6533b822fe1ef96bd127d841

RESEARCH PRODUCT

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

Klaus-peter HoffmannWerner KneistAndreas KogutKarin H. Somerlik-fuchsJonas F SchiemerU ReichHeidi OlzeRüdiger RuppThilo B. KruegerFlorian C. Uecker

subject

Computer sciencebusiness.industryProcess (engineering)010401 analytical chemistryMarket access01 natural sciencesBridge (nautical)030218 nuclear medicine & medical imaging0104 chemical sciences03 medical and health sciences0302 clinical medicineSoftwareDocumentationDevelopment (topology)Equipment and SuppliesProduct (category theory)Software engineeringbusinessGraphical user interface

description

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.

yearjournalcountryeditionlanguage
2019-07-01Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference
10.1109/embc.2019.8857935https://pubmed.ncbi.nlm.nih.gov/31946167