Accelerating digital innovation in clinical neuropsychology: simulation approach to support medical device certification.

Background: In recent years, the focus on digitization of neuropsychological procedures in memory clinics has become paramount. Several teleneuropsychology platforms have been developed for testing patients with cognitive deficits, but only a few have been registered as medical devices (MD) being available in clinical practice. Hereby, we present a simulation-based novel approach designed to test technical performance and provide pre-clinical validation of a novel teleneuropsychology platform (i.e., Tenèpsia®) as required for the certification of Software as a Medical Device (SaMD) under the European regulation 2017/745 (MDR). Methods: Six dummy cognitive profiles simulating virtual patients with different cognitive performances were created. Five internal and two external experts evaluated simulated performances for representativeness, coherence and credibility. Results: One cognitively unimpaired and five mild cognitive impairment (MCI) profiles were considered. Demographic features and target cognitive scores were derived by reference literature for each simulated user. Representativeness was rated as more than 75% accurate by internal and external experts. Coherence and credibility were considered adequate to support SaMD certification. Conclusions: Certification of digital solutions as SaMD may require costly and time-consuming validation procedures. Simulation-based approach based on synthetic data is a valid method to overcome this limitation, that can be easily implemented to test platform, accelerating innovation in teleneuropsychology and providing adequate evidence of safety, efficacy and long-term comparability with the standard of care.