Need to standardize methodology for clinical evaluation of new medical products: member of NITI
With advancements in the medical technology industry, there is a need to standardize methodologies for clinical evaluation of innovative high-quality products, Dr. Vinod Paul, a fellow at the National Institution for Transforming India (NITI) Aayog, said on Tuesday.
“In a few years, the Indian medical device market could grow from US$11 billion to US$65 billion. If several devices have been developed, they must be tested before being marketed. There are rules and ethics committees for a clinical drug trial. However, the methodology, ethics, and measurement of impact are still evolving for testing medical devices,” Dr. Paul told reporters on the sidelines of a reception hosted by Boston Scientific Corporation to inaugurate its second research center and development (R&D) at Balewadi in Pune.
🗞️ Subscribe now: get Express Premium to access the best election reports and analysis 🗞️
“This is an important area as young people think and come up with innovative products, which come from Atal Innovation Mission, BIRAC initiatives and Stanford India Bio design, AIIMS. So a lot of products are coming. However, they remain products and must be tested. Therefore, we want to standardize the methodology for clinical evaluation of new products so that they can be validated for safety and efficacy and meet the highest standards. This area requires the work of universities, industry and regulators,” added Dr. Paul.
In his address, Dr. Paul talked about the core philosophy of Atmanirbhar Bharat and the Make In India initiative. “However, both cannot be achieved unless we discover, develop and deliver to India,” Dr. Paul said.
Dr Paul also praised Boston Scientific – a US-based medical device company – for choosing Pune to set up its second R&D center. The first center was established in Gurgaon in 2014 and has contributed over 100 patent filings and innovation ideas. Spread over an area of 45,000 square feet, the Pune center will initially employ 170 engineers. “It’s (Pune) the right city with the right mix of educational hub and ecosystem here,” Dr Paul said.
Ralph Cardinal, vice president, R&D, Boston Scientific Asia Pacific, said the new center will provide expertise in areas including interventional cardiology, peripheral interventions, cardiac rhythm management, endoscopy, neuromodulation, urology and pelvic health.
Art Butcher, Executive Vice President and President, Boston Scientific APAC, Sanjeev Pandya, Director, R&D, Boston Scientific India, and Manoj Madhavan, Managing Director, Boston Scientific, India were present for the occasion.