April 2003
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
User Fees: Out the Window?
COVER STORY
Microblasting: Expanding Options
Garry Slemp and Colin Weightman
Uses for modern microblasting technology in medical device manufacturing are increasing as devices become smaller.
Testing
Strategies for Bench Testing
Medical Devices
Robert Mosenkis
For successful testing, choose the right tests and conduct them at the right time—in an appropriate facility.
Sidebar: Testing to Support a 510(k)
Design Control
Making Design Controls Useful
for R&D
Gerald E. Loeb and Frances J. R. Richmond
Identifying constraints explicitly in the design-input document facilitates project management and reduces risk.
Sidebar: Sample design input and output for
a neuromuscular stimulator
Sidebar:
Definition of Terms
WASHINGTON
WRAP-UP:
James G. Dickinson
Budget Offers Bleak Device Outlook at FDA
The government gives plenty of lip service to the device center, but does it back up its words with money? Judging by the proposed 2004 budget, the answer is no.
Plus:
- Noncompliant Firms Kill Warning Letter Pilot
- No Extra Fees for Bundling
- Grassroots FDA Dialogs Returning
- More Modular Submissions?
- What to Include in a PMA or PDP
- Don’t Exempt from 510(k), AdvaMed Says
NEWSTRENDS
- Hot Medical Sectors to Watch in Coming Years
- North American Component Mark Proposed by CSA Group
- Guidance on Quality Information
- New Electrodes Allow Use of AEDs to Treat Small Children and Infants
- Future Engineers Scholarship
R&D DIGEST:
- Neurological Biosensor Chip Measures Electrical Activity in Living Cells
- Can Heart Muscle Cells Be Produced from Bone Marrow?
- Research Could Lead to Higher-Resolution Functional MRI
PRODUCT DEVELOPMENT INSIGHT
Solid Modeling and Medical Devices:
Maintaining Compliance in a Virtual Design Environment
David Warburton
Advances in 3-D digital design have yielded huge gains in speed and flexibility, but going paperless also raises significant legal and regulatory hurdles.
Sidebar: PCB FABRICATION VS. Solid part modeling
REGULATORY OUTLOOK
Getting Started with a Combination Product
Part II: European Regulations
Barry S. Sall, Peter Lassoff, and Bruce Babbitt
The European Union adds further wrinkles to the combination product market.
Sidebar: European Regulatory Decision Makers
