Nidhi Gani

Nidhi Gani is a Staff Regulatory Engineer spearheading Software and Product Security of embecta’s flagship product – Diabetes Management System. She also teaches Regulatory Affairs - Product development in digital health and cybersecurity, as an adjunct lecturer at Northeastern University. She has voiced her expertise in Regulatory Affairs in various medical device conferences around the world: InnoHEALTH - ‘Make in India Opportunities for Drugs, Biologics and Medical Devices’ Malta Med-tech Summit - ‘Is it time for AI regulations in the MedTech industry’ She is enthusiastic about bringing cutting edge technologies to the world leading her to navigate regulatory pathways for Scandinavian life sciences startups for Gen.era: A Digital Genomic Alliance. She has also contributed her efforts to improve patient health outcomes in the capacity of a Discovery to Delivery (iD2D) Digital Health Fellow- sponsored by the AHA, Verily, AstraZeneca, and Quest Diagnostics. Her love for the natural world and its relationship with humans led her to pursue Biotechnology Engineering followed by a Master’s in Regulatory Affairs in Drugs, Biologics and Medical Devices. Throughout her industry experience of 8 years, she has worked for larger corporations, start-ups with a passion for incorporating regulatory process in design and development and postmarket activities to produce safe and effective devices. Her current focus is on medical device cybersecurity and its impact on patient safety and national security. Besides healthcare Nidhi is also passionate about Education and has cofounded FORCE (Foundation Of Research in Careers and Education) to empower high school students to build their careers freely and fearlessly. Fun facts about Nidhi – She was the winner of Model United Nations Assembly (MUNA) in 2011 and can hold a headstand for 5 seconds.

Publications

Multi-Sector Analysis of the Digital Healthcare Industry
Multi-Sector Analysis of the Digital Healthcare Industry
Lagnajita Chatterjee, Nidhi Gani. © 2024. 302 pages.
In the wake of the digital healthcare revolution, a critical challenge has emerged: the lack of a comprehensive understanding stemming from fragmented research. Despite the...