When potentially game-changing medical discoveries don’t fit easily into a standard business model, they can languish in a netherworld of limbo known as the Valley of Death. The term refers to the gap between a drug or medical device that holds promise for patients and the resources required to bring it to market. Recognizing their responsibility to improve lives even when profits prove uncertain, universities have begun to identify unconventional ways to advance innovations that could serve society.
Jen French is one of the lucky ones. A longtime athlete, she still competes in outdoor adventures despite the spinal cord injury she sustained in a 1998 snowboarding accident that left her arms and legs paralyzed. Thanks to an electrical-implant system, she continues to sail, ski and scuba dive—all while maintaining a successful career as a nonprofit executive.
The problem? She’s among only a handful of patients to have access to this transformational technology, which she received as a participant in a federal research project.
Estimates show about 1.3 million Americans are paralyzed due to spinal cord injury. The number looks sizable, until you consider figures for some common conditions: Heart disease and diabetes each affect more than 33 million people; more than 29 million men have erectile dysfunction; and more than 18 million people are afflicted with cancer.
Medical research is a lengthy and costly enterprise, and business investment in the field represents a gamble under even the best of circumstances. When it comes to research on solutions for spinal cord injuries and other such “smaller market” conditions, treatments promise modest profit at best—particularly when compared with the audience for, say, Viagra.
It’s not that French’s device and others like it wouldn’t benefit patients immensely. Rather, investors prefer the seemingly safer bets on solutions that can affect many more people. A population exists for these innovations—companies simply find it too tiny to be lucrative.
“Sometimes, commercialization is not possible through conventional for-profit channels,” says Case Western Reserve University biomedical engineer P. Hunter Peckham, PhD, who heads the Cleveland Functional Electrical Stimulation Center, a multi-institutional collaboration where researchers developed French’s device and other technologies that restore function in paralyzed individuals. “In these cases, alternatives must be identified based on a social responsibility to carry medical products through the Valley of Death.”
The valley he refers to is a dangerous gap that threatens to swallow scientific advances that stumble along the path to traditional commercialization, usually for lack of funds.
Medical companies easily spend hundreds of millions of dollars navigating rounds of clinical trials, safety studies and federal approvals to release a single medication. When the patient population is sizable, executives can rationalize the investment as an opportunity to reap major returns, and perhaps offset a few attempts that miss the mark. When the numbers don’t add up to obvious profit, investors aren’t as easily convinced, and the discovery falls into the cracks, often never to be heard from again.
