Episodes
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...
Published 03/16/24
Published 03/16/24
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...
Published 02/12/24
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]...
Published 01/29/24
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...
Published 01/15/24
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...
Published 01/04/24
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...
Published 12/03/23
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...
Published 11/01/23
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...
Published 10/09/23
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...
Published 09/25/23
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...
Published 09/04/23
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...
Published 08/16/23
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...
Published 08/01/23
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...
Published 07/14/23
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 -...
Published 07/09/23
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...
Published 06/28/23
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...
Published 06/13/23
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...
Published 06/04/23
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...
Published 05/17/23
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 -...
Published 05/03/23
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...
Published 04/20/23
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...
Published 04/02/23
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...
Published 03/09/23
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...
Published 02/21/23
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...
Published 02/08/23