MD+DI, September 2010, Volume 32, No. 9

September 2010


This Issue's Articles
The U.S. Innovation Struggle: 
One Model to Follow
by: Sherrie Conroy

So Many Polymers, So Little Time
With so many options, manufacturers should arm themselves with enough information to make a smart choice.  
by: Charles O'Neil

Practical Use of FEA for Medical Rubber Components
A good understanding of rubber is essential to getting the most out of finite element analysis for this material.
by: Kai Zhang and Shu Peng

Streamlining the Complaint-Handling Process
A risk-based approach to complaint handling could help capture commonly missed data and reduce the burden on medical device OEMs.
by: Trudy Yin

Juggling Act: How to Design with Multiple Materials
Collaborating with manufacturing partners fosters efficient innovation when working with two or more materials.
by: Jeff Randall

Deciphering De Novo Reviews
The overall review duration for de novo submissions has climbed in recent years. Is FDA living up to its end of the deal?
by: Zvi Ladin and Michael Imhoff

A Stricter 510(k) Process Offers Challenges, Promises
by: Heather Thompson

Highlights of Proposed Changes to 510(k)

Frost & Sullivan Honors Siemens for CT Technology
by: Sherrie Conroy

User Fee Rates Announced
by: Lawrence Lloyd

Designer Molecules Could Lead to Fast Medical Images
by: Heather Thompson

Device Puts Preterm Labor in Check
by: Maria Fontanazza

FDA Continues Campaign to Upgrade Quality
After going after makers of infusion pumps, the agency has focused on makers of enteral feeding tubes.
by: Jim Dickinson

September 2010 Contributors