a research-based startup, and what advice he'd give to his younger self.This episode gives an inside look at the intersection of engineering, medicine, and entrepreneurship — and how Penn State alumni are driving innovation in healthcare.Episode Chapters1:30 No avoiding a medical-based career3:25 Choosing and navigating Penn State05:42 Exploring research as an undergrad at Penn State8:24 Launching first medical device startup at Penn State, Summer Founders Program11:54 Moving forward with startup through graduate school at Michigan14:43 Meeting co-founder, learning about the tech behind AVS16:07 The potential to create tremendous impact in cardiovascular disease treatment19:43 Translating and commercializing research out of a university20:49 Where AVS is today, looking to the future22:45 Rapid Fire Round24:27 Student Section25:13 Building the right startup team27:15 Filling in the blanks of business acumen28:04 Advice for securing early funding29:57 Navigating FDA regulations31:02 Advice for aspiring entrepreneursAbout Robert ChisenaRobert Chisena is the co-founder and CTO of AVS. He graduated from the Penn State College of Engineering with a bachelor's degree in mechanical engineering with honors from the Penn State Schreyer Honors College. Robert went on to receive his Ph.D. in mechanical engineering at the University of Michigan.About Marzia MominMarzia Momin is a Ph.D. candidate in the Engineering Science and Mechanics Department at Penn State, specializing in neural engineering. She is working on a neuro-tech startup developing personalized, 3D-printed neural implants for neurological disorders, with applications in therapy and brain-computer interfaces. Marzia recently participated in both the Invent Penn State NSF I-Corps regional short course program and the NSF I-Corps National Teams program The Dare to Disrupt podcast is made possible by the generous support of the Penn State Smeal College of Business.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastToday we get to learn from Cade Cook who broke into Medical Device Sales right out of college with a distributorship! Today he goes over the difference of working at a distributorship and a Large Medical Device CompanyHe also shares why he pursued Medical Device Sales over nursing and how he has been able to change his life because of it
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastToday we get to learn from Cade Cook who broke into Medical Device Sales right out of college with a distributorship! Today he goes over the difference of working at a distributorship and a Large Medical Device CompanyHe also shares why he pursued Medical Device Sales over nursing and how he has been able to change his life because of it
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Marc Penna, CEO of Voyager Biomedical. Voyager is a clinical-stage company tackling one of the most persistent challenges in dialysis care: reliable vascular access. Marc has more than 20 years of experience leading clinical research and regulatory programs across cardiology, vascular disease, and oncology. Since 2014, he has focused on early-stage ventures, with leadership roles at Intact Vascular and Vesper Medical — both acquired by Philips — as well as senior positions at Edwards Lifesciences, Boston Scientific, and AngioDynamics.In this interview, Marc shares how to pressure-test new medtech ideas, why collaboration with regulators and trial sites builds lasting credibility, and how disciplined fundraising and smart exit planning can set startups apart.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 Marc Penna.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Episode 313 hosts Dr Konstantin Frank (Aesthetic Doctor from Regensberg, Germany) In our ‘Masterclass Series' we host global experts to teach us about fillers, bio-stimulators, bio-remodellers, polynucleotides, exosomes and other products. (For toxin insights, check out our other mini-series, ‘The Tox Talks') In Chapter 9 we do something different by discussing the entire range of fillers made by Croma. We learn about who Croma are, get an understanding about their portfolio of products and what features to look out for when choosing a filler. 