The MedTech Podcast

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 r...

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 De...

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 s...

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 cri...

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 Neuroplasti...

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 r...

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 en...

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...

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...

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 li...

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...

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 Technolog...

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 health...

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 diagnost...

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 det...

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 fat...

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, t...

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 in...

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 gr...

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 ort...

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 l...

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, a...

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...

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 buil...

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 a...