“Healthcare reform has brought the 510(k) process under increased scrutiny, transforming a decades-old process into a hot-button issue. Critics of the process are concerned about patient safety, while supporters worry that overhaul will deny patients new opportunities for use of advanced technologies that may hold less pain and fewer or shorter hospital stays.”

The above are the observations of Martyn Howgill, executive director of the Institute for Health Technology Studies (Inhealth) and this month’s R&D Notebook contributing author.

Kudos to InHealth for providing $240,000 in grant money to Northwestern University for a study that will do what no 510(k) effort has yet done: focus on the systematic collection of evidence about the 510(k) process by gaining input from those most closely associated with the design and development of medical devices and equipment, including entrepreneurs, academic physician-inventors, manufacturers, and federal regulators.

For more on the study and an “evidence-based future,” go to Howgill’s article.

**********

If you find the phrase, “evidence-based future” intriguing and want to learn more about the topic, then make plans now to attend the Medical Silicone Conference Anaheim, Nov 3-4. InHealth’s Steve Halasey will dig deep into how healthcare reform may impact device companies during his keynote address. In addition, legal expert Davy Crockett, principal of Crockett & Crockett, will discuss “The Ins and Outs of Intellectual Property.” And Ted Kucklick, author of The Medical Device Handbook, founder and president of Cannuflow, and a regular Medical Design R&D Notebook contributor, will discuss the “ABCs of NDAs.” Five materials/processing sessions will address multicomponent molding, simulation, surface treatment, mold selection, and silicones for implantables as speakers from Shin-Etsu, Phillips Plastics, Kruse Analysis, Milliken, Kipe Molds, and NuSil share their expertise. And 22 exhibitors will be on hand to discuss innovations for medical. For more on MSC Anaheim, turn to page 25 and then visit www.medicalsiliconeconfernence.com for details on registration and special pricing for device OEMs.