Medical Device Link.

March 1999 MD&DI
Selected Contents

BUSINESS OUTLOOK:
1999 Business Outlook: Competing in a Complex Market
by Jon Katz

Despite new concerns, executives remain confident.

SPECIAL SECTION:
Developments in Biocompatible Glass Compositions
by David C. Greenspan

The use of bioactive glasses has shown promise in promoting tissue repair and regeneration.

TESTING:
Residual Stress Testing for Transparent Polymers
by Alex S. Redner and Barbara Hoffman

Even parts that are well designed can fail if poor processing conditions produce improper orientation and residual stresses. Manufacturers need reliable, practical stress-testing methods.

CLINICAL TRIALS:
Implementing Computerized Data Management in Clinical Research
by Barry Sall

Technologies relatively new to medical device clinical trials promise to change the face of more traditional studies.

DESIGN CONTROL:
Engineering Process Improvement through Error Analysis
by Daniel P. Olivier

Conducting analyses of previous projects can improve the effectiveness of review and testing procedures.

FIRST PERSON:
Reprocessing Single-Use Devices: An Undue Risk
by Stephen J. Northrup

According to a trade organization official, the reuse of medical devices originally designated for single use raises serious concerns about safety, effectiveness, and equitable FDA oversight.

WASHINGTON WRAP-UP:
Lightening the Regulatory Burden
by James G. Dickinson

Defining "least-burdensome" concept is turning out to be quite a burden.

R&D HORIZONS:
Fashion Platelets: New Coats for Coronary Stents
by Joe Chinn and Jeff Mabrey

Complications associated with the use of coronary stents provide the opportunity for better devices through surface modification.

BOTTOM LINE:
A Diagnosis for Southeast Asia
by Amarjit Sahota

Despite the current slump in sales, the medical diagnostic equipment market is expected to recover as the region's economy improves.

HELP DESK:
EtO and Plastic Bags; Shrink-Wrap versus Netting; Is Cyclohexanone Safe for Bonding?
Barry F. J. Page, an industry consultant (Garner, NC), member of the AAMI Sterilization Standards Committee, and cochair of the AAMI Ethylene Oxide Sterilization Residuals Working Group, provides answers to two EtO sterilization queries.

Tom Vincent, general manager of Brevet Inc. (Irvine, CA), details various steps to consider when examining the safety of a material for a specific application.

SNAPSHOT:
Marketing Strategy Addresses Matters of the Heart
by Kassandra S. Kania

EDITOR'S PAGE:
How Now, Mad Cow? Strong Measures to Forestall a Potential Killer
by John Katz

Taking a hard look at the past, the British government enacts extraordinary policies to combat what is still a hypothetical risk.