Medical Device Link.

January 2000
MD&DI
Selected Contents

DESIGNER'S NOTEBOOK:
User-Centered Design: A Clinician's Perspective
by Matthew B. Weinger

Throughout the design and production process, manufacturers must focus on the needs and requirements of the end-user in the environment where the device will ultimately be used.

SPECIAL SECTION:
Surface Modification Using Low-Pressure Plasma Technology
by Johan Palmers

Plasma treatment of material surfaces can impart a range of desired physical or mechanical properties or induce specific biological responses when a device is placed in the body.

COVER STORY:
Producing Bubble/Taper Tubing for Medical Applications
by Dave Wille

The extrusion of tubing that features an integral connector requires a thorough knowledge of the process and precise control of forming parameters.

PROCESS CONTROL:
A Structured Approach to Rapid Process Development and Control
by Raymond Augustin

The use of a structured development plan helps companies integrate statistical and analytical methodologies to optimize process gains faster.

QUALITY:
Validation of FDA's New Quality System Inspection Technique
by Georgia A. Layloff, Robert G. Ruff, and Timothy R. Wells

An extensive validation project includes a range of tests and analyses designed to determine whether or not QSIT in fact meets user needs and intended uses.

TECHNOLOGY 2000:
Technology Forecast: New Prospects for Medical Devices in 2000
by Gregg Nighswonger

Medical devices in the next century will take advantage of stronger, lighter materials, nanoscale components, and faster processing capabilities.

MEDICAL PACKAGING:
A Comparison of Heat Seal Coating and Peelable Film Technologies for Medical Packaging
by Glenn Petrie

Understanding the relative strengths and weaknesses of different package materials is critical in selecting the best packaging system for a particular device.

CLINICAL TRIALS:
Complying With FDA's Financial Disclosure Regulation
by Barry Sall

Although it does not preclude financial arrangements between research sponsors and investigators, the intent of the regulation is to ensure that financial interests are disclosed and that collected data accurately reflect actual clinical situations.

MANUFACTURING:
Issues in Hermetic Sealing of Medical Products
by Kevin Ely

Ensuring hermeticity in a medical device is a function of materials choice, final seal design, fabrication processes and practices, and use environment.

EMI:
Examining Potential EMI between Medical Devices and Electronic Security Systems
by Donald Witters

Given safety concerns and the complex nature of electromagnetic interference with medical devices, regulators are taking a cautious approach.

ISO 10993:
Biocompatibility Safety Assessment of Medical Devices: FDA/ISO and Japanese Guidelines
by Vasudev P. Anand

Amid efforts at harmonization, important differences exist between U.S./FDA/ISO and Ministry of Health and Welfare (Japan) medical device biocompatibility requirements.

WASHINGTON WRAP-UP:
FDA Going "Direct" to Companies
by James G. Dickinson

Also:

• What makes FDA inspectors mad
• Standards for reprocessed devices
• HIMA rebuffed by CDRH chief
• Key CDRH staff changes
• ISO problems for FDA foreseen
• No "surrogate" inspections

R&D HORIZONS:
ANNs Provide Tools for Increased Diagnostic Accuracy
by Gregg Nighswonger

Use of artificial neural networks is yielding medical devices that can "learn" to support care providers.

BOTTOM LINE:
Funding a Medical Device Start-Up
by Leslie Bottorff

Understanding the way venture capital funding works can help entrepreneurs attract the capital critical to a start-up's success.

HELP DESK:
ISO 9000 Revision
Susan B. Jacobs, CQA, a senior quality systems specialist with Medical Device Consultants Inc. (North Attleboro, MA), and program chair for the ASQ Biomedical Division, discusses upcoming changes to the ISO 9000 standards.

HELP DESK:
Natural Rubber Substitutes
Len Czuba, director, medical sector, Herbst Lazar Bell Inc. (Chicago), suggests alternatives to using natural rubber in medical device components.

SNAP SHOT:
Beyond the Lab: Bringing Academic Research to the Marketplace
by Robert Drummond

In the winter of 1997, Eric Swanson was struggling with a personal and professional dilemma: remain in academia, where he enjoyed an enviable position at the Massachusetts Institute of Technology (MIT), or make the leap into the corporate world and start a company based on a new technology.

EDITOR'S PAGE:
The Shape of Things to Come Designing Better Devices... and Magazines
by John Katz

Two new columns for 2000 reflect MD&DI's continually sharpening focus on device design information and Internet developments.