MD+DI, February 2010, Volume 32, No. 2

February 2010


This Issue's Articles
An Era of Change: New ­Director, New ­Direction for FDA?
by: Sherrie Conroy

Neurostimulation in the New Decade
Revamping product development strategies and business models will give companies an edge in the neurostimulation field.
by: Rahul Sathe

10 Steps to Managing Master Data for Devices
Medical device companies should consider critical technologies for compliance and risk management.
by: Ravi Shankar

Detecting Nitinol Surface Inclusions
Surface inclusions can cause primary fatigue, corrosion, and nickel leaching sites in nitinol stents. A new method could help OEMs test for such flaws.
by: Ryszard Rokicki

Biocompatibility Testing: Tips for Avoiding Pitfalls, Part 2
Biocompatibility testing isn’t simple, but several key pieces of information can make the process more bearable.
by: Laurence Lister

When FDA Takes Its Complaints to Your Customers
The agency makes an unconventional move to point out a company’s alleged noncompliance.  
by: James G. Dickinson

Following the Road to Regulation
FDA’s goal is to address the gaps in regulatory oversight of certain diagnostic assays.
by: Margretha Susan Zecchini, Johns Hopkins University

Mapping the Regulatory Path of Digital Pathology Systems
by: Heather Thompson

CDRH Launches Probe into Radiation Overdoses
by: Lawrence Lloyd and James G. Dickinson

GHTF Outlines Recommendations for a UDI System
by: Lindsey Rooney

AAMI Vows More Interaction in 2010
by: Maria Fontanazza

Making Minimotors with Paper: Just Add Liquid
by: Maria Fontanazza

Italian Researchers Create Synthetic Bone from Wood
by: Heather Thompson

Great Pretenders: Polymer Creates Blood Cell Mimics for Drug Delivery
by: Heather Thompson