Recent European legislation demands that new medical devices can only be brought on the market when they are as least as efficient as existing technologies. Maroeska Rovers, professor in evidence based surgery at the Radboud university medical center has no less than three new operating theaters available to test the efficiency of new medical devices.
“Last year the European Parliament voted in favour of the revision of the medical device directives”, professor Rovers explains. “That means that in the near future companies not only have to prove whether their new technologies are safe, but they also have to demonstrate their efficiency.”
Sub-standard metal hips
Recently it could happen that a new model of metal hip was brought to the market, while a similar device was deemed unfit some years ago. Because assessment had not been necessary, these sub-standard hips were commonly used.
Another case in point is the Da Vinci robot, widely used for prostatectomy operations. Rovers: “The robot itself costs $ 1 to $ 2 million, the maintenance costs $ 150.000 yearly. However reviews do not show that the robot is better – or worse for that matter – than normal surgical procedures. The costs however vary a lot.”
Not happy with legislation
“Many companies are not very pleased with this new piece of European legislation”, Rovers says. “They look at the pharmaceutical assessments with EMA and FDA and fear that this legislation kills off all innovation. I think that this fear is reasonable. On the other hand there is much to improve in terms of health care costs.”
“At the moment 25% of our gross domestic income goes to health care and our projection is that in ten years’ time this will be 40%. If we only allow evidence based technology on the market, we might just stabilize or even reduce the costs.”
Testing in the operating room
That the world of medical devices needs to change, proofs a study of Cochrane collaboration. A group of researchers investigated 743 randomized studies with in total 300.000 patients that received a new form of therapy. Only half of all these new treatments turned out better than existing treatments. About 30% of the new therapies was substantially better.
Various companies have already shown interest in working together with professor Rovers. Rovers hopes to soon start testing new devices in the special operating theaters. “At our medical center, the operating room is a hotbed for innovation and creativity. Without exaggeration I can see that we will create an unique fieldlab to test efficiency right in the operating room itself.”
The latest news from the Radboud university medical center is that a spin-off company will be started, specifically for the systematic evaluation of health technology devices. Rovers: “That spin-off, MITeC BV, will perform the whole cycle of health technology assessments for companies that want to introduce new devices.”
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