Welcome to Episode 14 of The Only Way is Ethics, hosted by Dean Mawson, Founder and Clinical Director of DPM Digital Health Consultancy Ltd.
Today, we’re thrilled to have a deep-dive conversation with Lyndon Johnson, CEO of 8foldgovernance, a respected leader in regulatory compliance, digital health strategy, and quality management. Lyndon’s expertise extends to mentoring and coaching industry leaders, senior team members, and board-level professionals, making him a key figure in guiding organisations through the complexities of digital health.
 
In this episode, we’ll explore the unique challenges digital health startups face in navigating regulatory compliance, the importance of establishing a solid Quality Management System (QMS), and Lyndon’s insights on creating agile and compliant digital strategies. We’ll also discuss the competitive landscape of digital health, highlighting funding and market access opportunities for startups, and the challenges of entering the UK market and NHS procurement. Additionally, we’ll look at evolving regulatory frameworks, particularly as they adapt to innovations in software as a medical device (SaMD), and the essential role of demonstrating clinical and economic value to NHS decision-makers.
 
Whether you’re a digital health entrepreneur, a regulatory professional, clinical informatician, or just interested in the intersections of technology, healthcare, and ethics, this episode offers a wealth of insights into the regulatory landscape and governance strategies critical for success in this evolving field. Join us as we delve into these vital issues with Lyndon Johnson.
 This podcast is for informational purposes only and should not be considered legal health advice.
We are not responsible for any losses, damages, or liabilities that may arise from the use of this podcast.
This podcast is not intended to replace professional medical advice.
The views expressed in this podcast may not be those of the host or the management.

Ver todos los episodios