Medical Device & Diagnostic Industry

February 1998 MD&DI
Selected Contents

INTEGRATED CIRCUITS:
Choosing Semiconductor Components for Medical Products
by Jim Gentile

By considering 10 technical and economic issues, manufacturers can find the right integrated circuit for their devices.

STERILIZATION:
A Guide to AAMI's TIR for EtO-Sterilized Medical Devices
by Barry F.J. Page and W. Howard Cyr

AAMI's new TIR-19 can assist manufacturers in their quest to meet ISO 10993's biological evaluation standards for EtO-sterilized devices.

CLEANROOM STANDARDS:
Cooperation Leads to Rapid Development of Global Cleanroom Standards
by Anne Marie Dixon and Richard A. Matthews

A surge in the popularity of cleanrooms and controlled environments has hastened the harmonization of cleanroom standards.

LASER MARKING:
Laser Marking Medical Devices and Packaging
by Chuck Bosnos, Natalie Bruton, and Terry McKee

Several laser-marking techniques encode information on hard-to-mark materials and offer a variety of solutions to other materials marking problems.

ISO 10993:
A Practical Guide to ISO 10993-14: Materials Characterization
by David E. Albert and Richard F. Wallin

In this installation of an 11-part series, manufacturers will learn about various materials characterization methods that can reduce the possibility of adverse biologic effects.

FIRST PERSON:
Lessons Learned, New Challenges:
Life After FDA Reform
by Jeffrey J. Kimbell

MDMA's former executive director examines the medical device industry's history, recent legislative victories, and the challenges it faces.

WASHINGTON WRAP-UP:
Device Industry Wins Big in FDA Reform
by James G. Dickinson

The FDA Modernization Act of 1997 makes many changes to the agency requested by the medical device industry.

HELP DESK:
Issuing Product Certificates for CE Marking

Harald Rentschler, president of Medical Device Certification GmbH (Memmingen, Germany), explains how several notified bodies can issue company product certificates for CE marking.

R&D HORIZONS:
Implants and Disposables Drive the Search for Stronger Glues
by Greg Freiherr

Biochemists are teaming up with marine biologists to examine an unlikely source of superadhesive technology.

BOTTOM LINE:
Empowering Your Employees
by Kim Campbell Thornton

Kaizen gives employees the power to make rapid changes and keeps companies competitive.

FIELD NOTES:
Design Considerations for EMI Gaskets
by Joseph Butler

Selecting the proper EMI gasket is a complex task that requires careful examination of all criteria.

SNAPSHOT:
Health-Care Improvements for the Masses from a Caring Engineer
by Jennifer M. Sakurai

EDITOR'S PAGE:
Should You Adopt Kaizen? Continuous Improvement Shores up the Bottom Line
by Stacey L. Bell

Kaizen's continuous improvement process views even a change that reduces manufacturing time by as little as half a second as a valuable contribution to a company's overall efforts.