Medical Device Link.

EDITOR'S PAGE:
From Pluripotent to Impotent


Postponement Stalls Government-Sponsored Research

COVER STORY:
Advances in Analytical Valve Technology
Stephen J. Neil, Craig Occhiato, and Sandro Schneider

Today's valves for biomedical applications must be smaller, more accurate, and able to effectively handle aggressive media.

SOFTWARE:
Medical Device Software Standards: Vision and Status
Sherman Eagles and John Murray

For manufacturers of software-containing devices, a clear understanding of all relevant standards is crucial. This article takes a close look at the past, present, and future state of those standards.

MRA IMPLICATIONS:
The U.S.-EU Recognition Agreement: Its Implications for the U.S. Medical Device Industry
Christopher Johnson

Its supporters say that the MRA has the potential to improve patient access to safe and effective technologies, accelerate regulatory approvals, and make it easier and cheaper for U.S. and European companies to enter each other's markets.

Extrusion Gets a Boost from New Equipment

William Leventon

Technological advances promise many improvements to extrusion processes and products.

STERILIZATION:
Exploring the Feasibility of Using Dense-Phase Carbon Dioxide for Sterilization

Michael A. Matthews, Langdon S. Warner, and Heinz Kaiser

Though still in the research stages, sterilizing with CO2 may soon be a viable option—both economically and logistically—for medical device manufacturers.

PRODUCT DEVELOPMENT:
Integrating Clinical Research into the Product Development Cycle
Nancy J. Stark

A systematic approach that views the clinical research department as an integral part of the development team can enhance the likelihood of success in the creation of new products.

PLASTICS WELDING:
Infrared Welding of Polymers
Robert A. Grimm

Using a transmitting substrate as a waveguide enables the creation of difficult-to-fabricate polymer joints.

WASHINGTON WRAP-UP:
Shifting the Device Risk Burden
James G. Dickinson

Does a recent device approval indicate a softening of FDA's "appropriate use" worries?

MEDICAL PLASTICS & BIOMATERIALS:
Considerations for the Biocompatibility Evaluation of Medical Devices
Raju G. Kammula and Janine M. Morris

FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this process.

R&D HORIZONS:
Developing New Tools for Minimally Invasive Surgery
William Loob

Advanced surgical techniques are becoming less invasive and less traumatic to patients, but navigating the body's complex tissues and organs requires innovative systems for guidance and control.

FIRST PERSON:
Listening to Industry: Ombudsman Les Weinstein Comments on His Role in CDRH

CDRH Ombudsman Weinstein details the responsibilities and initiatives of his position, and shares industry dispute and complaint statistics for the year 2000.

BOTTOM LINE:
The First 25 Years of the Medical Device Law: Its Impact on the Orthopedics Industry
Richard W. Treharne and Thomas L. Craig

What has been the effect of the landmark legislation on the device industry? An analysis of one key sector draws some interesting conclusions.