Nitesh heads product development and commercialisation at InAccel (a medical device company from India), and has been referred to as a trailblazer by the Royal College of Engineering. 

In this episode, Nitesh discusses his background and role within InAccel. He shares his experience with the Stanford India BioDesign Program and how it shaped his approach to health technology innovation. Nitesh explains the process of identifying critical unmet needs (in the Indian and global healthcare space) and prioritising which problems to tackle through medical device innovation. He also discusses the journey from identifying a healthcare need to bringing a regulatory certified product to market, using VapCare as a case study. Nitesh also shares his perspective on the FDA and CE Mark regulatory pathways and his vision for making India a manufacturing hub for medical devices.

He also provides advice for innovators in health tech and discusses building for different market segments. Nitesh highlights the impact of his work and the recognition he has received for his contributions to healthcare.

1:24 What does it mean to get into product development and commercialisation for med devices?
2:23 Experience with Stanford India BioDesign Programme
4:18 Unmet critical needs - how to prioritise them and evaluate prospective impact?
5:38 Regulatory pathways as a lens to evaluate creation of a medical device?
6:31 Volume of medical needs requiring solutions that don't need higher regulatory pathways
7:14 Top 2 filters to assess unmet critical medical needs
9:30 Journey from identifying a healthcare need to bringing a regulatory certified product to market
18:04 Preference between #CE Mark and #fda
19:56 The amended UK MDR
21:06 FDA clearance helps enter other developing nations
22:10 Regulating #ai  - screening versus diagnostic - brief thoughts
23:50 Hopes from and working with Indian regulators
24:45 VapCare - Process of demonstrating product efficacy and safety
29:17 Medical device developed. Now how to ensure effective implementation?

Reach Nitesh via his LinkedIn here: https://www.linkedin.com/in/nitesh-ku...