The MedTech Podcast

• #84 Fast-Tracking Clinical Trials with Julio G. Martinez-Clark: LATAM Strategy, FIH Studies & MedTech Market Access

  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 capitalIn 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 innovationTimestamps:[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 & PodcastingGet 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/@KarandeepBadwalSubscribe to the Podcast

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• #83 Frequencies, Fields and the Future of Wellness with Mark L. Fox: From NASA to Neuromodulation and PEMF Therapy

  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 innovationIn 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 gritTimestamps:[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 TinkerGet 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

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• #82 The 5 Pillars of MedTech Startup Success with Jón Ingi Bergsteinsson: MedTech SaaS, Clinical Trials and Commercial Strategy

  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 DoingGet 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/@KarandeepBadwalSubscribe to the Podcast

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• #81 Artificial Intelligence in Cardiology with Mark Goddard: Real-Time ECGs, Home Monitoring and the Atrial Fibrillation Crisis

  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 diagnosticsIn 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 careTimestamps:[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/@KarandeepBadwalSubscribe to the Podcast

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• #80 Sleep Apnea & Surgical Neurostimulation with Kirk Huntsman: FDA Breakthroughs, Childhood Prevention and the CPAP Controversy

  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 applianceIn 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 cureTimestamps:[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 PermanentlyGet 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/@KarandeepBadwalSubscribe to the Podcast

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