Check out the YouTube preview of the conversation: https://youtu.be/mihXUUomM6s

Richard Houlihan is an IT expert who has been involved with the development of EUDAMED (the European Databank for Medical Devices). In this episode, Richard explains exactly how EUDAMED works, how it was developed and its current state of implementation. There are 6 core modules to EUDAMED, with almost half already rolled out. Richard warns that a lot of companies are going to be caught with their backs against the wall due to a lack of understanding of what the EUDAMED system is and the urgency for medical device manufacturer's to start transferring their data to the existing modules. Luckily, he reassures me that he is willing to train and help all those that are willing to learn! 

Ryan Noach is the CEO of Discovery Health, one of the most recognizable South African companies, specializing in health insurance. In this episode, Ryan shared how his upbringing in apartheid South Africa shaped his desire to make the country a better place. We spoke about the general health of the South African public, the impact of Discovery Health as a whole, and the current mechanism of health insurance. Finally, Ryan revealed a few of the many new products that Discovery Health is working on that the public can look forward to.

Dr Oliver Eidel is a medical doctor turned software developer and open innovation enthusiast. He joined me in this episode to discuss some his views and ideas regarding open-sourcing the medical technology regulatory space.

Bart de Witte is the founder of the Hippo AI Foundation, a nonprofit organization that focuses on defeating global inequalities in healthcare by fostering open-source medical AI. The Hippo AI Foundation makes "data available without reward for open-source usage that benefits communities or society at large, such as the use of breast-cancer data to improve global access to breast cancer diagnostics". Bart is a distinguished individual, having been a TEDx speaker. We had a deeply insightful, philosophical and challenging conversation.  

Monir El Azzouzi is the founder of Easy Medical Device, a regulatory affairs consulting company with a focus on educating and training professionals in the medtech industry. We had a great conversation about the profession, the need for a regulatory framework and what it takes to be a consulting business.

Dr Boitumelo Semete-Makokotlela is the CEO of the South African Health Products Regulatory Authority (SAHPRA). SAHPRA's job is to ensure that all health products (medical devices and medicines) are safe and operate the way that their manufacturers claim they operate. We have a discussion about topics such as the relationship of the regulator with industry, engagement and collaboration, alignment with already-existing systems and how to handle the pressure of leading an influential organization.  

Michelle Lott is the founder and principal at leanRAQA. We sat down and had a chilled discussion on the medtech industry and what it means to work in quality assurance and regulatory affairs.