Biodesign Alum Frees Diabetes Patients from Painful Glucose Monitoring

The FreeStyle Libre System from AbbottThe FreeStyle Libre System from Abbott.

In late 2016, the FreeStyle Libre Flash Glucose Monitoring System from Abbott was chosen by Popular Science as one of the 12 most important health innovations of the year. Joel Goldsmith, a 2006-07 Stanford Biodesign Innovation Fellow, and a founding member of the product innovation team at Abbott Diabetes Care, was the driving force behind the conception, design, development, and commercialization of the system. According to Goldsmith, the innovation process he learned at Biodesign gave him essential tools to apply to his quest to improve care for people living with diabetes.

When Goldsmith became a Biodesign Innovation Fellow, he was five years past his MBA, had been in the health care industry for almost ten years, and was working on diabetes–related products at Medtronic. “I represented a different profile for the fellowship at the time,” Goldsmith recalls. “Most of the fellows were engineers and physicians.  As a business guy, I balanced the composition of the team, so that we were not just looking at clinically unmet needs and technological solutions, but also the pathway to market and whether we had a commercially viable product.”

Joel GoldsmithJoel Goldsmith, 2006-07 Biodesign Innnovation Fellow and senior director of product innovation at Abbott Diabetes Care.

After spending his fellowship year focusing on musculoskeletal devices, in which “…the customer is the surgeon or hospital buyer,” Goldsmith was eager to return to more consumer-focused devices and solutions. “I have been a technologist at heart my entire life – balancing my interests in computing / software and life-sciences. Diabetes is a perfect fit for me because devices in this space look, feel, and operate like consumer electronics. And diabetes is a growing epidemic around the globe.”

When offered the chance to define his own role in diabetes innovation at Abbott, Goldsmith eagerly accepted. “Although I had planned to join a smaller medtech firm, Abbott was one of three companies in the world that had commercially-proven glucose sensing technology, which had the potential to eliminate the need for needle sticks to monitor blood glucose levels,” remembers Goldsmith.  “And as anyone living with diabetes knows, the single thing they hate most is that daily painful reminder that they’re living with a chronic condition.” 

Reaching back to his Biodesign training, Goldsmith began by defining the need and, in particular, the must-have criteria a sensor-based glucose monitoring solution had to achieve in order to gain adoption. The first was effectiveness. “A growing body of clinical evidence showed that there’s a correlation between testing frequency and the patient’s ability to control glucose variability. We believed that by replacing needle pricks with a sensor, we could remove a fundamental barrier to more frequent monitoring.” 

Another issue was cost, because at the time, sensing technology was very expensive.  A third criterion was user experience. “The product had to be incredibly safe, effective, and simple to use,” Goldsmith describes. “Basically, our product needed to provide many of the known benefits of sensor-based solutions with a cost and use profile that was similar to conventional blood glucose test strips. The guiding design principles were simplicity, convenience, affordability, actionable information, and discretion.”

Working from this conceptual blueprint, Goldsmith and his team dug in. As they began to brainstorm technological solutions, Goldsmith turned again to his Biodesign training. “When you’re coming up with new ideas, you have to stay open-minded. We were defining a totally new category, and there were some natural biases from people who had worked in diabetes before.  It was important to defer judgment and remain open-minded,” he recalls.

He also knew that the success of the project would depend largely on the chemistry of the team. “Team dynamics are always vital, whether you are in a fellowship, at a start-up, or at a big company,” he explains. “An endeavor like this starts and ends with the people driving the project.” Accordingly, he took the time to forge trust and build solid working relationships among his team members. “It was essential to get the team aligned around a shared sense of ownership and a common vision,” he says.

The result of his team’s shared vision is the FreeStyle Libre system, which comprises a tiny glucose sensor (0.2 inches in length, about the thickness of a hair) inserted through the skin and connected to a small, water resistant, plastic patch on the skin’s surface. The sensor remains in place for 14 days. To obtain readings, users hold a touchscreen reader device close to the sensor patch and wait for it to beep. In less than a second, users can see their real-time glucose value, a trend arrow, and a graph showing the last eight hours of their glucose history. Information displayed on the reader can be downloaded to a computer. A US version designed for use by health care professionals and available by prescription only, the Freestyle Libre Pro, was approved by the FDA in September of 2016. A US consumer version of the technology is currently under FDA review.

From concept to the first launch of the Freestyle Libre system in Europe at the end of 2014 took roughly five years. This relatively swift timeline is impressive given that the technology was completely novel, requiring extra time to navigate clinical and regulatory pathways and develop the necessary manufacturing capacity to scale the product globally. Goldsmith attributes the speed of the project to the hard work of his team and, to a certain extent, to some of the advantages large companies have over startups. “One major difference is the financial resources. It’s much harder for smaller, earlier-stage companies to support manufacturing and scale. Another advantage we had is that, as a global brand, we have recognizable presence in many countries, which gave us a head start in commercialization, credibility, and trust.”

The European launch of Freestyle Libre “blew away our projections for demand,” Goldsmith reports, forcing Abbot to rush to increase production capacity.  By mid-2016, the product had over 200,000 users in Europe. “Based on this rate of adoption, it’s clear that the Freestyle Libre is one of the most significant innovations in this category in two decades.”