Around the globe, the need for health technology innovation to provide cost-effective solutions to pressing health care needs is acute. In the U.S., the rising cost of care is one of the most urgent economic and political issues of our time. Other nations share similar concerns – from Japan’s rapidly aging demographic to Brazil’s shifting burden from communicable diseases to chronic conditions.
But how do researchers address these challenges, and more specifically, how can they shorten the timeline between invention and implementation in one of the most highly regulated and costly fields? The most effective way, says Stanford professor of bioengineering Paul Yock, is to start with a need rather than a technology.
Need-driven innovation starts with identifying problems, or pain points, firsthand by immersing oneself in a variety of health care delivery settings, from hospitals to home care. The idea, Yock says, is to identify dozens or even hundreds of problems, and then quickly translate each one into a rough need statement; a single sentence that encapsulates the problem, the affected population and the targeted change in outcome. “The purpose of the need statement is to frame the problem in a way that makes it actionable for the innovator,” says Yock, a cardiologist by training and the founder and director of the Stanford Byers Center for Biodesign.
For example, if someone has observed a problem with high infection rates among ICU patients with long-term urinary catheters that can often add days to a patient’s hospital stay, the need statement might focus on “a better way to reduce the incidence of urinary tract infections in catheterized ICU patients to reduce total hospital stay.”
Each such need statement can then be investigated through progressively detailed background research to determine which ones could be the most promising to address. This requires a deep dive into understanding the relevant disease or condition, existing solutions and the perspectives of all of the different stakeholders with an interest in the need area. This helps the innovator get a sense for how difficult it may be to devise a compelling new solution, and whether stakeholders would be open to adopting an alternate approach.
Deeply understanding each need also means evaluating whether solving it would make sense from a business perspective. “While innovation isn’t necessarily about making money, translational researchers won’t be able to get the funding needed to bring a technology into patient care if it won’t sustain a viable business,” says Yock.
It’s also important to consider the cost of delivering care. Gone are the days when new medical technologies would be embraced at any price as long as they improved patient outcomes. “Now we have to think about cost and clinical benefit early on,” explains Yock. “Technologies that improve outcomes while holding costs steady – or, better yet, reducing them – are far more likely to be adopted.”
By the end of this deep dive into many need statements, the innovator has enough information to determine which needs hold the most translational promise and should be taken forward into invention. However, before the innovator begins to think about prototyping, there’s one more essential step in Yock’s process. This is developing “need criteria,” the key attributes that any solution to that need must have in order to have the greatest chance of being adopted.
This information guides the design of the technology by establishing the practical constraints within which the innovator must work. “Once you’ve taken the time to articulate what three or four things a great solution must have to meet the need, it becomes a contract – basically, you agree not pursue a concept unless it meets these criteria,” says Yock. “This is particularly helpful because inventors tend to get attached to their ideas.”
When inventors plow forward with an idea for a technology first, then search for the right scenario to apply it, Yock calls it a “ready-fire-aim” approach. “Sometimes inventors get lucky and their technologies are wonderfully successful. But in health technology and medical devices, where it can take 5 to 7 years and more than $80 million to get to market, not every inventor has the luxury of taking such a gamble,” he notes.
In Yock’s experience, innovators who fall in love with a technology, rather than letting the need dictate the design of the solution, may end up with an invention that misses the mark. As an example, he cites one of his first inventions: the Smart Needle. “Early in my medical training, I was doing a lot of blood draws,” Yock recalls. “And for some patients, it can be hard to find the vein. So I came up with this great idea to put a micro-Doppler transducer in the tip of the needle. My vision was that that you could hover the needle over the skin and listen, and that would make it easier to land the needle in the vein.”
At the time, Yock didn’t utilize the approach of developing a need statement and criteria before inventing. If he had, however, his need statement for Smart Needle might have read, “A way to localize arteries and veins to improve the speed and accuracy of needle sticks in patients requiring a blood draw.” The accompanying criteria for the invention would be that it had to be fast, be accurate, maintain sterility and use a needle that was not bigger than the current standard (so as not to increase patient discomfort).
After inventing the Smart Needle and launching it in the marketplace, Yock realized he’d missed something important. The existing standard of care – regular needles – were cheap. So cheap, in fact, that for most patients the time saved by using the Smart Needle wasn’t worth the additional cost. “The real need was in high-risk patients where seconds count, such as trauma, heart attack or in the neonatal ICU,” he says.
Yock says he missed something else important, too. “If I’d thought about it, I’d have paid attention to the fact blood draws are performed by people with varying levels of expertise, which meant that another criterion for the Smart Needle was that it had to be easy to use.” However, that hadn’t been considered, and the technology was, in fact, problematic. “Both arteries and veins have a pulse,” he explains. “Basically, we ended up doing backflips trying to train people in the nuances of the different signals.”
The result of these oversights? “We flunked the market launch,” says Yock. “We spent millions of dollars and the product didn’t get out until years later.” He notes that if he had spent more time researching before he started inventing, he would have more clearly understood the core need and could have better defined the criteria for what would constitute a great solution the first time. As a result, “I would have developed a different product, utilized a different sales and marketing strategy, and avoided two years of tepid market launch,” Yock says.
“Characterizing your need at the outset is the single most effective strategy for managing translational innovation risk,” Yock emphasizes. “It provides the basis for all subsequent technical, clinical and business strategy decisions.”
Yock harnessed what he learned through experiences such as this to formalize a new way of thinking for innovators. And this is now the essence of what he and his colleagues teach at the Stanford Byers Center for Biodesign. “We help people learn a disciplined, step-by-step process for determining what opportunities you should invest your time and energy in addressing before you begin inventing,” he summarizes. Biodesign trains hundreds of fellows, students and translational researchers in its approach each year.
While need-based innovation is not the answer for all researchers and innovators, it’s an approach worth considering when resources are scarce, time is short or the need to bring a solution into patient care is pressing – conditions that are becoming increasingly common in the health care environment. “The fundamentals of the process that we teach are spreading,” says Yock. “I hear a lot of people talking about needs now.”