Episoder
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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
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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
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Manglende episoder?
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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
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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
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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
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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
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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
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Raghu Bala Founder of Clinitraq, a company specialising in Smart Radiation Dosimeters that reduces the time for measuring cumulative radiation from 60 days to 60 secs. Raghu possesses an MBA in Finance from the Wharton School (University of Pennsylvania), an MS in Computer Science from Rensselaer Polytechnic Institute and a BA/BS in Math and Computer Science from the State University of New York at Buffalo. He is the Head Managing Instructor for MIT courses in AI, Decentralized Finance and Blockchain on the 2U platform. He is also an Adjunct Professor at VIT (India) and an ex-adjunct Lecturer at Columbia University.
In this episode, we explore the lack of education surrounding the pernicious consequences of radiation exposure, discover the hidden hazards healthcare workers face, oblivious to their exposure levels due to measurement inadequacies, delve into his transition from the tech industry to MedTech and the motivations behind it, uncover his strategies for funding multiple companies he nurtured and eventually sold, alongside diverse capital-raising methods and gain valuable insights from his candid revelations about the mistakes he encountered as a serial entrepreneur
Timestamps:
[00:02:32] Antiquated methods of radiation diagnostics
[00:05:41] Radiation health risks overlooked, ignored
[00:12:14] Misconceptions about radiation risks
[00:18:01] Underestimated risks
[00:23:20] Medical tech advances: Embracing tech for better care
Get in touch with Raghu Bala - https://www.linkedin.com/in/raghubala/
https://clinitraq.com/
Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/
Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal
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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
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Ziv Yekutieli CEO of Mon4t a company that turns any standard smartphone into a sophisticated, personalized neurological medical testing device for remote and in-person testing the data of which can be used monitoring of neurological and psychiatric patients. He started his career as an electrical engineer, having experienced one of his teachers suffer from ALS, he began to study neurology alongside engineering eventually going on to study a PhD in Brain Science whilst in his engineering career eventually going to cofound Mon4t.
In this episode, we discuss his journey from studying medicine and engineering to connecting neurology and technology, the prevalence of neurological conditions affecting up to one in eight people, how the number of neurologists per capita is falling and his advice for aspiring entrepreneurs to know the box before thinking outside of it.
Timestamps:
[00:00:01] How Telehealth accelerates teleneurology treatment
[00:06:36] Telehealth advancing neurology and its complexity
[00:14:02] Neurology, engineering, technology: lifelong journey
[00:22:08] Know the box, identify beachhead, nurturing customers
[00:28:31] Exploring brain and starting a business
Get in touch with Ziv Yekutieli - https://www.linkedin.com/in/ziv-yekutieli/
https://mon4t.com/
Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/
Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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