MD+DI, January 2011, Volume 33, No. 1

December 2010


This Issue's Articles
Experts Tell You What to Expect in 2011
by: Richard Nass

Mobile Health Devices Require New Strategies for Manufacturers
by: Maria Fontanazza

CDRH Shows Impatience with Defibrillator Issues
by: Jim Dickinson

Looking for a Competitive Advantage in Puerto Rico
by: Heather Thompson

What Happens to Medical Device Reports Once They Reach FDA?
Ever wonder what happens to the thousands of medical device reports that are filed every month with FDA? Are they being put to good use?
by: Jeffrey K. Shapiro

FDA Addresses Data Harmonization Concerns
Drug and device evaluation standards will remain separate despite calls to bring them closer in line with each other.
by: Jim Dickinson

Optimizing Package Design for EtO Sterilization
An algorithmic method has been created to evaluate the sterilization potential of various Tyvek header package designs in a defined EtO cycle.
by: Denise Dacey

Common Mistakes in Medical Sealer Equipment Designs
Companies may have variation in their sterile sealing process and not know it, but there are ways to ensure consistent performance.
by: Charlie Rivera

The Microsphere of Influence
A variety of microspheres are useful in validating and testing medical devices.
by: Yelena Lipovetskaya

Exploring Systems EMC in Medical Devices
Keeping several guidelines in mind can help medical device makers avoid pesky EMC problems.
by: William D. Kimmel and Daryl D. Gerke

Patient-Centric Human Factors
There are several elements to consider when conducting usability testing for home healthcare and patient self-administration environments.
by: Rebekkah Carney and Tom Donnelly

InsideLook: Can EnteroMedics Gain Access to the Neural Pathway to Manage Weight?
EnteroMedics doesn't have a product on the market, but its still getting attention for its plans to fight obesity.
by: Heather Thompson