Harshal Shah, vice president of the Global Medical Technology Division at Cambridge Consultants, gave an interview for MD+DI online earlier this month on his insights on FDA approval processes and commercialization strategies for medical devices. As he works closely with medtech companies and innovators, Harshal advises that product developers must identify the category in which the product is going to fall into according to FDA’s guidelines and interact with the agency in the early stages of the development. The FDA has improved drastically and has a well-published process for requesting FDA’s feedback and meeting with some of the key people who are directly involved and relevant to the innovation. He also suggests that these startups and innovators should try to invest and plan out costs for hiring regulatory advisors, as it’s a complex process.
Regarding product development, Harshal explains that innovators should work with Quality by Design and the Design for Manufacturing principles: have specific experts who specialize in Quality by Design principles and QbD audits and Design for Manufacturing audits of design work. So, one can make changes early on and produce prototypes as well as the clinical trial devices in line with what will be able to produce for commercial scale in the future, after approval
“My deep expertise is more towards the late end of the development cycle when you’re preparing for your trials and approvals. Even before you think about producing your trial size batches for your new product, it’s really a must to get a good understanding of how you’re planning to get this product into the commercial market.”