Medical Devices & Product Development: following every step

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.”

How 3D printing can help babies with Flat Head Syndrome

3D printing applications in the medical sector has impressed many around the world and been adopted by many hospitals and physicians. One of the many reasons of this widespread adoption is due to the technology’s ability to develop customized products from body to the exact specifications of the patient.

Source: 3dprint.com

Here is another case where 3D printing comes in handy: “CranioCaps” to treat a condition in infants’ known as Flat Head Syndrome – “a condition that occurs when a baby positions his or her head the same way repeatedly; this positioning can either occur on the side or the back of the head, and over time the pressure on that part of the head flattens it”. The American Academy of Pediatrics launched a campaign in 1992 called “Back to Sleep” in order to raise awareness about infants sleeping on their backs to prevent Sudden Infant Death Syndrome (SIDS). One way to avoid this is with the use of helmets known as “CranioCaps” for the babies to wear during a 14-week growth period.

St. Paul, Minnesota’s Gillette Children’s Specialty Healthcare luckily had Stratasys 3D printer to print their own CranioCap. It took 5 hours overall: three hours to make the replica of the baby’s head and two to make the CranioCap. Gillette Children’s Specialty Healthcare reports that it treats around 1,100 children with Flat Head Syndrome annually – proving that the printer will definitely be a welcomed addition at the hospital.