The MedTech Podcast

Jordan Pollack, biomedical engineer, entrepreneur and CEO of Sub-Q Bionics. Jordan began his career at Boston Scientific, later founded VeinWay in Israel and is now focused on building a new treatment paradigm for lymphoedema in cancer survivors. In this episode, we explore what actually creates momentum in MedTech, from networking with intent to building the resilience needed to survive the founder journey. Jordan shares why conferences alone rarely deliver results, how warm introductions and targeted roadshows outperform generic networking and what he had to unlearn after leaving corporate structure behind to become a startup CEO. He also offers a brutally honest take on entrepreneurship, explaining why the role is not for everyone and why persistence, resilience and equanimity matter more than titles or ambition alone. We also go deep into the story behind Sub-Q Bionics and why Jordan chose to focus on lymphoedema, particularly in women recovering from cancer treatment. He explains the clinical reality of the disease, the lack of meaningful treatment options beyond maintenance, and why reimbursement, not just good technology, is often the deciding factor in whether a device company succeeds. Along the way, he shares sharp insights on women’s health being chronically underfunded, the differences between the U.S. and Israeli startup ecosystems, and why mission-led companies are far more likely to stay the course when things get hard. Timestamps [00:00:32] Why Generic Conferences Rarely Create Real MedTech Opportunity [00:02:05] How Networking Shaped Jordan’s Move from Boston Scientific to Israel [00:03:29] What Corporate MedTech Taught Him and What He Had to Unlearn [00:05:54] Why Being a Founder Is Not for Everyone [00:08:49] The Origin of Sub-Q Bionics and the Shift Toward True Disease Treatment [00:11:53] What Lymphoedema Actually Is and Why It Is So Devastating [00:14:06] Why Women’s Health Remains Underfunded and Where Innovation Is Emerging [00:18:25] Why Reimbursement Matters More Than Technology Alone [00:20:58] U.S. vs Israel: Two Very Different Startup Ecosystems [00:25:10] Balancing Founder Life, Health, Travel and Relationships Connect with Jordan - ⁠https://www.linkedin.com/in/jordan-pollack-81464827/ Learn more about Sub-Q Bionics - ⁠⁠https://subqbionics.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

Dave Rosa, CEO and President of NeuroOne, medtech entrepreneur, board member and former executive at St. Jude Medical, Boston Scientific and C.R. Bard. With three decades in medical devices and more than $200 million raised, Dave brings a rare mix of operator, inventor and capital markets experience to the future of neurotechnology and pain care. In this episode, we unpack one of the biggest mistakes medtech companies make: building technology without enough real-world user feedback. Dave explains why innovation for the sake of innovation often fails, especially in larger companies, and why the best products are shaped by how physicians and patients actually use them. We also explore NeuroOne’s unique approach of combining diagnostics and therapeutics through the same electrode, and why that kind of multifunctional platform thinking can be both clinically powerful and commercially strategic. A major theme in this conversation is regulatory strategy. Dave walks through NeuroOne’s deliberate “diagnostic first, therapeutic second” FDA pathway, explaining why starting with an easier regulatory indication can de-risk the technology, shorten timelines and create a stronger platform for later therapeutic claims. We also discuss the value of reusing the same generator across multiple indications, how founders often wait too long to engage with FDA, and why platform leverage matters from both a business and development perspective. We also go deep on chronic pain and lower back pain. Dave shares why today’s pain solutions often fall short, how different triggers require different treatment approaches, and where technologies like ablation, stimulation and smarter electrode design could shift outcomes. He also highlights how seemingly small user-experience issues, like frequent recharging, can destroy patient adherence and wipe out billions in company value. Timestamps[00:00:08] Why MedTech Companies Fail When They Ignore Real User Feedback [00:02:04] Innovation vs Iteration: When “New” Adds No Real Value [00:02:22] Combining Diagnostics and Therapeutics With the Same Electrode [00:03:52] Why NeuroOne Chose a Diagnostic-First FDA Strategy [00:05:21] Pain Management Today: Ablation, Stimulation and Complex Back Pain [00:08:21] What Is Fundamentally Broken in Lower Back Pain Solutions [00:09:26] How Small Patient Frictions Can Destroy Adoption and Valuation [00:11:11] The Power of Reusing the Same Generator Across Multiple Indications [00:13:00] The FDA Mistake Many Founders Still Make [00:21:15] Where Neurotechnology and Pain Management Are Heading Next Connect with Dave - https://www.linkedin.com/in/daverosa/ Learn more about NeuroOne - ⁠https://nmtc1.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

