The MedTech Podcast

Karandeep Singh Badwal
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The MedTech Podcast shares the journey behind the path of the people shaping the MedTech industry and its future. Join me as I connect with industry leaders, thought providers and innovators. Hosted by Karandeep Singh Badwal, Karandeep is a Quality & Regulatory Consultant specialising in the MedTech Industry. If you have any ideas for future episodes or would like to be on the podcast then feel free to connect with me via the links below Follow Karandeep on LinkedIn: https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube: https://www.youtube.com/c/KarandeepBadwal/

  1. #93 How QMSR Is Reshaping U.S. MedTech: ISO 13485, FDA Inspections and AI in Auditing with Dr. Yuan Li

    6 NGÀY TRƯỚC

    #93 How QMSR Is Reshaping U.S. MedTech: ISO 13485, FDA Inspections and AI in Auditing with Dr. Yuan Li

    Dr. Yuan Li, Director of Medical Business at DQS and a former medical device auditor with deep expertise across orthopaedic manufacturing and regulatory systems. In this episode, we discuss the sweeping regulatory transition coming to the U.S. with the introduction of the Quality Management System Regulation (QMSR), which formally aligns 21 CFR Part 820 with ISO 13485. Yuan unpacks what this shift means for U.S.-based manufacturers, why FDA is phasing out the QSR audit model and why contract manufacturers and software-based device firms are particularly vulnerable if they delay planning. We also explore the growing use of AI in QMS platforms, the pitfalls of template-driven compliance, and why “regulatory fatigue” is no excuse when patients’ lives are at stake. From post-market surveillance strategies to paperless QMS migrations and the validation grey zone, Yuan offers pragmatic, deeply informed advice for those navigating FDA audits, ISO certification and international expansion Timestamps [00:02:36] Why QMSR is a Big Deal for U.S. Manufacturers [00:04:09] Key Differences Between 21 CFR 820 and ISO 13485 [00:05:09] Why Companies Wait Too Long to Comply [00:07:19] Impact on Contract Manufacturers and Supply Chains [00:08:36] Do You Really Need ISO 13485 Certification? [00:10:18] AI-Generated QMS Systems: Useful or Risky? [00:11:52] Most Memorable Audit Story: Iterative Design Gone Wrong [00:14:46] How to Spot Proactive vs Reactive Post-Market Surveillance [00:17:03] Why Software Companies Struggle with The Regulatory Mindset [00:20:57] What Validation Really Means Under ISO 13485 Connect with Yuan - ⁠https://www.linkedin.com/in/yuan-li-phd-3bb14013/ Learn more about DQS - ⁠https://www.dqsglobal.com/en/ Get in touch with Karandeep Badwal - ⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠ Follow Karandeep on YouTube - ⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠ Subscribe to the Podcast

    25 phút
  2. #92 From NASA to SaMD: Building Galen Data with Chris DuPont: Risk, Resilience & Regulatory Realities

    24 THG 11

    #92 From NASA to SaMD: Building Galen Data with Chris DuPont: Risk, Resilience & Regulatory Realities

    Chris DuPont, a seasoned MedTech engineer, entrepreneur, and co-founder of Galen Data, which was acquired by Matrix One in late 2024. With a background in aerospace software from NASA and a career dedicated to medical device connectivity, Chris shares a rare behind-the-scenes look at starting a cloud platform with just $600, scaling it into an FDA compliant infrastructure solution and navigating both technical and financial risk. In this episode, we dive into the unexpected similarities between outer space and inner space, how “Twiddler Syndrome” inspired a connected care solution and why the future of SaMD relies on proactive, cybersecure, cloud native design. Chris opens up about managing through the SVB collapse, regulatory war stories from his days at Cyberonics, and what he learned about entrepreneurship that no incubator can teach. From minimal viable features to medical-grade quality systems, this episode is packed with real lessons from a founder who’s seen it all. Timestamps [00:01:05] From Space Station Freedom to Inner Space: NASA to MedTech [00:02:56] Launching Galen Data with Just $600 [00:06:21] Why They Built Their Own Incubator [00:08:36] Fundraising in a Non-VC Town (Houston) [00:11:33] The Silicon Valley Bank Collapse and Business Risk [00:16:25] Twiddler Syndrome and the Birth of a Connected Platform [00:19:35] Cybersecurity and Compliance in the Cloud [00:22:20] FDA Approval Without Reimbursement: A Regulatory War Story [00:24:32] Why Not Every Feature Deserves to Ship [00:29:13] “You Can’t Fake Science”: Betting on Yourself in MedTech Connect with Chris - https://www.linkedin.com/in/chris-dupont-38b5ba15/ Learn more about MatrixOne - https://matrixone.health/ Get in touch with Karandeep Badwal - ⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠ Follow Karandeep on YouTube - ⁠https://www.youtube.com/@KarandeepBadwal⁠ Subscribe to the Podcast

