Select Page

3 Q&A Interview with Dr. Efstathios Vassiliadis, CEO new MVA-member Evnia

Jan 23, 2024

Q1: What do you consider the key barriers to accelerate innovation in the medical device industry?

In the current complex regulatory environment, especially in EU, under Medical Device Regulation, poor regulatory decisions and clinical strategy can have a detrimental effect on both the time and resources needed to reach to the market. Especially in the field of clinical evidence in support of application, this is crucial since it can take considerable time to organise and execute timely. We always recommend initiating a regulatory affairs plan that includes clinical activities from the very first day of device development. Another aspect is sufficient venture and grands for start-up companies, this is an area where meaningful progress must occur swiftly.

Q2: What do you believe will be the future role of Real World Evidence (RWE) in the industry?

Up until EU/MDR, collection of RWE was often an afterthought and clinical activities were and largely still are considered a necessary evil. This means that RWE activities were rarely part of integrated lifecycle planning.

I believe that the future key process and practice swift is to integrate all RWE activities as part of the device lifecycle, embedded, planned and executed throughout the device lifecycle. This have several added benefits in addition to steady influx of proactively planned data, namely a closer insight into users and patient needs and daily use that can invoke meaningful design changes towards reduced risks and increased device benefits.

What is your evaluation of the overall framework conditions for innovation in the Nordics/The Medicon Valley region?

Undoubtably there is a fertile ground of impactful ideas and innovation, in the region. The presence of some really large organisations is a two-edged sword, since from one hand they support innovation strictly related with those organisations product portfolio, yet from the other hand this practice stagnates innovation on other therapeutic areas. The presence of venture funds that support innovation not only with funds but with the added backing of regulatory and clinical support can greatly impact meaningful transformation of innovation to actual tangible clinical solutions.


3 Q&A interviews