September 7, 2011

3 Min Read
Defining Medical Device Innovation in a Global Arena

The term medical device innovation means different things to different people. In the United States and other developed nations, it is typically marked by cutting-edge technology or a revolutionary design. But the same term has an entirely different definition based on very distinct needs in low- and middle-income markets.

A recent piece in the New England Journal of Medicine (NEJM) titled "Health Technologies and Innovation in the Global Health Arena" offers an interesting perspective on the dire need for medical device innovation for low- and middle-income markets. And that doesn't usually translate to the need for the flashiest new technology on the market with touch technology and a compact design like it may in the United States, for example. In contrast, these markets can, in many cases, significantly benefit from low-cost, relatively low-tech medical products.

Medical device innovation for these markets is often exemplified by the ability to directly address the unmet need of a specific region or population rather than forcing them to use expensive, high-tech devices that are not practical for a given setting. "The urge to apply technologies without proper identification and understanding of the most compelling needs is a frequent source of failure for medical innovation," the NEJM authors state.

Venkat Rajan, industry manager, medical devices, at Frost & Sullivan, echoed this sentiment in a keynote address hosted by MPMN earlier this year. "In the past, most manufacturers have simply taken the approach of selling the same products in emerging markets that are available in the U.S., Western Europe, Japan, etc. However, I think moving forward we will start to see increasing unique designs tailored to the needs of those markets," he said.

And it's imperative that we do. True medical device innovation in these settings thus typically exists in the successful ability to assess and address an unmet need in a manner that is cost-effective and user friendly. Furthermore, it needs to meet these criteria in a design that can be used in remote locations, with limited access to resources, or by untrained or low-tech personnel.

Without question, producing innovative medical devices for these markets requires a different perspective and a nontraditional tool kit. But it can also be a rewarding challenge to take on. And interesting, too! After all, a low-cost design doesn't always equate to antiquated technology. In some areas, for example, healthcare may be limited or sparse, but cell phones abound. Medical device innovation in such regions could be presented in the form of a simple, low-cost cell phone-based technology. This is an angle currently being explored by students, notably at Caltech where they have been developing Android-based prototypes that could eventually enable a 10-cent medical checkup for remote regions. Likewise, the NEJM article cites mobile phone-based pulse oximetry and vital signs monitoring that is being field-tested in Uganda.

"A climate of innovation should be promoted globally, but we must acknowledge the enormous differences among developing economies," the NEJM authors add. "Fostering technologies that 'disrupt' or leapfrog more expensive conventional methods may be ideal for most developing countries, and incremental innovations that increase the value of current medical devices may sometimes be the most useful approach. By contrast, promoting relatively expensive 'blue sky' innovation -- which represents a major departure from existing solutions and generally requires substantial academic and commercial infrastructure -- may work in countries such as China and India but would be quixotic in most developing countries."

At the end of the day, it doesn't matter how medical device innovation is defined. It only matters that patients' needs around the globe are being met and new products are improving healthcare in some fashion. --Shana Leonard

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