Below is an excerpt from a 2010 interview between David Mantey, Editor of Product Design and Development magazine and Coghlin Companies President and CEO Chris Coghlin:
PD&D: How did you get your start in the Medical industry?
Chris Coghlin: It was a natural extension of our flagship contract manufacturing division Columbia Tech. We were producing subassemblies to medical devices at Columbia Tech, and our customers expressed desire to have the Coghlin Companies produces the entire finished device.
In order to do that, we had to be ISO 13485:2003 Registered and Compliant to 21CFR Part 820.
We thought forming a specific medical device division would be a great strategic move as the Greater Boston area is loaded with medical, clinical and life science innovation companies. We invested significantly in branding, an educated leadership team and all major certifications. Cogmedix was born
PD&D: In your opinion, how healthy is the contract manufacturing industry today?
Coghlin: Healthier than ever if the contract manufacturer is well capitalized and has a total turnkey solution. Our model enables innovation companies to engage the Coghlin Companies at any stage of the product development process.
We can assist innovation companies in not only enhancing the design of their products, but also manufacturing, globally fulfilling orders and providing spare and refurbishment services as well. We are a true one-stop-shop.
PD&D: How will the industry continue to evolve in the next five years?
Coghlin: My belief is more medical innovation companies will be partnering with companies like Cogmedix as early as possible in the product lifecycle to obtain benefits of GMP, DFM and detailed assembly documentation — enabling cost effective scaled manufacturing. A total turnkey solution will be essential.
PD&D: How big of a role will re-shoring (manufacturing services coming back to the U.S.) have on the county’s role in the manufacturing industry?
Coghlin: I believe the U.S. is poised for continued growth in medical device manufacturing as medical innovators will seek the perfect balance of domestic manufacturing partners with strong global component sourcing capabilities, top-notch quality systems, compliance adherence and strict protection of intellectual property. It should be excellent for the U.S. economy.
PD&D: Electronics contract manufacturing services sometimes face a negative stigma with the proliferation of counterfeit components. How does Cogmedix protect itself from counterfeiters?
Coghlin: Cogmedix buys components exclusively to the customers AVL (Approved Vender List) from reputable and globally recognized suppliers wherever possible.
There is no benefit whatsoever to deviating from this process. If parts are unavailable for any reason, we consult our customer for approval of replacement parts or recommendations for additional approved suppliers.
PD&D: What’s the most interesting project you’ve seen at Cogmedix?
Coghlin: I cannot pick just one project as they are all incredibly cool.
When you walk through our plant you can see such a broad range of incredible device technologies including an ADHD Diagnostic Kiosk, a cellulite treatment product, home healthcare monitoring systems, blood profusion monitors and robotic arm braces for rehabilitation therapy. It is so incredible; we cannot wait to see what tomorrow brings.
PD&D: What is Cogmedix forte?
Coghlin: Assisting early to mid-stage medical device innovators bring their class I and class II medical device products to market in a very cost effective, compliant and scalable manner with a very experienced, knowledgeable and focused team.
PD&D: What can Cogmedix do for a design engineer?
Coghlin: Cogmedix is focused on working through validation builds with customers of early stage products and enhancing the overall documentation and assembly process by wringing out any opportunity for tribal knowledge.
This enables less downstream challenges and more scalable product launches.
PD&D: What keeps you up at night?
Coghlin: The thought of U.S. medical device innovators investing millions of dollars on market research and product development time only to compromise the quality and intellectual property of the device by outsourcing to an offshore partner just to save a few dollars. I just don’t get it.
I am also concerned about the new tax that is being placed on medical devices as a result of the new healthcare bill. My concern is that any additional taxation on these innovative companies that are designing life-saving technologies and creating jobs could delay innovation and further job growth.