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March 2007
Guide to Outsourcing
Medical Device & Diagnostic Industry
Selected Contents













From the Editors

Generic Devices: New Concept or Clever Marketing?

Erik Swain

Escalating healthcare costs are making the idea of generic medical devices appealing. But can it really be done across industry?

Cover Story

Fluidic System Design Is No Easy Task

William Leventon

OEMs faced with designing fluidic systems must consider a number of factors when choosing pump, valve, and connector components.

Sterilization

New Gamma Methods Increase Options for Allograft Materials

Steve Burns

Musculoskeletal tissue components can be sterilized with other materials in sterile barrier packaging using high-dose gamma methods.

Sidebar:
Who Regulates Tissue?
Tips for Risk Mitigation

Stent Inspection

Casting a New Light on Visual Inspection

Dan Freifeld

Although vision inspection has traditionally been a labor-intensive process, line-scan systems can automate the process.

Material Processing

Laser Basics: Interactions with Materials

Girish Kelkar

When using lasers to process materials, it's important to understand the fundamentals of how lasers interact with different materials.

Special Section

Reimbursement

As the issues surrounding reimbursement become increasingly challenging, there are several trends that should be examined. There are also many ways to approach those challenges.

What to Do if Your Device Doesn't Get Reimbursement

Top Reimbursement Developments of 2006

Washington Wrap-Up

FDA Warning Letter Web Site Convicts Companies Unfairly

James G. Dickinson

To nonindustry observers, the lack of posted responses to warning letters may give the impression that FDA is always correct in their notifications.

Product Development Insight

The Art of Screen Design: Part 1

Michael Wiklund and Jonathan Kendler

Investing in software user interface aesthetics can result in a well-accepted useful device.

Regulatory Outlook

Crossing the Line: Kickbacks Come Under Increased Government Security

Jeffrey Wasserstein and Michelle Butler

Device manufacturers need to know the implications of the federal antikickback law, especially in light of recent government investigations.

Sidebar:
Medtronic Settlement

First Person

HGPII: Transparency Is King

Greg Radinsky

The GPO industry has launched an initiative In an effort to make group purchasing organizations' practices more transparent.

Industry News

R&D Digest

Guide to Outsourcing

Beyond Customer Service: The Supplier as Consultant

Sherrie Conroy

If an OEM's competencies do not include designing critical parts or subsystems, it may consider tapping into its supplier's knowledge may be a good choice.

Guide to Outsourcing

Protecting IP in Offshore Outsourcing

Steven Yu and John Flock

OEMs can take certain steps to protect their IP when they outsource R&D tasks overseas.

Guide to Outsourcing

Understanding Insourcing and Core Competencies

Marian Robinson and Steven van Engen

As OEMs face increasing challenges in managing their supply chain, they may decide to bring some product production aspects back in-house.

Guide to Outsourcing

Postmarket Clinical Studies: The Era of Outsourcing Is Here

Erik Swain

Contract research organizations can provide OEMs with expertise and guidance on how to best conduct postmarket studies.

Guide to Outsourcing

Bringing Partnership to a Quality Management System

Roger Brink

It's important to identify the responsibilities of both the OEM and the contract manufacturer when entering into an outsourcing agreement.

Guide to Outsourcing

All Signs Point to Outsourcing

Mark Kesti

A survey of device companies indicates that the industry will continue the trend of using contract manufacturers and other outsourcing partners.

Guide to Outsourcing

Managing Suppliers Drives Quality Performance

Michael Kuehne

Rigorous quality management of a supplier's products and services can improve the supplier's performance.

Sidebar:
Supplier Management In Action

Guide to Outsourcing

Opening the Doors to India: Offshoring Medical Devices

Pradep Nair

India offers many opportunities to OEMs that offshore there; however, it is important to be realistic about the challenges of offshoring to that country.

Outsourcing News