The CONTOUR brand of blood glucose meters and test strips has long been known for quality, reliability, and accuracy. For years, the business behind the CONTOUR portfolio was part of Bayer Healthcare. Acquired by Panasonic Healthcare Holdings in January of 2016, the business was reborn as Ascensia Diabetes Care, operating as a stand-alone company focused exclusively on diabetes care.
As the first new product to be submitted for FDA review since the acquisition, Ascensia received FDA clearance for its CONTOUR NEXT ONE blood glucose monitoring system in November 2016 and has recently launched it in the United States. The system features the new Bluetooth-enabled CONTOUR NEXT ONE meter and the CONTOUR DIABETES app for mobile devices. The CONTOUR NEXT ONE system recently received CE Mark approval in Europe and is currently available in most European countries.
The app links via Bluetooth connectivity to the CONTOUR NEXT ONE meter to gather blood glucose measurements and analyzes the data for tracking and detection of patterns. Among other capabilities, users can also review value graphs, add commentary, and attach photos.
“All of the features are intended to enable people with diabetes to learn more about their condition, which can help them make the appropriate management decisions,” Rick Stadterman, Global Head of R&D for Ascensia, says. “If data is presented in simple, practical, and meaningful ways, this information can engage and empower users to take action to impact their health in positive ways.”
Stadterman has led the R&D department at Ascensia that has developed the app and the new meter. Beyond the development of a new, highly accurate meter and an app with a user-friendly experience, the program has included various aspects in preparation for the commercialization of the product. This has included translating the content and packaging into dozens of languages, coordinating regulatory approval processes that vary widely between jurisdictions, and building a customer-facing organization.
“If data is presented in simple, practical, and meaningful ways, this information can engage and empower users to take action to impact their health in positive ways.”
Other challenges for the development team have included navigating variations in regulations for data privacy and data protection, especially involving protected health information. This is complicated by users’ ability to create cloud accounts to store their data. With the EU’s Safe Harbor provision (which permitted US companies to store and access data from customers residing in EU countries) being struck down in October 2015, there is also some uncertainty about relying on the new Privacy Shield agreement as a replacement. As a result, processes and consent forms must be tailored to meet different privacy requirements across multiple countries.
“Data privacy requirements across countries differ considerably. While in the United States users are accustomed to checking a box that indicates they agree with a company’s data use and privacy policies, depending on the country and a user’s age, consent in some areas might need to be obtained via e-mail. Processes around the world aren’t always as simple as checking a box and pressing ‘OK,’” Stadterman explains.
As apps in healthcare and cloud access for patients have become commonplace, it is important to understand how to meet the demands of increasingly tech-savvy consumers. “We’re not the first diabetes management app in the market, but as one of the leading meter providers worldwide, we have taken our time to ensure that we provide an exceptional and intuitive user-experience that seamlessly links to a reliable, dependable meter,” Stadterman says. “That means consumers can expect a product that meets not just regulatory requirements, but targets their expectations as well. In the future, we also hope to be able to integrate information from a variety of partners that will enable us to help patients improve the quality of their lives to support the best possible outcomes.”
Ascensia’s new autonomy as a stand-alone company will also allow it to address opportunities to innovate with more flexibility and agility than in the past. “Now we can focus solely on diabetes and invest in development programs that meet the needs of the patients we serve,” Stadterman explains. “When we see an opportunity, we have the ability to move forward immediately. We also have the opportunity to work more closely with the R&D teams at our partners at Panasonic Healthcare, with a combined R&D team of nearly eight hundred engineers.”
In addition to the CONTOUR DIABETES app, Ascensia has a number of other new products in development that are planned to launch around the world. They all provide an exciting start to an entirely new chapter for the company’s business.