Zippel, C. and S. Bohnet-Joschko (2016). "Innovation for Safe and Effective Medical Devices Contributions From Postmarket Surveillance." Therapeutic Innovation & Regulatory Science. Vol. 51(2) 237-245.
Format: Peer-reviewed journal article
Experience level of reader: Fundamental
Annotation: Companies thrive when they are able to better meet patients’ needs, and so many companies search for ways to improve existing products and manufacturing processes. Post-market surveillance of medical devices is useful for improving devices and managing risk. An online questionnaire surveyed 118 surveillance experts on which instruments manufacturers use to disseminate information gleaned from post-market surveillance. Post-market knowledge led to more incremental developments than new, radical developments.
Instruments for sharing knowledge fall into three general categories: technological (i.e. user complaint databases), organizational (knowledge officers, etc.), or human resources policies. The study found technical and human resource instruments to be the most effective means of knowledge transfer, whereas organizational instruments were used least.
Setting(s) to which the reported activities/findings are relevant: University, Business.
Knowledge user(s) to whom the piece of literature may be relevant: Intermediaries, Researchers, Designers, Manufacturers.
Knowledge user level addressed by the literature: Basic
This article uses the Commercial Devices and Services version of the NtK Model
Pharmaceutical companies are heavily scrutinized and collect extensive testing data which is useful for incremental development. Producers in other less regulated disciplines (devices, clinical care procedures) could benefit from such a well-documented R&D process.
Postmarket questionnaire results
Occurrences within model: NtK Steps 5.2, 6.1, 9.2