Medical Device Link.

August 1999 MD&DI
Selected Contents

COVER STORY:
Comparing Tensile and Inflation Seal-Strength Tests for Medical Pouches
by Stephen H. Franks and Donald S. Barcan

Clarifying the relationship between tensile and burst testing for the evaluation of package seals can help manufacturers establish more effective process control.

ELECTRONICS:
Economies of Scale: Electronics Manufacturing Services Bring Balance
by Sherrie Steward

Outsourcing electronics manufacturing reduces operating costs and enables companies to focus resources on designing and marketing devices.

MDEA AWARD WINNERS
Medical Design Excellence Awards Recognize Form and Function
by Jeffry Still

Twelve companies recognized for outstanding achievements in medical device development received gold awards during the presentation ceremony for the Medical Design Excellence Awards of 1999.

SPECIAL SECTION
Understanding Wear and Friction in Medical-Grade Stainless Steels
by John D. Jarrell and Frank Bejbl

A knowledge of the different types of wear and friction and of current test methods can lead to better-designed stainless-steel devices.

WASHINGTON WRAP-UP:
Third-Party Device Reviews Beat FDA's
by James G. Dickinson

Also:

• Agency Will Audit Device Data for Y2K Compliance
• FDA Guidance on Reporting Y2K Problems
• Advisory Committee Questions Now on the Web
• FDA Approves Bone-Density Test Device
• Inspectors Going High-Tech
• Withdrawn Flush Syringe Is Approved
• Bladder Cancer Test Needs More Data for FDA Approval
• Down-Classifying Shoulder Prostheses
• Home Uterine Monitor 510(k) Draft Guidance

R&D HORIZONS:
New Polymers and Nanotubes Add Muscle to Prosthetic Limbs
by Gregg Nighswonger

Research efforts are under way to use novel materials that can emulate the simplicity and function of human muscles.

FIRST PERSON:
Device Companies and Contracts: Don't Overlook the Regulatory Implications
by Jeffrey N. Gibbs

Manufacturers are certainly aware of the importance of FDA issues during the product approval process. However, according to a device attorney, companies often fail to consider regulatory factors when preparing routine commercial contracts.

SNAPSHOT:
A Welcome Change:
Creative Thinker Succeeds by Adapting to New Environments
by Kassandra S. Kania

EDITOR'S PAGE:
You Better Watch Out:
Blue-Ribbon Panel Examines Plasticizer Safety
by John Katz

The presence of a former U.S. Surgeon General adds some weight to a group discounting claims that plasticized PVCs are dangerous to your health.