MD&DI, August 2010, Volume 32, No. 8

August 2010


This Issue's Articles
Just Say No to FDA’s Idea of Transparency
by: Sherrie Conroy

Building a Plug-and-Play Future for Healthcare
Smart pumps offer a bounty of benefits for both OEMs and patients. But interoperability could make these devices even smarter.  

Protecting Devices with Silver-Based Antimicrobials
Hospitals are turning to device makers for innovations in materials science for battling infections at surgical sites. Silver ion technology could be the weapon that wins a war.
by: Jeffrey A. Trogolo

Analyze This: Device Cleanliness Testing
Three analytical methods can help manufacturers avoid 
residual material product contamination.
by: Tina May and Brent Shelley

Medical Devices Come Home
Open standards and new technologies have the potential to make treating chronic conditions more cost effective.
by: Haritha Treadway

Piezo Motors and Actuators: Medical Device Performance
Piezoceramic motors and actuators could represent a significant improvement over conventional electromagnetic motors for the execution of precise movements with medical equipment.
by: Jim McMahon and Stefan Vorndran

New Interval Offers Confidence—Without Limits
Reasonable confidence limits for binomial proportions could be easier to defend to regulatory bodies, including FDA. Reasonable limits are not statistically different from the sample proportion.
by: John Zorich

Risk Analysis: Beyond Probability and Severity
Incorporating detectability, correctability, and utility in the risk score is helpful in making better decisions about risk acceptability.
by: Nataly F. Youssef and William A. Hyman

Risky Business
The Medical Device Safety Act and government investigations are changing the business landscape for medical device companies.
by: Evan Smith and Caryn M. Silverman

As Social Media Evolves, the Device Industry Must Also
by: Peter Von Dyck

Device Reviews Not Hostage to Safety Over Efficacy
Sharfstein insists that the agency is not hung up on product risks when evaluating medical devices for approval.
by: Jim Dickinson

FDA Backs Risk-Based Approach for Lab Tests

FDA's Town Hall Tour Comes to the West Coast

Investment in Industry Is Leaner, but Still Alluring
by: Maria Fontanazza

Do Unproven CAD Tools Get the Benefit of Reimbursement?
by: Lawrence Lloyd

Memry: The Virtues of Vertical Integration
by: Norbert Sparrow

Ohio a Rapidly Growing Hub for Device Innovation
by: Maria Fontanazza

Dissolving Microneedles Take the Edge Off Sharps Risks
by: Heather Thompson

Thin-Film Nitinol Could Hold Key to Reducing Thrombus
by: Heather Thompson

Night Vision Sees a New Enemy
by: Maria Fontanazza

Japanese Device Manufacturers Warm to Rapid Heat Molding
by: MIki Anzai

Device Makers Should Respond to Industry Shifts by Going Global
by: Heather Thompson

Outsourcing on the Rise
Factors such as tightening global regulations, increased global competition, and new market opportunities have prompted manufacturers to outsource a range of critical operations.  
by: Gaet Tyranski

Managing Outsourcing for Success
The secret to success begins and ends with communication.
by: Tim Bosch and David Ennen

Top Tips for Scaled Manufacturing
Outsourcing and scaled manufacturing 
go hand in hand.
by: Lianne Coppinger

Manufacturing Medical Devices with Confidence in China
China has moved beyond high-volume, low-cost, commodity medical products to medical imaging, diagnostic equipment, and implantable devices.
by: Mark Slaven