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The MedTech Podcast
Karandeep Singh Badwal
87 episodes
6 days ago
The MedTech Podcast shares the journey behind the path of the people shaping the MedTech industry and its future. Join me as I connect with industry leaders, thought providers and innovators. Hosted by Karandeep Singh Badwal, Karandeep is a Quality & Regulatory Consultant specialising in the MedTech Industry. If you have any ideas for future episodes or would like to be on the podcast then feel free to connect with me via the links below Follow Karandeep on LinkedIn: https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube: https://www.youtube.com/c/KarandeepBadwal/
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Life Sciences
Science
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All content for The MedTech Podcast is the property of Karandeep Singh Badwal and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
The MedTech Podcast shares the journey behind the path of the people shaping the MedTech industry and its future. Join me as I connect with industry leaders, thought providers and innovators. Hosted by Karandeep Singh Badwal, Karandeep is a Quality & Regulatory Consultant specialising in the MedTech Industry. If you have any ideas for future episodes or would like to be on the podcast then feel free to connect with me via the links below Follow Karandeep on LinkedIn: https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube: https://www.youtube.com/c/KarandeepBadwal/
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Life Sciences
Science
Episodes (20/87)
The MedTech Podcast
#87 Diagnosing the Undiagnosable with Dr. Brittany Partain: T-Cell Biomarkers, Clinical Trust and Women in Biotech

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

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18 hours ago
29 minutes 11 seconds

The MedTech Podcast
#86 Sepsis, Speed and Saving Lives with Dr. Rolland Carlson: Gene Signatures, Clinical Trials, and the Future of Infection Detection

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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2 weeks ago
29 minutes 52 seconds

The MedTech Podcast
#85 Under the Skin with Martin Burns: Bedsores, Biology-Based Prevention & The Hidden Cost of Inaction

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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4 weeks ago
28 minutes 21 seconds

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 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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1 month ago
29 minutes 1 second

The MedTech Podcast
#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 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

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2 months ago
30 minutes 54 seconds

The MedTech Podcast
#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 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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3 months ago
31 minutes 10 seconds

The MedTech Podcast
#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 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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3 months ago
30 minutes 7 seconds

The MedTech Podcast
#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 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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4 months ago
33 minutes 3 seconds

The MedTech Podcast
#79 Medical Device Packaging & Contract Manufacturing with Keith Smith: Avoiding Catastrophic Failures, Supply Chain Secrets & Million-Dollar Mistakes

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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4 months ago
31 minutes 13 seconds

The MedTech Podcast
#78 Stroke Recovery Reinvented with Kenneth Monaghan: Home Rehab, Game-Changing Therapies and the Future of Neuroplasticity

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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5 months ago
37 minutes 7 seconds

The MedTech Podcast
#77 The Power of Real-World Data with Praveen Kumar: Drug Development, AI in Healthcare and Regulatory Evolution

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

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6 months ago
31 minutes 43 seconds

The MedTech Podcast
#76 Embedding Quality Culture with Katie Cooney: Leadership Lessons, Training Strategies and Preventing Recalls

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 maintaining a robust quality culture that stands the test of time


Timestamps:

[00:00:27] The Role of Leadership in Quality Culture

[00:02:30] Creating a Mock Production Environment for Training

[00:05:22] Building Psychological Safety in Teams

[00:07:33] Reducing Over-Assignment in Training Curriculums

[00:12:09] Enhancing Training with Contextual E-Learning

[00:15:33] The Impact of Neglecting Quality: Case Studies

[00:18:10] From Retail to MedTech: Katie’s Journey


Get in touch with Katie Cooney - https://www.linkedin.com/in/katie-cooney-08ab7061/

https://www.leapcompliance.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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6 months ago
30 minutes 3 seconds

The MedTech Podcast
#75 Medical Device Innovation and Entrepreneurship with Axel Strombergsson: AI Breakthroughs, Startup Growth and Investor Insights

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 impactful pitch decks, and addressing key investor concerns


Timestamps:

[00:00:24] MedTech Innovation Trends

[00:04:02] From Engineering to MedTech

[00:08:21] Proactive Healthcare Models

[00:10:30] Building Investor Confidence

[00:14:09] Navigating Global Markets

[00:21:49] The Role of Venture Capital

[00:25:33] Startup Growth Challenges


Get in touch with Axel Strombergsson - https://www.linkedin.com/in/axel-strombergsson/

https://www.veeva.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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7 months ago
31 minutes 41 seconds

The MedTech Podcast
#74 Navigating Regulatory Affairs with Kristen Mittal: Global Challenges, Breakthrough Devices and Career Insights

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 AI/ML in medical technology


Timestamps:

[00:00:20] Rewards of a Regulatory Career

[00:01:53] Key Qualifications for Regulatory Success

[00:08:21] EU vs. USA Regulatory Pathways

[00:10:30] Understanding Pre-Submission and 513G Processes

[00:14:09] Designing Clinical Studies for Global Approval

[00:21:49] Emerging Trends: Pediatric Devices and FemTech

[00:25:33] Breakthrough Devices and Total Product Lifecycle Advisory Program

Get in touch with Kristen Mittal - https://www.linkedin.com/in/kristenmittal/

https://www.mittalconsulting.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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7 months ago
30 minutes 30 seconds

