With a Little Help from My Friends – How Patients and Caregivers Become User Entrepreneurs in the Medical Device Sector

Prior research has shown that some patients and relatives are innovating with respect to their unmet medical needs. However, there is little evidence if and how these ideas are commercialized later on. In our paper, we analyze... [ view full abstract ]

Prior research has shown that some patients and relatives are innovating with respect to their unmet medical needs. However, there is little evidence if and how these ideas are commercialized later on. In our paper, we analyze the case of patients and their caregivers as user entrepreneurs – persons who develop medical devices according to their own/their relative’s needs. We apply the framework of opportunity recognition and exploitation and conduct 13 case studies with medical device developers who successfully brought their product to the market. Our findings indicate that the innovation opportunity was mostly recognized during time-consuming and exhausting daily routines where no suitable medical device was present. In 11 cases, the inventor founded a company for commercialization of the product, in the remaining two cases the idea was licensed out after IP was secured. In all cases, the innovation had a significant impact on the quality of life of the patient and – in case of a caregiver – on both, patient and relative. As technical knowledge was not present in the majority of cases, friends and relatives were often consulted and integrated into the product development. The most prevalent reasons for further development and diffusion are the aspiration to validate the product idea and to deliver the benefit to others suffering from the same ailment. One major constraint to diffuse a medical device are regulations within the healthcare sector. Nine products in our sample were approved medical devices – four being classified as a higher-risk product and five being classified as a lower-risk product. We conclude that patients and caregivers do recognize and exploit their ideas in the medical devices market, although market entry barriers are particularly high in this sector. Thus, few patients and caregivers are capable to bring even higher-risk medical devices to the market. Healthcare companies should leverage this source of innovation and include innovative patients and caregivers into their R&D process.