The MedTech 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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

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 Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

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 Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Dr Adam Power Co-Founder and CEO 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 Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

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 Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Christian Espinosa Founder and CEO of Blue Goat Cyber is a leading medical device cybersecurity expert, who started his career within the United States Air Force as a Computer Systems Officer and is now a serial entrepreneur, best-selling author, avid adventurer and Ironman triathlete. In this episode, we delve into the vital necessity of safeguarding medical devices to avert potential harm or fatalities stemming from hacking. We cover the significance of initially designing devices with security in mind and advocating for ongoing monitoring throughout their lifespan. Furthermore, Christian offers valuable insights for companies on effectively integrating cybersecurity from the outset of development. Timestamps: [00:03:27] Securing wireless connections [00:06:57] Threat modelling methods [00:13:43] The need for continuous testing for medical device security [00:19:47] How military discipline helped build a successful business. [00:26:08] The importance of delegation [00:28:47] Focusing on mono-tasking for productivity Get in touch with Christian Espinosa - https://www.linkedin.com/in/christianespinosa/ https://bluegoatcyber.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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Ethan Drower Co-Founder and CEO at Cite Medical brings a unique blend of expertise to the table. His background as a trained software engineer, coupled with his partner's veteran experience in regulatory affairs and quality makes him an expert in the clinical space In this episode, we discuss the impact of EU MDR on medical device manufacturers, the changes in clinical evidence requirements, the concept of state of the art alongside what this means in practice in addition to the need for adequately qualified reviewers and the challenges faced by smaller startups in finding the required expertise Timestamps: [00:02:36] Importance of literature review in research [00:15:30] Continuous monitoring critical for device safety [00:19:21] Regulatory and clinical synergy in business [00:21:26] Clinical data and evaluation are crucial. [00:24:56] Passionate about travel and cultural experiences. [00:28:05] Sailor and motorcycle enthusiast, open to travel anywhere. Advice: improve regulatory skills, not fight against regulations. Get in touch with Ethan Drower - https://www.linkedin.com/in/ethandrower/ 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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Christa Natoli Executive Director at Center for Telehealth and Ehealth Law has extensive policy experience and knowledge in the areas of physician and nurse licensure, Internet prescribing, e-consultations, Medicaid reimbursement, mHealth and international telemedicine. She has led research efforts on these topics and is a published author and noted lecturer and speaker In this episode, we dive into the world of telehealth technology discussing its origins, challenges, and potential benefits. We also explore the role of AI in reducing clinician workload alongside the misconceptions around this type of technology and discuss the future of global healthcare Timestamps: [00:02:38] Telehealth defined as point-in-time care [00:05:11] Accessibility for all in digital health [00:07:48] Regulations on AI and medical devices [00:20:27] Early AI adoption in healthcare: IBM Watson [00:26:16] Inaccuracy of online information Get in touch with Christa Natoli - https://www.linkedin.com/in/christa-natoli/ 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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Carlo Odicino CEO and Founder at One TEAM Partners has over 24 years of experience working with therapeutic, medical device and diagnostic companies and is an expert in guiding CEOs and their leadership teams through the challenges that come with bringing a new innovation to market while achieving exceptional results. In this episode, we explore why certain life science company CEOs struggle to grow their company despite working long hours, the key aspects in scaling a company alongside building a suitable team, what makes the location of Orange County a hub for life sciences and Carlo managed to get into consulting very early on his career Timestamps: [00:06:43] Learning from mentors and embracing vulnerability [00:10:23] Key to great relationships [00:17:14] Supporting life sciences companies with growth [00:23:15] Convince CEOs to work smarter, not harder. [00:30:37] Simple hack to improve your morning Get in touch with Carlo Odicino - https://www.linkedin.com/in/cjodicino/ or https://oneteampartners.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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Steve Curran Senior Regulatory Consultant at Trinzo, a medical device and pharmaceutical consultancy firm. He has over 20 years experience in the medical device industry both as an engineer and leader developing medical devices but also as a Notified Body regulator ensuring that devices are compliant when they reach the market. He has a broad range of experience from general medical devices to orthopaedic and dental devices and combination devices incorporating drugs and biologics In this episode, we explore why Ireland is becoming a growing sector in this industry, the parallels of working at a notified body to a consultancy, the concept of a virtual manufacturer, which market to enter first the UK, EU or USA and Steves advice for those looking to get into quality and regulatory roles. Timestamps: [00:03:08] Virtual Manufacturing [00:07:08] Common Mistakes manufacturers make [00:15:11] UK, EU v USA Markets [00:17:48] Time constraints and interdepartmental cooperation challenges. [00:24:25] Enforcing safety in the medical device industry. Get in touch with Steve Curran - https://www.linkedin.com/in/vincentcafiso/ 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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Vincent Cafiso Founder of Practical Compliance Results a quality and regulatory consulting practice. In this episode, we explore our Vincents journey as an FDA inspector, revealing intriguing stories, we the importance of getting an early grasp of the regulatory process and what the FDA seeks in Medical Device Companies, extending to insights on securing FDA roles, founding a consulting firm and leveraging LinkedIn for networking Timestamps: [00:03:52] Working in the FDA [00:07:37] Securing a role [00:11:16] Importance of compliance [00:15:26] Content-based networking [00:25:12] Surgery and faulty blood pressure cuffs [00:31:17] The Future of AI in Software Get in touch with Vincent Cafiso - https://www.linkedin.com/in/vincentcafiso/ 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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Nicola Thorn CEO and Founder of Tento+ a company that helps companies generate technical documentation that is audit-ready. Nicola is an expert in technical compliance for medical devices working across FDA, UKCA, and CE market approvals for digital health tech products and completed her PhD in Mathematics at the University of Reading, as well as founding Tento+, Nicola is CEO of AND Technology, an award-winning product development consultancy, she has worked in product development in electronics, software, machine learning and Tech 4 Good for over 10 years. In this episode, we explore the application of generative AI tools in software development, examining their advantages for content creation and emphasizing the crucial need to verify their outputs. We also shed light on the entrepreneurial pursuits of individuals within the NHS, discussing the underlying reasons and the existing programs supporting this transition. Additionally, we delve into the risks associated with retroactively documenting design controls, providing insights into the potential pitfalls of such practices. Timestamps: [00:01:55] Design Controls in Retrospective [00:12:26] Generative AI Tools [00:15:53] Reality of Medical Device regulatory timelines [00:20:26] NHS Clinical Entrepreneurship [00:22:56] Reasons for getting into entrepreneurship [00:25:38] The future of AI in Software Get in touch with Nicola Thorn - https://www.linkedin.com/in/nicola-thorn-725131ab/ https://andtr.com/ https://tentoplus.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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Mark McDonough CEO of ChromaCode, an innovator in molecular genomics providing easy to implement, cost-effective workflows within Oncology and Genomics. Mark has over 25 years of experience helping build high growth HealthCare organizations. He most recently was the CEO of Pierian (now Velsera) which he led to a successful sale to Summa Equity, a private equity firm, in 2022. Prior to Pierian, he led CombiMatrix for five years, culminating in a sale to Invitae in 2017. Over his career, Mark has held various executive and commercial positions, and even once served as a US Naval Officer. In this episode, we delve into Marks experience in the healthcare space and his thoughts on the future of healthcare with HDPCR technology, we discuss his experiences of growing and selling multiple businesses alongside the many lessons he learned along the way, he shares his advise in terms of what he looks for in potential board member and advisory roles alongside the reasons of why you may not want to consider such positions and his reasons for continuing to work within the healthcare sector Timestamps: [00:00:15] Delivering high-impact testing faster and cheaper [00:04:08] Lesser known facts of Lung cancer. [00:09:38] Developing targeted markers for lung cancer. [00:16:12] Add value to your tech team [00:20:52] Importance of Authenticity to success. Get in touch with Mark McDonough - https://www.linkedin.com/in/mark-mcdonough-b1055216/ https://www.chromacode.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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Eric Horesnyi CEO of Matrix Requirements, a leading platform in design and quality control for Software Medical Devices. Eric started his career in finance in tech having co-founded Radianz a financial data exchange and Streamdata.io for real-time API. However during the pandemic of 2020 after organising a hackathon for his company at the time, he realised a lot of skills and knowledge he had built in these industries could be beneficial in digital health hence his transition to healthcare in 2022. In this episode, we delve into the intriguing parallels among finance, tech and healthcare. Discover the contrasting approaches of agile and waterfall methods in software development for medical devices. Learn expert strategies for fostering seamless collaboration between departments, navigating the common challenges faced by developers and quality teams. Gain insights into the significance of advisory board positions, exploring reasons to embrace or reconsider them and share our firsthand encounters and effective tips for maximising the value of industry conferences. Timestamps: [00:08:16] Developers and FDA Compliance. [00:13:41] Traceability requires multiple dimensions. [00:15:53] Reality of Medical Device regulatory timelines [00:19:04] Preparation for Industry Conferences [00:22:21] Effective networking [00:25:34] Helping others, finding passion and gaining skills Get in touch with Eric Horesnyi - https://www.linkedin.com/in/horesnyi https://matrixreq.com/?utm_source=podcast&utm_medium=referral&utm_campaign=2023-06-themedtechpodcast-all-all Get in touch with Karandeep - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

