Outsourcing Decisions Require Diligence, Caution

Outsourcing is all the rage these days. If you're a manufacturer seeking to make and sell your medical devices worldwide, the demands of the global economy pretty much require it.

But it has to be done carefully. If outsourcing agreements are consummated without proper consideration of risks, the results can be disastrous. Reading the articles in MD&DI's Guide to Outsourcing, out this month, can help you avoid some of the pitfalls.

India is becoming one of the most attractive global markets, and so naturally it's no surprise that device manufacturers are seeking partnerships with outsourcing firms there. These have produced much successful collaboration on device manufacturing and development. Pradep Nair of HCL Technologies tells you how to carefully assess the risks and obstacles unique to the Indian market.

Having long benefited from the global outsourcing of labor and manufacturing, the device industry is exploring such arrangements in product engineering, design, and technology development. But this raises intellectual property concerns. If R&D is to be outsourced to a foreign country, then due diligence must be performed before any sensitive information is shared. Steven Yu and John Flock of the law firm Kenyon & Kenyon LLP show device manufacturers how to navigate the overseas IP waters.

The nature of the global market requires device firms to use a diversity of materials and suppliers. But managing all of them can be tricky. How can that be done? Michael Kuehne of Acsys Inc. explains how a robust supplier quality management program can be implemented.

A requirement for an outsourcing partner is to have a sound quality management system in place for each client. Device firms can play a role in how their contract manufacturers set this up and integrate it into the management process. Failure to do so can lead to all sorts of quality problems. Roger Brink of ATEK Medical has tips on what to do in order to implement such a system successfully.

Outsourcing partnerships are common practice in the clinical realm, too, and will get even more common as FDA begins to require a greater number of postmarket studies and begins to scrutinize them more diligently. Choosing a clinical research organization to run your postmarket study is not something that should be taken lightly. Executives from some of the leading medical device CROs reveal some of the questions you should be asking before you enter into an agreement.

Outsourcing is serious business, and device manufacturers must proceed cautiously before committing to a partner or a process. But if the right decisions are made, the rewards can be tremendous. We hope this guide helps you get on the right path.

Erik Swain
erik.swain@cancom.com

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

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

Stent Inspection
Casting a New Light on Visual Inspection
By Dan Freifeld
Although vision inspection has traditionally been labor-intensive, line-scan systems can automate the process.

Material Processing
Laser Basics: Interactions with Materials
By Girish Kelkar
It is important to understand the fundamentals of how lasers interact with different materials.

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