Overcoming Legal Complexity for Commercializing Digital Technologies: The Digital Health Regulatory Navigator as a Regulatory Support Tool

The increasing regulatory complexity presents a major challenge for digital startups, particularly in the European Union (EU). To address this, we introduce a new type of tool called regulatory support tools, which assist startups in navigating complex regulations. Based on insights from digital health startups in the highly regulated EU market, we apply a Design Science Research approach to derive key meta-requirements and develop design principles. These principles guide the creation of the Digital Health Regulatory Navigator (EU), a regulatory support tool that helps startups understand EU medical device regulations and strategically leverage regulatory opportunities for smoother market entry. Evaluations with experts and target groups confirm its practical value. Beyond this case, our study contributes generalizable design knowledge for regulatory support tools, emphasizing their role in integrating regulatory requirements early in commercialization. Furthermore, we highlight the potential of such tools to enhance entrepreneurial activities when designed and used responsibly.