    29 phút
  3. #91 Ending Trial and Error Cancer Care with Jim Foote: Functional Precision Medicine, AI and Personalised Oncology

    3 THG 11

    #91 Ending Trial and Error Cancer Care with Jim Foote: Functional Precision Medicine, AI and Personalised Oncology

    Jim Foote, CEO and Founder of First Ascent Biomedical a pioneer in functional precision medicine (FPM) that aims to eliminate guesswork from cancer treatment. After losing his son to cancer, Jim left a career in cybersecurity to build a data-driven platform that combines AI, robotics and real-time tumour testing to help doctors choose the right therapy for each patient. In this episode, we explore how FPM differs from traditional genomics-only testing, why tumours can respond differently even with the same patient and how AI can support rather than replace clinicians in treatment decisions. Jim also shares the economic impact of ineffective therapies, the challenges of scaling regulatory innovation in oncology, and why the future of cancer care depends on personalisation at the  cellular level. Timestamps: [00:00:45] What Is Functional Precision Medicine? [00:02:00] Jim’s Personal Journey from Tech to Healthcare [00:05:50] Overcoming Regulatory and Systemic Gatekeepers [00:08:13] From Reactive Care to Personalised Treatment [00:09:08] What Lab Findings Reveal about Cancer Cells [00:10:30] Why Genomics Alone Isn’t Enough [00:12:03] AI as Decision Support Not a Decision Maker [00:15:55] Cancer in Younger Populations and Misconceptions [00:20:25] Reducing Cost and Waste in Cancer Treatment [00:26:34] What Success Really Means to Jim Foote Connect with Jim - https://www.linkedin.com/in/jim-foote/ Learn more about First Ascent Biomedical - https://www.linkedin.com/company/firstascentbio/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast

    25 phút
  4. #90 The Metabolic Signal You’re Probably Ignoring with Jari Närhi: NAD Testing, Longevity & Cellular Health

    22 THG 10

    #90 The Metabolic Signal You’re Probably Ignoring with Jari Närhi: NAD Testing, Longevity & Cellular Health

    Jari Närhi, Co-Founder and CEO of NADMED, a University of Helsinki spin-out revolutionising how we understand and monitor NAD levels. With a background in mechanical engineering and a career spanning medtech, diagnostics and hospital operations, Jari brings a unique systems-level view on cellular health and innovation in clinical testing. In this episode, we explore why NAD (nicotinamide adenine dinucleotide) is so vital for human health, from fuelling ATP production to supporting DNA repair and immune regulation. Jari breaks down the science of NAD+, NADH and glutathione and why traditional lab methods like mass spectrometry have long failed to make NAD testing practical or scalable. We discuss the real-world impact of measuring NAD levels, from chronic illness to long COVID, and how this simple test could become as common as checking haemoglobin in the future. Jari also opens up about NADMED’s regulatory journey, the ethical dilemmas of DIY supplementation, the rise of longevity tech, and how AI will transform personalised diagnostics through pattern recognition in metabolic biomarkers Timestamps: [00:00:45] Age vs Disease: What Really Impacts NAD Levels [00:02:28] Why NAD Is Essential for Life [00:03:52] How NAD Decline Signals Deeper Health Issues [00:05:05] From Niacin to NAD: Understanding the B3 Pathway [00:06:00] CE‑Marking and Regulatory Hurdles for Diagnostics [00:06:59] How NADMED Made Testing Faster and More Accessible [00:09:02] The Ethics of Supplementation Without Testing [00:10:16] The VC Path: Funding Deep‑Tech MedTech Innovation [00:14:02] Metabolic Fingerprints and Personalised Medicine [00:17:11] AI, Data and the Future of Longevity Diagnostics Connect with Jari - https://www.linkedin.com/in/jari-n%C3%A4rhi-38b44/ Learn more about NADMED - https://www.nadmed.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast

    26 phút
  5. #89 Reframing Fertility with Kirsten Karchmer: AI, Cycle Health, and FemTech’s Untapped Potential

    6 THG 10

    #89 Reframing Fertility with Kirsten Karchmer: AI, Cycle Health, and FemTech’s Untapped Potential

    Kirsten Karchmer, founder of Conceivable, is one of North America's first reproductive acupuncturists. With a career spanning clinical practice, software development and AI integration, Kirsten brings a fresh, deeply personal perspective to the future of women’s health In this episode, we explore the root causes of infertility and why simply timing intercourse isn’t enough. Kirsten breaks down the concept of the “Conceivable Cycle,” how subclinical symptoms reveal deeper fertility issues, and why most women are misled by generic wellness advice. She also shares the story behind building an AI-powered virtual care platform, one designed not to replace doctors, but to give millions of women access to tools that previously cost tens of thousands in clinical care. We also talk about IVF, when it should be used, and how even women in their 40s can significantly boost fertility outcomes by improving internal health metrics. The conversation ends with Kirsten’s advice to female founders, the role of automation and AI in running a business and how her unexpected obsession with houseplants helps restore balance in a founder's high-stress life Timestamps: [00:00:45] From MS Diagnosis to Reproductive Medicine [00:02:26] Why Fertility Monitors May Be Doing More Harm Than Good [00:04:22] How to Actually Know If You’re Fertile [00:05:00] What the “Conceivable Score” Reveals [00:07:04] Building an AI OS for Women’s Health [00:10:15] Signs of a Healthy vs. Unhealthy Menstrual Cycle [00:13:46] When IVF Makes Sense and When It Doesn’t [00:16:03] Fertility After 35: Misconception or Reality? [00:18:00] The Resistance (and Reception) from Clinicians [00:21:02] Advice for Female Founders and Women in FemTech Get in touch with Kirsten - ⁠https://www.linkedin.com/in/kirsten-karchmer-0139808/ ⁠ Learn more about Conceivable - ⁠https://conceivable.com/⁠ Get in touch with Karandeep Badwal - ⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠ Follow Karandeep on YouTube - ⁠https://www.youtube.com/@KarandeepBadwal⁠ Subscribe to the Podcast

    28 phút
  6. #88 Hydrogel Tech and Lab Automation with Sinan Golhan: Hydrogel Robotics, Startup Fundraising and Battlefield Medicine

    1 THG 9

    #88 Hydrogel Tech and Lab Automation with Sinan Golhan: Hydrogel Robotics, Startup Fundraising and Battlefield Medicine

    Sinan Gölhan, Founder and CEO of GelTech is helping scientists develop life-saving hydrogel treatments faster through automation. From cancer-fighting gels to battlefield-ready biomaterials, Sinan’s journey fuses deep technical insight with an intensely personal mission. In this episode, we talk about why hydrogels, the “Jell-O of medicine”, are so important in modern biotech, and how Sinan’s frustration with repetitive lab work led him to build robotic systems to accelerate testing. He shares hard-won lessons from early fundraising, what labs get wrong about automation, and how he turned rejection into resilience. We also dive into the world of battlefield bleeding control, nanotech-based drug delivery, and the future of AI-driven materials science. Timestamps: [00:00:18] What Are Hydrogels and Why They Matter [00:02:30] A Personal Mission: Cancer, Family and Science [00:04:45] From Lab Frustration to Robotic Innovation [00:06:33] Fundraising Real Talk: Angels, Grants, and Grit [00:10:42] How GelTech’s Platform Actually Works [00:13:33] Hydrogels in Your Fridge and in the OR [00:14:54] Why Lab Automation Isn’t a Luxury [00:16:23] The Coming Wave of Smart Materials [00:20:11] Battlefield Nanotech: Bleeding Control with Gels [00:27:25] Advice to Founders: Obsession, Vision and Persistence Get in touch with Sinan - https://www.linkedin.com/in/sinan-g%C3%B6lhan-a49691b6/ Learn more about Exagen - https://www.geltechlabs.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast

    27 phút
  7. #87 Diagnosing the Undiagnosable with Dr. Brittany Partain: T-Cell Biomarkers, Clinical Trust and Women in Biotech

    5 THG 8

    #87 Diagnosing the Undiagnosable with Dr. Brittany Partain: T-Cell Biomarkers, Clinical Trust and Women in Biotech