00:00 Introduction to Inside Aesthetics 00:46 Live from the Fresh Life Conference 01:08 Masterclass Series: Fillers Discussion 02:22 Introducing Dr. Konstantin Frank 03:44 Exploring the Aesthetic Industry in Europe 05:59 Dr. Konstantin's Background and Journey 10:05 Deep Dive into Croma Fillers 20:37 Manufacturing Insights and BDDE Discussion 27:30 Croma Fillers: Unique Selling Points 29:23 Differences in Syringe Design Between Europe and Australia 29:51 Colour Coding and Safety in Injectables 30:05 Regulatory Approvals and Quality Control 30:48 Medical Devices vs. Drugs: A Legal Perspective 31:28 Minimally Invasive Procedures and Safety 31:48 Using Croma Products: A Detailed Guide 34:21 Tips for Practitioners Using New Products 36:59 The Importance of Proper Training and Education 37:19 The Role of Anatomy in Successful Injections 47:08 The Impact of Social Media on Aesthetic Medicine 51:27 Global Perspectives on Aesthetic Practices 56:29 Concluding Thoughts and Future Episodes NEW - WATCH THIS EPISODE ON YOUTUBE NEW - OR WATCH THIS EPISODE ON SPOTIFY CHECK OUT OUR PATREON & GET A 7 DAY FREE TRIAL ACCESS THE IA OFFER MENTIONED IN THIS PODCAST (& use the discount code IA10) CLICK HERE IF YOU'RE A BRAND OR COMPANY & WANT TO WORK WITH US CLICK HERE TO APPLY TO BE A GUEST ON OUR PODCAST CONTACT US
Sales legend and trainer Steve Gielda—co-founder of Ignite Selling—joins Samuel to break down what truly drives performance in medical device, pharma, biotech, and diagnostics. Steve traces his path from selling 3M copiers out of a van to leading life-sciences consulting with Neil Rackham (of SPIN Selling) and building Ignite's simulation-based, gamified training that accelerates pipelines and product launches. We get tactical fast: how today's top reps think strategically, map real stakeholders (beyond the “friendly” contacts), and use smarter questions that challenge clinical and business assumptions—not just needs. Steve explains when SPIN still shines, where Challenger-style questions raise the bar, and why role-playing strategy is as critical as role-playing the call. For frontline managers, Steve lays out the playbook: coach early in the pipeline, ask more than you tell, know when to sell vs. when to coach, and—yes—let your reps fail on safe calls so they learn to win without you. We dive into work ethic vs. knowledge, turning average reps into top performers, and the signals that a high producer is (or isn't) ready for leadership. If you want practical frameworks to sharpen your questioning, focus your account strategy, and elevate your team's coaching culture, this episode delivers candid insights you can apply on your very next call. Connect with Steve: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today!
bersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals for evidence. In this article (based on the podcast episode), we explore: How to prepare cybersecurity documentation for audits and inspections Building post-market processes for vulnerability handling and reporting Linking cybersecurity with standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001…) Managing supplier and open-source component risks Implementing and maintaining an SBOM Key trends like the NIS2 Directive and the EU AI Act
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastGot the opportunity to sit down with Dr. Brian Blackwood and discuss what he looks for in his reps. Dr. Brian Blackwood is a board-certified orthopedic expert who specializes in joint replacement of the hip and knee, including Mako SmartRobotics™ joint replacement. With extensive training in the latest joint replacement and revision techniques, Dr. Blackwood is dedicated to providing the advanced orthopedic care his patients need to get back to an active lifestyle.In addition to being Boulder's first fellowship-trained hip and knee replacement specialist, Dr. Blackwood is a nationally renowned robotic-assisted total joint surgeon. By specializing in this minimally invasive technique, he is able to reduce pain, restore mobility, and promote a quick return to normal activities for patients suffering from joint pain. Dr. Blackwood is also a certified national educator for robotic-arm assisted surgery and has trained hundreds of other providers in this technique.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastGot the opportunity to sit down with Dr. Brian Blackwood and discuss what he looks for in his reps. Dr. Brian Blackwood is a board-certified orthopedic expert who specializes in joint replacement of the hip and knee, including Mako SmartRobotics™ joint replacement. With extensive training in the latest joint replacement and revision techniques, Dr. Blackwood is dedicated to providing the advanced orthopedic care his patients need to get back to an active lifestyle.In addition to being Boulder's first fellowship-trained hip and knee replacement specialist, Dr. Blackwood is a nationally renowned robotic-assisted total joint surgeon. By specializing in this minimally invasive technique, he is able to reduce pain, restore mobility, and promote a quick return to normal activities for patients suffering from joint pain. Dr. Blackwood is also a certified national educator for robotic-arm assisted surgery and has trained hundreds of other providers in this technique.
