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Medical Outsourcing Balloons
Contract design expands in regulated field
Andy Diston, managing director, Cambridge Consultants -- Design News, June 4, 2006
How is outsourcing in the medical field changing? Companies are beginning to realize that outsourcing isn't as straightforward in product design as in other parts of their business. In the past, they outsourced manufacturing and the development of products to one company. They're separating the two now, since most manufacturing contract houses have limited design capabilities.
Are the major corporations outsourcing? Large companies are outsourcing a substantial amount of the products they develop. When we work with them, we often find we're not the sole supplier. For one big project, there were 20 suppliers.
Another thing we see is that big organizations do less product development. They tend to grow through acquiring small companies that have neat products. These small companies need to have good design and good documentation to be acquired.
How does the medical industry differ from other fields? Because this is a regulated environment, designers need to know the reason behind design decisions and document them. Companies need to have quality systems in place and use design processes that make sure quality practices and good documentation take place. That's absolutely vital if you're designing a medical device.
Consulting companies have to be staffed with a mix of product development engineers and scientists, so they can carry out design development and a certain amount of research. Being able to do both gives you the best chance of providing a true breakthrough.
Does a design consulting firm need to succeed in medical? To successfully complete projects, companies need engineers and scientists who have varied skills, usually they need to have PhDs or master's degrees. That's especially important in the medical field, because they have to not only say "I've got a good feel that this will work best," but also prove mathematically that it works well.
Another reason you need variety and experience is that, before you can stick a medical implant into the body, you need to understand the chemistry of the materials and how they interact with the body, as well as understanding how to do the best job.
When do companies turn to consulting firms? We're used largely when companies are looking for a breakthrough product, not just the next generation of something they have. From a design perspective, we've got to bring in ergonomics, industrial design and usability. The ultimate deliverable from an outsourcing company is a complete solution, not just the engineering portion.
A message I think is key is, that when companies are looking for outsourcing partners, they should find companies that have done medical devices before. A key thing in a regulated industry is to have experience in the medical field. That's vitally important.
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