MD&DI - January, 2007

January 2007
Medical Device & Diagnostic Industry
Selected Contents

Editor's Page

Erik Swain

MD&DI 's new online and print project will follow the changes in Congress and FDA in the coming months. These changes could reshape the way CDRH regulates industry.

Cover Story

Using Acrylic to Lower Costs and Make Smaller Devices

Peter Colburn and Holger Tinz

Prudent materials selection can help device makers reduce the cost of manufacturing small devices.

Molding

Multishot Makes Inroads in Medical Molding

William Leventon

In appropriate applications, multishot molding can streamline production and improve product quality.

Packaging

Consider the Basics when Developing Packaging

Randall Troutman

Package designers must understand the device, the packaging material, and all the end-user requirements before achieving a successful package.

Materials

CFR PEEK Composite for Surgical Applications

Stuart Green

A composite of PEEK and carbon fibers can make load-bearing implants act like bone.

Process Control

Design of Experiments with Process Signature Verification

Laura Dierker and Drew Wilson

Although it is unfamiliar to many device makers, process signature verification can help them analyze their manufacturing processes.

Regulatory

Medical Device Regulatory Update: The Asian Market

Ames Gross

As Asian countries step up their efforts to regulate medical devices, it is important that U.S. manufacturers stay abreast of the developments.

Drug and Device Combinations

Combination Medical Products: Capitalizing on Convergence

Chris Cramer and Sharad Rastogi

Manufacturers that can master the technical, regulator, and business challenges associated with combination products will be ahead of the pack.

Pumps

Using Miniature Diaphragm Pumps to Get Portability, Power

Dan Schimelman

How can manufacturers respond to requests for diaphragm pumps that are small but also powerful and long lasting?

Washington Wrap-Up

Will the Democrats' New Broom Sweep CDRH?

James G. Dickinson

Speculation abounds about what changes may occur under a Democrat-led Congress, especially in light of current concerns about the agency's enforcement actions.

Product Development Insight

Using Design Controls to Reduce Time to Market

David Vogel

Implementing design controls is essential for device designers hoping to get a product to market quickly.

Regulatory Outlook

Empowering the Quality and Regulatory Compliance Functions

J. Glenn George, Kenneth Immler, and Nancy Singer

Every employee in a firm should shoulder quality and regulatory responsibility; however, it is management's responsibility to make sure it happens.

Q&A

Reshaping Policy to Polish Compliance

Erik Swain

Consultant Steve Neidelman, an FDA veteran, wants to change what he sees as complacency he sees from industry.