Medical Device & Diagnostic Industry
September 1997 MD&DI
Selected Contents
COVER STORY:
Accelerating the Product Development Cycle
by Bill Evans
Applying product development tricks can help get new designs to market in record time, like this laparoscopic instrument handle made by direct data machining.
EUROPEAN REGULATION:
CE Marking via Self-Declaration
by Hans Haindl
Earning a CE mark is easiest for Class I manufacturers, but even they must deal with vague and confusing requirements.
INDUSTRY TRENDS:
Tracking Trends in Industrial Sterilization
by Michael H. Scholla and Mary E. Wells
The industrial sterilization market is projected to increase 25% in the next few years, and new technologies are already emerging.
FDA REGULATIONS:
The New FDA Regulations on Reports of Corrections and Removals
by Jonathan S. Kahan
FDA's new regulations for reporting corrections and removals require manufacturers to set up new SOPs and maintain detailed report files.
STERILIZATION:
Industry Responds to Pyronema domesticum: HIMA Screening Studies
by Joyce Hansen, Trabue Bryans, Carol Lampe, Gerry O'Dell, Arnold Shechtman, Thelma Wilcott, and Ann Baldwin
Despite undergoing sterilization, cotton from both overseas and domestic sources has been contaminated by Pyronema domesticum, prompting various studies to examine the effectiveness of EtO sterilization on cotton products.
DESIGNER'S TOOLBOX:
Rapid Tooling Provides Molded Parts Early in Development Cycle
by Joe Frantz
The need to determine what materials will maintain necessary tolerances makes rapid tooling crucial in the early stages of development.
WASHINGTON WRAP-UP:
Historic MRA Signed with Europe
by James G. Dickinson
Much work remains before the US-EU mutual recognition agreement deadline in 2001.
R&D HORIZONS:
Implantable Pumps Improve Drug Delivery, Strengthen Weak Hearts
by Gabriel Spera
As pumps and their delivery systems become smaller and smaller, they become more valuable for patients suffering from a wide array of conditions.
BOTTOM LINE:
Chile: A Trailblazer in South America
by Duaine A. Priestley
With Chile's economy strengthening and medical products one of its top 10 imports, U.S. manufacturers would be wise to gain a foothold in this market before their competitors edge them out.
HELP DESK:
Where to Go for EtO Info
Two experts identify publications and trade associations that offer assistance with sterilization.
LETTERS:
Statistics help engineers analyze risk during device testing.
FIRST PERSON:
Innovation Is Key to Motivating Change in Health Care
by John B. Parkinson, Jr.
For the assistant director of SRI International (Arlington, VA), complying with regulatory issues is but a sliver in creating a winning device.
SNAPSHOT:
Fighting Heart Disease with Software
by Daphne Allen
Award-winning software engineer Suresh Gurunathan explores how to steady a fibrilating heart.
EDITOR'S PAGE:
An Awards Program Dedicated to Medical Design Excellence
by John Bethune
An awards program exclusive to the device industry can serve to increase the visibility not only of the winning companies, but also of the industry as a whole.
1997
August | July | June | May | April | March | February | January
1996
December | November | October | September | August | July | June | May | April | March
