Medical Device & Diagnostic Industry
June 1997 Cover Story
LOGISTICS
SOFTWARE DEVELOPMENT
Risk management is not as complex or expensive as many small device manufacturers may think. In fact, it can actually save money. (Cover photo illustration by Chuck Carlton, Index Stock.)
By John Suzuki and Dale W. Karolak
SITE SELECTION:
Plugging into an Untapped Business Development Resource
by Leslie Laine
Public utilities offer a variety of business development services to entice medical device companies to relocate to—or expand in—their areas.
FDA & TESTING:
Assessing Pass/Fail Testing When There Are No Failures to Assess
by Thom R. Nichols and Sheldon Dummer
Sometimes pass/fail testing of a sample of products or components goes too smoothly. A zero failure rate can lead to a false sense of security if sample size isn't taken into account.
CLINICAL TRIALS:
Using Pilot Studies to Chart a Course in Clinical Research
by Karen Becker Witkin
Pilot studies can help manufacturers not only make better devices, but also save time, money, and resources.
DESIGNER'S TOOLBOX:
Getting a Grip on Hand/Product Interactions
by Bryce G. Rutter
Anthropometric data help designers develop devices that involve the use of hands.
WASHINGTON WRAP-UP:
In Its Bold New Course, FDA Needs Industry's Help
by James G. Dickinson
Facing budget cuts, CDRH considers procedural changes and the use of third-party reviewers.
BOTTOM LINE:
Top Ten Tactics for Surviving Medicare Reform
by Robin R. Young
How manufacturers can survive Medicare reform.
HELP DESK:
Using Patents to Secure Rights to Concepts and Inventions
by Stephen Glazier
When and how to apply for a patent for medical devices.
R&D HORIZONS:Telemedicine: Seeking to Prove Itself in Niche Markets
by Greg Freiherr
Telemedicine helps specialists bridge distances.
LETTERS:
FDA guidance on 510(k) submissions: When do product modifications really need agency review?
EDITOR'S PAGE:
A Growing Consensus for Regulatory Conform
by John Bethune
Cooperation between industry and government will be the key to meaningful transformation of the regulatory process.
FIRST PERSON:
Design Controls: Why They Don't Go Far Enough
by Edward V. LaBudde
Doesn't just applaud design controls, he feels they should be toughened.
SNAPSHOT:
Dedication to Developing Quality Products
by Sherrie Steward
Günter Frey of Pryon Corp. explains how quality certification helps his company produce quality products and remain competitive.
1997
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1996
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