Sprint Workshop 1: Navigating MedTech regulation pathways in developed and emerging markets

3.00pm British Summer Time (BST)

7:00am Pacific Daylight Time (PDT)

10:00am Eastern Daylight Time (EDT)

19:30pm India Standard Time (IST)

Overview

Medtech product development and commercialisation for devices and diagnostics is a complex process and has a long gestation period. There are many uncertainties that Medtech product development has to navigate especially during technology development and validation stages of product development as well as being able to meet regulatory standards. Successful navigation of the regulatory maze is important in product development roadmap.

There are subtle and distinct variations in regulatory standards for Medtech products across different geographies especially between developed and developing countries. Another layer of complexity is the continuous change in regulatory landscapes both in mature and evolving markets across the world.

The workshop (virtual webinar), as part of the Longitude Prize Sprint programme, will draw upon insights from experts in Medtech regulation and address the nuances of regulation in different geographies which will guide Medtech companies in their product development strategies.

Moderator

Dr. Satya Dash, Member, Board of Directors, NCL-Venture Center, Pune, India

Speakers

Lakshman Balajepalli, Head of Quality and Regulatory of Ras Life Sciences

Steven Gitterman, M.D., Deputy Division Director for Microbiology Devices, U.S. FDA, Center for Devices and Radiological Health

Dr. Sally A. Hojvat independent consultant former Director of the Division of Microbiology at FDA, currently a part time advisor for the WHO pre-qualification team and for Partners in Diagnostics, LLC. Regulatory Consulting to Advance Global Health

Dr Malathi Laxmikumaran, Laxmikumaran and Sridharan

Robyn Meurant, NSF International

Dr Gill Morgan, Sestria Ltd

Ruth Neale, Project Manager, Longitude Prize, Nesta Challenges