Skip to : [Content] [Navigation]
 

Medical Device & Diagnostic Industry

 
 
Email article link Print article

 

May 2002
Medical Device & Diagnostic Industry
Selected Contents

EDITOR'S PAGE

As Inspections Dwindle, Will a Crisis Grow?

MEDICAL PLASTICS

Enhancing Medical Device Performance with Nanocomposite Polymers
Lawrence A. Acquarulo Jr. and Charles J. O'Neil

Advances in compounding medical plastics with nanoclay fillers are pushing the materials envelope for minimally invasive devices.

Sidebar: The Language of Nanocomposites

PLASTICS MOLDING

Part Making on a Very Small Scale: Micromolding for Medical Devices
William Leventon

Some medical microparts measure less than a cubic millimeter, but micromolders and their customers want to go even smaller.

Sidebar: New Tools Aid Plastic-Device Makers

SOFTWARE

Using UML to Represent Regulatory Material
Bruce Knoth and Barry Craner

A software-development tool for understanding complex systems, the unified modeling language can confer several benefits, including reduced training costs, more-precise standards, and higher-quality FDA submissions.

 

MATERIALS TESTING

Examining Elliptical Surface Defects on Angioplasty Balloons
Abbas Tcharkhtchi and Erik Andersen

Defects in angioplasty balloon material, which result in product discards, may represent a significant portion of production.

Sidebar: Ensuring the Saftey of Balloon Catheters

SINGLE-USE DEVICES

A Review of Selected Articles on the Safety of Reprocessing SUDs
David N. Cowan, Stephen O. Cunnion, and Tina M. Swift

Of the literature cited by reprocessors to support SUD reuse, few documents, if any, provide indisputable evidence of the safety of reprocessing.

 

HUMAN FACTORS DESIGN

Eleven Keys to Designing Error-Resistant Medical Devices
Michael E. Wiklund

Manufacturers can help reduce use error in the clinical setting by integrating good human factors practices and user-friendly design into their medical devices.

 

FLOW CONTROL

Viewing Flow Management as a Critical Subsystem of Devices
Gregg Nighswonger

From infusion pumps to valves and IV sets, flow-control systems are providing new capabilities in care while helping to ensure patient safety.

 

FIRST PERSON

Combination Products: Incrementalism Won't Work
Kshitij Mohan, PhD

Proposals currently before Congress for changing the regulation of combination products fall short of the needed reform.




WASHINGTON WRAP-UP

Jim Benson Remembers When FDA Wasn't Talking
James G. Dickinson

The former head of FDA's device center, now retiring after a decade with AdvaMed, played an important part in improving FDA's relationship with the medical device industry.

R&D DIGEST:

BULLETIN BOARD

Elastomeric compound provides new balance of properties. Conformal coatings are suitable for rubber, metals, and plastics. Light curing resins improve end-product quality, and more!

NEWS & ANALYSIS