Medical Device & Diagnostic Industry

February 1997 MD&DI
Selected Contents

COVER STORY

EMI CONTROL
by Michael J. Major

What can U.S. manufacturers do in the face of ambiguous FDA and strict European electromagnetic interference requirements?.

DESIGNER'S TOOLBOX:
Using a Matrix to Incorporate Values into Products
by Jerry Proctor

Developing products that meet the needs of all stakeholders requires a tool that measures and scores those characteristics.

News

• FDA's Third-Party Pilot in Need of Submissions
• Consolidations Put the Squeeze on Small Manufacturers
• MR Innovation to Allow Scans of Standing Patients
• Manufacturers Move Ahead to Meet New Regulations
• Medical Device Packagers Honored for Innovation

WASHINGTON WRAP-UP:
After Kessler, What Kind of FDA?
by James G. Dickinson

The resignation of FDA's most controversial leader in years presents FDA reformers and the medical device industry with a new challenge.

R&D Horizons

Biotech Devices Promise Benefits in Wound Repair and Surgery
Greg Freiherr

The first medical devices to be produced by means of tissue engineering are now on the market. The number of artificial-skin and related products is small but growing rapidly.

Sterilization

Speeding EtO-Sterilized Products to Market with Parametric Release
Paul J. Sordellini

The difficulty of measuring EtO and water vapor during processing has been a major obstacle to adoption of parametric release by EtO sterilizers, but the latest gas analysis techniques are making in-process monitoring and control possible.

Bottom Line

Becoming the Ideal Engineering Manager
Bill J. Wood

Maximizing management and leadership skills produces engineering managers who can meet today's demand for getting innovative products to market quickly.

Medical Electronics

EMI and Power Supplies in Medical Electronics
William D. Kimmel

Electromagnetic interference can be minimized by using care when selecting and mounting supply components, and when designing filter elements.

VERBATIM:
Quality Systems on the Fast Track Toward Implementation
An interview with Kim Trautman, Quality Systems Expert, Office of Compliance, FDA Center for Devices and Radiological Health.

HELP DESK:
Biocompatibility Testing Is Needed Despite Material Supplier Claims
by Paul Sordellini

Paul Sordellini, a consultant with Quality Solutions, Inc. (Annandale, NJ), and a member of the EtO Sterilization Association, explains why biocompatibility tests are necessary even when material suppliers claim that their materials are biocompatible.

Regulatory Affairs

FDA Makes Quality the Rule (Part 2)
W. Fred Hooten

In this second installment of a two-part series, Hooten picks up the discussion of FDA's new quality system regulation, focusing on requirements for document controls.

SNAPSHOT:
Responsiveness and Planning Ensure Success in Quality Management
by Richard R. Cox

Peter Chevalier of Medtronic reveals his quality secrets.