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February 2008
Medical Device & Diagnostic Industry
Selected Contents










From the Editors

Who Has Control of Your Software Analysis?

Sherrie Conroy

FDA’s static code analysis could have significant implications for the device industry.


Web Exclusive

Web Site Directory

Need a quick reference point for your favorite manufacturers’ Web sites? Look no further.


Cover Story: Molding

The Selection of Device Materials

Michael Hansen

Manufacturers should keep performance, processing, and price as the top considerations in choosing the most appropriate material.


Design

Exploring Ethnography for Design Research

Stephen Wilcox

Ethnographic research can help device companies make key business decisions.


Design

Considerations for Home-Based Devices

Matthew Jordan

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

Barry Sall

A merger or acquisition in the device world requires significant attention to due diligence.


Washington Wrap-Up

CDRH Promises Punishment

James G. Dickinson

A recent report reveals CDRH’s ongoing battle with the makers of two unapproved medical devices.


Regulatory Outlook

Revised EU Directives Mean Many Changes

Roger Gray

Changes to European medical device regulations are scheduled to take effect in 2010.

Web Exclusive: Expanded Version


Product Development Insight

Integrating Human Factors

Reade Harpham, David Wourms, and Donna Pydlek

Several tips could help device makers incorporate human factors into the development process.


NewsTrends


R&D Digest