Turning innovative ideas into marketable medical devices
The market for medical devices is very diverse. The areas of application range from band-aids and artificial heart valves to AI-supported assistance systems in the operating room. However, the innovation cycle from the initial idea to the approved medical device is taking increasingly longer, due to ever more complex systems on the one hand and ever more demanding approval processes on the other. Medical devices must meet a large number of legal requirements for approval and use. This is similar to the situation with cars or toys. These regulatory requirements form the legal framework and are intended to ensure the safety, performance and effectiveness of a medical device. After all, medical personnel and patients want to use medical devices that improve health and are safe to use. However, many of the latest innovations in medical technology are based on artificial intelligence or rely on algorithms that can change within months, weeks or days. Especially for these AI-based medical devices, the regulatory framework is too rigid. To keep pace with technological developments, approaches to medical device certification must also become more innovative.