Defining a $77 billion food safety problem

A ‘Goldilocks’ problem statement is the first step toward designing a successful prize competition.

Problem

The U.S. Food and Drug Administration (FDA) Office of Foods and Veterinary Medicine (OFVM) sought to improve food safety through an incentive prize competition produced by Luminary Labs in 2014. While the American food supply is among the safest in the world, the Centers for Disease Control and Prevention (CDC) estimates that one in six Americans are sickened by foodborne illness annually. The overall negative economic impact of foodborne illness in the United States, including medical costs, quality-of-life losses, lost productivity, and lost life expectancy, is estimated to be as much as $77 billion per year.

Context

In an era in which people are seeking the ‘iPhone of healthcare’ or the ‘Uber for homelessness,’ it is easy to gloss over the problem at hand. Rather than putting the spotlight on prescriptive solutions or novel technologies, successful prize competitions commence with a clear and concise definition of the problem to be solved, as well as the piece or pieces of the problem that they aim to address through an open innovation mechanism. Defining a problem too broadly can make it difficult to obtain actionable results. Too narrow a definition can limit innovation within a prescriptive range of approaches. An ideal problem sits somewhere in the middle, where it has the opportunity to stimulate and expand a market.

In our early conversations, the FDA noted that it was already connecting with food safety innovators on a regular basis. The purpose of the competition, therefore, was to identify new approaches beyond the known solver base. We set out to design a ‘Goldilocks’ call to action — one that wasn’t so broad that it would elicit intangible solutions, and yet not so narrow that it would only appeal to insiders. Striking a balance would require us to be clear on which part of the food safety problem to address. Was there a preferred pathogen? In which produce categories would we focus? Where in the food production system were we most interested? Was there a trade-off regarding acceptable thresholds, such as speed or accuracy? And would we consider novel technology — such as spectroscopy or metagenomics — a bonus or a requirement?

Solution

Early in the process, we settled on the pathogen Salmonella and the speed at which it can be detected. Salmonella causes over 1 million illnesses in the United States every year, with about 23,000 hospitalizations and 450 deaths, and is particularly hard to detect. According to David G. White, PhD, FDA OFVM’s chief science officer and research director:

“Detecting low levels of Salmonella in produce can be like finding a needle in a haystack: difficult, expensive and time-consuming. Even a simple tomato might have up to a billion surface bacteria that do not cause harm to humans. Quickly detecting just the few types of bacteria that do cause harm, like Salmonella, is a daunting task.”

To further narrow the problem, we focused on produce — which is responsible for nearly half of foodborne illnesses and almost a quarter of foodborne-related deaths — and specifically, leafy greens, with an emphasis on sample preparation and/or enrichment in the testing process. We now had a problem to solve and a call to action.

At this point, we took a step back and asked the FDA what would constitute a ‘big win.’ They noted that their internal teams were either tracking or researching a number of revolutionary approaches such as metagenomics and quantum detection, as well as new applications of existing technologies, such as spectroscopy. As a thought exercise, we considered a more specific call to action that included this technological focus: “to improve the speed of Salmonella detection in leafy greens through spectroscopy.” Ultimately, however, we determined that narrowing the areas of technology would be too prescriptive and would reduce our ability to tap into a broad and diverse solver base. As a result, the FDA Food Safety Challenge criteria noted that FDA was most interested in solutions that made use of revolutionary approaches or new approaches for existing technologies, but did not make this a formal requirement.

Results

The Purdue University team that was named grand prize winner developed more advanced prototypes in partnership with other investigators and the challenge runner-up; collectively, they continued to work with FDA scientists to create an instrument for field testing.

This case study is adapted from Luminary Labs CEO Sara Holoubek’s chapter in “Perspectives on Impact: Leading Voices On Making Systemic Change in the Twenty-First Century.” Learn more about open innovation outcomes: view highlights from our 2018 survey of prize recipients.