Medical Device Link.

EDITOR'S PAGE:
Sometimes Keeping Patients in the Dark Makes Sense


Patients in clinical trials should always be fully informed—but the media don't need to be fully informed about the patients.

COVER STORY:

Ethnographic Methods for New Product Development
Stephen B. Wilcox and William J. Reese

Product developers who observe end-users' behavior in the actual environment of use generate tangible, workable information about a device—and the requirements of the people who use it.

The Seven Deadly Sins of Medical Device Development
Brian Kelleher

When development efforts aren't well managed, appropriately documented, or realistically planned, a company's most innovative product ideas might never make it to market.

Cultivating Profits in the Midwest
Stacey L. Bell

Medical device firms searching for new areas to locate facilities are finding fertile ground in the Midwestern United States.

Calculating Accumulated Lethality and Survivorship in EtO Sterilization Processes
Alfredo C. Rodriguez, Bill Young, Ken Caulk, Jodie Zelewski, Susan Kwasnica, and Sylvia Aguirre

The availability of two new equations makes it possible to compare the effects of dissimilar process cycles.

R&D DIGEST
A monthly review of new technologies and medical device innovations

THIS MONTH: Cooling the Body from the Inside Out * Microstamping Used to Create Neuronal Networks * Basic Cancer Research Aided by Specialized PET System * Ongoing Clinical Trials Test Artificial Retina

WASHINGTON WRAP-UP:
Agency's 510(k) Rescission Plan Criticized
James G. Dickinson

Proposed rule viewed by some as committing "too much to trust."

HELP DESK:
Revisiting Establishment Registration

VERBATIM:
LOOKING BACK, MOVING FORWARD

C.R. Bard's Susan Alpert discusses her transition from director of FDA's Office of Device Evaluation to her new role in the private sector.

Bulletin Board

High-strength adhesive bonds metals.
Coating line promotes rapid fluid transfer.
Thermoplastic elastomers help prevent allergenic reactions, and more!