Medical Device Link.

June 1999 MD&DI
Selected Contents

REFLECTIONS ON MD&DI'S 20th ANNIVERSARY:

Devices Past and Future: Gauging the Pace of Change
by Kshitij Mohan

Organizing for Compliance: Reflections Twenty Years Later
by Richard D. Manthei

Quality and Productivity: Then and Now
by Chuck Truby

SPECIAL SECTION:
Cross-Linking Thermoplastic Elastomers for Improved Product Performance
by Lawrence A. Acquarulo Jr. and Charles J. O'Neil

A study examines the effect of different TPE formulations and radiation dosages on changes in material physical properties following cross-linking.

ADHESIVES:
Hydrocolloid PSAs: New Formulation Strategies
by Roger Lipman

New hydrocolloid compositions minimize skin reactions by eliminating the tackifying agents in adhesives integrated with styrene-isoprene-styrene thermoplastic elastomers.

510(k) PARADIGM:
The Development of a New 510(k) Program
by Philip J. Phillips and Joanne R. Less

Device companies stand to benefit by important changes in the premarket notification process that were initiated by FDA reengineering and codified in FDAMA.

FIRST PERSON:
Human Factors and the Future of Telemedicine
by Barry H. Beith

A human factors specialist describes how human factors engineering can play a positive role in the development of telemedicine.

WASHINGTON WRAP-UP:
Device User Fees: More Needed than Ever, Just as Unpopular
by James G. Dickinson

FDA's budgetary problems are garnering little sympathy with device manufacturers, who remain unmoved by renewed calls for user fees.

HELP DESK
EtO Compatibility—and More
by James M. Gibson, Jr., and Susan Edel Satter

Why is humidity an important factor in EtO sterilization? How can humidity inside the chamber be measured during the sterilization process? What's the compatibility of polyamide materials and EtO sterilization? Is it true that products sterilized by gamma radiation should not be resterilized with EtO because of potential toxic byproducts?

R&D HORIZONS:
Patient Simulators Breathe Life into Product Testing
by Michael E. Wiklund

Patient simulators enable device manufacturers to conduct realistic usability tests early in the development process, without placing patients at risk.

BOTTOM LINE:
Successful Recruiting in the Medical Device Industry
by Howard Klein and David Ducharme

Finding and hiring well-qualified candidates can be a challenge in today's job market.

SNAPSHOT:
Benefitting Mankind: An executive's motivation stays true to an old school motto
by Jennifer M. Sakurai

INSIDE MD&DI:
Twenty Candles for the Past, Some Thoughts for the Future
by John Katz

EDITOR'S PAGE:
The More Things Change... MD&DI Builds on a Mission Set 20 Years Ago
by John Katz

On MD&DI's 20th anniversary, a review of the magazine's first editorial reveals that although the cutting edge is always advancing, the overriding goal remains unchanged.