Insulet (Nasdaq:PODD) had to clear a series of hurdles to bring the Omnipod 5 automated insulin delivery system to those who need it.
Speaking at DeviceTalks West in Santa Clara, California on Oct. 18, Mark Field, Insulet’s CTO, explained the trials and tribulations. He presented in a session titled “Overcoming Challenges to Develop the Omnipod 5 Automated Insulin Delivery System.”
“This was one of the most important highlights of my career and also one of the most challenging, delivering Omnipod 5,” Field said. “It’s probably one of the hardest jobs I’ve done in software to date. In that process, we learned a lot.”
The Omnipod 5 system became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January 2022. Insulet fully launched Omnipod 5 in the U.S. in August 2022, then began its launch in the UK in June of this year. It received CE mark approval for children aged two and up in September 2022 and Insulet commenced a launch in Germany in August of this year.
“Omnipod 5 is now the No. 1-most prescribed insulin pump in the U.S.,” Field said. “A product we released just a year ago completely changed the trajectory of hundreds of thousands of peoples’ lives. It makes me incredibly proud to be a part of that.”
About the Insulet Omnipod 5 system
Omnipod 5 is a tubeless pod enhanced with SmartAdjust technology that integrates with the Dexcom 6 continuous glucose monitor (CGM). The company is also working on integrating with the Abbott FreeStyle Libre 2 to reach even more CGM users.
It features the Omnipod 5 mobile app with an integrated SmartBolus calculator, too. Users can download the app onto a compatible smartphone or use the Omnipod 5 controller, provided free with the first prescription.
Omnipod 5 includes the tubeless pod, enhanced by SmartAdjust technology and the handheld controller with the SmartBolus capabilities. With CGM data, SmartAdjust predicts where glucose will be 60 minutes into the future. Omnipod 5 then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target.
The system — interoperable with G6 for automated insulin delivery — protects against high and low glucose levels.
“It’s the first version,” Field said. “We can expect this to keep getting better and smarter, to keep delivering outstanding results to our customers.”
Starting out, COVID-19 and Mexico
Field joined Insulet less than a year before the COVID-19 pandemic turned the world on its head. Serving as CTO at Thermo Fisher, he joined Eric Benjamin, now chief product & consumer experience officer (CPXO), for lunch to talk Insulet. (Benjamin spoke about Insulet’s journey at DeviceTalks Boston in 2022.)
Drawn in by Benjamin’s description of Insulet’s mission, Field joined in May 2019. Right away, part of his task was to find more engineers as the company moved forward in Omnipod 5’s development.
“We needed hundreds of engineers,” Field said. “The technical complexity of the system — connecting to another glucose monitor, a person’s mobile phone to be managed through the cloud — was huge. The amount of work that was needed was massive.”
Located in San Diego at the time, Field said the company struggled to find those hundreds of engineers. So, it looked to Mexico. Just 30 minutes away in Tijuana, Insulet opened a Center of Excellence and tapped into a new market of talent. While building the team and continuing to add in San Diego, the company had to open another office in Sorrento Valley, a San Diego neighborhood.
“We thought, ‘wow, what can possibly go wrong?'” Field said. “[COVID-19] came as a huge blow in early 2020.”
Fortunately, Field said, through the operations established just prior to the onset of the pandemic, Insulet managed to stay the course with Omnipod 5.
“We had a system, we could see who’s assigned what on the software side and just pivoted,” Field said. “What was built for Mexico, these sort of operating mechanisms, suddenly became the standard operating mechanism for the whole company. We just pivoted.”
Despite the FDA’s focus on COVID-related products, Insulet managed to wade through the regulatory process, too.
Approval came, then a limited release followed and the full release came within nine months of authorization.
“Oh my goodness,” Field said. “Our wildest expectations were exceeded 10-fold. Omnipod 5 was such a massive hit.”
Field said that, once Insulet made Omnipod 5 available, it began onboarding thousands of customers a week. He said the pent-up demand for the product had customers waiting, stretching the company’s cloud infrastructure to the limit.
“We started noticing processing times going from seconds to tens of seconds to minutes to hours,” Field explained. “It was scary. It was all hands on deck. We needed to actually improve our infrastructure. … We were not prepared for this.”
Partnerships across industries saved the day in this regard, Field said. Cloud experts at Wipro came to Insulet’s aid to help build out an architecture set to go live “in the next few months.” Wipro offers technology and IT consulting services for addressing complex digital transformation needs.
Within medtech, Insulet also maintains strong relations with Dexcom and Abbott, two leaders in the CGM space. Omnipod 5 launched as an integrated system with the Dexcom G6 and, as previously mentioned, progress is being made on FreeStyle Libre 2 integration. The company continues work on integrating Dexcom’s next-generation G7 CGM as well.
“We’re working on integrating with G7 and Libre and have submitted our 510(k) for iOS and I’m very confident that will get approved soon,” Field said. “In the meantime, our team will also have to work on the next generation of insulin delivery algorithms on Omnipod 5.”
Field lauded the Omnipod 5’s insights and capabilities for in silico testing, too. The company can now take real-world data to see what would have happened with a different algorithm, accelerating R&D further.
“It’s an exciting time for medtech with all the technology at our disposal,” Field said. “All of this, building the team, delivering a best-in-class product, feeling part of a winning team, just has an awesome feeling. What’s even more profound is when our customers tell us how their experiences have changed their lives.
“This helps us make Omnipod 5 even better, delivering on our mission to improve the lives of people with diabetes.”