Behold, convergence.
A startup backed by the likes of Medtronic and Novartis has combined sensors with mobile technology, pharmaceuticals and medical devices to develop what’s being hyped as the U.S.’s first smart pill system.
Just cleared by the U.S. Food and Drug Administration, Proteus Digital Health‘s tiny ingestible sensor is used with a companion wearable patch and mobile app to improve medication adherence.
The sensor, which the company says is about 1 square millimeter and made out of silicon and ingredients found in food, can be embedded in a pill and swallowed. Fluids in the stomach act as a power source to activate the sensor, which communicates a signal to the wearable patch that marks the timing of ingestion. The battery-operated, wearable patch can also measure heart rate, temperature and activity but must be changed every seven days.
Data collected by the sensors is relayed to a mobile phone application where it can be accessed by caregivers and clinicians. The system was tested in many different therapeutic areas including tuberculosis, mental health, heart failure, hypertension and diabetes, CEO Andrew Thompson told Nature earlier this year.
Known formerly as the Raisin System, the technology took four years of work with the FDA to usher through the de novo regulatory pathway. It’s had the CE Mark since 2010, and the company rolled out its first application in Europe with LloydsPharmacy earlier this year.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
As for upcoming plans in the U.S., a company rep couldn’t be reached for comment, but Proteus’ website indicates that patients taking medication for diabetes, central nervous system disorders and immune suppression after organ transplant are potential targets for the system.
Some heavy hitters have pumped millions of dollars of venture capital into Proteus over the years. Novartis has invested $24 million, and earlier this year, Proteus raised $17.5 million. Funding has also come from the Carlyle Group, Essex Woodlands, Kaiser Permanente, Medtronic and St. Jude Medical.
The commonly cited prescription noncompliance rate in the U.S. is around 50 percent, but there’s no telling how much of that could be addressed by Proteus’ system. Patients’ personal attributes probably have the greatest effect on adherence, but other factors including out-of-pocket costs for medication, lack of coordinated care and side effects of medications, which the technology doesn’t address, likely come into play.
Adherence is a hot market for new products, with apps like PillJogger and HealthPrize, and products like RememBottle. Will a tracking system like this that doesn’t require patients to input data work better than others that do? Or could this be a case of using technology for technology’s sake?
