Operation and efficacy of health technologies
Are you a developer of a health technology? Then comes the time when you want to test your technology with users. In many cases, this is even mandatory before you can market your health technology. This brings up a variety of questions. At what stage of development can or should I test my technology with users? What information is needed to CE certify my health technology? What do I need to substantiate the (medical) claim of my health technology? In what way should I test my technology so that it complies with laws and regulations under the Medical Device Regulation? What should such a validation of a prototype with users look like? What groups should I involve in such testing: healthy people, patients, their loved ones, healthcare professionals? How do I connect with them and involve them in such research? RRD can help find the answers to these questions.
RRD examines impact of health technologies
Putting meaningful health technologies into practice takes a lot besides expertise about the health technology itself. To know whether the health technology works, a prototype must be validated whether it meets specifications, or a final product evaluated for its effect in practice. For this, thorough testing with the participation of the intended target groups is indispensable. Doing research with people is RRD's core business. We know how to draw up a good evaluation protocol, tailored to the applicant's request. We have an extensive network of healthcare organizations and potential (end) users to be able to involve the right target groups in testing. We can conduct a test with a prototype of your health technology in one of our labs with that target group. Or we can measure the effect of your health technology in (healthcare) practice by conducting a clinical evaluation at the rehabilitation center, hospital or other healthcare facility, or at users' homes or workplaces.
What does it provide?
Our researchers help you to obtain the correct information about the effect or efficacy necessary to bring your health technology into practice or onto the market. Naturally, we do this in a way that complies with the laws and regulations, such as medical-ethical procedures (including according to the Medical Research Involving Human Subjects Act (WMO)), data security (including AVG), Medical Device Regulation in the case of a medical device, etc. All our investigators are certified according to Good Clinical Practice (ISO 14155). Our investigators can help you ask the right questions and create corresponding test plans to find the needed answers about the operation or efficacy of your health technology. Through our years of experience in research during health technology development in close cooperation with developers, we know what information developers need regarding efficacy and safety as part of CE certification. We can help you to do the testing of your health technology with users, as a prototype or as a finished product, in the most focused way possible and according to the applicable quality requirements.
Case study
An example of a large-scale clinical evaluation commissioned by RRD for a developer is the study of a soft-robotic glove. Bioservo Technologies (Sweden) engaged RRD to design and conduct a multi-center clinical evaluation of the effect of their soft-robotic glove, Carbonhand. At Bioservo's direction, this study is being conducted in full compliance with the requirements of the Medical Device Regulation and follows the Good Clinical Practice guideline for research with Medical Devices (ISO 14155). In doing so, RRD, in close coordination with Bioservo, drafted the study protocol and went through the ethical procedures, and in collaboration with 8 healthcare organizations in our network, investigated the efficacy of the Carbonhand on hand function in a group of 63 study participants, and reported the results to Bioservo. The results of this evaluation are intended as input for substantiating the medical claim of Carbonhand as part of the CE certification by Bioservo.