⭐ Introduction
Welcome to another episode of Career Diaries by Elemed! This episode is perfect for anyone interested in working in academia or working for a Competent Authority or is curious about either. Enter our distinguished guest, Tom Melvin, who has done both and provides the inside scoop on both worlds. He used to work for HPRA, the Irish Competent Authority and is now the Associate Professor in Medical Device Regulatory Affairs at Trinity College Dublin.
Tom has had an exciting and ‘atypical’ career journey so far, and he spoke to Elena about what working at a Competent Authority is really like, his expert opinion on the future of medical device regulations and how AI is shaping it, and much more!
To give you a taster of the full podcast, here are some of the key insights that Tom shared:
🔎 From medical doctor to working in regulatory
Tom’s decision to make a career change happened when the opportunity presented itself to join HPRA. He was working as a junior doctor at the time in Ireland and had been planning to take a year off to travel South America. Instead, his background in both law and medicine was ideal for the Competent Authority, and they hired him despite – in Tom’s words – ‘a patchy interview’.
This was a great decision for Tom, who was hooked after the first files landed on his desk at the new job. Working at a Competent Authority, you get to see a lot of what isn’t working, and bad cases can really help to give a sense of purpose and a desire to improve device and patient safety. Tom felt privileged to meet some of the patients whose lives are affected by devices with safety challenges and that then became his motivation to see how the system can be made better. A real driver for Tom that fueled his desire to do well at HPRA was the realisation that if you can be impactful in a public health sense, you can get more done for the public interest than you might ever in a lifetime of going around a hospital.
🧐 Working at a Competent Authority
Tom’s experience working in HPRA, a regulatory authority, was a bit of a culture shock for him as he was used to working long hours in a hospital environment. However, once he got used to office hours, he realised how much free time he had. Working in a regulatory authority was a busy job as they are often minimally resourced, and managing cases from different time periods and places was part of the job. At HPRA, the work was very cross-disciplinary, dealing with engineers, toxicologists, lawyers, clinicians, hospitals, and various other stakeholders. The job required a keen eye for detail, managing busy work, and prioritising tasks. Communication was also vital as the work was complicated, and the ability to explain regulations in plain English was crucial.
✨ The real-world impact on patients
Working at HPRA and meeting patients had a profound effect on Tom, and he believes it is important to understand the real-world impact on patients and the value of talking to patients or patient representative groups. He notes that while numbers and data are important, speaking to patients impacted by medical device safety issues gives a clearer understanding of the true human impact. Tom gives an example of the transvaginal mesh safety issue in Ireland in 2018, where the decision to ban surgery involving these products was made based on evidence of a high rate of safety outcomes. However, speaking to affected women gave a much more comprehensive impression of the true human impact, including the impact on their quality of life, home life, and personal life. Tom believes that it is important to understand the context of patients’ experiences to inform decision-making as a regulator. These real-world examples are what motivate him to improve parts of the system, even when discussions become more abstract.
💫 What is next for digital health?
Tom pointed out that current regulations for medical devices were initially designed for trade purposes, with the goal of creating a single market and removing trade barriers. However, healthcare presents unique challenges that require a different approach to regulation. He believes that the current layering approach to regulation, where new rules are added on top of existing ones, can make it technocratically challenging to comply with regulations, particularly in markets with many players, like the Digital Health and Health and Wellness App marketplace.
Tom suggests that a more rational approach would be to carve out specific regulations for AI and other new technologies in healthcare rather than adding layers to existing regulations. However, creating tailored regulations for the sector is not an easy task, and it’s likely that the more generic rules currently in place will continue to be the norm. Despite this, Tom emphasises the need to create predictability within regulations to make compliance more manageable for software companies in the healthcare industry.
🔮 The future of regulation
Tom discusses the future of regulation in the Medtech industry, stating that while the MDR transitionary timeline will last until 2028, regulations always need to be updated. He notes that it’s hard to predict where things will go beyond the timeline, but would like to see regulations become more agile and adaptive, with a technology-focused approach that matches the public health risks of new technologies. Tom believes that clinical science can help make market access more predictable and obvious to developers, but one of the challenges is the technocratic and procedural mindset that often dominates the regulatory process. Tom warns that the dynamic of Europe being an innovation-friendly first launch market seems to be changing and that clinical science and technology-focused rules are essential for the industry’s success. He hopes that there will be better development of common specifications in the future and that the industry will continue to focus on technology.
🎙️ Conclusion
This wide-ranging episode packed a lot in! From Tom’s interesting career as a medical doctor to HPRA and now into academia, the impact of AI and the future of Medtech regulations, and much more. Now Tom is at Trinity College Dublin and they have launched a master’s course in Regulatory Affairs. Make sure to listen to the full podcast to soak in all of the insight!
