The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
When a device is implanted in a human body, there is always a distinct reaction of the body’s immune system, often resulting in a thick layer of scar tissue surrounding the implant. With device miniaturization and by providing a ‘biomimetic’ device encapsulation, this body reaction will be reduced.
User needs and expectations continue to advance. Medical device technology needs to keep pace. For a successful design, take the following requirements into consideration.
The idea of harnessing the body’s response to heal and defend is no longer the stuff of science fiction.
Skin is a window—it can indicate our overall health. And when it’s damaged, it can hurt both psychologically and physically.
A U.S. launch of the product is expected in just a few weeks.
Modern technologies have taken biomaterials to another level, but hurdles remain in developing next-generation materials.
With differing cultural attitudes towards tissue donation and transplantation, be prepared for some complex hurdles.
Via partnerships with pharmaceutical companies, Insulet expands its platform technology past insulin delivery.
The rise in chronic disease and the effort to reduce healthcare costs presents a large opportunity for the field of regenerative medicine.