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

Type: Survey

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

• Some employees resist encouragement from human resources to share knowledge across inter-departmental boundaries.
  Postmarket questionnaire results
  Occurrences within model: NtK Steps 3.2, 4.1, 4.4
• Devices used in clinical care are particularly hard to improve incrementally based on field results because processes must be standardized, as must training. Variations in training and implementation skew user feedback.
  Postmarket questionnaire results
  Occurrences within model: NtK Steps 4.11, 9.2, 9.3

• Healthcare providers including surgical staff (advanced users) are a group capable of making significant contributions as co-developers or innovators.
  Postmarket questionnaire results
  Occurrences within model: NTK Step 1.1, 3.1, Step 9.3
• Complaint and issue feedback databases store and quantify issues with devices and processes in a more standard method than human resource led initiatives, which are less empirical and more likely to give employees qualms about sharing.
  Postmarket questionnaire results
  Occurrences within model: NtK Steps 5.2, 6.1, 9.2

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