The Launch of New Medical Devices: Taking a Lesson From Pharma

July 6, 2011

by David C. Robson, VP of Development

In the medical device industry, we all know that revenue projections drive development programs, probably with few contingencies built in. Our client companies face intense pressure to realize development goals on time. And rightly so, they don’t have patience for projects that fall behind schedule. So when they get down the long road past product development, the last thing they want is a hang up at commercialization.

Needless to say, there’s a lot to think about when it comes to new product introduction. But medical device manufacturers striving to quickly introduce new products to the market could take a lesson from a distant cousin: the pharmaceutical industry. Looking for ways to cost-effectively advance candidate molecules from discovery to proven evidence that the drug will work on a human (clinical proof of concept), a number of pharma companies are turning to alternative drug development approaches. These focus exclusively on bringing new compounds to the proof-of-concept stage as efficiently as possible, without the burdens of all the downstream planning that go along with traditional drug development. For example, Eli Lilly’s Chorus initiative has reached decisions about a year earlier and at about half the cost of the current industry model.

In a study by Axendia, Inc. & Cambashi, Inc., most medical device companies say they’ll be introducing new products to the market more quickly than ever before—at rates in excess of 10 percent faster. Like pharmaceutical companies, these device makers can also look to an alternative approach to help them do it: centralizing new product introduction services with the same partner who completes design and development, they can perfect processes during the high-risk, yet critical time period between validated product design and full-scale, long-term production.

These services—let’s call them “specialized” new product introduction services—start with low-volume production and can include a whole of array of tasks, such as production planning, quality engineering, sophisticated process validation, metrology, part qualification, electromechanical assemblies, clean room assembly and testing, secondary operations, kitting and packaging, sterilization management, supply-chain management, global sourcing, clinical builds, and market test quantities. It’s about ensuring new or second generation medical devices work as designed to decrease risk, eliminate multiple transfers to long-term production, and ultimately accelerate market speed. Device makers who take this cue from pharma may avoid the complications of navigating and setting up a long-term manufacturing partner and strategy until their programs are fully refined—and proven.