October 2005
Medical Device & Diagnostic Industry
Selected Contents
From the Editors
A Wake-Up Call for Ethics
When mainstream media focuses on unethical practices by a few OEMs, it becomes essential that device companies make an effort to embrace their code of ethics.
Cover Story
Building Better Barriers
Erik Swain
As more and more sensitive devices come onto the market, manufacturers must choose their barrier packaging material carefully.
Packaging
The Cost of Package Integrity
Michael B. Foster
Manufacturers trying to satisfy packaging requirements can avoid pitfalls by examining a few key issues.
Software
Device Makers Access Key Data from a Distance
William Leventon
Innovations in monitoring software enable manufacturers to remotely track the status of their products and their manufacturing processes.
Electronic Records
Developing Dynamic Device History Records
Joseph Vinhais
The QSR requires manufacturers to document each step of their manufacturing processes. But are paper or electronic device history records the right choice for you?
Fluoropolymers
Fluoropolymers: Fitting the Bill for Medical Applications
Karl Graffte
Fluoropolymers have properties that manufacturers may find useful in meeting demanding device requirements.
Sterilization
Parametric Release for Low-Temperature Gas Plasma Sterilization
Benjamin M. Fryer and James P. Kohler
Devices that cannot use EtO sterilization may find a solution with an increasingly popular sterilization method that uses an aqueous hydrogen peroxide solution.
Leak Testing
Leak Detection for Medical Equipment
Claes Nylander
Although several leak detection tests can be used for medical devices, discerning the right one for your medical device requires some consideration.
WASHINGTON WRAP-UP
Company Secrets at Risk in FDA
James G. Dickinson
Sources at FDA allege that CDRH has a history of disregard for safeguarding sensitive company information.
NEWSTRENDS
- Congress, Industry Optimistic about New User-Fee Program Despite Fee Hikes
- Outdated Payment Policies Hurt Diagnostics Innovation
- Combination Products: Primary Mode of Action Refined
- New Coverage Scheme Only for National Decisions
- More Trials and Tribulations for Clinical Monitoring
- Discussion Boards Offer Problem Solving minus Sales Pitches
- Award-Winning Products Employed Human Factors
R&D DIGEST
- A Cooler Way to Stop Seizures
- Better Artificial Bones through Carbon Nanotubes?
- A Breath of Fresh Air for Diagnosing Disease and Implant Rejection
- Simulators Test Spinal Implants for Durability
- Device Performs Balancing Act
Product Development Insight
Integrating Product Development Part 1: Design for Six Sigma
Vinni Sastri
Product development processes can incorporate six sigma to yield products with extremely low defects based on requirements that are critical to the customer. In addition, using six sigma can help companies meet the requirements of the QSR.
Regulatory Outlook
The Business of Clinical Trials Part 2: Finance and Risk Allocation
Katherine R. Leibowitz
Hogan & Hartson LLP
When negotiating a clinical trial agreement, it’s important that the parties not overlook issues such as financial interests and allocation of risk. Although these issues are fairly standard, they are equally important to the sponsor and the investigator.
Q&A
Going the Extra Mile for Compliance Pays Dividends
Erik Swain
Wally Pellerite shares his insights about what FDA expects in terms of compliance and offers advice on handling FDA inspections.
