Sara Finocchietti has 15 years of experience in the medical device industry, in a wide range of therapeutic areas, with a specific focus on orthopedics, neurovascular and neuroscience. Her career started in public research developing innovative medical devices as well as providing clinical and regulatory strategy for market access in Europe. Her previous experiences include working as a Clinical Affairs Manager at a French manufacturer with a full orthopedic portfolio, defining the strategy to transition to the EU’s Medical Device Regulation (MDR). She has been an Assistant Professor in Biomedical Engineering in Denmark and Guest Professor in Clinical Research in Italy.

Sara holds an MSc in Biomedical Engineering from the University of Genoa (Italy) and a PhD in Clinical Science from Aalborg University (Denmark). She has authored more than 30 research articles in the field of pain, neuroscience, rehabilitation engineering and user design.

Sara has a keen interest in new technologies and innovation. She has extensive experience working within cross-functional and cross-cultural teams.

CORE COMPETENCIES

• Provide CE-marking strategies for innovative medical devices to make them attractive for acquisitions and/or external investments
• Supporting Sponsors in the interaction with Notified Bodies and National Competent Authorities
• Management and execution of complex premarket and post-market studies worldwide, including feasibility investigations for first-of-its-kind medical devices
• Present on industry panels and workshops to discuss clinical and regulatory strategies
• Provide ad-hoc training on MDR and ISO14155

RECENT PROJECTS

• Led the project on clinical & regulatory strategy (EU, US, China) for an innovative contact lens for children
• MDR PMCF clinical strategy for Class IIa and IIb devices CE marked under MDD
  • Lead the clinical survey development (rank 4)
• EU strategy for complex clinical studies with pre-submission discussions with the national competent authorities

PUBLICATIONS

• Finocchietti, S. (2023); Randomized controlled trials are not always the solution. European Heart Journal, ehad805.
• Cappagli, G., Finocchietti, S., Cocchi, E., Giammari, G., Zumiani, R., Cuppone, A.V., Baud-Bovy, G. and Gori, M., (2019). Audio motor training improves mobility and spatial cognition in visually impaired children. Scientific reports (Nature), 9(1), pp.1-9.
• Finocchietti, S., Gori, M., & Souza Oliveira, A. (2019). Kinematic profile of visually impaired football players during specific sports actions. Scientific reports (Nature), 9(1), 10660.
• Finocchietti, S., Cappagli, G., Giammari, G., Cocchi, E. and Gori, M., 2019. Test–retest reliability of BSP, a battery of tests for assessing spatial cognition in visually impaired children. Plos one, 14(4), p.e0212006.
• Gori, M., Cappagli, G., Tonelli, A., Baud-Bovy, G. and Finocchietti, S., 2016. Devices for visually impaired people: High technological devices with low user acceptance and no adaptability for children. Neuroscience & Biobehavioral Reviews, 69, pp.79-88.
• Graven-Nielsen, T., Vaegter, H.B., Finocchietti, S., Handberg, G. and Arendt-Nielsen, L., 2015. Assessment of musculoskeletal pain sensitivity and temporal summation by cuff pressure algometry: a reliability study. Pain, 156(11), pp.2193-2202.
• Finocchietti, S., Takahashi, K., Okada, K., Watanabe, Y., Graven-Nielsen, T. and Mizumura, K., 2013. Deformation and pressure propagation in deep tissue during mechanical painful pressure stimulation. Medical & biological engineering & computing, 51(1-2), pp.113-122.
• Finocchietti, S., Nielsen, M., Mørch, C. D., Arendt-Nielsen, L., & Graven-Nielsen, T. (2011). Pressure-induced muscle pain and tissue biomechanics: a computational and experimental study. European journal of pain, 15(1), 36-44.