The MedTech 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...

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...

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 le...

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.

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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...

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, clou...

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 ...

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 f...

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 repla...

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...

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...

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 milita...

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...

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...

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...

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...

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 sh...

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...

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...

Dr. Kenneth Monaghan, University Lecturer at Atlantic Technological University, a world-leading expert in stroke rehabilitation, digital health and neuroplasticity research. With over 32 years of clinical, academic and research experience, Kenneth is revolutionising stroke recovery by making cutting-edge therapies accessible from home

As a lecturer in health science and director of the Neuroplasticity Research Group at Atlantic Technological University, Kenneth has pioneered groundbreaking rehabilitation solutions that challenge traditional recovery models. He shares insights on why home-based rehab can be more effective than hospital treatment, how digital health is transforming stroke recovery and the science behind innovative therapies like...

Praveen Kumar, Director and Heard of Clinical Sciences at nference, a physician, clinical pharmacologist and an advocate for real-world data in drug development and medical devices. Praveen is passionate about leveraging AI, machine learning and data-driven insights to optimize clinical trials, reduce development costs and improve patient outcomes

In this episode, we explore the critical role of real-world data in shaping the future of medicine, how it differs from traditional clinical trials and why it’s increasingly being used for regulatory approvals. Praveen shares real-world case studies of drugs and devices that have successfully used real-world data, th...

Katie Cooney, founder of Leap Compliance an expert in quality culture, training and compliance. With extensive experience in MedTech, including roles at Boston Scientific and leading training initiatives globally, Katie is on a mission to ensure that quality is woven into every aspect of organizational culture

In this episode, Katie discusses her journey into MedTech and how she transitioned to entrepreneurship with Leap Compliance. We delve into effective training strategies, the importance of leadership in fostering a quality-first mindset and real-world examples of what happens when quality is neglected. Katie also provides actionable advice on building and...

Axel Strombergsson, Vice President, QuickVault at Veeva Systems a seasoned leader in medical device development and commercialization. With over 18 years of experience in R&D, operations and startup growth, Axel has a proven track record in navigating the complexities of regulatory pathways, venture capital, and global market strategies

In this episode, Axel shares his journey from mechanical engineering to becoming a driving force in medtech innovation. We discuss AI-powered diagnostic tools, the importance of proactive healthcare models, and the evolving role of startups in advancing medical technologies. Axel offers valuable advice on preparing for funding rounds, building...

Kristen Mittal, Founder & CEO of Mittal Consulting a seasoned expert in regulatory affairs with over a decade of experience in the field. Kristen’s expertise spans across global regulatory challenges, innovative pathways and mentorship in quality and regulatory careers

In this episode, we dive into why regulatory affairs is a rewarding yet complex career path, explore innovative programs like the FDA’s Breakthrough Device Designation and Total Product Lifecycle Advisory Program, and discuss the importance of harmonizing global standards in medical device submissions. Kristen also shares insights into the evolving landscape of sectors like pediatric devices, FemTech and...

Dr. Morgan Taylor, Chief Nursing Officer of Archer Review has redefined nursing education with her innovative teaching methods and empathy-driven approach, fostering confidence and competence among the next generation of nurses.

In this episode, we explore the gaps in nursing education exposed during the pandemic and how Dr. Taylor is addressing these challenges through groundbreaking solutions like virtual reality and AI-enhanced training. We discuss her global health experiences in Guatemala, her passion for pediatric care and how she leverages technology to bridge educational gaps. She also shares her insights on telehealth, the adolescent mental health crises during...

Sam Libby President and Managing Director of TCB Capital Advisors is one of healthcare’s most impactful leaders, with a career devoted to revolutionising patient care through strategic investments, Sam has navigated over $20 billion in transactions across the life sciences and diagnostics sectors

In this episode, we delve into how healthcare companies raise capital alongside the traits he seeks in potential partners, how he went from investment banking to more of a focus on the medical sector, his introduction to the disparity within female health and his early career within martial arts

Ti...

Dr Adam Power Co-Founder and CMO of Front Line Medical Technologies is a leader in innovative medical devices for trauma and emergency care who is committed to lowering the barriers to bleeding control and resuscitation, having previously worked as a vascular surgeon he quickly realised that there needed to be a better way for haemorrhage control so went on to co-found Front Line Medical Technologies in 2017.

In this episode, we delve into the fascinating world of trauma care and the groundbreaking innovations in haemorrhage control, Dr. Powers journey from general surgery to vascular surgery, the importance of...

Alexandria DeVito Founder and CEO of Poplin is a functional nutritionist who specialises in fertility and preconception health, prior to founding Poplin, she worked as a management consultant in the finance industry before making the jump into healthcare

In this episode, we delve into the single most important thing someone can do to enhance fertility and increase their likelihood of having healthy children, the meaning of the term Preconception expert alongside what their roles are, the process of writing a book from start to finish and the common misconception of fertility rapidly declining in women after the...

Bob Roda President and CEO of Hemosonics, the creators of the Quantra Hemostasis Analyzer, a diagnostic platform that provides a comprehensive blood analysis detailing hemostasis in the operating room in less than 15 minutes. Bob joined HemoSonics in February 2020 as the company’s President and CEO, bringing more than 25 years of global experience developing and commercializing innovative diagnostic and medical device products and services

In this episode, we explore his transition from economics to medtech, highlighting the urgent global need for blood donations and the causes behind the current blood shortages. We also examine the significant effects of CO...

