The Flip Side of Med-Tech Innovation
WHY YOU SHOULD CARE
Turning the traditional medical technology innovation model on its head might be our best shot at making health care helpful and affordable for the whole world.
When Jonathan Pillai’s father suffered a heart attack, surgeons inserted a device called a stent to prop open his damaged coronary artery — racking up a whopping 30,000 rupees, or about $5,000 at the time, in medical bills. Although his company shouldered much of the expense, the procedure nearly wiped out his family’s savings, forcing them to live for years without a car. Pillai recalls many other families in his native India – where most people don’t have health insurance – sacrificing their college and dowry money. Others offered up their farms.
Twenty years later, little has changed. Companies design and manufacture high-end medical devices in the U.S., Europe and Japan and export them to developing countries. But their top-of-the-line materials and manufacturing processes cost thousands of dollars — too expensive for most people in developing countries, where patients often pay out of pocket. And many of these technologies fail to meet the needs of the developing world. For example, the bulky imaging equipment made for Western hospitals make little sense in rural areas with poor road access.
So when Pillai heard about the Stanford-India Biodesign (SIB) fellowship program, he could “barely contain [his] excitement” and applied right away. Based at Stanford University, the Indian Institute of Technology and the All India Institute of Medical Sciences, SIB turns the traditional med-tech innovation model on its head — designing affordable, lifesaving technologies for both developing and industrialized countries.
That model of designing products based on the clinical needs of the developing world — known as reverse innovation — is steadily gaining steam. Besides the biodesign training programs SIB fellows develop in India, similar programs have cropped up around the world, from Rice University’s Rice 360° to ITESM in Mexico.
At Stanford each year, four Indian fellows study for six months to learn the university-created biodesign process for med-tech innovation. They then head back to India, where they spend three months observing medical care in high-volume urban hospitals and rural clinics, compiling a list of patient care needs. Working with program faculty advisors, they launch at least one innovation based on those needs.
It really does have to be built from the need on up rather than the technology on down.
-Paul Yock, MD, Stanford Biodesign Priogram Director
Traditionally, big med-tech companies like GE and Medtronic would consult practicing doctors for suggestions about how to modify their existing products for developing countries. “It can lead to the identification of smaller, incremental needs,” says Rajiv Doshi, the U.S. executive director of SIB and a consulting associate professor at Stanford’s School of Medicine. A doctor might suggest molding the handle of a device into a different shape, for example.
“This whole model is totally broken,” says Pillai, now an intellectual property and regulatory affairs manager at IndioLabs, a medical technology startup in Bangalore. “The concept of higher technology developed in the West with the assumption that it’s going to work for every patient in every country and expecting the rest of the of world to pay for it is ridiculous.”
Developing a truly appropriate, cost-effective approach requires full immersion in developing countries’ clinical settings. Otherwise, “you bypass understanding the need in that country’s context,” says Stanford School of Medicine professor and biodesign program director Paul Yock. “It really does have to be built from the need on up rather than the technology on down.”
Launched in 2008, SIB centers on the premise that innovation can be taught. Fellows learn a systematic biodesign process, beginning with the most crucial step: identifying patient needs. “If you get the need right, you can pretty much always come up with the invention that will satisfy it,” Yock says. Based on their clinical observations, fellows must list at least 200 needs — which they whittle down to four, with the help of four “filters,” such as the existence of business mechanisms to deliver the product to patients.
Pillai, Siraj Bagwan, and two other SIB fellows zeroed in on the need for safe biopsy procedures to diagnose liver conditions, such as hepatitis and liver cancer. During their clinical immersion, they noticed doctors repeating risky biopsy procedures, since the first attempt often yielded a sample that was too small. Many also feared handling hepatitis-B-infected samples and causing internal bleeding.
So the team launched IndioLabs and developed BioScoop, a low-cost device that essentially sucks up a sufficiently large tissue sample into a protective chamber and administers a clotting agent – all in three seconds. IndioLabs expects to roll out BioScoop in Indian clinics by March 2015, with a launch planned for the U.S. and Europe in a few years.
Other SIB fellows have launched a low-cost, disposable leg splint to immobilize broken legs while patients are transported to hospitals, while Rice 360° fellows have developed a device in Malawi that opens up the airways of infants with acute respiratory infections. And GE has developed a low-cost, portable, battery-powered electrocardiogram (ECG) in rural India.
Adapting its existing products to the developing world helped boost GE’s revenues outside the U.S. from $4.8 billion in 1980 to $97 billion in 2008.
But reverse innovation might also be a win for industrialized countries, which tend to push the boundaries of innovation with little attention to cost, says Bagwan, now IndioLabs’ chief technology officer. “It will help the developed world to reduce or rationalize the cost of care delivery. Take BioScoop… which can be applied as is, or with some tweaks for developed nations.” GE is already selling its Indian-developed ECG in the U.S. at 80% the cost of similar products.
Reverse innovation could also benefit established healthcare companies. Simply adapting its existing products to the developing world helped boost GE’s revenues outside the U.S. from $4.8 billion in 1980 to $97 billion in 2008. “What many companies are starting to recognize is the much larger opportunities to serve the needs of the emerging middle class,” Doshi says.
But he also notes that there are still relatively few successful examples of the fledgling reverse innovation model in healthcare; many of these technologies are still under study or have only just launched.
That said, one thing’s clear: medical care is expensive, no matter where you live. Even if the solution doesn’t lie in reverse innovation, this might be one case in which thinking backward might still be smarter than pushing forward.
* Editor’s Note: An earlier version of this article did not adequately credit a source, the Stanford-India Biodesign Partnership.