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

Abstract

Background: 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. Objectives: An initial evaluation of this orientation guide to improve the comprehensibility, the simplicity, and to validate the benefit. Methods: 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. Results: the orientation guide was rated as very helpful and comprehensible. 80 % would highly recommend it to others. Conclusion: 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.