Evaluation of a Regulatory Orientation Guide for Young Entrepreneurs in the Field of Digital Health.

Abstract

The number of software products in the field of health and medicine increases excessively. Self-tracking, fitness, dose calculation, and analysis of physiological data - apps are popular and commonly used. 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 was developed to help start-ups to understand the difference and to find the right strategy for placing their product on the market. An initial evaluation of this orientation guide to improve the comprehensibility, the simplicity, and to validate the benefit. The evaluation was performed using a questionnaire. In total, 15 employees from start-ups or those in foundation phase and in regulatory affairs positions or comparable were interviewed. the orientation guide was rated as very helpful and comprehensible. 80 % would highly recommend it to others. The orientation guide was positively evaluated and can be used in field. Nevertheless, further investigations must be performed, and a post-market surveillance will be necessary.