The MedTech Podcast

Karandeep Singh Badwal

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/QRAMedical/ Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support read less
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Episodes

#67 Cybersecurity From Design to Lifecycle with Christian Espinosa: Securing Medical Devices, Exploring Obscure Vulnerabilities and Real-World Impact of Hacking
1w ago
#67 Cybersecurity From Design to Lifecycle with Christian Espinosa: Securing Medical Devices, Exploring Obscure Vulnerabilities and Real-World Impact of Hacking
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
#66 Navigating the Impact of EU MDR and Clinical Evidence with Ethan Drower: Post Market Surveillance, State of the Art and Continuous Monitoring
29-04-2024
#66 Navigating the Impact of EU MDR and Clinical Evidence with Ethan Drower: Post Market Surveillance, State of the Art and Continuous Monitoring
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
#63 Medical Device Markets with Steve Curran: Which market to enter first, Irish MedTech scene and the effects of Brexit
12-02-2024
#63 Medical Device Markets with Steve Curran: Which market to enter first, Irish MedTech scene and the effects of Brexit
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
#61 Software as a Medical Device with Nicola Thorn: Design to documentation, Navigating the complexities of compliance and Generative AI
15-01-2024
#61 Software as a Medical Device with Nicola Thorn: Design to documentation, Navigating the complexities of compliance and Generative AI
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
#60 Lung Cancer with Mark McDonough: Biomarker Testing, High Definition PCR Technology, Growing and Selling Multiple Businesses
04-01-2024
#60 Lung Cancer with Mark McDonough: Biomarker Testing, High Definition PCR Technology, Growing and Selling Multiple Businesses
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
#59 Digital Health with Eric Horesnyi: Focussing on patient experience, software development, transitioning to digital systems and IoT
03-12-2023
#59 Digital Health with Eric Horesnyi: Focussing on patient experience, software development, transitioning to digital systems and IoT
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
#58 Smart Radiation Diagnostics with Raghu Bala: Consequences of Radiation Exposure, Serial Entrepreneurship and Raising Capital
01-11-2023
#58 Smart Radiation Diagnostics with Raghu Bala: Consequences of Radiation Exposure, Serial Entrepreneurship and Raising Capital
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
#57 Software Medical Devices with Weronika Michaluk: Agile vs Waterfall Methodologies, SaMD & SiMD and Exploring Complex Fields
09-10-2023
#57 Software Medical Devices with Weronika Michaluk: Agile vs Waterfall Methodologies, SaMD & SiMD and Exploring Complex Fields
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
#56 Teleneurology & Entrepreneurship with Ziv Yekutieli: Connecting Technology With Neurology, At Home Diagnosis and Nurturing Existing Customers
25-09-2023
#56 Teleneurology & Entrepreneurship with Ziv Yekutieli: Connecting Technology With Neurology, At Home Diagnosis and Nurturing Existing Customers
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
#55 Regulating AI in MedTech & Investing with Mariusz MÄ…sior: The AI act, Effective Networking and Risks, Applications and Dangers of AI
04-09-2023
#55 Regulating AI in MedTech & Investing with Mariusz MÄ…sior: The AI act, Effective Networking and Risks, Applications and Dangers of AI
Mariusz MÄ…sior 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 MÄ…sior - 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
#54 Regulatory & Clinical Intelligence with Ivan Perez Chamorro: Ever changing regulatory frameworks, the power of mentorship and Artificial Intelligence
16-08-2023
#54 Regulatory & Clinical Intelligence with Ivan Perez Chamorro: Ever changing regulatory frameworks, the power of mentorship and Artificial Intelligence
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
#53 The power of Tregs with Arun Swaminathan: Harnessing Regulatory T cells to Address Neurodegenerative, Autoimmune and Metabolic Diseases & Mysteries of the human body
01-08-2023
#53 The power of Tregs with Arun Swaminathan: Harnessing Regulatory T cells to Address Neurodegenerative, Autoimmune and Metabolic Diseases & Mysteries of the human body
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
#49 Equity in Clinical Trials with Sans Thakur: Empowering Female Health, Tackling Gender Bias, Revolutionizing Digital Trials, Equalizing Funding and Accelerating Patient Treatment
13-06-2023
#49 Equity in Clinical Trials with Sans Thakur: Empowering Female Health, Tackling Gender Bias, Revolutionizing Digital Trials, Equalizing Funding and Accelerating Patient Treatment
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
#48 Risk Management with Bijan Elahi: Transferring from Aerospace to Medical Devices, Becoming an Author, Getting Into Teaching and Upcoming Challenges With Advancements in Medical Technologies
04-06-2023
#48 Risk Management with Bijan Elahi: Transferring from Aerospace to Medical Devices, Becoming an Author, Getting Into Teaching and Upcoming Challenges With Advancements in Medical Technologies
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