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 Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Weronika Michaluk Digital Health Principal and SaMD Lead at HTD, a company specialising in the planning, designing and development of custom healthcare software. Weronika is an experienced professional with a diverse background in the fields of biomedical engineering, international business and public health. Her career began as a Biomedical Engineer, where she contributed to the development of various biomedical devices, including a wireless ECG system, then she worked in South Korea in the Neuroscience Department and after that, she focused on digital health solutions and consulting in the medical device space. In this episode, we delve into the world of software medical devices, explore the agile and waterfall approaches in software development and their application to regulated medical devices. We discover the crucial role of software in medical devices, uncover how some companies unintentionally market unregulated medical products and learn how to stay updated with the ever-evolving regulations. Timestamps: [00:00:10] What makes a software a Medical Device [00:05:57] Complexity of regulating software [00:11:52] Agile individuals and interactions over processes [00:17:30] Software medical device: engineering, research, business and coding [00:23:00] How to keep up with regulations Get in touch with Weronika Michaluk - https://www.linkedin.com/in/weronika-michaluk-mba-43811698/ https://htdhealth.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

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 Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Mariusz Mąsior CEO of Consonance, a medical device development company providing multiple services from prototyping to manufacturing. He has a very strong academic background, he is an Author and co-author of numerous publications in reputable scientific journals and a visiting Scholar at Stanford University and Nagoya Institute of Technology. In this episode, we discuss the implications of the AI Act including how it is not application-specific by not taking into account the risks and applications of AI therefore making it difficult for new companies, the unique challenges of investing in MedTech startups in respect to product and ethical considerations and how ResearchGate and Web of Science can be used as effective networking tools. Timestamps: [00:00:02] AI, machine learning, regulation issues [00:06:46] AI: Magical, not dangerous and its application [00:14:07] Networking for startups: Be social, talk, attend events. [00:20:06] Network to find experts: Six words [00:27:48] Exploring new things fearlessly Get in touch with Mariusz Mąsior - https://www.linkedin.com/in/mariuszmasior/ https://consonance.tech/ 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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Ivan has both strong science and business background, he holds a BSc and MSc in Physics and an MBA. Having worked for nearly 15 years within the industry, in leading medical companies and also as a consultant in the areas of regulatory, product and business development, he has broad experience with different types and classes of products, supporting a variety of organisation models and management, from start-ups to large corporations. In this episode, we explore the challenges of staying abreast of constantly evolving regulations and guidance documents on a global scale. Ivan shares invaluable insights on successful networking and imparts valuable advice for aspiring entrepreneurs. Furthermore, we delve into his personal journey, uncovering how a sports injury compelled his shift from physics to medical devices, prompted by a misdiagnosis that persisted for more than 4 years. Timestamps: [00:01:01] Importance of networking early on in your career [00:04:35] Keeping up with changes in regulations and guidelines [00:18:38] Turning a negative into a positive [00:22:05] Dealing with failure [00:25:08] Explaining entrepreneurship to your peers Get in touch with Ivan - https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22/ https://www.medboard.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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Arun began his career in clinical development and commercial roles of increasing responsibility at BristolMyers Squibb and Covance has over 20 years of hands-on healthcare business executive experience with an emphasis on corporate and business development, strategy and finance. In this episode, we delve into the paramount importance of prioritising patients amid physician shortages in the US healthcare system, the cutting-edge approach of targeting regulatory T cells to combat neurodegenerative diseases effectively, the pivotal role of biomarkers in diagnosing these conditions together with the potential of combining them with physician tests, cognitive assessments and advanced scans for a truly ideal approach alongside how the intricacies of the human body remain a profound challenge and that there is still an abundance of knowledge to unravel and discover. Timestamps: [00:00:00] Excellent healthcare: Patient-centered excellence. [00:06:09] Treating neurodegenerative diseases with Tregs. [00:11:45] Bringing therapies to patients faster. [00:18:00] Forming a company to fight neurodegenerative diseases. [00:24:39] Evolution of Coya: Follow Your Calluses. Get in touch with Arun Swaminathan - https://www.linkedin.com/in/arun-swaminathan-a8571b3/ https://coyatherapeutics.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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Bethany is a healthcare innovation and femtech attorney with almost a decade of experience working at multiple different law firms before founding FemInnovation. In this episode, we delve into issues the Femtech industry faces in terms of growth and advancement. we discuss the lack of investment in women's health issues, the difficulties of advertising women's health products, the importance of involving an attorney early on in the process and recommended organisations for those looking to get involved in this space such as Femtech Lab and Impact 51. Timestamps: [00:00:00] Driving femtech growth: healthcare, menopause, breast/uterus health. [00:04:36] Women's health neglected, femtech data traded for money. [00:12:09] Women's health inequities in VCs [00:17:54] Femtech: Mentoring, Advising and Collaborating [00:23:54] Exploring FemTech: Don't be afraid. Get in touch with Bethany Corbin - https://www.linkedin.com/in/bethanycorbin/, https://feminnovation.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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

In this captivating bonus episode, we embark on an exploration of our individual backgrounds and the fascinating paths that led us to our present achievements. Join us as we discuss the exciting possibilities of in-person podcast recordings, delve into the current regulatory landscape and delve into Rodney's thrilling globe-trotting adventures. Get in touch with Rodney Moses - https://www.linkedin.com/in/rodmoses/ 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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

