Sponsored by:

Complimentary Webinar
May 16, 2024 | 12:00 PM ET

2024 State of US MedTech Regulation: Innovation, Regulatory Transformation, and Artificial Intelligence


Essenvia unveils its 2024 State of US MedTech Regulation Industry Report that highlights shifts in innovation, AI & digital transformation in MedTech operations, and regulation in the United States medical device industry and provides MedTech executives and regulatory leaders with strategic insights, guidance, and best practices to navigate the shifting landscape in 2024 and beyond. 

The report covers topics including the rising role of artificial intelligence and digital transformation in MedTech regulation, explores the value-benefit and opportunity of Breakthrough Device Designation and TCET for novel devices, and unveils a vibrant and record-breaking innovation landscape in the United States post-COVID-19. With a focus on digital transformation, AI integration, and innovative device pathways, the report serves as an indispensable guide for navigating the evolving regulatory landscape, offering MedTech leaders strategic intelligence for future-proofing their operations.


  • Understand shifts in innovation, digital transformation, and AI in MedTech regulation
  • Learn strategic insights on cost-benefit of various FDA pathways and programs
  • Discover specific use cases for AI & Machine Learning in MedTech regulatory operations
  • Executive guidance and best practices for navigating US regulation in 2024 and beyond
  • Strategic guidance for investing in digital technologies to achieve regulatory excellence


  • MedTech CxO’s
  • Regulatory Leaders
  •  R&D Leaders
  • Product & Strategy Leaders


Dhriti Roy

Dhriti Roy, PhD
VP, Regulatory Affairs Transformation

Dr. Dhriti Roy, Ph.D., MBA, RAC, is seasoned MedTech executive, innovator and professor dedicated to the advancement of medical technology and the digital transformation of regulatory systems. She serves as Vice President of Regulatory Transformation and Customer Success at Essenvia, Advisor at the UK MHRA, and professor of Strategy and Innovation and Oxford University. Throughout her career, she has served in regulatory leadership and advisory roles at prominent MedTech companies including Medtronic, Abbott, Genpact, LabCorp, Danaher, and more. She regularly advises on investments in new ventures and supports the advancement of novel health and environmental technologies. 


Soumya Mahapatra

Soumya Mahapatra is a seasoned technologist, product leader, and thought leader in healthcare with over 18 years leading strategic transformation initiatives at Fortune 500 companies. He is founder and CEO of Essenvia, a leading MedTech RIM platform that enables medical device companies to manage regulatory workflows across the product lifecycle, accelerate global market access, and generate exponential business value. In just a few years, over 100 medical devices have been authorized for the market in the US and Europe leveraging Essenvia’s innovative platform. Essenvia’s mission is to guide MedTech companies towards regulatory excellence for the purpose of accelerating the delivery of innovative medical solutions to patients and providers worldwide. 

Share This