Medical devices play an important role in enhancing patients’ quality of life and supporting the healthcare system, but there is a need for improved methodology to obtain evidence for their safety, performance and efficacy.
According to the report Establishing high-level evidence for the safety and efficacy of medical devices and systems from the UK Royal Academy of Engineering, med-tech innovation could learn from engineering how to do so. One of the guidelines outlined in the report, produced following a roundtable discussion featuring clinicians and engineers, is the requirement to develop devices that meet real clinical needs. Clinicians, device manufacturers and the ‘end user’ should work together to identify which devices need to be developed to meet patient’s needs.
The recommendation is in line with Design Health Barcelona program, which places the hospital at the core of the innovation process. The three teams of fellows will experience at the very beginning an eight-weeks long clinical immersion to identify unsolved problems and to later develop innovative solutions to address them.
Other transferable lessons mentioned in the report are:
1.The use of continuous monitoring of systems in use to improve design and reduce the risk to fail.
2. The use of observational studies where randomized controlled trials are not possible or appropriate because they can deliver valuable information about how technologies function in real-world settings.
3. The establishment of a regulatory framework that specifies the different levels of evidence required to ensure safety, performance and efficacy at different stages throughout the life and iterations of the medical device.
4. The establishment of a prescriptive, yet responsive, regulatory framework to ensure the withdrawal of faulty products from the market as quickly as possible.
5.To promote the integration and contribution of a more diverse range of stakeholders -patients, engineers, manufacturers, healthcare professionals and economists- in the design of medical devices.
If you want to read the full report, it is available here.