Eva van Rikxoort Founder and CEO of Thirona started her career as a scientist but transitioned as she wanted to create a business model to make AI centered around how to help a patient. She believes that AI is necessary in healthcare, unlike pharma, where she views AI as an option.

In this episode, we delve into the traditional methods of medical imaging and the benefits of using AI for better detection, why AI is proving to be popular in the radiology space, lesser-known causes for lung disease and her journey into entrepreneurship

Timestamps:

Christian Espinosa Founder and CEO of Blue Goat Cyber is a leading medical device cybersecurity expert, who started his career within the United States Air Force as a Computer Systems Officer and is now a serial entrepreneur, best-selling author, avid adventurer and Ironman triathlete.

In this episode, we delve into the vital necessity of safeguarding medical devices to avert potential harm or fatalities stemming from hacking. We cover the significance of initially designing devices with security in mind and advocating for ongoing monitoring throughout their lifespan. Furthermore, Christian offers valuable insights for companies on effectively integrating cybersecurity...

Ethan Drower Co-Founder and CEO at Cite Medical brings a unique blend of expertise to the table. His background as a trained software engineer, coupled with his partner's veteran experience in regulatory affairs and quality makes him an expert in the clinical space

In this episode, we discuss the impact of EU MDR on medical device manufacturers, the changes in clinical evidence requirements, the concept of state of the art alongside what this means in practice in addition to the need for adequately qualified reviewers and the challenges faced by smaller startups in finding the required expertise<...

Christa Natoli Executive Director at Center for Telehealth and Ehealth Law has extensive policy experience and knowledge in the areas of physician and nurse licensure, Internet prescribing, e-consultations, Medicaid reimbursement, mHealth and international telemedicine. She has led research efforts on these topics and is a published author and noted lecturer and speaker

In this episode, we dive into the world of telehealth technology discussing its origins, challenges, and potential benefits. We also explore the role of AI in reducing clinician workload alongside the misconceptions around this type of technology and discuss the future of global healthcare

Carlo Odicino CEO and Founder at One TEAM Partners has over 24 years of experience working with therapeutic, medical device and diagnostic companies and is an expert in guiding CEOs and their leadership teams through the challenges that come with bringing a new innovation to market while achieving exceptional results.

In this episode, we explore why certain life science company CEOs struggle to grow their company despite working long hours, the key aspects in scaling a company alongside building a suitable team, what makes the location of Orange County a hub for life sciences and Carlo managed to...

Steve Curran Senior Regulatory Consultant at Trinzo, a medical device and pharmaceutical consultancy firm. He has over 20 years experience in the medical device industry both as an engineer and leader developing medical devices but also as a Notified Body regulator ensuring that devices are compliant when they reach the market. He has a broad range of experience from general medical devices to orthopaedic and dental devices and combination devices incorporating drugs and biologics

In this episode, we explore why Ireland is becoming a growing sector in this industry, the parallels of working at a notified body to...

Vincent Cafiso Founder of Practical Compliance Results a quality and regulatory consulting practice.

In this episode, we explore our Vincents journey as an FDA inspector, revealing intriguing stories, we the importance of getting an early grasp of the regulatory process and what the FDA seeks in Medical Device Companies, extending to insights on securing FDA roles, founding a consulting firm and leveraging LinkedIn for networking

Timestamps:

[00:03:52] Working in the FDA

[00:07:37] Securing a role

[00:11:16] Importance of compliance

[00:15:26] Content-based networking

[00:25:12] Surgery and faulty blood pressure cuffs

Nicola Thorn CEO and Founder of Tento+ a company that helps companies generate technical documentation that is audit-ready. Nicola is an expert in technical compliance for medical devices working across FDA, UKCA, and CE market approvals for digital health tech products and completed her PhD in Mathematics at the University of Reading, as well as founding Tento+, Nicola is CEO of AND Technology, an award-winning product development consultancy, she has worked in product development in electronics, software, machine learning and Tech 4 Good for over 10 years.

In this episode, we explore the application of generative AI tools in...

Mark McDonough CEO of ChromaCode, an innovator in molecular genomics providing easy to implement, cost-effective workflows within Oncology and Genomics. Mark has over 25 years of experience helping build high growth HealthCare organizations. He most recently was the CEO of Pierian (now Velsera) which he led to a successful sale to Summa Equity, a private equity firm, in 2022. Prior to Pierian, he led CombiMatrix for five years, culminating in a sale to Invitae in 2017. Over his career, Mark has held various executive and commercial positions, and even once served as a US Naval Officer.

In this episode, we...

Eric Horesnyi CEO of Matrix Requirements, a leading platform in design and quality control for Software Medical Devices. Eric started his career in finance in tech having co-founded Radianz a financial data exchange and Streamdata.io for real-time API. However during the pandemic of 2020 after organising a hackathon for his company at the time, he realised a lot of skills and knowledge he had built in these industries could be beneficial in digital health hence his transition to healthcare in 2022.

In this episode, we delve into the intriguing parallels among finance, tech and healthcare. Discover the contrasting...

Raghu Bala Founder of Clinitraq, a company specialising in Smart Radiation Dosimeters that reduces the time for measuring cumulative radiation from 60 days to 60 secs. Raghu possesses an MBA in Finance from the Wharton School (University of Pennsylvania), an MS in Computer Science from Rensselaer Polytechnic Institute and a BA/BS in Math and Computer Science from the State University of New York at Buffalo. He is the Head Managing Instructor for MIT courses in AI, Decentralized Finance and Blockchain on the 2U platform. He is also an Adjunct Professor at VIT (India) and an ex-adjunct Lecturer at Columbia University.<...