At the recent Convergence event, ‘Disrupt & Deliver’, researchers and innovators gathered at the Wereldmuseum Rotterdam to discuss innovating in a regulated healthcare landscape. ‘The future starts with doing’. 

‘Healthcare faces enormous societal challenges, such as an ageing population and a decreasing workforce,’ emphasized Richard Goossens, Health & Technology program director, as he set the stage for the event. ‘We need to address these challenges not only through research but also by implementing solutions. The future starts with doing.’

Yet, innovation in healthcare is not without hurdles. Regulatory barriers often slow the path from discovery to implementation. Maarten Ijzerman, Dean of Erasmus University Rotterdam, revealed a sobering statistic: ‘It usually takes 17 years until a medical discovery reaches a patient. And only one in every five medical products will be successfully implemented.’ Goossens added: ‘Today, we are meant to understand and tackle those barriers.’ 

Practical insights from experts

The event featured a dynamic panel discussion with Marjolein Timmers (EUR assistant professor in law and healthcare), Kelly van der Geest (Erasmus MC Medtech team manager), and John van den Dobbelsteen (TU Delft professor in medical process engineering). Together, they unpacked the complexity of the law and the pain of getting your implementations off the ground and to the patients.

‘Start documenting everything as soon as possible. Even when your idea is still nothing but a concept and nothing seems relevant. You will save yourself a lot of time and effort later,’ was one of the practical tips that arose from the discussion. Another: ‘Remember that regulations are not just boundaries. They are also frameworks that help you make a safe and effective product. They offer structure and a plan.’  

Matchmaking with RAPS

To provide more targeted advice, the event hosted matchmaking sessions organized by the Regulatory Affairs Professionals Society (RAPS). These table discussions were led by experienced experts, offering tailored insights on topics like:

• Early product development – Annete van Raamsdonk
• Software as a medical device and AI – Leon Doorn
• Medical devices and implants – Gert Bos
• In-vitro diagnostics – Kristiane Schmidt
• Design validation vs. clinical data under art. 5.5 – Robert van Boxtel

Text continues below pictures.

One-stop-shop for impact

As the event concluded, Goossens unveiled a new initiative: the Convergence One-Stop-Shop, expected to launch in 2025. ‘We noticed that early career researchers within our community had a clear need for guidance to navigate the complexity of medical device development,’ he explained. Disrupt & Deliver marked a critical step in transforming these challenges into opportunities. The One-Stop-Shop aims to streamline the process for innovators, accelerating the journey from idea to impactful solution.

‘Our goal is to help innovators move swiftly through the tunnel toward the light,’ Goossens remarked. ‘By clarifying the pathway, we can bring impactful innovations to market faster.’