Medical Device Link.

February 1999 MD&DI
Selected Contents

MEDICAL ELECTRONICS:
PC Interfacing for the Medical Market: Is a New Standard Emerging?
by Kent Tabor and Clint Hanson

The development of high-speed serial buses has prompted the need for a specification to facilitate system expansion for the custom peripherals that are critical to fast-evolving medical device technology.

SPECIAL SECTION:
Hyaluronan-Modified Surfaces for Medical Devices
by Djoerd Hoekstra

A unique biopolymer with therapeutic applications is also gaining recognition as a versatile surface-treatment material for improving device biocompatibility.

STERILIZATION:
Validating Radiation Sterilization in a Global Marketplace
by Ed Arscott, Susanne Anderson, John J. Broad, and Dave Parente

A review of current standards and their implementation and validation and how they affect product release times to the marketplace.

CLEANROOMS:
Quality Management for Cleanroom Operations
by Anne Marie Dixon

Efficient contamination control requires a system that applies total quality management principles.

WASHINGTON WRAP-UP:
FDA Finalizes Off-Label Dissemination Rule
by James G. Dickinson

The agency's codification of requirements for companies communicating unapproved-use information reflects stringent interpretation of FDAMA.

BOTTOM LINE:
The Narrowing Distribution Funnel: How to Get Your Medical Device to Market
by Richard S. Cohen

Especially for smaller companies, creating a compelling product line and getting it to the buyers requires resourcefulness and considerable strategic planning.

EMI FIELD NOTES:
Susceptibility Testing Requirements for Medical Systems
by Harald Buchwald

Tests required in several basic and collateral standards are important to achieving marketability in Europe. Tougher standards are coming soon.

SNAPSHOT:
Not Settling for the Silver Lining: New technology adds silver's benefits to polymers
by Jennifer M. Sakurai

EDITOR'S PAGE:
Be Still My Beating Heart? A Shorter Detour Around Coronary Obstructions
by John Katz

Does a simplified procedure for coronary-bypass surgery signal a fork in the road for cardiac-care technology?