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

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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

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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

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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

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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

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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

Subscribe to the Podcast

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

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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