Need to standardize methodology for clinical evaluation of new medical products: Policy Member

Dr Vinod Paul, Member, National Institution for Transforming India (NITI) Aayog on Tuesday said that with advancements in the medical technology industry, there is a need to standardize the methodologies for clinical evaluation of high quality innovative products.

“After a few years, the Indian market for medical devices could grow from US$11 billion to US$65 billion. While many devices have been developed, they have to be tested before marketing. Rules for Clinical Drug Trials And there are ethics committees. However, methodology, ethics and measurement of effectiveness for testing medical devices are still evolving,” said Dr. Paul at the inauguration of his second Research and Development (R&D) center at Balewadi in Pune. told reporters on the sidelines of an event organized by the Boston Scientific Corporation.

“This is an important area as young people are thinking about and introducing innovative products, which are coming from Atal Innovation Mission, BIRAC initiative and Stanford India Bio Design, AIIMS. So, a lot of products are coming Although they remain in product form and have to be tested, we want to standardize methodology for clinical evaluation of new products so that they can be validated for safety and effectiveness and the highest be at par with the standards. This sector needs work from academia, industry and regulators,” said Dr. Paul.

In his address, Dr. Paul explained the core philosophy of Atmanirbhar Bharat and Make in India initiative. “However, both cannot be achieved if we do not discover, develop and deliver in India,” Dr Paul said.

Dr Paul also commended Boston Scientific, a US-based medical device company, for selecting Pune to set up its second R&D centre. The first center was established in Gurgaon in 2014 and has contributed to over 100 patent filings and innovation ideas. Spread over an area of ​​45,000 square feet, the center in Pune will initially employ 170 engineers. “It (Pune) is 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 such as interventional cardiology, peripheral intervention, cardiac rhythm management, endoscopy, neuromodulation and 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 on the occasion.