New and stricter European rules for medical equipment may lead to severe delays in introducing innovative technology in healthcare. Add to that an eventual ‘hard Brexit’, and the consequences in healthcare will be felt to a larger extent than we can imagine right now, says Professor Ruud Verdaasdonk. For him, it is clear that in the pre-clinical phase, like in the new TechMed Centre of the University of Twente, time can be saved considerably. Verdaasdonk says this in his inaugural lecture as a Professor of Health Technology Implementation at the University of Twente, 10 October.
May 2020 will be the deadline for the new European Medical Device Regulation (MDR), involving rules that are much stricter than before, for certification of medical equipment, tools and apps. This is done for a good reason, Verdaasdonk says. Recent commotion on implants showed that these often weren’t registered or traceable. The other side is that MDR makes it necessary to recertify all existing medical equipment, putting fully new devices on a waiting list. The certification process is done by ‘notified bodies’: a relatively large amount of experts comes from UK and will not be allowed to do European certification in case of a Brexit. Stricter rules may even cause existing medical companies to withdraw from the market, because they want to avoid another process like this.
For introducing fully new technology, certification always was a tedious process. One of the rules is that a new devices may not be tested on patients unless it has a CE mark. But for getting this CE mark, it should have been tested on patients. This chicken-egg problem can be avoided asking a medical-ethical committee for permission, but this also may imply a long procedure. All this is not just about large scanners or robots. It is also about useful tools and applications that can help elderly people in their home environment, for example: ‘patient empowerment’ technology. “The current generation of smartphone has many sensors, and of course camera’s, on board that could help medical diagnostics and care. In reality we see only a few, because the developers of apps, including the tech giants, see too many risks for claims”, says Verdaasdonk. One of the exceptions is the Apple Watch that is able to record an ECG and monitor your heart activity. In terms of technology, much more would be possible.Two valleys of death
As a clinical physicist, Verdaasdonk has been involved in the introduction of new technology in hospitals for many years. In general, this was from the hospital’s perspective and with a clearly defined clinical demand as a starting point. The other side is ‘technology push’, taking the new possibilities of technology as a starting point. Looking at tech startup companies in general, there is always the risk of a ‘valley of death’: there is an idea but the company is still spending, not earning money, and is waiting for an investor. In many medtech startups, Verdaasdonk even sees the danger of two valleys of death. The certification phase is one, finding markets and investors is the second.
The right experts
According to Verdaasdonk, the Technical Medical Centre of the University of Twente (TechMed Centre) can play a crucial role in this process. “I would call it a technical hospital, in which we can test technology in a very early phase. We have experts that will be able to analyze the market potential, we have experts that know a lot about the perception of patients. In case of the MDR regulations, we can do a lot of preparatory work speeding up the introduction of new technology.” Training professionals that have the right knowledge for MDR-certification is another important role for the TechMed Centre: technical physicians, biomedical engineers and health scientists.
Ruud Verdaasdonk is Professor Health Technology Implementation at the University of Twente. His inaugural lecture ‘Building bridges for healthcare technology’ (in Dutch) will be held Oct 10 at 16h00. Before that, a symposium is organized ‘How do I survive the MedTech implementation adventure: from idea towards a medical product’ (in Dutch as well).
This article was first published 10 October 2019 by University of Twente.