Medical Device Link.

EDITOR'S PAGE:
In Pursuit of Failure

COVER STORY

Medical Device Design: The State of the Art
Stacey L. Bell

The trends and technologies that are influencing the design of today’s medical devices reflect an increased focus on  the end-user and home healthcare.

Sidebar: Medical Devices Go Green

CORPORATE OUTLOOK

Preparing for a World of Change
Gregg Nighswonger 

How are device manufacturers getting ready for technological change and new market factors? Four industry executives share their views.

Sidebar: Roundtable Participants

RISK MANAGEMENT

Establishing Overall Risk for Medical Devices
Mike W. Schmidt

In addition to reducing individual risks, device makers must develop an overall risk index in accordance with ISO/IEC 14971, Clause 7.

WASHINGTON WRAP-UP:
James G. Dickinson

McClellan Hits the Ground Running

The new FDA commissioner is demonstrating an impressive decisiveness and understanding of agency bureaucracy. A top priority is reduction of medical errors.

Plus:

• Who Reviews Combination Products?
• Bard Avoids Liability for Labeling
• Uterine Fibroids Device Cleared
• Stair-Climbing Wheelchair (pictured)
• Carbon Dioxide Monitor Guidance
• More Answers on Reprocessed Devices

NEWSTRENDS

• Robotic Surgery Litigation Offers IP Lessons, Caveats
• Health Canada Moves One Step Closer to Harmonization
• Expanded Notification of Device Recalls Urged
• ISO 13485 Splits from ISO 9000
• Mohan Assumes Key Role in IVD Firm 
  

R&D DIGEST:

• Monitor Noninvasively Measures Premature Infants’ Vital
• Using Sound to Sterilize Medical Instruments 
• Rapid Method Maps Blood Vessels in Live Tumors
• Hands-Free Medical Assistance Software Aids Emergency Treatment

PRODUCT DEVELOPMENT INSIGHT

Project Advisory Boards: Improving Product Development Quality and Consistency
Richard Rosen

Advisory boards enhance development efforts and help companies meet the ever-increasing challenges of developing and launching new products.

REGULATORY OUTLOOK

FDA’s Regulation of Analyte-Specific Reagents
Jeffrey K. Shapiro and Randy J. Prebula

Confusing and at times counterintuitive, the ASR rule applies to materials used in in-house-developed tests, not the assays themselves.