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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/
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/
88 Episodes
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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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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.
In this episode, we explore the lack of education surrounding the pernicious consequences of radiation exposure, discover the hidden hazards healthcare workers face, oblivious to their exposure levels due to measurement inadequacies, delve into his transition from the tech industry to MedTech and the motivations behind it, uncover his strategies for funding multiple companies he nurtured and eventually sold, alongside diverse capital-raising methods and gain valuable insights from his candid revelations about the mistakes he encountered as a serial entrepreneur
Timestamps:
[00:02:32] Antiquated methods of radiation diagnostics
[00:05:41] Radiation health risks overlooked, ignored
[00:12:14] Misconceptions about radiation risks
[00:18:01] Underestimated risks
[00:23:20] Medical tech advances: Embracing tech for better care
Get in touch with Raghu Bala - https://www.linkedin.com/in/raghubala/
https://clinitraq.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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Ziv Yekutieli CEO of Mon4t a company that turns any standard smartphone into a sophisticated, personalized neurological medical testing device for remote and in-person testing the data of which can be used monitoring of neurological and psychiatric patients. He started his career as an electrical engineer, having experienced one of his teachers suffer from ALS, he began to study neurology alongside engineering eventually going on to study a PhD in Brain Science whilst in his engineering career eventually going to cofound Mon4t.
In this episode, we discuss his journey from studying medicine and engineering to connecting neurology and technology, the prevalence of neurological conditions affecting up to one in eight people, how the number of neurologists per capita is falling and his advice for aspiring entrepreneurs to know the box before thinking outside of it.
Timestamps:
[00:00:01] How Telehealth accelerates teleneurology treatment
[00:06:36] Telehealth advancing neurology and its complexity
[00:14:02] Neurology, engineering, technology: lifelong journey
[00:22:08] Know the box, identify beachhead, nurturing customers
[00:28:31] Exploring brain and starting a business
Get in touch with Ziv Yekutieli - https://www.linkedin.com/in/ziv-yekutieli/
https://mon4t.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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Chuck grew up as a cattle farmer eventually getting into engineering working on various aerospace and military projects, he then got involved in gaming as a animator, producer and developer with one company he worked at being EA Sports working on the popular games at the time of Madden NFL 2000 and NCAA football 99. He eventually went on found PRSONAS in 2013 which was acquired by nuMedia in 2019 and still remains CEO of the company to date.
On this episode, he discusses the differences between digital humans and digital personalities, how such technologies can be used in healthcare, how around 1% of the US population uses American sign language and how his technology at PRSONAS helps improve communication with those people, current oppositions to this technology including how some fear it may result in job losses, where to learn more about digital personalities and his love for musical instruments and aviation.
Get in touch with Chuck Rinker - https://www.linkedin.com/in/chuckrinker/ or https://www.prsonas.com/
Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/
Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical
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Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with large Healthcare companies such as Johnson and Johnson, he decided to become an independent consultant eventually going on to create his own consulting firm Easy Medical Device GmbH and now delivers knowledge through his own videos, podcasts and online courses
Get in touch with Monir – Easymedicaldevice.com I https://www.linkedin.com/in/melazzouzi/
Get in touch with me - https://www.linkedin.com/in/karandeepbadwal/
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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 battlefield bleeding control, nanotech-based drug delivery, and the future of AI-driven materials science.Timestamps:[00:00:18] What Are Hydrogels and Why They Matter[00:02:30] A Personal Mission: Cancer, Family and Science[00:04:45] From Lab Frustration to Robotic Innovation[00:06:33] Fundraising Real Talk: Angels, Grants, and Grit[00:10:42] How GelTech’s Platform Actually Works[00:13:33] Hydrogels in Your Fridge and in the OR[00:14:54] Why Lab Automation Isn’t a Luxury[00:16:23] The Coming Wave of Smart Materials[00:20:11] Battlefield Nanotech: Bleeding Control with Gels[00:27:25] Advice to Founders: Obsession, Vision and PersistenceGet in touch with Sinan - https://www.linkedin.com/in/sinan-g%C3%B6lhan-a49691b6/ Learn more about Exagen - https://www.geltechlabs.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
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 innovationIn 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 industryTimestamps:[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 ChangeGet 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/@KarandeepBadwalSubscribe to the Podcast
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 conditionTimestamps:[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 PioneerGet 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/@KarandeepBadwalSubscribe to the Podcast
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 biotechnologyAt 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 assessmentsIn 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 workflowsTimestamps:[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 WorkGet 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/@KarandeepBadwalSubscribe to the Podcast
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
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
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
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
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
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 transportIn 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 spaceTimestamps:[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 BusinessGet 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/@KarandeepBadwalSubscribe to the Podcast
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 homeAs 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, ActionTimestamps:[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 BrainGet 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/@KarandeepBadwalSubscribe to the Podcast
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
Subscribe to the Podcast
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
Subscribe to the Podcast
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
Subscribe to the Podcast
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
Subscribe to the Podcast
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