Medical Device & Diagnostic Industry
March 1997 MD&DI
Selected Contents
First Person
Industry Advice to FDA: Put Patients First
William W. George
The chairman of the Health Industry Manufacturers Association and
chairman and CEO of Medtronic, Inc. (Minneapolis), offers a
prescription for improving FDA’s relationship with industry.
Designer's Toolbox
Before Design: Thoroughly Evaluate Your Concept
Floyd V. Edwards
Washington Wrap-Up
A "New Way of Life" at FDA
James G. Dickinson
Center for Devices and Radiological Health director Bruce Burlington
reveals new strategies for reforming the agency from within.
R&D Horizons
The Race to Develop A Painless Blood Glucose Monitor
Greg Freiherr
Hopes are high for alternatives to finger sticks, but so are the technological hurdles.
Bottom Line
Site Selection Criteria for the Medical Device Industry
Chris Dray
Cover Story
1997 Business Outlook: Greater Risks, Greater Rewards
John Bethune
With improvements in FDA product review performance—and despite an ever more challenging domestic market—device company executives are more optimistic than ever.
Product Design
Mapping Human Anatomy from MRI Data for Improved Product Development
James W. Kristoff
Magnetic resonance imaging is not just for diagnostics. Converted into CAD models, MRI data can also create virtual anatomies upon which to build medical devices that are sure to fit patients.
Clinical Trials
New IDE Manual Clarifies FDA Policy on Clinical Studies
Gerard J. Prud'homme
Sponsors of clinical trials need to become familiar with the new IDE manual to interact better with FDA and to speed product development.
Product Liability
Medtronic V. Lohr Decision Underscores Importance of Regulatory Compliance
Daniel G. Jarcho
Help Desk
Submitting a 510(k) for Changes in Device Design
Modifications may affect
the safety and effectiveness of a device. Such changes may also require manufacturers to submit 510(k)s to FDA. This month FDA assists the
editors in determining whether design changes warrant such a submission.
Snapshot
Seeking Growth in a Dynamic Market by Embracing Change (Profile of Duane Hopper)
John Bethune
1996
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