Medical Device & Diagnostic Industry

September 1996 MD&DI
Selected Contents

Editor's Page

IP Is Hip: What Makes Patents So Hot?
John Bethune

Reading through a raft of quarterly earnings reports from medical device companies recently, I noticed a curious trend: seemingly every report mentioned patent litigation expenses.

Technology Transfer

Government Labs Offer R&D Resources
Greg Freiherr

Through its Office of Technology Transfer, NIH is awarding licenses to private firms to develop and sell technologies invented by scientists and engineers working in laboratories affiliated with the more than 20 institutes on the Bethesda, MD, campus, as well as at FDA.

Product Approvals

FDA Launches Pilot Program for Third-Party Device Deview
Daphne Allen

Seven companies have been selected to participate in FDA's pilot program for the third-party review of selected 510(k) premarket notifications. First proposed by FDA's Center for Devices and Radiological Health in April 1995, the program took nearly a year and a half to design and implement.

Communication Standards

Bar Code Standards: For Medical Products, More Work Is Needed
Walter W. Mosher

Bar coding systems have long been touted as a significant means for increasing efficiency. But despite more than a decade of work by a number of organizations in the United States and abroad, the medical manufacturing industry has so far been unable to implement an acceptable universal standard for bar code labeling of medical products.

Interview

Biomaterials Research in the 1990s

Jack Lemons, chairman of the American Society for Testing and Materials Committee F-4 on medical and surgical materials and devices, has followed biomaterials and the evolution of biomaterials and biomechanics from probably every aspect.

Washington Wrap-up

New-Age FDA Brings Many Reforms
James G. Dickinson

Combined with pilot testing of external product reviews by FDA's Center for Devices and Radiological Health, the earnest changes under discussion in grassroots meetings add up to a new age for FDA and its relationship with industry.

Design and Engineering

Speeding Product Design Through Rapid Prototyping
Bill Evans

A an engineer's guide to the numerous--and quickly evolving--rapid prototyping techniques and direct data-transfer methods.

Business and Marketing

FDA's New Approach to Export Regulation
Jonathan S. Kahan

The Export Reform Act was part of the Omnibus Consolidated Recissions and Appropriations Act of 1996. The new law revamps the export provisions of sections 801 and 802 of the FD&C Act and significantly lessens the burdens on the medical device industry in the export of unapproved and uncleared products to foreign countries.

Packaging

Europe Tosses Device Industry Tough Recycling and Reuse Requirements
Paul Fielding

While its ultimate impact is as yet unclear, the European Union's packaging waste directive has serious implications for medical device manufacturers. It is clear that companies operating in Europe or supplying packaged goods to Europe will have to integrate environmental, health, safety, and hygiene requirements into their packaging.

Software

Increasing Safety in Medical Device Software
Bruce Levkoff

While software design and coding are but two of the practices in the development process, they provide key points for the introduction of defects that can cause device failures.

Testing

Advances in OD/ID Systems Benefit Medical Tubing Extrusion
Scott H. Taylor

Dimensional measurement and control systems have recently undergone significant technological advances. These advances are partly the result of the demands of other markets--wire and cable foremost among them--also served by gauging suppliers.