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 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

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• #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 Subscribe to the Podcast

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• #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 Subscribe to the Podcast

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• #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 Subscribe to the Podcast

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• #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 Subscribe to the Podcast

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