Medical Device & Diagnostic Industry
April 1998 MD&DI
Selected Contents
COVER STORY:
Innovative Injection Molding Techniques for the Medical Industry
by Ken A. Kerouac and Peter F. Grelle
Molding techniques and applications share a corresponding cycle of improvement, each one pushing the other to ever-more innovative processes and uses.
IN VITRO DIAGNOSTICS:
Packaging Technology for Miniature IVD Instrumentation
by Carlos González, Jeffrey Y. Pan, Scott D. Collins, and Rosemary L. Smith
MEMS research is helping IVD manufacturers shape a new future for point-of-care diagnostics.
FDA MODERNIZATION ACT:
The FDA Modernization Act of 1997: Part II
by Jonathan S. Kahan and Howard M. Holstein
Various sections of the new act are described, including device tracking, postmarket surveillance, adverse event reporting, and off-label uses.
QUALITY IMPROVEMENT:
Seven Basic Tools That Can Improve Quality
by Ashweni Sahni
Standardizing quality systems doesn't have to be complicated if one knows which tool to use in a given situation.
ISO 10993:
A Practical Guide to ISO 10993-5: Cytotoxicity
by Richard F. Wallin and Edward F. Arscott
This segment of the continuing series on ISO 10993 discusses the methods of cytoxicity testing and their benefits.
CLINICAL TRIALS:
For Emergency Use Only . . .
by Barry Sall
In some emergencies, an investigational device can be used without obtaining prior informed consent from the patient.
WASHINGTON WRAP-UP:
FDA Faces the Budget Ax
by James G. Dickinson
Also:
- FDA's New Power
- 63 Devices Deregulated.
R&D HORIZONS:
Biomaterials Research Focuses on Developing New Applications
by Jon Katz and Gabriel Spera
From drug release to tissue scaffolding, new biomaterials and engineering techniques may change the way we think about medicine.
BOTTOM LINE:
Suppliers and Liability: Coping with the Materials Shortage
by Kevin M. Quinley
What manufacturers can do to ameliorate suppliers' concerns about product liability suits while maintaining access to raw materials.
HELP DESK:
Choosing Discrete-Event Simulation Software
Steve Mallory, senior software specialist for 3M Health Care (Ann Arbor, MI), and Wayne Rogers, principal investigator for Rogers Medical (Temecula, CA), describe what to look for when choosing a discrete-event simulation software package.
EMI FIELD NOTES:
Protecting Devices From Radiofrequncy Transmitters
by Dan Hoolihan
New EMC guidelines will help engineers test and manage electromagnetic interference from nearby transmitters.
VERBATIM:An Entrepreneurial Company Grapples With Rapid Growth
Colette Cozean, PhD, chair of the board, president, and CEO of Premier Laser Systems, Inc., shares the strategies behind her company's stellar advances.
SNAPSHOT: Ed Kimmelman
Harmonizing Quality Systems for the Global Market
by Annie Gorton
EDITOR'S PAGE:
FDA's Newest Guidance Document: When the Label Doesn't Fit
by Stacey L. Bell
FDA is asking manufacturers to change label content to include individualization of treatment and patient counseling.
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