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Monday, August 13, 2007
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The Essence of Outsourcing
The two most essential issues in medical device outsourcing are how to go about choosing a partner and how to manage the projects that result from the partnership. In MD&DI’s Guide to Outsourcing, a supplement to our August issue, we are running articles that tackle both of those questions. Those both new and old to outsourcing should take heed.
Of particular importance is the condition of a potential partner’s cleanroom. How does a medical device maker search out a facility that packages a product that anyone would willingly implant in their body? An article by Kelly Lucenti of Millstone Medical (Fall River, MA) looks at the top ten reasons to contract with one outsourcing partner instead of another because they have the cleanest cleanroom around.
For those who need to select an electronics manufacturing services (EMS) provider, Ed Evangelista of Federal Electronics Inc. (Cranston, RI) has you covered. His article shows how the selection of a competent EMS provider will serve as a source for business, manufacturing, and operational innovation and efficiency that can be leveraged to an OEM’s advantage. If you make the right choice, you can have a partner whose plant is a seamless and efficient extension of yours.
Once an outsourcing arrangement is agreed upon, the question becomes how to manage it. In order to best do so, argues Jeff Stephens of Ixian Consulting (Jefferson, GA), medical device firms need to understand what their core competencies–and their competitive advantages–are.
Is your firm good at extending existing medical device patents into new product lines? Leveraging market dominance to add value? Developing original innovative therapies and technologies with a proven R&D team? These traits and others can inform how best to manage any outsourced project and form an overall outsourcing strategy.
Also critical is knowing what outsourcers are available for your particular needs. That is why we’ve moved the Who’s Who in Contract Manufacturing feature to this supplement issue. The directory provides a comprehensive and current list of contract manufacturers of finished medical devices.
We hope that these articles will help you develop your outsourcing strategy, too.
Erik Swain
erik.swain@cancom.com
Molding
New TPEs Provide Material Flexibility
By Raj Varma and Joe Kutka
Thermoplastic elastomers help device OEMs meet an increasing number of needs for molding.
Imaging
Image-Guided Surgery: New Approached for Improved Navigation
By Vaishali Kamat
Advances in imaging technology have been the catalyst for new minimally invasive techniques.
Software
Software User Interface Requirements for Medical Devices
By David Vogel
Even nonengineers can navigate user interface software with the help of guidance documents.
Risk Management
Essential Performance of Medical Electrical Equipment
By Mike Schmidt
IEC 60601-1 is the guide to navigating single-fault risk management in medical equipment.
Guide to Outsourcing
Transferring to an Outsourcing System
By Jeffrey Stephens
Transferring manufacturing processes from a device OEM to an outsourcer can be done efficiently.
More from this issue of MD&DI
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