Medical Device Link.

EDITOR'S PAGE:
REMEMBERING THOMAS BURNETT JR.

COVER STORY:

Is ISO 9001 Obsolete?
Edward R. Kimmelman

With the publication of the 2000 revision of the general ISO quality systems standard, the medical device industry has concluded that it must follow a separate course. A pending update to the industry's own ISO standard, 13485, will formalize the split.

Using Measurement to Improve Quality
Daniel P. Olivier and Paschal Dwane

The new ISO 9001:2000 standard puts an unprecedented emphasis on measurement. Although companies may find compliance challenging, they will benefit from improved quality systems.

Reliability Technology for Manufacturers: Engineering Better Devices
B.S. Dhillon

The medical device industry is among the wide cross section of industries that benefit from reliability engineering. Four methods presented here offer manufacturers concrete techniques to improve the effectiveness of their medical devices.

CONTRACT MANUFACTURING:

Outsourcing: Striking the Proper Balance
William Leventon

While outsourcing design and manufacturing processes, OEMs should stay involved and maintain in-house expertise.

COMPUTER-AIDED DESIGN:

Using Computer-Aided Design to Enhance Product Development
Gregg Nighswonger

More than a design tool, CAD can improve communication, help control the design process, and reduce time to market.

Sidebar: Developing A Fingertip-Sized Implantable Heart Pump

ALARMS:

Answering the Call for Harmonization of Medical Device Alarms
Michael E. Wiklund and Eric A. Smith

Industry sounds off on a new document aimed at standardizing the design of alarm systems for use in medical equipment.

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

THIS MONTH: Microjaws to Deliver Drugs at Cellular Level * Creating Imprinted Gels for Insulin Biosensors * Clay Reduces Permeability of Implantable Polymer Components * Body Simulator Preserves Kidney for Transplant * Nanosensor Detects DNA Without Amplification

Sidebar: President's 2002 Budget Request Continues Commitment to NIH

WASHINGTON WRAP-UP:
Bush Taming FDA? Some Think Not
James G. Dickinson

The appointment of a conservative chief counsel at FDA has industry wondering if it is the first in a series of moves designed to establish an attitude of less-rigorous enforcement at the agency.

FIRST PERSON:
Looking Toward A New Medical Technology Policy

The emergence of new medical technologies requires FDA reform, liability relief, and a reassessment of current policies on third-party reimbursement.

Bulletin Board

Curing system developed.
Press slide granulators designed for extrusion and blow molding.
Corporation announces expansion, new focus, and more!