IBM announced, during the International Consumer Electronics Show (CES) in Las Vegas, separate agreements with medical device giant Medtronic and sports apparel maker Under Armour to utilize IBM Watson's machine learning algorithms to power predictive diabetes apps and fitness apps.
Medtronic and IBM are teaming up on a predictive diabetes management solution, whereby Medtronic's insulin pumps using Watson artificial intelligence (AI) could warn patients of abnormally low blood sugar levels up to three hours in advance. The objective is for diabetics to achieve better glycemic control and outcomes.
"We’re building Medtronic apps that will apply cognitive computing to data from Medtronic devices (glucose monitors and insulin pumps) and we expect to include other information sources—such as GPS, wearable activity trackers, and calendar details," writes Annette Brüls, president, Global Diabetes Service & Solutions, Medtronic, in a blog post. "The solutions we’re co-developing with IBM may one day enable Medtronic to provide real-time insights and coaching to help people understand the impact of daily activities on their diabetes and make adjustments as needed."
Brüls explains that Medtronic and IBM have collaborated on this project since April, and have collated 600 anonymous patient cases and applied cognitive analytics to real-time streaming data from diabetes devices to test how Watson could predict hypoglycemic events before the patient becomes symptomatic.
At a demonstration at CES, Medtronic CEO Omar Ishrak and IBM CEO Ginni Rometty showed a prototype app that "gathers a patient’s readings from Medtronic insulin pumps and glucose monitors, and combines them with information taken from the individual’s activity trackers and diet. The system uses pattern recognition gleaned through IBM’s Watson to provide feedback on how a patient can manage their diabetes," reports Bloomberg.
Rometty says the "breakthrough" diabetes management app will be launched in the summer, pending regulatory review, according to the report.
In her blog post, Brüls points out that Medtronic is shifting from solely a medical device company to becoming a healthcare solutions company, one that will also focus on clinical outcomes through data management, care coordination, and coaching, rather than just selling devices. The partnership with IBM will help Medtronic transform.
"It’s essential for Medtronic to make this transition because the world’s healthcare systems are shifting from payment for services to payment for outcomes," writes Brüls. "Because of that shift, we believe we have an imperative to make use of data that could help people with diabetes use our devices in the most effective way to manage their disease."
For IBM, the Medtronic deal adds to its growing list of customers in the healthcare field who want to utilize the analytical capabilities of its vaunted Watson platform, in order to glean new insights to diseases and their treatments or cures. Of note, Bloomberg says that the company has created two new business units to market Watson’s services to the healthcare and the Internet of Things (IoT) industries, to help reverse a 14-quarter revenue slide, and to act as a lynchpin of IBM’s long-term growth strategy.
“As the first system of the cognitive era, Watson infuses a kind of thinking ability into digital applications, products and systems,” said John Kelly, senior VP, IBM Research and Solutions Portfolio, in a separate announcement at CES of IBM's new partnership with Under Armour. “We have already seen this capability begin to transform industries as diverse as healthcare, insurance and retail."
Under their deal, Under Armour's UA Record app with a "Cognitive Coaching System" powered by IBM Watson, will collect and analyze fitness, activity, sleep, and nutrition data from smartphones, wristbands and fitness trackers. Watson will even analyze current weather reports and environmental factors to deliver relevant training advice. UA Record will provide users with timely, evidence-based health lifestyles coaching, and the ability to share data to friends through a custom social network.
"This partnership will allow us to provide value back to the consumer in an unprecedented way, as we integrate IBM Watson’s machine learning technology with the robust data from Under Armour’s Connected Fitness community – the world’s largest digital health and fitness community of more than 160 million members," said John Kelly, senior VP, IBM Research and Solutions Portfolio, in a statement.
FDA's regulation of mobile medical apps is constantly evolving, and app developers have to follow different guidance covering many facets of design and development. Generally, if a mobile medical app is subject to FDA oversight, it will pass through a 510(k) application, unless it is deemed a Class I device, according to Keith A. Barritt, a principal in the Washington, D.C., office of Fish & Richardson, in an MDO guest column.
"Beyond the basic elements of any 510(k) application, mobile medical app developers should consult several specific FDA guidance documents," he writes, including the cybersecurity guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.