February
2008
Medical Device & Diagnostic Industry
Selected Contents
From the Editors
Who Has Control of Your Software Analysis?
FDA’s static code analysis could have significant implications for the device industry.
Web Exclusive
Cover Story: Molding
The Selection of Device Materials
Design
Exploring Ethnography for Design Research
Ethnographic research can help device companies make key business decisions.
Design
Considerations for Home-Based Devices
Manufacturers should create a positive user experience for devices that will primarily be used by patients at home.
Mergers & Acquisitions
The Ins and Outs of Regulatory Due Diligence
A merger or acquisition in the device world requires significant attention to due diligence.
Washington Wrap-Up
A recent report reveals CDRH’s ongoing battle with the makers of two unapproved medical devices.
Regulatory Outlook
Revised EU Directives Mean Many Changes
Product Development Insight
NewsTrends
- Lack of Resources Compromises Product Safety
- Manufacturers Lose R&D Tax Credit
- AdvaMed Appoints Associate VP
- Sleep Apnea Therapy Hits the Big Time
- Device Trials Get More Efficient Via Software
R&D Digest
- Alternative Hygienic Aid Protects Incisions
- Device Improves Orthopedic Shoulder Surgery
- Device Could Crack Case on Pulmonary Diseases



