New product development process for medtech combination products

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