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March 2008
Guide to Outsourcing
Medical Device & Diagnostic Industry
Selected Contents













From the Editors

FDA Needs More Money and More Ideas

Erik Swain

FDA can't accomplish its mission on its present budget. Besides more money, it also needs to evaluate whether changes in its processes could help.

Cover Story: Pumps and Valves

Optimizing Pumps and Valves

Dan Schimelman

As more devices become portable, smaller diaphragm pumps and solenoid valves are needed.

Sterilization

The Role of Biocides in Medical Devices

Jeffrey Ellis

To fight a rise in hospital-acquired infections, more medical devices are being developed with antimicrobial features.

Postmarket Surveillance

Strategies After Product Approval

Erik Swain

Approval isn’t the end—device firms must have a strong postmarket surveillance strategy for their products.

Supply Chain

Increased Mobility for Medical Device Sales

Mark Lagunowich

Handheld software devices can ease tracking and documentation processes for sales reps.

Diagnostics

Exploring Cap Inspection Systems

Niels Wartenberg

Miniature imagers combine megapixel technology and vision capabilities to create a suitable choice for many designers.

Process Validation

The Basics of Process Validation

Nancy Cafmeyer and Jonathan Lewis

Process validation requires device firms to meet a predefined set of requirements.

Washington Wrap-Up

Power Not Coming from the Top

James G. Dickinson

Critics believe top FDA officials have not always wielded authority.

Product Development Insight

The Benefits of Verification and Validation

Bryan Chojnowski

Software verification and validation activities could bring more value to an organization.

Regulatory Outlook

Staying on the Right Side of the FCPA

Bethany Gilbert and Michelle Merola Kane

Device firms will be held accountable for violating the Foreign Corrupt Practices Act.

Industry News

R&D Digest

Guide to Outsourcing

Making the Outsourcing Shoe Fit

Sherrie Conroy

Both parties should make sure that their goals are aligned.

Web Exclusive!

What Your Mother Never Told You About Outsourcing to China

Rick Rogers and Gray McCord

Thinking about moving your manufacturing to China? It's not an easy process, so be sure it's the right decision.

Guide to Outsourcing

U.S. GMP Compliance: A Blueprint for Outsourcing

Kevin Randall

Device companies can develop a GMP strategy that meets FDA requirements and the specific needs of their outsourcing situations.

Sidebar:
Definitions
Design Change Checklist

Guide to Outsourcing

All Eyes on Singapore

Audrey Soon

Growth in the country’s biomedical sector could mean more opportunities for U.S. device manufacturers.

Guide to Outsourcing

Selecting an Offshore Community

Mario España

Medical OEMs can identify the right locations for offshoring by evaluating regulatory factors and local governments, as well as by asking key questions.

Sidebar:
Foreign Direct Investment in Nicaragua

Guide to Outsourcing

Planning For and Mitigating Risk

Lori Gipp

Standard practices can reduce risk and facilitate continuous improvement.

Sidebar:
Understanding Risk Probability

Guide to Outsourcing

Seeking a True Product Developer

J. Kirkland Douglass

If product development is not a core competency, device firms may want to outsource.

Guide to Outsourcing

Finding the Best Outsourcing Partner

Ron Kirscht

Research. It’s the foundation of selecting a partner that meets a company’s needs.

Outsourcing News