Medical Device Link.

From the Editors

Time to Turn Talk into Action

FDA, industry, and Congress all say they want to work together to fix MDUFMA. But teamwork involves a lot more than just talk.

Cover Story - Outstanding Design Teams

Design Success Takes Collaboration, Communication

The medical device industry is a haven for inventors and entrepreneurs. It may take only one person to come up with an idea, but it takes many to bring that idea into the real world.

Design Teams

The Ekos Team
The Midmark Team
The College Park Team
The Dade Behring Team
The Clozex Team
The Sorenson Medical Team
The Baxter–Insight Team
The Tech Group–Bionix Team
The Key Technologies Team
The IMS–WRAIR Team
The VidaCare–BC Tech Team
The Innovative Spinal Design Team
The Epicor–Aubrey Team
The Restore Medical Team
The Fresenius Design Team
The Medtronic–Metaphase Team

Metals

Avoiding Material Damage with Cold Laser Cutting

Delphine Perrottet, Roy Housh, and Bernold Richerzhagen

A new technology that uses a water jet to guide a laser enables precision micromachining without causing damage to delicate metal materials.

Electronics

Improving Data Transfer and Battery Life for Implanted Devices

Carl Falcon

Conserving power is essential for implanted devices. New low-power mixed-signal ASICs are ideal for such applications.

Combination Products

Regulatory Strategy: Drug Testing of Combination Products

Stuart Portnoy and Steven Koepke

Device and pharmaceutical manufacturers must understand the differences in scientific expectations and cultural environments between CDRH and CDER to obtain FDA approval of drug-device combination products.

WASHINGTON WRAP-UP

Crawford Nomination Delayed by Affair Probe
James G. Dickinson

On the eve of Crawford’s nomination as FDA commissioner, an anonymous letter’s allegations raise questions about his conduct at FDA.

NEWSTRENDS

• Device-Related Intervention Could Be the Wave of the Future
• China’s Regulations, Like Its Market, Becoming More Transparent
• Tread Carefully on Advertising Terrain
• No Consensus Near on Coding Mandate for Devices
• Reimbursement Hinges on Perceived Value
• SOPs Can Ease the Pain of a Recall
  

R&D DIGEST:

• Nanopolymer Boasts Special Delivery
• Cancer Spotting at the Speed of Light
• Nanocarriers Zoom in on Diseased Cells

Product Development Insight

Developing Drug-Delivery Devices: Early Involvement Is Key
John Taenzler and Richard Vanderveer
V2 GfK

Devices that deliver innovative drugs well can lift a product to blockbuster status. Success, however, requires early involvement of device manufacturers in the drug-development process.

Regulatory Outlook

How to Avoid an MDR Disaster: Set Up An Effective Reporting System
Pamela J. Furman
Olsson, Frank, and Weeda PC

It is essential that device manufacturers understand their medical device reporting obligations and how to fulfill them.