Against the backdrop of health care reform and a controversial medical device tax, medical technology companies are focusing more than ever on products that deliver cheaper, faster, more efficient patient care. They are also making inroads with U.S. Food & Drug Administration regulators to re-engineer the complex review and approval process for new medical devices.
Many in the industry have long felt overly burdened by what they consider to be an unnecessarily complex approval process. Critics claim it impedes innovation and delays the availability of better health care. To change that perception, the FDA last year announced a new Medical Device Innovation Consortium (MDIC) charged with simplifying the process of designing and testing new technologies.
With input from industry, government, and other nonprofit organizations, public-private MDIC will prioritize the regulatory science needs of the medical device community and fund projects to streamline the process.