Need to standardise methodology to evaluate medical devices: Niti Aayog member V.K. Paul

Niti Aayog member Dr. V.K. Paul has stressed on the need to standardise the methodology for evaluating innovative medical devices.

Dr. Paul was in Maharashtra’s Pune city on March 15 to inaugurate a new research & development facility of a company providing medical device solutions.

“...We know how to conduct clinical trials for a drug test. There are set rules. But, as far as testing a medical device is concerned, the methodology for it is still evolving as it should be done in a safe manner,” he said.

This is an important area because young people are offering innovative (medical) products.

“A lot of products are there, but they stay as products and have to be tested. We would like the methodology for it to be standardised for clinical evaluation of such innovative products,” Dr. Paul said.

The products developed by the innovators should not be stopped at one stage, but should go through the evaluation process, like safety, effectiveness and validation, and this area needs work from the academia and industry, he added.

He was speaking at the inauguration a new spacious R&D facility of Boston Scientific, a U.S.-based medical device company and an innovator of less-invasive medical solutions.