[From idea to standard care-a field report]

Area of Science:

• Digital Health
• Healthcare Innovation
• Medical Device Regulation

Background:

• Digital health products are transforming healthcare delivery and prevention.
• Startups are key innovators in the digital health sector.
• Medical digital products require stringent regulatory compliance, including CE-marking and ISO 13485 certification.

Purpose of the Study:

• To explore the experiences of two startups navigating the regulatory and reimbursement landscape for digital health products.
• To identify challenges faced by startups in integrating digital health solutions into standard healthcare.
• To highlight the need for streamlined processes for evidence generation and market access.

Main Methods:

• Qualitative insights from two digital health startups.
• Analysis of regulatory requirements (CE-marking, ISO 13485).
• Examination of reimbursement pathways and evidence generation demands.

Main Results:

• Startups encounter significant hurdles in achieving reimbursement and becoming part of standard care.
• The process for statutory health insurance assessment is lengthy and demanding.
• Early-stage evidence of product benefit is crucial but resource-intensive for startups.
• Alternative revenue streams are often pursued due to reimbursement challenges.

Conclusions:

• Digital health startups require support in generating evidence for their products.
• Streamlined regulatory and reimbursement procedures are essential for successful market integration.
• Adequate testing and validation procedures are needed to facilitate evidence generation.