Medical Device Link.

EDITOR'S PAGE:
Agenda for the Century: Henney Pledges Good Science, Openness at FDA
by Jon Katz

Addressing the National Press Club on a politically historic day, FDA Commissioner Jane Henney outlines the agency's fundamental operating principles for the years ahead.

COVER STORY:
Design Considerations in Small-Diameter Medical Tubing
by Ron Roth

Effective design specification methods and early manufacturing involvement can optimize product manufacturability.

PACKAGING:
Adapting Packaging Technology to Meet Device Industry Needs
by William Leventon

Medical device manufacturers seek cost-effective packaging solutions that can offer increased functionality and performance.

BIOMATERIALS:
Developments in Medical Polymers for Biomaterials Applications
by Jon Katz

As materials designers confront the fundamental challenges of medical science, the discovery of new biocompatible polymers is creating unprecedented excitement.

SINGLE-USE DEVICES:
Establishing Substantial Equivalence of Reprocessed Single-Use Devices
by David L. West, Timmie Topoleskie, and William MacFarland

In light of the recent FDA enforcement decisions, companies submitting reprocessed SUDs for premarket review must pay careful consideration to scientific and regulatory considerations.

EXECUTIVE ROUNDTABLE:
Human Factors Roundtable Part I: The Regulatory Imperative

Human factors can be defined as knowledge regarding the characteristics and capabilities of human beings that is applicable to the design of systems and devices of all types. In the medical industry, there is increasing awareness of the importance of good human factors...

MEDICAL DEVICE REPORTS:
The Admissibility of Medical Device Reports in Civil Litigation
by Anthony G. Brazil, Matthew L. Marshall, and Michele L. Abracen

To limit their product liability exposure, device manufacturers need to stay well-informed of MDR issues and prepare their reports with care.

PACKAGING:
Reshaping the Medical Device Packaging Industry
by Gregg Nighswonger

The U.S. market for medical device packaging is expected to continue notable levels of growth over the next few years. Forecasts of annual growth rates have ranged from 4 to 5.5% among industry observers

WASHINGTON WRAP-UP:
FDA Guidance on Review Procedures Made Available
by James G. Dickinson

FDA explains methods for identifying and responding to deficiencies.

Also:

• Is FDA Biased against EU Devices?
• SUD Reprocessing Enforcement
• New Vascular Graft 510(k) Guidance

R&D HORIZONS:
Robotics and Electronics Research Aid in Building "Smart" Prostheses
by William Loob

The next generation of prosthetic limbs will incorporate technology that provides a more natural gait and greater comfort and efficiency, and may restore certain sensory functions.

BOTTOM LINE:
Integrating Innovation Into Medical Device Companies
by Stacey L. Bell

Already known for their creativity, device manufacturers can benefit from the adoption of an "innovation culture."

MEDICAL PLASTICS & BIOMATERIALS:
A New Family of HF-Weldable Polyolefin Films
by Robert Kelch

Novel films under development that can be efficiently processed with high-frequency sealing technology may offer alternatives to flexible PVC and other materials.