NEW PRODUCT DEVELOPMENT PROCESS FOR MEDTECH COMBINATION PRODUCTS

Abstract The MedTech product development is experiencing a growing complexity of the design process. challenge to keep medical device simple and user-friendly while maintaining its interconnectivity with other systems products. additional layer comes from need satisfy both - direct customers (pharma companies), indirect ones (patients, health care practitioners, pharmacists). Solving those challenges must not compromise safety end-user follow regulatory requirements. This research proposes systematic process for combination emphasis on strategy concept operationalized by thinking participative toolkit. proposed approach serves purpose increasing traceability between early made business decisions level company, engineering level. ultimate goal support decision-makers methods tools which would allow them make informed investment in new Pharma companies.