The Stanford University Medical Center has long been a hotbed of medical device innovation. In combination with the fertile atmosphere for innovation and technology development that exists there, the San Francisco Bay area has become the premier region in the US for new device creation. In an effort to capture, preserve and pass on this inventive and entrepreneurial spirit, Stanford is launching a Biomedical Technology Innovation program designed to cover in a year-long series of courses the essential skills for the development of new biomedical technologies. The program is primarily looking to draw people from medicine and engineering, although they will also consider candidates with relevant business experience. The program will bring experienced device start-up entrepreneurs, as well as experts in all of the ancillary fields necessary for a successful start-up, including patent attorneys, regulatory and reimbursement experts, and manufacturing and clinical testing executives. A small pilot program will begin in September 2001.

Contrasting first-quarter preannouncements from a DNA sequencing company and a molecular diagnostics company may, with other seasonal pressures, imply a comparatively weak first quarter for therapeutic drug companies.

The EU’s Medical Device Regulation applies in just over a month’s time and the IVD Regulation in just over a year. But the standards underpinning them are way behind. Will they get the green light at last