Medboard EUROPE Guidance on the implementation of the Master UDI-DI - MDCG 2024-14 - rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf Updated - Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf There's a significant backlog: far more applications submitted than certificates issued, especially for IVDs. Time for certification: between 13 to 18 months on average Delay due to application missing critical information and refusal due to submission outside NB scope No transparency on capacity Germany new radiation protection regulation - Start July 1st, 2025: https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Strahlenschutz/_artikel.html?nn=986770If device emit radiation and need clinical investigation in germany: Include a radiation risk assessment in your clinical investigation dossier Coordinate with Radiation protection authorities Update investigator brochure and patient information Stricter Monitoring & Reporting Impact on Timelines So stricter documentation, more authorities involved and longer approval times UK MHRA launches Route B notification pilot Clinical trials regulations rollout: https://www.gov.uk/government/news/mhra-launches-route-b-notification-pilot-as-part-of-clinical-trials-regulations-rollout - https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device Switzerland New in Swissdamed - Medical Device registration with UDI Device Module: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-mepprodukte-moeglich.html 1 july-2026 Magazine Easy Medical Device Mag - Your QA RA Magazine: https://mailchi.mp/easymedicaldevice/emdmag1 Podcast: Best 40 Medical Device Podcast - Thanks: https://www.millionpodcasts.com/Medical-Device-podcasts/ REST OF THE WORLD SaMD and/or Artificial Intelligence on the spotlight - All countries want their regulation on it: USA: PCCP - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence SFDA: Workshop September 9th: https://www.sfda.gov.sa/en/workshop/4387139 TGA: Understanding regulation of software-based medical devices: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices#samd-and-ai-medical-device-compliance SAHPRA: Regulatory Requirements of AI/ML: https://www.sahpra.org.za/document/regulatory-requirements-of-artificial-intelligence-and-machine-learning-ai-ml-enabled-medical-devices/ Medical Device or Wellness device - Choose your side: https://www.sfda.gov.sa/sites/default/files/2025-08/MDS-G027.pdf
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Christopher Haig, co-founder and CEO of Efemoral Medical. Efemoral is developing bioresorbable scaffold technology for peripheral arterial disease. Chris has over 25 years of experience in cardiovascular devices, holding leadership roles at strategics including Guidant Corporation and Abbott Vascular, and driving growth at startups such as Calypso Medical and QT Vascular, where he built commercial infrastructure and launched multiple products ahead of its $55 million IPO.In this interview, Chris shares how bioresorbable scaffold technology found new life for peripheral arterial disease — and the lessons on matching tech to significant needs and choosing trial sites for lasting data.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Christopher Haig.
We're at the ACPA Annual Meeting with returning guest and CozeeCoo founder and CEO Jennifer Stelmakh. Born from her real life frustrations with medical solutions and interventions, Jennifer created CozeeCoo, a thoughtfully designed surgical recovery vest that keeps little arms safe and healing cozy while finally replacing stiff elbow restraints. Jennifer shares how the energy and collaboration at ACPA fuel her passion for innovation and community impact. Tune in as she reveals new CozeeCoo updates, what she's learned on her entrepreneurial journey, and why the annual meeting remains critical to transforming support for cleft families everywhere. Links and Resources: Patreon Subscription Tiers for Exclusive Content Our Forever Smiles Merch Store NC Cleft Mom FB Group Our Forever Smiles FB Group ______________________________________________________________________________ Today's sponsor is sienna dawn media Integrated Marketing Agency sienna dawn media is more than just a marketing agency—they are your partners in progress. Their mission is simple — to alleviate marketing bandwidth, allowing creative business owners to focus on what they set out to do: create. sienna dawn media empowers creatives to thrive without the burden of managing their own social media and marketing campaigns. So, if you're ready to set sail toward new horizons, let sienna dawn media chart the course and steer your business toward success. Visit siennadawnmedia.com.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastTired of hearing it's “impossible” to break in at six figures? Jacob shares the truth behind high-paying entry roles in medical device sales and why most reps are giving you bad advice. If you're aiming for a $100K+ starting salary, this episode gives you the mindset, strategy, and real-world insight to make it happen—no fluff, no excuses.00:00 - Start01:05 - When It's OK To Get Hired Under 100K04:15 - Do Your Research12:56 - Be Strategic16:27 - Expand The Expectations18:45 - Overall Advice
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastWhat's the real difference between people who break into medical device sales at $60K and those who land $160K jobs straight out the gate? In this episode, Jacob unpacks what separates average from elite. From mindset to coachability to who you're listening to. If you're tired of feeling stuck or settling for less, this episode is your wake-up call.00:00 - Start01:33 - What Is Average03:48 - Develop A Healthy Circle Of People06:42 - Being Coachable09:50 - Invest In Yourself11:38 - Don't Do It All Alone14:29 - Average Thoughts vs Top Performer Thoughts
A medical sales rep blows the whistle on an alleged kickback scheme where he says a company bribed staff at a Veterans Affairs hospital to buy unnecessary medical devices at taxpayer expense, and use them in medically unnecessary procedures on veterans. The company and doctors dispute the allegations and deny any wrongdoing.Order Sharyl's new bestselling book: “Follow the $cience.” Subscribe to my two podcasts: “The Sharyl Attkisson Podcast” and “Full Measure After Hours.” Leave a review, subscribe and share with your friends! Support independent journalism by visiting the new Sharyl Attkisson store.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
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