What we learned about navigating global MedTech Regulation pathways
14 Aug 2020
In the first of our Longitude Prize Sprint virtual events, we convened experts from around the world to explore the subtle and distinct variations in regulatory standards for medtech products, particularly between developed and developing countries. 70 people participated: Longitude Prize competitors, researchers and other players in the diagnostics product development space.
Here are our key takeaways from the discussion:
1. Product developers need support through regulatory and validation processes. When we surveyed attendees, two-thirds of those on the call told us ‘navigating regulation and clinical validation’ was the most difficult area to overcome when developing diagnostics to help tackle AMR.
2. Risk-based framework is the holy grail of all regulatory agencies globally. While there are subtle differences in the mode of regulation amongst regulatory agencies of different geographies, all regulatory agencies use a risk-based regulatory classification to categorise medtech products during development and introduction. Patients’ safety and good science underly decisions of all agencies.
3. Get in touch with a regulatory agency from the word ‘go’. All experts urged the medtech innovators to seek advice from regulatory agencies, especially those in their target markets, early on in their product development cycle such that there is clarity about the regulatory burden that the product needs to overcome. However, as of August 2020 many agencies have little bandwidth for non-COVID tests. With limited direct access to regulators, outside experts may be able to fill immediate gaps in helping test developers with filing strategies.
4. Don’t underestimate the growth potential in different markets. Lakshman Balajepalli, Head of Quality and Regulatory of Ras Life Sciences, told us that the population of the Middle East & North Africa is close to 500 million people, making it a springboard for global expansion. Similarly, it was highlighted by Dr Malathi Lakshmikumaran, Executive Director of Lakshmikumaran & Sridharan, that India, with 1.3 billion population, is fast emerging as a significant market for in vitro diagnostics. The Indian regulatory system is rapidly changing and aligning to global standards.
5. Covid-19 has exposed the fragility of global supply chains. Covid-19 has exposed the fragility of global supply chains. Turn-key disease solutions or end-to-end solutions will become increasingly attractive to certain countries as they emerge from the pandemic. NSF International’s Robyn Meurant reminded listeners to make the product something that the market wants, not what you think they want.
6. Find allies, make friends: In a globalised world, the benefit of strong tactical and technical relationships cannot be underestimated. For product developers with limited clinical testing or marketing experience, finding a supportive and trusted partner can be a game-changer, plugging gaps in expertise and vital know-how. Meurant recommended contacting non-profits groups that are active in health delivery and that are adept at navigating the lay of the land.
7. Did you know that regulatory authorities collaborate across borders? Today, pre- and post-market compliance product issue alerts are shared between the competent regulatory authorities. Dr. Sally Hojvat, former Director of the Division of Microbiology at FDA, explained to us that if one authority in Europe finds a particular product with performance problems, they will alert the FDA in the US and vice versa.
If you would like to find out more, stay tuned for video recordings per session.
The next Longitude Prize Sprint event will take place at the end of September 2020, with a focus on Understanding the landscape of investment and available funding.