The MedTech Podcast
#73 Nursing Innovation and Pandemic Lessons with Dr. Morgan Taylor: Burnout Solutions, AI in Training, and Adolescent Mental Health Challenges

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 the pandemic and the shift toward proactive value-based care models


Timestamps:

[00:00:27] Gaps in Nursing Education During the Pandemic

[00:02:30] Global Challenges in Practical Nursing Training

[00:05:35] AI as a Tool in Nursing: Opportunities and Risks

[00:06:36] Unique Challenges in Paediatric Care

[00:08:55] Telehealth’s Role in Enhancing Accessibility

[00:13:13] Moving Toward Proactive, Value-Based Healthcare

[00:15:38] Burnout and New Career Paths for Nurses

Get in touch with Morgan Taylor- https://www.linkedin.com/in/morgan-clark-taylor/ https://www.archerreview.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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8 months ago
29 minutes 50 seconds

The MedTech Podcast
#72 Colorectal Cancer and Raising Capital with Sam Libby: Delayed Treatments, The 60 Million Annually Undiagnosed and Healthcare Disparities for Aging Women

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


Timestamps:

[00:00:15] First exposure to colorectal cancer

[00:05:23] Importance of early detection and diagnosis

[00:09:47] Challenges in colorectal cancer treatment

[00:14:02] Working with EDP Biotech and its mission

[00:19:18] Innovations in cancer screening technology

[00:24:35] The role of data in advancing cancer diagnostics

[00:30:12] Future trends and goals in cancer research


Get in touch with Sam Libby - https://www.linkedin.com/in/shmuel-libby-b4530b48/

https://www.tcbcapitaladvisors.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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9 months ago
35 minutes 2 seconds

The MedTech Podcast
#71 Trauma Care and Vascular Surgery with Dr Adam Power: Preventive Medicine, Innovations in Haemorrhage Control and The Future of Emergency Medical Devices

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 preventive medicine alongside the role of new technologies in healthcare and the effect of the pandemic on global healthcare systems.


Timestamps:

[00:02:38] Quick haemorrhage control techniques.

[00:07:00] Gearing up for European CE Mark

[00:09:30] From Physician to entrepreneur in med tech.

[00:12:51] Shortage of physicians, focus on prevention.

[00:15:39] Impact of pandemic on healthcare

[00:18:49] Uses for telehealth

[00:22:21] Barriers in telehealth


Get in touch with Dr Adam Power - https://www.linkedin.com/in/adamhpower/ https://frontlinemedtech.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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11 months ago
30 minutes 7 seconds

The MedTech Podcast
#70 Preconception Wellness and Enhancing Fertility with Alexandria DeVito: Pregnancy Planning, Misconceptions around Fertility and Differences Between Physical and Biological Age

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 age of 35.

Timestamps:

[00:03:15] Biological Markers for Pregnancy Success

[00:06:28] Optimizing health before conception for fertility

[00:13:10] Proactive approach in preconception

[00:15:39] Impacts of Chronic Stress on fertility and pregnancy

[00:20:34] Process of Book writing

[00:22:59] Writing a Book Vs Entrepreneurship

[00:25:47] Importance of Continuous Learning

Get in touch with Alexandria DeVito - https://www.linkedin.com/in/alexandria-devito-3381553/ https://getpoplin.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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1 year ago
29 minutes 47 seconds

The MedTech Podcast
#69 Revolutionising Blood Management with Bob Roda: Transforming Healthcare, Women’s Health & The Emergency Blood Crisis

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 COVID-19 on blood supply, the biological process of bleeding and its implications for military trauma care.

Timestamps:

[00:02:34] Blood crisis due to COVID, global issue.

[00:05:23] Blood product technology helps save lives.

[00:08:22] Technology for acute bleeding management, military applications.

[00:14:38] Body's response to injury and bleeding.

[00:21:35] Vetinary Applications

[00:24:58] Responsibility of leadership: be present, humble.

[00:27:56] Passion for healthcare can change lives.

Get in touch with Bob Roda - https://www.linkedin.com/in/bob-roda-8175b24/ https://hemosonics.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


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1 year ago
30 minutes 56 seconds

The MedTech Podcast
#68 Lung Disease Detection and Treatment with Eva van Rikxoort: AI in Automated Screening, Early Disease Detection, from Scientist to Entrepreneur

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:

[00:02:41] AI in Medicine

[00:10:41] Lung cancer causes and advancements in AI

[00:13:43] Regulating AI in Medical Devices

[00:16:30] Early Detection for Rare Diseases

[00:19:34] Gathering Data and Clinical Trials

[00:21:39] CT screening for lung cancer, emphysema detection.

[00:25:15] Bootstrapping a Start-Up

Get in touch with Eva van Rikxoort - https://www.linkedin.com/in/evavanrikxoort/ https://thirona.eu/

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


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1 year ago
28 minutes 39 seconds

The MedTech Podcast
The MedTech Podcast shares the journey behind the path of the people shaping the MedTech industry and its future. Join me as I connect with industry leaders, thought providers and innovators. Hosted by Karandeep Singh Badwal, Karandeep is a Quality & Regulatory Consultant specialising in the MedTech Industry. If you have any ideas for future episodes or would like to be on the podcast then feel free to connect with me via the links below Follow Karandeep on LinkedIn: https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube: https://www.youtube.com/c/KarandeepBadwal/