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

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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

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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

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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

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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

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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

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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

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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 mirror therapy and sensory substitution. We also discuss his role in securing over $2 million in research funding, his patented rehabilitation devices and the mission behind his book Lights, Mirrors, Action

Timestamps:

[00:00:27] The Silent Killer: Biggest Risk Factors for Stroke

[00:02:30] Home-Based Rehab: Why It Works Better Than You Think

[00:05:41] Overcoming Fear: Getting Patients to Engage in Therapy

[00:08:02] How Testosterone Boosts Stroke Recovery

[00:11:35] Digital Health & Remote Monitoring in Stroke Rehab

[00:17:37] Mirror Therapy: A Stroke Recovery Game-Changer

[00:25:51] Sensory Substitution: Using Vibration and Sound to Retrain the Brain

Get in touch with Kenneth Monaghan- https://www.linkedin.com/in/kenneth-monaghan-msc-phd-miscp-75b746103/

https://www.lightsmirrorsaction.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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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, the challenges in global regulatory acceptance and how AI is transforming patient recruitment and trial efficiency

Timestamps:

[00:00:27] What is Real-World Data?

[00:02:30] The Key Differences Between Clinical Trials and Real-World Data

[00:06:46] How Real-World Data is Used for Drug Approvals

[00:08:28] Cutting Drug Development Costs with AI

[00:15:33] The Growing Role of Drug-Device Combinations

[00:21:53] Emerging Trends in AI and Real-World Evidence

[00:25:38] Challenges in Global Regulatory Acceptance

Get in touch with Praveen Kumar - https://www.linkedin.com/in/praveen-kumar-m-33a6bab3/

https://nference.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal