Medical Device Link.

Medical Device & Diagnostic Industry

May 1997 Cover Story
LOGISTICS
The Supply Chain: Operational Efficiency Is No Longer Just an Option
By Sherrie StewardAs device companies refine their logistics, focusing on three key areas will enable them to cut costs and provide more value to customers.

DEVICE REUSE:
The Manufacturer's Role in Safe Reuse
by Anne F. Booth
With the increasing need for reusable devices, manufacturers need to validate safe reprocessing strategies for their products.

STERILIZATION:
An Introduction to Gas-Diffusion Sterilization
by Lauren Andersen, Marcus Delvers, and Edna Hu
Gas-diffusion technology offers device manufacturers a cost-effective and environmentally safe alternative to traditional in-house EtO sterilization.

FDA & THE INTERNET:
FDA Contends with Regulating the Internet
by Dvorah A. Richman and Elaine H. Tseng
For FDA, formulating an effective policy on Internet regulation will mean dealing with complex, and unprecedented, issues.

MOTION CONTROL:
Advances in Motor Technology for the Medical Industry
by Stephen J. O'Neil
Improvements in motor technology help manufacturers meet the demands of developing state-of-the-art medical devices.

HUMAN FACTORS:
Designing Medical Devices to Minimize Human Error
by Michael E. Maddox
Medical device designers should be familiar with the causes of end-user error and use safety analysis techniques to reduce its likelihood.

PROCESS CONTROL:
Validating with Confidence: Meeting Minimum Strength Specifications
by Vaughan Weeks
When doing its own product testing, how can a device company be sure that test results will lead to both a safe product and FDA approval?

CLINICAL TRIALS:
Auditing to Ensure Reliable Clinical Trials
by Barry Sall
For medical device manufacturers who must conduct clinical trials, extra effort early in the process, in the form of voluntary auditing, can prevent costly errors.

DESIGN:
Product Development: Making the Most of the Company Team
by Greg Freiherr
FDA's new design control requirements are just one more reason why the team approach to product development is gaining ground.

DESIGNER'S TOOLBOX:
3-D Object Printing Improves Designer Communication
by Sherrie Steward
A new way to make 3-D objects can help designers communicate better early in the product design and development cycle.

WASHINGTON WRAP-UP:
Politics as Usual
by James G. Dickinson
The Clinton administration is advocating user fees for medical device review--but neither industry nor Congress is buying in.

R&D HORIZONS:
Digital Sensors to Launch Revolution in Medical Imaging
by Greg Freiherr
New digital technology promises to improve image quality and give health-care providers faster access to images.

BOTTOM LINE:
Keeping Up with Changes in the Japanese Medical Device Market
by Ames Gross
For manufacturers exporting medical devices to Japan, understanding recent regulatory developments there is essential to success.

HELP DESK:
Determining Sample Size for Testing Equivalence
John S. Kim, director of corporate statistical resources at Medtronic, explains the statistical strategies used during clinical trials for determining equivalence and offers ways to calculate sample sizes.

SNAPSHOT:
The Changing Role of a Packaging Engineer
by Daphne Allen
Award-winner Robert Thompson on developing medical packaging.

EDITOR'S PAGE:
Cooperation and the Device Industry: Escaping the Prisoner's Dilemma
by John Bethune
In the managed-care marketplace, medical device companies may increasingly find cooperation more beneficial than competition.

FIRST PERSON:
The Progress and Potential of FDA Inspections
by Nancy Singer
Associate vice president and special counsel for HIMA commends FDA for its recent reforms but urges the agency to continue change

VERBATIM:
MRAs and Beyond: European Industry's Role in a Rapidly Globalizing Market
An interview with Michael Baker, director-general, European Confederation of Medical Devices Associations (EUCOMED)