There are approximately half a million medical devices in use at the moment, a number that is set to increase in future. New medical devices must be tested thoroughly on numerous aspects before they can be used clinically or at home. The evaluation procedure must not, however, be so complex that it leads to unacceptable delays in the introduction of a valuable device.
An Academy committee has studied how the relevant parties can select the most ‘suitable’ evaluation method, depending on the type of medical device involved.
More and more medical devices are becoming available for diagnosis, treatment and monitoring. They range from medical robots, MRI scanners and echo equipment to pumps for administering medicines intravenously, pacemakers, prosthetics, and blood and urine tests. The medical technology sector is innovating rapidly. It is not easy to test new devices to evaluate whether they have benefits, what those benefits are and for whom (patient, physician or others). In addition to technical quality and safety, such tests must cover various utilisation and user criteria, anticipated effects and side effects, and expected costs. But all the ‘ifs, ands and buts’ should never throw up unnecessarily large barriers to the introduction of promising medical devices.
New medical devices must not only be safe, but must also work as they are meant to. That is true both for the equipment used by medical professionals and for the aids that patients use themselves (without a professional’s intervention), for example diagnostic tests and blood pressure meters. When a new device is launched, it should, ideally, have already shown itself to be at least as good as existing products as well as an interesting option price-wise. Cost considerations are no unnecessary luxury, given the size of the investment that is often involved: there are already approximately 500,000 types of medical devices in circulation, from thermometers to surgical robots.
At the proposal of the Council for Medical Sciences, an Academy committee chaired by Professor Carl Moons has studied possible strategies for evaluating and testing the safety and quality of new medical devices. The study has resulted in a report, Evaluation of new technology in health care, which aims to offer the various stakeholders specific guidelines for selecting the research method that best suits the relevant medical device, including postmarketing surveillance. The report makes clear that there are different ways of tackling such evaluations, and that a ‘one-size-fits-all’ approach is insufficient.