Medical Device Link.

From the Editors

Surprisingly, Washington Walks the Walk

Though many said it couldn't be done this quickly, industry, Congress, and FDA banded together to come up with legislation preserving the user-fee program but curbing its exorbitant increases.

Cover Story: Extrusion

Coextrusion: Changing the Face of Tubing
Chris O'Connor

Coextrusion's versatility makes it a solution for many types of tubing applications. As new product lines grow, the opportunities for coextrusion will grow as well.

Sidebar: Contract Manufacturing Considerations

Manufacturing

Choosing the Right Welding Process
Mike Johnston

Plastics welding may not be the obvious choice, but it might be the best one for building your medical device.

Process Verification

Process Signature Verification for Device Manufacturing
Laura Dierker and Nathan Sheaff

Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

WASHINGTON WRAP-UP

FDA Reorganizes Its Inspections Command
James G. Dickinson

Margaret Glavin, FDA's new associate commissioner for regulatory affairs, wants to reorganize FDA's field command structure. The plan, announced in July, is the first major reorganization FDA has seen in several decades.

NEWSTRENDS

• GPO Reform Plan Unveiled, but Industry Unsatisfied
• FDA to Emphasize Human Factors
• EU Devices Directive Changes Not Radical, but Not Insignificant
• MedSun Shifts Focus to Improved Reporting
• Implantable Nerve Stimulator Approved amid Controversy

R&D DIGEST:

• Tissue Analysis on the Cutting Edge
• DNA Chip Could Spot Cancer Early
• Robot Arm Lends a Hand for Remote Breast Exams
• Pathogens Detected in Minutes, Not Days

Product Development Insight

Improving the Design Process through Portfolio Excellence
John Lamb
PRTM Management Consultants

Good portfolio management requires good strategy development and project execution capability. All these elements together can give medical device companies a better handle on emerging technologies, future IP needs, and partner strategies.

Regulatory Outlook

The Business of Clinical Trials, Part 1: Negotiating Confidentiality, IP, and Publications
Katherine R. Leibowitz
Hogan & Hartson LLP

Clinical trials play a big part in successfully bringing a device to market. Understanding what each party needs in the clinical trial agreements can help smooth the process.