gms | German Medical Science

Introduction: The European Medical Device Regulation (MDR) [1] imposes requirements on the developers and manufacturers of medical device software depending on the state of development. Developers and manufacturers in academia are often unaware of these requirements. Therefore, a method for supporting the development of medical device software (MDSW) is necessary. The technology readiness levels (TRL) are a method consisting of a 9-step model for estimating the degree of maturity of technologies within the development steps. They are used to evaluate innovative technologies up to their commercial use [2]. Only when step-specific requirements are met is it completed. Our aim is to adapt the TRLs for the development of MDSW in research, enabling them to be used as a maturity model.

????Methodology: Our approach was to analyze and categorize the development steps required by the MDR and translate them into recommendations for action. The focus was on academic research that addresses translation and transfer. A distinction was made between basic research, preclinical research, clinical research and market readiness of the MDSW. The approach has been developed in collaboration with medical informatics experts, legal experts and software developers.

Results: This resulted in only seven levels of TLR for MDSW. The higher-level categories were “Idea”, “Development and Production”, “Translation I”, “Translation II (Transfer with Business Plan)” and “Post Market Surveillance (PMS)”. In comparison with the original method, TRL 1 and 2, and TRL 4 and 5 have been merged in the MDSW concept.

• TRL 1 Basic research: The basic principle or general algorithm and a basic concept or research hypothesis is established.
• TRL 2 Product development planning: A concept is developed as to how the basic principle or general algorithm is to be applied. This also includes the definition of the intended use and the medical device class.
• TRL 3 Proof of Concept: must be substantiated by experimental data collection and data analysis using the finished product, checking parameters such as safety, interoperability and reliability. Applicable standards are also considered in this phase.
• TRL 4 Fulfilment of product requirements: The product is evaluated through clinical investigations/field studies. Basic safety and performance requirements are met.
• TRL 5 Marketability: The product demonstrates that it can be integrated into IT environments. Sufficient data has been collected for clinical evaluation.
• TRL 6 Marketing authorization: The declaration of conformity has been issued and the product can be CE marked.
• TRL 7 Post-market surveillance: The final product is placed on the market and continuously monitored.

Discussion: There are TRLs for software [3], [4] and for medical technology [3], [4]. The 9-step models were not suitable for medical device software development (MDSW). As part of this work, it was possible to combine levels from existing concepts. Future work on this model will include the development and integration of alternative conformity assessment methods. In the meantime, the presented model will be tested and evaluated in practice as part of research project fit4translation (01ZZ2310A-C) to generate empirical data to support further evolution of both model and application best practices.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.