November 2003
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
Want
an Early Coverage Decision? Communicate with CMS.
COVER STORY
Extrusion
Changes to Meet New Challenges
William Leventon
Tube
makers report on developments in materials, processes, and the extrusion
business.
Outsourcing
Contracting
Out: Outsourcing Strategies for Medical OEMs
Maureen Kingsley
Medical
device makers are outsourcing design, manufacturing, and assembly with
increasing regularity. To do it right, however, they must make quality a
priority and determine to what extent they are able to apply vendor-managed
inventory strategies.
Sidebar: JUDGING
QUALITY: LOOKING PAST THE PAPERWORK
Sidebar: You Say “Tomato,” I Say. . .
Circuit
Protection
Avoiding
the Common Mistakes of Circuit Protection
Ken
Cybart
Circuit protection is not
difficult, but it is crucial to patient care.
WASHINGTON
WRAP-UP:
James G. Dickinson
How
Not to Expand Your 510(k)
Don’t bother
mentioning in your 510(k) application a device use other than the intended one.
You’ll offend CDRH.
NEWSTRENDS
- Promise of Drug-Eluting Stents Confirmed
- Breast Implant Manufacturer to Return to U.S. Market
- Same Submission Form for Different Nations in Pilot Program
- Device Stocks up 3.8% in Second Quarter 2003
- Gifts and Other Perks for Doctors Restricted Under New Code of Ethics
- Battelle Offering Blends Development, Economics
- CMS
Clarifies Process for National Coverage Decisions
R&D DIGEST:
- Biologically Based Nanomotors Could Have Medical Applications
- Bone Implant Research May Suggest Better Materials, Textures
- Device Could Help Overcome Barriers to Organ Transplantation
- Bonding
Material May Strengthen Vertebrae
PRODUCT DEVELOPMENT INSIGHT
Medical
Devices That Talk
Michael E.
Wiklund
Talking medical devices can enhance the way users interact with such products. But how can you ensure that your device is actually helpful?
Sidebar: What
about two-way communication?
REGULATORY OUTLOOK
Do We Need
Medical Device Risk Management Certification?
Harvey Rudoloh
Underwriters
Laboratories Inc.
A popular catchphrase these days is risk management. It is being used by
regulators worldwide, as well as by standards developers and others whose
business is the safety and effectiveness of medical devices.
Sidebar: FDA
Guidance Documents
Referencing Risk Management
