March 2004
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
Controlling
Device-Related Errors in Hospitals
COVER STORY:
Hedden Miller and Ronald R. Lamonte
To maximize the benefits of injection molding for production of parts made from engineering plastics, designers must balance many interrelated variables.
Sterile
Processing
Steven G. Richter
Medical products contaminated with the sclerotia of P. domesticum may not be sterile after an EtO cycle based on B. atrophaeus spore kill.
Patent Litigation
Merriann M. Panarella
With the right business strategy, it is possible to avoid, manage, or reduce patent litigation costs.
Guide to
Outsourcing
Andrew Kinross
More and more medical device companies are looking for one-stop options for outsourcing manufacturing. The result is an upsurge in consolidation of these providers.
Guide to
Outsourcing
Jeffrey Stephens
Many companies seem eager to outsource, but is outsourcing always the right choice for your company?
Q&A
Erik Swain
Deciding to outsource may be an easy judgment, but analyzing cost and quality implications, finding the right partners, and forging strong relationships are tough tasks.
Guide to Outsourcing
ISO Certification: Standing Out by OutsourcingDarryl Duayne Baird
The use of consultants can help your organization obtain, enhance, and defend ISO 9000 certification.
WASHINGTON WRAP-UP
Federal Court Rules Against PreemptionJames G. Dickinson
In recent years, courts have tended to view FDA approval as a shield against litigation. But a recent ruling bucks that trend.
NEWSTRENDS
- Implant Sponsor “Disappointed” by Guidance Document
- Administration Proposes Record Increase in CDRH Funding
- Spending on Healthcare Technology Beneficial
- Preparation, Honesty Keys to Avoiding Red Flags for Inspectors
- Spacelabs Sold for Third Time in Two Years
- Risk Management Must Be Applied Systematically
- Cleveland Clinic Spin-off Reaps Investment
R&D DIGEST:
- Microheaters May Pave Way for Easier Tissue Engineering
- Modification to Particles Could Lead to Better Surgical Imaging
- Nanostructures a Key to Curing Some Paralysis?
- Discovery
Could Improve Treatment of Cataracts
Product
Development Insight
Integrating
Industrial Design into the Product Development Cycle
Stephen G. Hauser
Although
industrial design is becoming an integral part of product development,
successfully integrating it into the development cycle begins with the proposal.
Sidebar: Some Simple Rules to Follow
Regulatory
Outlook
The
Use and Misuse of FMEA in Risk Analysis
Mike W. Schmidt
Failure
modes and effects analysis can be a helpful tool in risk management for medical
devices, but it has several inherent traps that should be recognized and
avoided.
