October 2003
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
A
New Take on Technology Transfer: Technology Migration
COVER STORY
3-D
Packaging for Medical Products
John P Merritt
Shape
and size are key considerations for manufacturers of high-profile, sterile,
disposable devices.
Software
Tough
Decisions
Erik Swain
Device
companies are faced with more—and more difficult—choices for manufacturing
and quality software.
Alarms
A Sound Approach to Device Alarms
Lawrence Harris
Although
most complex medical devices have alarms, problems still frequently occur.
Proper alarm system requirement specifications may offer solutions.
Sidebar:
Try
it Out Before You Finalize the Design
WASHINGTON
WRAP-UP:
James G. Dickinson
Small
Firms Upset over Large User-Fee Hike
MDMA is concerned
that the unanticipated 35% user-fee increase for FY 2004 will seriously hurt
innovation. Should the fee-hike trend continue, the group fears its members will
be marginalized the way small drug companies have been for years.
NEWSTRENDS
- Third-Party 510(k) Reviews Gaining Popularity
- FDA Limits Part 11 Scope
- AMDR, AdvaMed at Odds over Reprocessed SUD Applications
- Jorkasky to Head Vision Research Group
- GPOs
Tout Reforms, but Concerns Remain
R&D DIGEST:
- Cognitive Machines May One Day Strengthen Capabilities of Medical Devices
- Imaging Software May Aid Medical Diagnoses
PRODUCT DEVELOPMENT INSIGHT
Controlling
User Requirement Changes
David Warburton
Procedures
for managing changes in specifications should be flexible enough to allow useful
improvements, but rigorous enough to prevent feature creep and other product
development snags.
REGULATORY OUTLOOK
Third-Party 510(k) Review: A More
Attractive Alternative?
Robert Mosenkis
President, CITECH
Now
that user fees have increased, device makers are advised to give third-party
reviewers a second look.
Sidebar: How
fast is fda review?