Dr. Amel Havkic, founder of EvoMed Consulting and a lung and critical care specialist, hospital clinical lead. Amel works at the intersection of bedside medicine and MedTech strategy, helping innovators build clinician-approved solutions that scale safely across real healthcare systems. In this episode, we unpack why “clinicians love it” is rarely enough to win adoption, and what hospital purchasing actually looks like when procurement, IT, finance, compliance and workflows all have a seat at the table. Amel breaks down why switching away from legacy tools is painful, how integrations can break care pathways, and why solutions that feel like a natural part of the hospital ecosystem win faster. He also shares a practical lens for building frictionless implementation by aligning with standards like HL7, FHIR and DICOM, while proving measurable value for patients and payers. We also go deep on decentralising healthcare. Amel explains how the Dutch model centralises high-end expertise while decentralising access through remote monitoring and home-based onboarding, and why this becomes a winning approach as staffing pressures rise. On AI, he makes the case for reframing it as augmented intelligence, not autonomy, and shows where decision support can raise the baseline of care by supporting clinicians in time-critical situations, as well as offloading admin burden that drains capacity. Finally, Amel shares the thinking behind the EMC StarMap framework, a navigation tool built from real-world patterns of what makes MedTech succeed or fail. His core message is simple: regulatory approval is a milestone, but clinical adoption is the real finish line. Timestamps [00:00:05] Clinician + Consultant Lens: Seeing Adoption and Safety Risks [00:01:22] Why “Physicians Love It” Does Not Mean Hospitals Will Buy [00:03:27] What Hospitals Consider Beyond Cost: Workflow, Integration and Training [00:05:09] Frictionless Implementation: Standards, EHR Fit and “Team Player” Products [00:06:24] Real Clinical Workflow: ICU Reality and Why UI Clicks Matter [00:07:31] Decentralising Care: Centralised Expertise With Home-Based Delivery [00:10:37] AI in Healthcare: Reframing as Augmented Intelligence [00:12:55] Staffing Shortages: Where AI Can Remove Waste and Scale Expertise [00:14:38] If You Could Change One Thing: Put the Patient Back at the Center [00:16:59] StarMap: Measuring What Drives Clinical Adoption Connect with Rick - ⁠⁠⁠⁠https://www.linkedin.com/in/a-havkic/ Learn more about Evomed Consulting - https://evomed-consulting.eu/ 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

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 points Connect 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/@KarandeepBadwal⁠⁠⁠⁠ Subscribe 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 founders Connect 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/@KarandeepBadwal⁠⁠⁠ Subscribe 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 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

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

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

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

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

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

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

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

Martin Burns, CEO of Bruin Biometrics is a former management consultant who worked with Deloitte and PwC and has also served as a guest lecturer at UCLA Anderson School of Management, where he taught entrepreneurship in biotechnology At Bruin, Martin is leading the charge to bring pressure injury (bedsore) prevention into the 21st century. Bedsores are entirely preventable yet remain one of the most under-discussed threats in hospitals today, especially among patients with darker skin tones who are often overlooked by traditional visual assessments In this episode, Martin explains why a biology-first approach is needed to tackle these “silent killers,” the major cultural and systemic hurdles to adoption, and why he believes sensor technology should become as routine as checking blood oxygen levels. We also explore investor skepticism, the importance of diverse clinical validation and the operational realities of implementing new technologies in hospitals without disrupting workflows Timestamps: [00:00:18] What Are Pressure Injuries and Why They’re Deadly [00:02:12] The Moment Martin Saw the Real Problem [00:03:58] The Biology of Subepidermal Moisture [00:06:53] Turning a Science Project into a Scalable Product [00:10:06] Why Traditional Risk Assessments Fail [00:12:41] Addressing Skin Tone Bias in Wound Care [00:17:14] From Skepticism to Adoption: Changing Clinical Culture [00:21:55] Beyond Bedsores: Future Sensor Applications [00:24:17] The Nurse Assistant That Frees Up Hours [00:26:52] Mountains, Gym Days & Recharging Outside Work Get in touch with Martin - https://www.linkedin.com/in/martin-burns-9391a57/ Learn more about Bruin - https://sem-scanner.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