    Dr. Brittany Partain, Associate Director of Clinical Affairs and Physician Education at Exagen has a background in biomedical engineering and a passion for problem-solving, Brittany has carved out a unique role at the intersection of diagnostics, clinical education and biotech innovation In this episode, we explore why autoimmune diseases like lupus and rheumatoid arthritis are so difficult to diagnose, and how Brittany is helping close that gap through physician education and the use of novel T-cell biomarkers. We also talk about building trust with clinicians, misconceptions around diagnostic tools, and the real challenges of advancing innovation in a field that’s historically lagging behind specialities like oncology. Finally, Brittany reflects on her journey as a female leader in MedTech, the importance of collaboration, and why passion matters when navigating a fast-paced, highly regulated industry Timestamps: [00:00:45] Why Autoimmune Diseases Are So Difficult to Diagnose [00:01:55] From Biomedical Engineering to Clinical Affairs [00:04:34] Why Rheumatology Has Lagged Behind [00:07:07] How T-Cell Biomarkers Work and What They Solve [00:09:18] What Autoimmune Diseases Are and How They Present [00:11:05] Common Misconceptions Among Clinicians [00:13:00] How Hospitals and Private Clinics React to New Tools [00:15:07] Building Clinical Trust Through Science [00:18:05] What Most People Don’t Know About Autoimmune Disease [00:21:58] Women in Biotech: Breaking Stereotypes and Leading Change Get in touch with Brittany - https://www.linkedin.com/in/brittany-d-partain Learn more about Exagen - https://exagen.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast

    29 phút
  8. #86 Sepsis, Speed and Saving Lives with Dr. Rolland Carlson: Gene Signatures, Clinical Trials, and the Future of Infection Detection

    22 THG 7

    #86 Sepsis, Speed and Saving Lives with Dr. Rolland Carlson: Gene Signatures, Clinical Trials, and the Future of Infection Detection

    Dr. Rolland “Rollie” Carlson, CEO of Immunexpress is a veteran of the molecular diagnostics space. With over 25 years of leadership across Abbott, WaferGen, Asuragen, and more, Rollie is now focused on solving one of healthcare’s most urgent crises: Sepsis. In this episode, we explore why sepsis, despite causing more than 48 million deaths annually remains so poorly understood and misdiagnosed. Rollie breaks down why early detection is so difficult, how gene expression profiling can finally distinguish between infectious and non-infectious inflammation and the real-world barriers to clinical trial design, FDA approval and physician adoption. We also cover military use cases, the lack of gold standards in sepsis diagnostics and what needs to change in how hospitals are incentivised to tackle this condition Timestamps: [00:00:26] Why Sepsis Remains Underdiagnosed Globally [00:01:42] What Sepsis Actually Is and Why It's So Deadly [00:03:14] Who’s Most at Risk: Age, Immunity, and Beyond [00:04:25] Detecting Sepsis Through Gene Expression [00:05:39] Why Blood Cultures Aren’t Enough Anymore [00:09:14] FDA Approval Without a Gold Standard: The Regulatory Maze [00:12:39] Sepsis Isn’t Always Bacterial and Why That Matters [00:15:20] How Physicians Are Reacting to New Molecular Tools [00:17:35] Beyond Sepsis: Expansion Into Infectious Diseases [00:18:57] From Marine Biologist to Diagnostics Pioneer Get in touch with Rollie - https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/ Learn more about Immunexpress - https://immunexpress.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast

    30 phút
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Giới Thiệu

The MedTech Podcast shares the journey behind the path of the people shaping the MedTech industry and its future. Join me as I connect with industry leaders, thought providers and innovators. Hosted by Karandeep Singh Badwal, Karandeep is a Quality & Regulatory Consultant specialising in the MedTech Industry. If you have any ideas for future episodes or would like to be on the podcast then feel free to connect with me via the links below Follow Karandeep on LinkedIn: https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube: https://www.youtube.com/c/KarandeepBadwal/

Thông Tin

  • Nhà sáng tạo
    Karandeep Singh Badwal
  • Năm hoạt động
    2021 - 2025
  • Tập
    93
  • Xếp hạng
    Thô tục
  • Bản quyền
    © Karandeep Singh Badwal
  • Trang web chương trình
    The MedTech Podcast