The German Chamber of Industry and Commerce (DIHK) has published the results of a survey among digital health startups. The result is hardly surprising: Complex requirements and a lack of experience in the healthcare industry are making it difficult E-health startups market access.
The complicated and uninnovation-friendly rules make it difficult to realize and implement digital business models in the healthcare sector in this country.
“Digital therapy companions, precise AI diagnostics or virtual reality in rehabilitation – the digital health market generally offers German startups great opportunities to develop and market innovative digital health applications,”
says Achim Dercks, Deputy Managing Director of the German Chamber of Industry and Commerce (DIHK). However, from the perspective of the approximately 160 young companies surveyed, there is a large gap between desire and reality.
The biggest hurdles for startups
Where do young entrepreneurs see the particular hurdles? Many founders lack the expertise of the highly regulated structures in the healthcare system. 44 percent of founders cited meeting the regulatory requirements for funding from payers as a major or very major problem. 31 percent cited challenges with CE marking. Many respondents are also unaware that with the introduction of the new European Medical Device Regulation (MDR) on May 26, 2020, significantly stricter requirements will apply to the CE marking process. 76 percent of those affected stated that they were at most "somewhat" familiar with the new regulation.
“The new European Medical Device Regulation will make access to the EU market even more difficult,”
explains Dercks.
Solutions for digital health startups
The German Chamber of Industry and Commerce (DIHK) is therefore calling for a more innovation-friendly framework. Otherwise, innovative digital health applications would not be able to reach market. This could jeopardize medical progress. Furthermore, the added value created by new technologies would be lost. Possible solutions include independent and rapid approval procedures for digital products, pragmatic solutions for AI technology in medicine, a well-connected digital infrastructure, less bureaucracy in general, and easier investor entry.
