Alberta Spreafico, Ph.D, MBA
Senior Vice President, Health Innovation
Expertise:
Alberta is a global health strategist, policy expert and advisor and digital health thought leader with 10+ years of experience working at the intersection of industry and academia. She co-founded and directed multiple health innovation development programs worldwide, effectively integrating digital health technologies across healthcare systems and clinical practice.
As SVP of Health Innovation at EVERSANA, Alberta leads health innovation advisory programs enabling co-ideation, scouting and development, commercialization and system readiness.
She also served as Knowledge Partner of the Digital Therapeutics Alliance on DTx Policies in Europe and is a member of the External Advisory board of the European Health Data Space’s HealthData@EU Project, scientific committee member of the Italian Digital Health Association (ASSD); TedX speaker on enhancing access to quality care worldwide and Adjunct Professor of Development Economics and Social Policies at the University of Pavia (Italy).
Articles by Alberta Spreafico, Ph.D, MBA
The Looming Legacy of Software as a Medical Device (SaMD) Misclassification Under Medical Device Directive (MDD)
Regulation (EU) 2017/745, the Medical Device Regulation (MDR), sent shockwaves through the industry with its stricter oversight and transparency demands. While the implementation challenges like delays, notified body capacity, and EUDAMED implementation have dominated discussions, a potentially bigger issue lurks for software as a medical device (SaMD) previously classified as Class I under the Medical Device Directive (MDD). The structure of the MDD allowed for broad and varied interpretations of the Directive, and some SaMD manufacturers relied upon this leeway to self-classify devices as low-risk Class I. Now, with the MDR in effect, these devices are stuck in a loophole and face serious challenges in meeting the rigors of the […]