Julio G. Martinez-Clark CEO of Bioaccess and President of IAOCR/GCSA Americas is a MedTech trailblazer helping startups accelerate First-in-Human (FIH) clinical trials across Latin America, with over 20 years of experience spanning healthcare, telecom and venture capital In this episode, we unpack why more MedTech companies are turning to LATAM for faster, more cost-effective trial execution. Julio shares how his Miami-based CRO helps deliver 58-day CE mark approvals, his experience supporting 100+ device startups and why time, not money, is the most precious currency for early-stage founders. We also touch on trial quality, regulatory strategy and why he believes Latin America will play a defining role in the next era of global MedTech innovation Timestamps: [00:00:47] Why LATAM Is the Next MedTech Trial Hub [00:02:21] The Problem with FIH Trials in the U.S. [00:04:42] How bioaccess® Reduces Approval Timelines by 70% [00:06:01] Strategic Sites, Patient Retention & CRO Infrastructure [00:08:17] Do LATAM Trials Hold Up to FDA & EU Scrutiny? [00:10:43] The Fundraising Pressure Behind Faster Clinical Results [00:12:22] Founder Mistakes in In-House Trial Management [00:14:11] Why LATAM May Overtake Eastern Europe in FIH Volume [00:17:26] Regulatory Standards, UNESCO, and Regional Quality [00:20:10] Julio Outside the Office: Family, Fitness & Podcasting Get in touch with Julio - https://www.linkedin.com/in/juliomartinezclark/ Learn more about Bioaccess - https://www.bioaccessla.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

Mark Fox founder and CEO of Resona Health is a former NASA space shuttle engineer turned wellness-tech entrepreneur. From designing spacecraft to pioneering wearable PEMF (Pulsed Electromagnetic Field) therapy, Mark brings a rare blend of hardcore engineering and holistic healthcare innovation In this episode, we dive deep into the world of energy medicine from the scientific foundations of PEMF and resonance frequency therapy to its real-world impact on mental clarity, emotional regulation and chronic pain. Mark also walks us through the uphill battle with FDA compliance, the hidden power of vagus nerve stimulation and the unexpected physics that connect hot air balloons to healthcare innovation. It's a fascinating mix of engineering, wellness tech and startup grit Timestamps: [00:00:35] From NASA to Neuromodulation: Mark’s Origin Story [00:03:05] What Is PEMF Therapy? Explaining the Basics [00:05:48] The New Vagus Nerve Device: Chest vs Neck Placement [00:08:40] Why Frequency > Voltage: Ditching Electrodes for Fields [00:11:22] How Resona Built a 98% Success Rate with Pocket PEMF [00:13:33] Frequency over Pharma: A Founder’s Clinical Pivot [00:16:02] The Compliance Trap: How the FDA Deals With Wellness Claims [00:18:50] Using GPTs for Regulatory Copywriting (and Staying Legal) [00:21:10] What the Body Teaches You When You Build for It [00:24:16] Life Outside of Resona: Flying, Sailing and Freedom to Tinker Get in touch with Mark - https://www.linkedin.com/in/mark-fox-ab589110/ & https://resona.health/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

Jón Ingi Bergsteinsson MedTech founder, former CTO of SMART-TRIAL and now a startup advisor and investor via LIFA Ventures. With 10+ years of hands-on experience scaling a SaaS company in regulated healthcare, Jón offers a rare blend of technical and commercial insight. In this episode, we talk about why founders should stop treating regulatory and commercial teams like separate planets, how VCs really evaluate MedTech startups, and what SaaS-style thinking can teach traditional device companies. Jón also walks us through his “founder-to-fund” journey, shares common pitfalls in clinical trial design and gives a blunt take on why copying pharma’s playbook won’t work in MedTech. Timestamps: [00:00:35] Why MedTech Startups Still Struggle to Scale [00:03:41] Building SMART-TRIAL Without Venture Capital [00:06:25] Regulatory & Clinical Teams Need to Talk More [00:09:50] LIFA Ventures: Investing Beyond the Spreadsheet [00:12:12] The Hidden Cost of Ignoring Commercialization [00:14:07] Copying Pharma? That’s a Mistake [00:17:33] Europe vs U.S. Startup Culture: What Founders Get Wrong [00:20:45] Advice for Early-Stage Founders in Regulated Health [00:24:28] Jón’s Life Beyond MedTech: Coaching, Family & Hobbies [00:26:12] One Thing He Wishes Founders Would Stop Doing Get in touch with Jón - https://www.linkedin.com/in/joningib/ 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

