Advancing the regulatory acceptance of in silico technologies

Marc was joined by Surash Surash (TUV SUD), Mark Grumbridge (MHRA), Martha De Cunha Maluf-Burgman (Edwards Lifesciences) and Chris Basciano (Becton Dickinson) for a panel discussion on the rapidly growing role of in silico technologies in medical device development and the importance of global harmonisation of regulatory acceptance.

What is the key takeaway?

The potential of in silico technologies goes far beyond innovation: they can help transform how medical devices are developed, evaluated and brought to patients. Yet, this potential can only be fully realised if robust scientific evidence is matched by regulatory confidence and consistent approaches across jurisdictions. What risks being missed is the opportunity to move beyond isolated initiatives towards a globally aligned framework that enables wider adoption of in silico evidence. Continued dialogue between industry, regulators, researchers and other stakeholders is essential to bridge this gap.

The strong engagement during the panel and the follow-up discussion highlighted the growing interest in these approaches and the importance of keeping this conversation moving forward.

For the Avicenna Alliance, these discussions are at the heart of our mission: supporting the responsible adoption of modelling and simulation and advancing the use of in silico evidence in regulatory decision-making.

A big thank you to RAPS for providing a valuable platform to discuss these topics alongside other key issues shaping the future of regulatory affairs, including New Approach Methodologies (NAMs), AI and cybersecurity.

Congratulations to RAPS on its 50th anniversary, and thank you to everyone who contributed to this important conversation. We look forward to continuing the dialogue!