Avoiding pitfalls in the road from idea to certified product (and the harsh clinical environment thereafter) when innovating medical devices

Avoiding pitfalls in the road from idea to certified product (and the harsh clinical environment thereafter) when innovating medical devices

Wieringa, F.P.
Poley, M.J.
Dumay, A.C.M.
van der Steen, A.F.W.
TNO Industrie en Techniek

2007

Innovation in medical technology is a critical chain of events, ideally leading to an improved situation for patient and staff as well as a nice profit for the supplier of the innovation. Unfortunately many innovative ideas are not successful in practice. This is often due to lack of: • Medical relevance, • Validity of the underlying technical principle, • Reliability (not only of the devices’ intended function, but also of alarms), • Ease of use, training and maintenance, • Mechanical robustness, • Compatibility with ambient factors and other devices (e.g. heat, dust, liquids, EMC), • Extensive analysis of possibilities for improper handling (including improper connections) and use not according to intended purpose(s), • Attention for regulatory affairs, pricing policies and reimbursement criteria of health insurance organizations. Even if a device manufacturer successfully bridges the gap between idea and certified product, the point of clinical introduction only means that now the real harsh clinical practice will prove whether, and to which extent, the projected innovation comes true. When developing medical devices, technological knowhow is just as important as knowledge of human factors, Murphy’s Law and the principle of Le Châtelier & Van’t Hoff (originating from chemistry) applied to people at work.

Biomedical Innovation
Research
Healthy Living

http://resolver.tudelft.nl/uuid:4470ce40-e79b-4309-9765-759f108ca29f

462057

Invited plenary Seventh Belgian Day on Biomedical Engineering, 30 November 2007, Academy Palace, Brussels, Belgium

conference paper