Mark Goddard, Vice President of Clinical Services at InfoBionic.Ai, a leading authority in cardiac remote monitoring. A registered nurse with over 20 years of experience in clinical electrophysiology, Mark has pioneered service lines across ambulatory ECG, cardiac event monitoring, mobile telemetry and heart failure management in hundreds of institutions. He’s also a certified Clinical Cardiac Device Specialist with deep knowledge of subcutaneous monitoring and AI-assisted diagnostics In this episode, we explore how AI and real-time ECG data are revolutionising arrhythmia detection, heart failure prediction and patient engagement especially for high-risk groups like those with A-Fib. Mark shares practical insights from the front lines of cardiac care, how to tell genuine innovation from AI hype and why the future of diagnostics may lie beyond traditional heart monitoring. We also cover clinical implementation challenges, device design for older populations and the fine line between wellness tracking and medical-grade care Timestamps: [00:00:27] AI-Powered ECG: From Novelty to Necessity [00:03:28] How Clinicians Are Separating Hype from Reality [00:05:07] Why Near Real-Time Beats Traditional ECG Monitoring [00:08:49] A-Fib and the Global Data Gap [00:11:36] When Good Tech Goes Bad: Early Pacemaker Mistakes [00:13:30] Hospitals, Homes and the Future of Cardiac Care [00:19:59] AI vs Machine Learning: What’s the Real Difference? Get in touch with Mark - https://www.linkedin.com/in/mark-goddard-035ab427/ 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

Kirk Huntsman, CEO of Vivos Therapeutics, a pioneer in the treatment of obstructive sleep apnea. With decades of experience in the dental and medtech space, Kirk has led Vivos to secure multiple FDA clearances including the first ever for treating moderate to severe pediatric sleep apnea using an oral appliance In this episode, we uncover why sleep apnea is a silent global epidemic, why it's so underdiagnosed and how Vivos is transforming the way we approach treatment, shifting from CPAP-based management to true rehabilitation. Kirk also shares how Vivos is achieving life-changing results in less than a year, and why even mild, untreated sleep apnea can lead to serious downstream health issues like hypertension, depression and cognitive decline. We also discuss societal misperceptions, global prevalence and exciting innovations that could one day lead to a cure Timestamps:[00:00:27] What Is Obstructive Sleep Apnea and Why It’s Dangerous [00:03:07] Why Sleep Apnea Remains Widely Undiagnosed [00:06:49] Changing the Narrative Around Snoring and Awareness [00:08:49] FDA Breakthroughs: Treating Children and Adults Differently [00:13:13] CPAP vs Vivos: Why Patients Need a Third Option [00:17:26] From Dentistry to MedTech: The Journey to Founding Vivos [00:26:07] The Future of Sleep Medicine and Ending Apnea Permanently Get in touch with Kirk - https://www.linkedin.com/in/kirkhuntsman 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

Keith Smith, President of Vonco Products, a leader in medical device packaging and contract manufacturing. Keith has spent years refining the science behind sterile packaging solutions, ensuring that medical products survive extreme conditions, from freezing temperatures to high-pressure airline transport In this episode, we uncover why medical packaging is far more than just a box, it's a critical component in ensuring safety, sterility and regulatory compliance. Keith shares real-world failures where improper packaging led to catastrophic outcomes, the rigorous testing required to meet global standards and how manufacturers can avoid costly recalls. We also discuss the benefits and pitfalls of outsourcing medical device production, why some companies thrive with contract manufacturing while others struggle and Keith’s own entrepreneurial journey from acquiring Vonco to leading it into the medical device space Timestamps: [00:00:27] Why Medical Device Packaging is Critical for Patient Safety [00:02:30] The Hidden Dangers of Poorly Designed Packaging [00:05:46] Surviving Extreme Conditions: Cold, Heat & Pressure [00:07:02] Global Packaging Regulations: Why Standards Vary by Region [00:10:16] The Pros & Cons of Outsourcing Medical Device Manufacturing [00:13:43] From Food Packaging to MedTech: The Evolution of Vonco [00:20:54] Leadership & Entrepreneurship: Lessons from Running a Business Get in touch with Keith Smith - https://www.linkedin.com/in/keith-smith-725508b/ 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