Medical Device Link.

From the Editors

New Pedigree Drug Laws May Snag Device Makers

Laws meant to prevent drug counterfeiting may mean more requirements for device manufacturers.

Cover Story - Top 10 Technologies

MD&DI’s Top Ten Technologies

MD&DI identifies and explores the Top 10 medical device technologies that drive industry today—and the applications that use them.

Implantable Elution Devices: Reshaping the Industry
Carotid Artery Stents: A Step Toward Preventing Strokes
Heart Assist Devices: Keeping Patients’ Interest at Heart
Artificial Bone and Skin Grafts: New Materials Provide Better Scaffolding
Artificial Orthopedic Disks: Flexible Disks Imitate Vertebrae
Nucleic Acid–Based IVDs: Diagnoses in a Day, Not Weeks
Medical Lasers: The Wavelength of the Future
Medical Imaging Technology: The Value Beneath the Surface
Wireless Technology: Hospitals and Homes Go Unplugged
Computer-Assisted Surgery: The Digital OR

Coatings

Coatings: Sustained-Release Drug Delivery for Retinal Disease
Signe Varner, Nancy Hupfer, and John Buan

A polymer coating applied to a coil surface enables the sustained release of drugs to the back of the eye.

Precision Technology

Producing Components with Precision Technology
Rick Meier

As devices become more complex, many manufacturers are turning to precision technologies to meet their requirements. However, not all precision processes are created equal.

WASHINGTON WRAP-UP

Are PMAs Legally Safer Than 510(k)s?
James G. Dickinson

Courts have ruled that FDA premarket approval decisions may protect products from product liability claims.

NEWSTRENDS

• Exhaustive Design Process Leads to Advance in Patient Monitoring
• Congress May Intervene If GPO Conduct Codes Lack Teeth
• Abiomed to Acquire Impella
• Third Parties Can Help Firms Attain Market Access
• CDRH Steps Up Tracking of Postmarket Studies
• Desert Plant Offers Latex Alternative
• Student Teams Submit Bright Ideas for Devices
• Proper Training Prevents Trouble When Promoting Products
  

R&D DIGEST:

• Device Eases Diagnosis of Concussions and Other Cognitive Conditions
• Tabletop Fusion Targets Cancer Cells
• Pelvic Splint Provides Safety, Access

Regulatory Outlook

Medical Device Clinical Trials in Japan
Kiyohito Nakai and Martin A. Yahiro
Japanese Pharmaceuticals and Medical Devices Agency and FDA Office of Device Evaluation

In an effort to globally harmonize medical device clinical trials, Japan has implemented new regulations on how to develop and conduct them.