The MedTech Podcast

Rick Bente, co-founder and CEO of Indomo, the company behind ClearPen, an investigational at home corticosteroid injection for inflammatory acne. Rick brings over two decades of experience in drug delivery and diagnostics with previous roles at Medtronic, Insulet and YourBio.In this episode we trace Rick’s journey from insulin pumps, large volume wearable injectors and remote blood collection to tackling one of the most common yet under-served conditions in medicine: acne. Rick explains why dermatology has seen far less innovation than fields like diabetes, why 40 percent of acne sufferers in the US live with deep inflammatory lesions that topicals simply cannot reach and how ClearPen aims to replicate in-clinic injections safely in the home.We dig into how dermatologists and GPs perceive acne severity, the mental health burden of adult acne and why telehealth has become a critical tool when wait times to see a dermatologist can exceed three months. Rick also unpacks the technical and regulatory complexity of combination products, from tying drug and device design histories together to generating RCT-grade evidence that satisfies regulators, payers and prescribing physicians.Finally, we talk about the realities of building a direct-to-patient model in a regulated market, balancing unmet patient need with the gatekeeping role of clinicians and insurers, and Rick’s own transition from corporate engineer to founder. He shares candid lessons on focusing beyond the patient to the full healthcare ecosystem, designing devices that are “hard to misuse” and why turning ideas into reality ultimately requires taking the leap.Timestamps[00:00:21] From insulin pumps and wearables to dermatology and ClearPen[00:02:27] Why acne and dermatology have been under-innovated compared to other MedTech fields[00:05:25] Acne beyond teenagers: genetics, adult breakouts and mental health impact[00:07:16] How dermatologists versus GPs understand acne severity and burden[00:09:27] Typical US acne care pathway and why Accutane was the last big breakthrough[00:11:54] Using telehealth to address three-month dermatologist wait times[00:15:16] Investigational at-home corticosteroid injections and designing for safe use[00:17:21] Biggest technical and regulatory challenges in drug-device combination products[00:19:59] Where founders go wrong with direct-to-patient models in healthcare[00:24:13] Moving from engineer to founder and building around value inflexion pointsConnect with Rick - ⁠⁠⁠https://www.linkedin.com/in/rick-bente/Learn more about Indomo - ⁠⁠⁠https://www.linkedin.com/company/indomotx/Get in touch with Karandeep Badwal - ⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠Subscribe to the Podcast

Renato (Ren) Circi, co-founder of SAVA, a London based MedTech company building a new generation of minimally invasive continuous glucose monitors and molecular wearables.In this episode we rewind to the underground labs at Imperial College London where Ren and his co-founder Raph first immersed themselves in biosensors and began questioning the status quo of health monitoring. Ren explains how their shared obsession with measuring the body more effortlessly led to SAVA’s founding and what it really looks like to push through years of scientific failure in order to build a complex medical device platform.We dive into why SAVA manufactures everything in-house, how their micro sensor architecture differs from traditional filament based CGMs and why controlling every layer from chemistry to algorithms is essential if you want to iterate fast on performance. Ren sets out SAVA’s long term vision of continuous molecular tracking for everyone, not just people with diabetes, and what could be unlocked once you can monitor many molecules in real time from a single patch.We also talk about regulatory expectations for CGMs, the reality of one way product decisions in medical devices and the difficulty of fundraising for a consumer facing yet highly regulated deep tech company. Ren closes with candid reflections on what he would do differently, how he protects time for family and why working on a problem you truly care about with people you genuinely like is the only way to survive the journey.Timestamps[00:00:21] Origins at Imperial and discovering biosensors[00:01:59] Long horizons, repeated failure and staying in the game[00:03:56] Why SAVA manufactures everything in-house[00:06:46] How SAVA’s micro sensor CGM platform actually works[00:09:36] From diabetes to universal molecular health monitoring[00:12:02] Patient experience and CGM adoption in healthcare systems[00:13:43] When CGMs become cheaper than finger-pricks[00:15:15] Misconceptions about CGM and continuous molecular sensing[00:17:21] Why building CGMs is one of the hardest engineering challenges[00:22:54] Fundraising in unconventional deep tech MedTech and advice for foundersConnect with Ren - ⁠⁠https://www.linkedin.com/in/circi/⁠Learn more about Sava - ⁠⁠https://www.sava.health/Get in touch with Karandeep Badwal - ⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠Subscribe to the Podcast

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 expansionTimestamps[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 13485Connect 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/@KarandeepBadwal⁠⁠Subscribe to the Podcast

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 MedTechConnect 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/@KarandeepBadwal⁠Subscribe to the Podcast

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 FooteConnect 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/@KarandeepBadwalSubscribe to the Podcast