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January 2008
Medical Device & Diagnostic Industry
Selected Contents










From the Editors

Companies Need More Than a Great Product

Erik Swain

Market positioning has become a major factor in a device company’s success.


Cover Story: Packaging

Trends in Device Packaging

William Leventon

New developments on the packaging front further protect medical devices from damage and contamination.


Web Exclusive

A Comprehensive Guide to the Quality System Regulation Preamble

Kristin Miller and William A. Hyman

A thorough understanding of FDA’s quality system regulation is crucial for medical OEMs.


Market Trends

Exploring Market Trends for Better Operating Models

Tom Hodson, Tom Beatty, Ohad Ludomirsky, and Kelly Fischbein

The future of medical device firms could hinge on four significant market trends.


Machining

The Advantages of Photoetching

John Daniels

Photoetching can be a useful technique for treating special materials.

Making the Most of Laser Ablation

Glenn Ogura

Medical OEMs can harness laser ablation for their polymer-based devices.

Magnetoelectropolishing Metallic Implants

Ryszard Rokicki, Tadeusz Hryniewicz, and Krzysztof Rokosz

Electropolishing is taken a step further with a constant magnetic field.


Software

Coupling Simulation Software Tools for Implants

Metin Ozen, Can Ozcan, and Kaan Divringi

Using Ansys and AnyBody in tandem can provide a reliable prediction of device performance.


Flexible Circuits

Improving Devices with Micro Flex Circuits

Luke Volpe

Reductions in conductive trace width and pitch have opened the door for miniature-scale microcircuits.


Software

The Benefits of Systems Thinking

Timothy Bowe

OEMs can deal with increasing device sophistication by using systems thinking for testing software-based devices.


Washington Wrap-Up

A Web of Conflicts of Interest

James G. Dickinson

Congressmen question conflicts of interest among FDA advisory committees.


Regulatory Outlook

Medical Device Certification in Japan

Steve McRoberts, Seiko Ohyama, and Tara Kambeitz

Perspectives on Japan’s medical device requirements.


Product Development Insight

Tips for Strategic Project Management

Bryan Chojnowski

Fourteen steps could lead to better project management.


First Person

Harnessing Software Technology

Andrew Dallas

New technology can transform the way device firms design, upgrade, and write software for their devices.


Q&A

Reaching Global Harmonization

Larry Kessler discusses the status of global harmonization in the medical device industry.

Web Exclusive: The complete Q&A session text


NewsTrends


R&D Digest