This groundbreaking technology empowered paralyzed individuals to navigate their world with newfound freedom. Building on this success, James embarked on his latest venture, Vistim Labs, aiming to solve a significant barrier in neurodegeneration with timely diagnosis. In this episode, we delve into the fascinating connection between stress, gene expression and the subconscious mind. We explore how stress can impact our DNA and the role our brain plays in regulating stress levels whilst uncovering the intriguing interplay between conscious and subconscious thoughts and how negative imagery may trigger subconscious responses with potential implications for our health. Get in touch with James Hamet - https://www.linkedin.com/in/jchamet/ https://vistimlabs.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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Prior to Medable Sans at the helm of Accenture's Global Life Sciences Research, assumed the pivotal role of orchestrating visionary market-shaping strategies and spearheading program execution in therapeutics, digital health, and scientific innovation. With over two decades in the industry, Sans's expertise graced the corridors of more than 30 companies, launching an impressive lineup of 10 groundbreaking products. Her guidance extended even further, advising digital health venture funds and masterfully managing a top 20 pharmaceutical portfolio. In this episode, she delves deep into the pervasive issue of gender bias in clinical trials unveiling the startling truth about how these trials predominantly focus on Males with little Ethnic Diversity, leading to medicines that may not be optimized for everyone. How in the late 1970s women of childbearing age were excluded from medical research, regardless of their intention or ability to have children, how despite women comprising over half the population, a mere 1% of healthcare research and development is invested in addressing their specific conditions and how both the FDA and EMA have undergone a transformative shift in their perception of digital tools. Get in touch with Sans Thakur - https://www.linkedin.com/in/sanskritithakur/, https://www.medable.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 --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Bijan's career began in aerospace back in 1985, where he played a crucial role in ensuring safety within NASA and overseeing space systems. However, it was a fateful encounter at a risk management conference in 1991 that sparked his interest in the field of medical devices. When someone sought his advice on this topic, it paved the way for his transition into the realm of medical devices. Since then, Bijan has become a respected figure, sharing his knowledge and expertise through lectures at numerous universities. He has also provided valuable guidance to multiple medical companies on the intricacies of risk management. As a testament to his deep understanding of the subject, he has authored two comprehensive books on risk management. In this episode, he delves into the intriguing world of risk management, drawing parallels between aerospace and medical devices. With years of experience as an advisor, he unveils the common misconceptions surrounding this crucial topic. He sheds light on his earlier days when risk management lacked standardized frameworks and how he navigated through that landscape. Above all, Bijan shares his unwavering passion for transforming uncommon knowledge into something accessible and widespread. Get in touch with Bijan Elahi - https://www.linkedin.com/in/bijanelahi/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

In this episode, Pietro discusses the concerns about the impact on physicians' workload with the increase in technology within healthcare, the key milestones in the development of AI in medicine, the concept of personalized medicine and the most promising areas of research at the intersection of AI and medicine. Get in touch with Pietro Arina - https://www.linkedin.com/in/dr-pietro-arina-64293213b/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

