These complex parts of the medical device development and commercialization process are where Keith Pennington and Vishaka Rajaram are most comfortable and most passionate — so much so that they formed their own business to help other companies with them.
Pennington and Rajaram run EQUIPT Global Health out of their home in Warsaw, Indiana. Their goal is to help entrepreneurs, groups or designers that have developed medical devices targeted at low-resource markets ensure that their devices are safe, reliable and consistent in design and manufacturing since many of these markets lack standardized regulatory procedures.
Pennington said he saw the potential for the consulting and quality services company in light of the emergence of social entrepreneurship, which has grown enormously over the last six or seven years thanks to young entrepreneurs and college students. He noted one example of a high-profile group of Stanford graduate students who started a company called Embrace to develop a portable, low-cost incubator for premature infants in India and have garnered huge publicity and acclaim for their sleeping bag-type device, which launched last year.
“It’s amazing that they can do these things, but they are kind of the exception to the rule,” Pennington said. “Most of the products that are made like that don’t make it that far. Ideas and prototypes are often produced as design examples by people who are unaware of quality systems, rather than by medical device groups.”
That’s where EQUIPT comes in. Pennington and Rajaram help companies create custom quality systems and documentation processes that are aligned with the Global Harmonization Task Force’s guidelines and with requirements of the U.S. Food and Drug Administration, ISO and other regulations applicable to the target market.
Pennington worked in biomedical engineering at a large medical device company and then at a startup, where he was one of two people trying to bring an implantable medical device to market. Rajaram brings in the quality and compliance expertise, having worked in that capacity for medical device companies for several years.
The companies and groups they’ve been working with, Pennington said, are often small but established groups with a proven design and several hundred units already produced but looking for guidance in scaling to these developing markets. Most of them are looking to solve dire medical problems in poor countries, not to make a fortune from their devices. But they’re still part of a trend that even the big guys are buying into — and could make a fortune from.
Medtronic, Smith & Nephew and St. Jude have all publicly discussed plans to expand their offerings in emerging markets like China, India, Brazil or Africa. As Medtronic’s head of innovation pointed out at a recent medical device conference, there appears to be a system-wide shift occurring toward “reverse innovation.” Rather receiving hand-me-down versions of yesterday’s best medical devices, developing countries are increasingly being viewed as fertile soil for innovating low-cost and often low-tech devices, many of which can be repurposed in traditionally wealthy markets like the U.S. and Europe.
As an example, look at GE Healthcare, whose battery-powered, portable ultrasound device and electrocardiograph machine were originally designed for emerging markets but were eventually released in the U.S. because of high demand.
“In the developing world, a new market disruption is selling to people who have never had this thing before,” Pennington said. “It takes its own kind of effort and it’s really exciting.”