May 2004
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
Strong
Leadership at CDRH Must Continue
Cover
Story
Portability
Drive Stokes Demand for Diminutive Pumps and Valves
William Leventon
Tiny gas- and
liquid-moving components fit the bill in smaller medical devices.
An
MD&DI Roundtable
The
Lessons of Winning Design
The winners
of the 2004 Medical Design Excellence Awards represent the best of the medical
industry. Four members of the awards panel share their insights into what makes
these products stand out.
Plastics
Making
Sense of Plastics and Their Properties
Hedden Miller
Plastics are
quickly gaining popularity as the material of choice for medical device
components. But with many options available, manufacturers need to know how to
select the plastic that will work best for their devices.
Quality
Compliance
Is Not Enough: The Benefits of Advanced Quality Systems Practices
Jennifer Parkhurst and Beth Shaw
A recent
survey suggests that basing quality strategies on more than just regulatory
compliance offers not only additional benefits, but actually improves
compliance.
Sidebar:
Beyond
Compliance: how the best device makers
Build on quality practices
Adhesives
Fast-Cure
Silicone Adhesives for Medical Devices
Bill Riegler, Rob Thomaier, and
Henry Sarria
In an
industry where customers demand more products in less time, fast-cure silicone
adhesives may help achieve those goals.
Labeling
IEC
60601-1: Medical Device Marking and Labeling
Leonard Eisner, Robert M. Brown, and
Dan Modi
IEC 60601-1
treats labeling as a critical component of medical devices and provides
comprehensive requirements for marking and labeling.
Clinical Research
Clinical
Studies: Europe or the United States?
Nancy J. Stark and Jeff Peacock
An
increasing number of companies are offshoring clinical research to Europe. But
is that the best way to prepare a device for release in the United States?
Sidebar: European
Terms
WASHINGTON WRAP-UP
Is FDA Up to Its Old Tricks?James G. Dickinson
Two device companies are claiming FDA’s inspections were mishandled, raising questions about the agency’s image as an industry helper.
NEWSTRENDS
- Taxus Stent Could Give Boston Scientific Market Leadership
- AdvaMed Launches Independent Research Foundation
- UTI to Buy MedSource
- Feigal Steps Down From CDRH
- U.S. Expert Calls Japan’s Reimbursement Policies Draconian
- Bigger EU Offers Little Opportunity to Life Sciences Industry
- Deal Creates Largest Diagnostics Firm
- Tool Quantifies Regulatory Affairs Performance
R&D DIGEST:
- Microbiosensor Chip Can Move DNA Molecules
- Microstructures Could Have Multiple Medical Applications
- Adhesives May Lead to Breakthrough in Tissue Mending
- New
Artificial Proteins Could Make Better Scaffolds for Tissue Engineering
Product
Development Insight
Effective
Project Management for Medical Devices
David Kolesar and Frank Winterroth
Because
it incorporates all functions and departments, a matrix management style is
ideally suited for medical device projects.
Regulatory
Outlook
Tony Chan and Edwin Bills
Agile Pharmaceutical and Bilanx Consulting
Regulations require the integration of risk analysis into all processes, including manufacturing. Applying HACCP principles can minimize the introduction of risk factors.
Sidebar: THE DEVELOPMENT OF MEDICAL DEVICE RISK MANAGEMENT
25th anniversary
Plus
Ça ChangeIn 1979, MD&DI launched its first issue. A look at what industry said in the magazine’s first few issues is very revealing.