In this episode, Josep discusses how hypertension can remain undiagnosed for years, potentially decades and why this is the case, how, unlike some other diseases that can just be treated once and forgotten about, this is one that you have to monitor for the rest of your life, the somewhat lack of regulatory hurdles he faced bringing his product to market compared to other types of devices and what he learned from over 15 years research on the disease. Get in touch with Josep Solà - https://aktiia.com/ or https://www.linkedin.com/in/josepsola/ Get in touch with Karandeep Badwal - https://aktiia.com/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Phil discusses the potential of machine learning and artificial intelligence to advance healthcare and shares his vision for the future of movement health and Sparta Science's role in it. He also provides valuable insights for aspiring entrepreneurs looking to break into the industry and discusses notable collaborations his company has had with other healthcare organizations. Finally, Phil shares ongoing research and development projects at Sparta Science and how they may impact the future of healthcare. Tune in for a fascinating conversation with a thought leader in movement health and technology. Thank you for listening to Episode 45 of the MedTech Podcast, if you have not already done so please subscribe, if you wish to learn more about Phil you can connect with him on LinkedIn or visit his company website, the links of which are provided in the description. If there are any particular topics or guests you would like me to have on the show in the future, feel free to reach out. Get in touch with Phil Wagner - https://spartascience.com/ or https://www.linkedin.com/in/drphilwagner/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Amy went through the exact same challenges as many women do during infertility and leveraged her expertise to develop an approachable remedy. She discovered that for herself and others, the crucial element in achieving pregnancy was surprisingly uncomplicated: comprehending the roles of hormones, their distinct functions, and ways to maintain equilibrium. This knowledge completely changed Amy's approach to fertility - ultimately resulting in the birth of her second child. On this episode she discusses the lack of education around healthy conceiving in the school systems, the misconceptions around ovulation in the current healthcare system, revealing the surprising ways that traditional off-the-shelf fertility tests fall short in truly testing ovulation. She also explains how traditional fertility tests available over-the-counter do not accurately measure ovulation. Additionally, she highlights the inadequate coverage for fertility treatments in health insurance plans and a discussion on the regulatory journey her device that was initially exempt from pre-market clearance by the FDA but eventually had to undergo a 510k process after contact with the FDA. Get in touch with Amy Beckley - https://www.linkedin.com/in/amybeckley/ or https://proovtest.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Karen has a diverse range of experiences under her belt. From working for large corporations in manufacturing and marketing to running her own successful consulting firm. she's also a passionate advocate for changes in healthcare, using technology to make a real difference in the lives of patients. Get ready to unravel the secrets of your body's "wires" as we dive into the fascinating world of nerves in this episode. From muscle movement to breathing and beyond, nerves are responsible for multiple functions that keep us going. But what happens when nerve damage goes undiagnosed? We'll explore the outcomes for patients and the need for education for both patients and physicians in this space. Plus, we'll take a closer look at the regulatory pathway for biological products and give you the inside scoop on the healthcare scene in sunny Florida. Get in touch with Karen Zaderej- https://www.linkedin.com/in/karen-zaderej-56342318/ or https://axogeninc.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Eli is a serial inventor and two-time founder. He started his first company, Singular Sound, with his brother in 2013; they have since launched eight blockbuster products. In 2017 he and his team created the first device that automatically flosses all your teeth in only 10 seconds, Instafloss. After five years of research and development, Instafloss is ready to change the world pre-sold $2.5 million, has 41k people on the waitlist. On this episode, Eli delves into the crucial topic of dental hygiene, specifically the importance of flossing, and uncovers why so many people still avoid this crucial habit despite its many benefits. He also explores the fascinating world of invention, including the process of sifting through ideas to determine which ones are worth pursuing, navigating investor relations, and the ins and outs of running a successful Kickstarter campaign. He then goes on to shares some surprising insights into the unexpected challenges of starting a business, and even gives us a glimpse into his thrilling hobby of wild camping. Get in touch with Eli Packouz - https://www.linkedin.com/in/eli-packouz-390701149/ Visit his company website - https://instafloss.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

