ACCELERATING DIGITAL INNOVATION IN CLINICAL NEUROPSYCHOLOGY: SIMULATION APPROACH TO SUPPORT MEDICAL DEVICE CERTIFICATION

Andrea Panzavolta^1*Federico Sternini^2,3Paolo Caffarra⁴Dalila De Vita⁵Alessandra Dodich⁶Cristina Fonti⁷Federica L'Abbate⁸Luigi Lavorgna⁹Valentina Laganà¹⁰Camillo Marra^11,8Costanza Papagno⁶Francesca Ferrari Pellegrini¹²Andrea Stracciari⁴Luigi Trojano⁵Tiziana Iaquinta¹³Roberta Pandolfi¹⁴Monica Calore¹⁴Sveva Sanzone¹⁴Alice Ravizza²Stefano F Cappa^1,15Chiara Cerami^1,16

• ¹IUSS Cognitive Neuroscience (ICoN) Center, Scuola Universitaria di Studi Superiori IUSS, Pavia, Italy
• ²InsideAI srl, I3P Politecnico di Torino, Turin, Italy
• ³PolitoBIOMed Lab, Politecnico di Torino, Turin, Italy
• ⁴Membro esperto Tavolo permanente sulle demenze del Ministero della Salute, Rome, Italy
• ⁵Department of Psychology, Universita degli Studi della Campania Luigi Vanvitelli, Caserta, Italy
• ⁶Center for Mind/Brain Sciences (CIMeC), University of Trento, Rovereto, Italy
• ⁷IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy
• ⁸Neurology Unit, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy
• ⁹Clinica Neurologica I, Azienda Ospedaliera Universitaria, Università della Campania “Luigi Vanvitelli”, Naples, Italy
• ¹⁰Associazione per la Ricerca Neurogenetica odv, Lamezia Terme, Italy
• ¹¹Università Cattolica del Sacro Cuore, Rome, Italy
• ¹²Geriatric Clinic Unit, Medical Geriatric Rehabilitative Department, University Hospital of Parma, Parma, Italy
• ¹³Xenia Reply, Milan, Italy
• ¹⁴Biogen Italy, Milan, Italy
• ¹⁵Department of Neurology and Laboratory of Neuroscience, IRCCS Istituto Auxologico Italiano, Milan, Italy
• ¹⁶Brain e-Health Aging (BeA) Laboratory, Department of Neurorehabilitation, Istituti Clinici Scientifici Maugeri IRCCS, Milan, Italy

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.