Medical Device & Diagnostic Industry

November 1997 MD&DI
Selected Contents

COVER STORY:
Computerized Manufacturing
by Robert S. Seeley

An MES can boost productivity by enabling MRP/ERP systems to communicate with shop-floor controllers.

PROCESS CONTROL:
Improving Resistance Welding Process Control in Medical Applications
by David Steinmeier

The new generation of resistance welding equipment incorporates control over key process variables directly into the system.

DESIGN:
The Discovery Phase of Medical Device Design: A Blend of Intuition, Creativity, and Science
by John Gosbee

Engineers who use human factors methods in early stages of design can decrease their time to market and increase the usability of their products.

FIRST PERSON:
Voyaging Into The New World of Medicare Reform

Medicare reform will have a profound effect on medical device manufacturers, according to HIMA's Ted Mannen.

WASHINGTON WRAP-UP:
Some Manufacturers to Replace MDRs with Summary Reports
by James G. Dickinson

Also:
• HMA encourages FDA to regulate reuse of single-use devices
• FDA's phantom two-year rule
• Development of foreign-facility list
• Investigation of document leaks

R&D HORIZONS:
Biosensor Research Targets Medical Diagnostics
by Gabriel Spera

Fusing biology, chemistry, physics, and electronics, the next wave of biosensors could revolutionize the markets for implantable monitors and point-of-care diagnostics.

BOTTOM LINE:
China's Growing Market for Medical Devices
by Lauren Brosler

China's growing population, strengthening economy, and governmental commitment to improving health care make it a market worth investigating.

HELP DESK:
Process Validation Requirements for Drugs and Devices
by Robert L. Spencer

An attorney and former FDA compliance officer explains the difference between process validation for drugs and for devices.

VERBATIM:
Industrial Design Moves Beyond Ergonomics

Ken Ritzel, a juror for the Medical Design Excellence Awards, describes industrial design's contribution to medical technology.

SNAPSHOT:
Niche Players Can Thrive in the Global Market

Lauren Andersen, president and CEO of Andersen Products, discusses small companies' roles in the global market and addresses the question of device reuse.

EDITOR'S PAGE:
Device Companies Explore the Competitive Advantages of Regulation
by John Bethune

In the long run, competitive challenges, whatever form they take, are good for all concerned.