David is a seasoned expert in the industry with a wealth of over 25 years' experience. He has an impressive track record of crafting and delivering compelling international regulatory presentations, submissions and reports to the most demanding of audiences - the competent authorities and certification bodies around the world. His background includes not only an illustrious career in academia where he was once a professor, but also a stint as a Director at Abbott Medical Devices where he led clinical and regulatory operations, a company I also spent a portion of my career with. On this episode he delves into the intricacies of quality, clinical and regulatory, breaking down what they mean and how they interact with each other, particularly in regards to language, he then takes the audience on a journey through his entrepreneurial career, sharing the inspiring story of how he got started and the process of writing a book. He also shares insights on what investors look for when evaluating companies during their pitch and how he made the transition from a background in pharmaceuticals to medtech. For students who are unsure about which field to pursue, David offers valuable advice and explains why Silicon Valley is such a thriving hub for business and emphasizing the importance of always having a hunger for learning, and how this drive for knowledge can greatly benefit one's career growth. Get in touch with David Rutledge- https://www.linkedin.com/in/david-rutledge-9291609/ or www.GlobalStrategicSolutions.com Get his book here: https://amzn.to/3HL7oKD Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

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 Subscribe to the Podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support

Marcel, a scientist and serial entrepreneur, holds a PhD in Machine Learning in Healthcare from the University of Cambridge. He was named on the Forbes 30 under 30 list, won the Alexander Fleming Prize from the Gates Foundation for his contribution to global public health and the Prix Galien Award for the best medical technology with Cyted's core product called Cytosponge™, a novel test for the early detection of cancer in the oesophagus. On this episode, he discusses the pre-cancerous Barrett esophagus alongside the causes of this condition, the minimally invasive technique his company has developed for the detection of oesophageal cancer together with its comparison to the traditional methods of endoscopy, the process of acquiring funding for his startup, how acid reflux and heartburn could be early warning signs of the disease, his advice for founders and the importance of developing different types of teams at various stages of your business. Get in touch with Marcel Gehrung - https://www.linkedin.com/in/marcel-gehrung/ or https://cyted.ai/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://anchor.fm/themedtechpodcast/support

