Medical Innovations Incubator

As a manufacturer and distributor of medical devices and in vitro diagnostics, a (usually certified) quality management system (QMS) is required. In addition, a technical documentation (TD) with all relevant development documents must be prepared for each product to show conformity with the essential requirements of the MDR/IVDR. Depending on the product risk class, the TD is submitted to the notified body for assessment. Both certification of the company as a medical device manufacturer and conformity assessment of the product to obtain CE marking are basic requirements for market entry. Understanding the underlying regulations, such as ISO 13485 for the QMS and the MDR/IVDR for the technical documentation, is therefore essential.

For a new medical device or in vitro diagnostic product to be sold on the market, its safety and performance must be proven and a positive benefit-risk ratio must be demonstrated in the clinical evaluation or performance evaluation. In order to obtain approval for reimbursement by health insurances (e.g. within the framework of a selective contract according to § 140a SGB V) or by Health Technology Assessment (HTA) Bodies (e.g. as a digital health application, DiGA), the clinical and/or health economic benefit of the product must in turn be proven. The respective evidence is usually provided by clinical data collected in clinical trials. When planning and conducting clinical studies, the regulatory requirements according to ISO 14155 for medical devices and ISO 13612 for in vitro diagnostic devices must be complied with, and in some cases high time and cost expenditures must be taken into account.

Protecting one’s own innovation and the company’s intellectual property through the use of intellectual property rights, such as patents, influences the company’s valuation, contributes to the success of negotiations with investors and licensees, and is central to the planning of exit scenarios. In addition to protecting innovation, a company must also consider the protection of personal data in accordance with the General Data Protection Regulation (GDPR), especially if the product collects health-related data from patients. The requirements of the GDPR must then already be taken into account during product development. But data protection requirements must also be observed during pre-clinical and clinical testing, as well as during subsequent market monitoring. Understanding the underlying regulations, both for the protection of one’s own intellectual property and for the protection of personal data, is therefore crucial for their strategic use.