Medical Device & Diagnostic Industry
March 1998 MD&DI
Selected Contents
COVER STORY:
1998 Business Outlook: Prospects for Growth
by Stacey L. Bell
Double-digit growth and a friendlier FDA are keeping prospects positive.
SIMULATION TESTING:
How to Meet the New Simulation Testing Requirements
by Michael Drues
To develop an effective and reproducible simulation, manufacturers must first ask the right questions.
FDA MODERNIZATION ACT:
The FDA Modernization Act of 1997: Part I
by Jonathan S. Kahan and Howard M. Holstein
In the first part of a series detailing the new Modernization Act, the authors discuss sections 201 through 210—including new stipulations for IDEs and PMAs—and how the law may be
implemented.
PROCESS CONTROL:
How to Implement a Statistical Process Control Program
by Dan Bracco
Careful set-up and implementation of charting activities can eliminate the need to test product lots, thus speeding up time to market.
WASHINGTON WRAP-UP:
Tighter FDA Budget May Mean Fewer, Shorter Inspections
by James G. Dickinson
Agency statistics indicate that FDA will refocus its enforcement activities in 1998.
R&D HORIZONS:
Shape-Memory Alloys Offer Untapped Potential
by Greg Freiherr
Engineers teach versatile materials how to work in the body.
BOTTOM LINE:
Site Seeing: How to Choose a Distribution Center
by Russ Dixon
Determining the right size and locations for a distribution network can mean the difference between keeping customers or losing them.
HELP DESK:
Standards and Methods for Using EtO
James M. Gibson, a sterilization consultant with J. M. Gibson Associates (Odessa, FL), provides information about EtO sterilization with regard to clinical trials, personnel exposure, and humidity readings.
EMI FIELD NOTES:
Protecting Circuits against Electromagnetic Threats
by Chris M. Kendall
Case shielding, circuit filtering, and cable protection are keys to meeting new electromagnetic compatibility requirements.
FIRST PERSON:FDA Reforms Are Rolling, so It's Time to Focus on Going Global
by John W. Galiardo
HIMA's chairman-elect suggests new issues the industry should tackle following the enactment of the FDA Modernization Act.
SNAPSHOT: Terry Ryusaki
Calculated Risks—
New Technologies and a Company to Take Public
by Jennifer Sakurai
EDITOR'S PAGE:
Will 1998 Be the Year of Reimbursement?
by Stacey L. Bell
To realize the full potential of the FDA reforms, manufacturers now need to smooth the reimbursement process as well.
1997
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November | October | September | August | July | June | May | April | March | February | January
1996
December | November | October | September | August | July | June | May | April | March