Mitch has an extensive background in the recruitment and staffing industry, prior to setting up his own firm, he worked a successful career for two nationally recognised search firms Spherion and Management Recruiters International. Mitch is also a content creator regularly posting videos online about recruitment alongside his tips for job seekers and hosts a weekly live show where he answers any questions about job seeking and the industry from the audience. He holds a bachelors degree in psychology and business from the University of Wisconsin-Madison. On this episode, he discusses how to approach hiring managers and how he used such techniques to find a job in his early days, the high demand for Quality & Regulatory staff alongside whether this demand is here to stay after the EU MDR situation has calmed down, his advice for candidates currently on the market for medtech roles, the importance of building a network early on in your career, how he got into content creation and his younger days as part of a rock and roll band. Get in touch with Mitch Robbins - https://www.linkedin.com/in/mitchrobbins/ or https://www.theanthonymichaelgroup.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://anchor.fm/themedtechpodcast/support

For the past 20 years, Erez had led various R&D projects in the healthcare and aerospace industries. He is a well-known 3D medical imaging expert, and most recently led the development of the Itero Element Intraoral Scanner, the leading 3D dental scanner in the world. He holds a BSc & MSc in Electrical Engineering, specializing in AI, a BA in Mathematics, and an MBA, all from Technion Israel Institute of technology and Tel Aviv University and has published several patents in the field of 3D cameras in medical applications. On this episode, he discusses the low success rate of spinal surgeries, the complexity of such procedures and how the spine should be seen as a combination of many organs rather than as just one. His background as an engineer, his time as an R&D Manager at Invisalign helping to develop their 3D Camera and the set up in Infrastructure in Israel for start-ups hence why it is deemed Start-Up Nation, the common mistakes start-ups make and the importance of learning sales an entrepreneur together with being able to sell your vision, dreams, company and team Get in touch with Erez Lampert - https://www.linkedin.com/in/erez-lampert/or https://www.path-keeper.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical --- Support this podcast: https://anchor.fm/themedtechpodcast/support

Jason brings a wealth of experience in strategic operations planning and technical projects management from his rigorous technical background. He began his career as a technical engineer working for Adecco at SC Johnson in 2009, where he developed comprehensive maintenance plans to support manufacturing processes at scale. His philanthropic work with the Juvenile Diabetes Research Foundation sparked an interest in biotech, leading him to co-found Biostem Technologies in 2014. Jason holds a bachelor's in mechanical engineering technology and a minor in Mathematics from the Milwaukee School of Engineering Andrew is a veteran and manufacturing operations expert with over eight years of experience working in FDA-regulated pharmaceutical and tissue processing firms, prior to his biopharmaceutical career, he served as an aviation mechanic and flight captain in the United States Marine Corps. He co-founded Biostem Technologies in 2014 and played a pivotal role in the development of the company ensuring compliance with FDA and state pharmacy board guidelines. Andrew studied at Florida Gulf Coast University and has completed Landmark Courses to hone advanced leadership skills On this episode, they discuss what a complex wound is, what causes it to form and how this condition can be debilitating for patients, how the nutrients from perinatal tissue can be used as a solution for healing advanced wounds, their unique process method know as BioRetain® and how it differs from existing methods on the market and how their technology has been used within sports injuries such as trauma wounds with UFC fighters. Get in touch with Jason Matuszewski - https://www.linkedin.com/in/jason-matuszewski-034163b4/ Get in touch with Andrew VanVurst - https://www.linkedin.com/in/andrew-vanvurst-ctbs-a69807b2/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://anchor.fm/themedtechpodcast/support

Navid is a seasoned entrepreneur in the artificial intelligence space, he is a sought-after panelist, judge, speaker and moderator on the topics of venture capital and entrepreneurship at forums such as CyberHive and MIT Forum. He holds a Bachelor's degree from UC San Diego in political science, economics and eastern history and an MBA in finance from the University of San Diego On this episode, he discusses his definition of Artificial Intelligence alongside the misconceptions people often have about it, the mistakes he made when founding his first few companies together with the advice he has for young entrepreneurs, the higher prevalence of undetected heart disease in women and how CureMetrix can help with this, the popularity of tech in San Diego along with the different boards and positions he holds outside of work and the concept of KRRAI plus how it differs from Machine Learning Get in touch with Navid Alipour - https://www.linkedin.com/in/navid-alipour-a295777/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast --- Support this podcast: https://anchor.fm/themedtechpodcast/support

