Health Software Product or Software as Medical Device

Abstract

The number of software products in the field of health and medicine increases excessively. Self-tracking, fitness, health advice, dose calculation, and analysis of physiological data - apps are popular and commonly used. Some of the products are affected by the medical device regulation, consciously or unconsciously. For young entrepreneurs, it is difficult to recognize and understand the distinction between software as medical product and health software products. A product-related orientation guide could help start-ups to understand the difference and to find the right strategy for placing their product on the market. All relevant information were collected and analyzed. Input came from a systematic literature research, an evaluation of the CHARISMHA study and a consideration of the medical device regulation as well as the relevant standards (e.g. IEC 62304 and IEC 82304). The guide was adapted to the particular situation of start-ups and microenterprises, inter alia having regard to missing regulatory affairs competences. A product-related orientation guide for young entrepreneurs was developed, which helps to identify whether products are affected by the medical device regulation or not. The guide uses a few simple questions, and it allows the entrepreneurs to estimate the related effort. Furthermore, it provides an overview of relevant standards and needed competences for the chosen path. The guide brings certainty and can help young entrepreneurs to identify the upcoming workload at an early stage. Due to the decision tree concept, it is easy to adapt the product-related strategy and see the consequences. This might help entrepreneurs to find the right strategy for placing their product on the market. Nevertheless, field testing with the guide is necessary to validate its benefit.