Research platform for medical device development to simplify translation to the market*

New regulations for medical products complicate research projects for new application fields and translation of innovative product ideas to refundable medical products becomes a high economic risk. All this demands for a CE-marked platform, which offers the possibility to access the recorded data online or even directly the hardware during research applications, to bridge the gap. This paper describes how a CE-marked medical product can be extended by different interfaces to enable basic research or simplify first proof-of-concept studies thus optimizing prototype development in research projects, simplifying the documentation process and reducing the risk for market access.

[1]  Piotr Augustyniak,et al.  Extracorporeal Stimulation of Sacral Nerve Roots for Observation of Pelvic Autonomic Nerve Integrity: Description of a Novel Methodological Setup , 2018, IEEE Transactions on Biomedical Engineering.

[2]  Klaus-Peter Hoffmann,et al.  Technical, Medical and Ethical Challenges in Networks of Smart Active Implants* , 2019, 2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC).

[3]  K. Hoffmann,et al.  Electrical stimulation with motility analysis of five parts of the gastrointestinal tract , 2018, Current Directions in Biomedical Engineering.