Adam is someone who I have been in contact with over the past few years sharing the occasional message, having spoken a few times we decided to record our conversation and share it with the medical device community On this episode, he discusses how to go about dealing with suppliers from auditing to reviews, the common mistakes companies make with quality management systems and how to stay on top of ever-changing regulations as a consultant. He also talks about how he got started as an independent consultant and his experiences running his own business, including the upsides of being independent and how to nurture better relationships with clients. Get in touch with Adam Isaacs Rae https://www.linkedin.com/in/adam-isaacs-rae/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast

Lishan has over twenty experience as a heart surgeon but his entrepreneurial and professional success was not an easy road, he fled political violence in Ethiopia as a teenager but despite this went onto study both physics and medicine at Harvard University. He serves as Board Chairman of The Boston ECG Project Charitable Foundation Inc., a non-profit corporation whose purpose is to save the lives of children and adolescents by preventing sudden cardiac death and identifying underlying cardiac abnormalities and conditions On this episode he discusses how he took his company public in 2016 including the process and reasons why a company may consider going public, the steps entrepreneurs can take to spot opportunities or create solutions for current problems, what he learnt about the heart during his years as a surgeon of which may not be common knowledge, the causes of oesophageal cancer together with EsoCheck a device he brought to market which aims to detect pre-cancer and oesophageal cancer, a deadly cancer with an 80% mortality rate at 5 years and his philanthropic projects. Get in touch with Lishan Aklog - https://www.linkedin.com/in/laklog/ or visit his company website https://pavmed.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast

Gray has over 20 years of experience in the healthcare industry, a large portion of which was at St Jude Medical now Abbott, a company of which I also worked at in early in my regulatory career. During his professional life, he held several commercial leadership positions. Most recently Gray, held the position of Chief Commercial Officer at Carecubes, a company created to provide a temporary and scalable negative pressure isolation technology solution based upon original joint request from the Defense Advanced Research Projects Agency (DARPA) and Centers for Disease Control and Prevention (CDC). He holds a Bachelor of Business Administration degree with a Major in Marketing from Stephen F. Austin State University in Texas and a certificate in Leadership in Excellence and Development (LEAD) Program from the University of Texas at Austin. On this episode he discusses how the idea of PURE EP came to fruition, the prevalence of Atrial fibrillation in the U.S making it one of the most deadliest diseases and how they are trying at BioSig to help detect this condition earlier, the concept of physician reimbursement including its importance in the sales of medical devices, the greatest challengers the industry faces today including how to overcome them and how he started his career from a clinical associate to modern day as CCO of BioSig. Get in touch with Gray Fleminghttps://www.linkedin.com/in/gray-fleming-5882a7b/ or visit his company website https://www.biosig.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical Subscribe to the Podcast

Vlado left school early to begin work across various industries from gardening, property development and Healthtech. His different work experiences and an interaction with a sports physiologist eventually led to him co-founding Advanced Human Imaging (formerly MyFiziq Limited) in 2014. He now has over 30 years of experience in assisting businesses with strategy, structure and entry to capital markets. On this episode he discusses how he first developed the idea and progressed the technology into Advanced Human Imaging, the process of bringing an idea to reality, the importance of execution and believing in yourself, trends in healthcare technology within Australia, how his company helps doctors to treat more patients in less time by providing vital information such as body composition, heart rate, blood pressure and respiration rate all of which can be used by doctors to determine if any and the extent of treatment needed. He also discusses the true cost of entrepreneurship and how it can impact every part of your life together with the advice he offers for those looking to embark on a similar journey to his. Get in touch with Vlado Bosanac https://www.linkedin.com/in/vladobosanac/ or visit his company website https://www.ahi.tech/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical