Redwood City, California-based Proteus Digital Health announced plans this week to open its first international digital medicine manufacturing plant in the United Kingdom along with partnerships with various arms of the UK's National Health Service (NHS) to validate its "smart pill" system. The NHS-affiliated groups that inked partnerships with Proteus this week include Eastern Academic Health Science Network (EAHSN), The Northern Health Science Alliance (NHSA) and Oxford University, Oxford University Hospitals NHS Trust and Oxford Academic Health Science Network (OAHSN).
The company, once called Proteus Biomedical, expects the new manufacturing facility to employ about 200 in the UK.
Proteus Digital Health's CEO Andrew Thompson told MobiHealthNews that he expects the partnership with NHS to lead to a wider rollout of its technology in the UK and worldwide: "A large public health system in Europe can't just buy products," Thompson said. "They issue a commission, which then validates and determines if the [healthcare] system should be buying products. Our anticipation is this is the beginning of a tendering and commissioning process for digital medicine."
Proteus' frame for digital medicine includes three key components: Measurement, engagement, and alignment.
The technology in the Proteus digital medicine platform includes unique measurement tools, like sensor-enabled pills, a peel-and-stick biometric sensor patch worn on the body, and companion smartphone apps. The patch records when a pill is ingested and also tracks other things like sleep patterns and physical activity levels. The ingestible sensor component secured FDA clearance in July 2012, while the company’s sensor-laden patch got FDA clearance in 2010.
"The information we measure is verifiably accurate and not just consumer-grade or a toy," Thompson said. "The second thing we actively build for our customers is the opportunity for our patients and their families to engage in their care... because when you swallow a drug [our system] creates information about what you swallowed and how your body is responding to it -- all of that is then going to be [displayed] on your mobile phone."
While Thompson didn't go into details about the Proteus' engagement strategy, he compared it to Amazon's personalized shopping experience. He also said that the engagement component of the Proteus strategy is still an area where the company is experimenting. He also described Proteus' commercial pilot with the UK's Lloydspharmacy as one such successful experiment -- that has run its course. Thompson said the company "learned what we had to learn" about how patients and their families interact with their platform in the wild, but, ultimately, the bigger opportunity for scaling intelligent medicine will be through massive rollouts in healthcare systems -- like, potentially, the NHS.
"The third value proposition that we assess with our partners is alignment," Thompson said. "This is the idea that we are going to build a business model that is uniquely enabled by digital products. What digital does is it moves the world from statistics and probability, which is partly why healthcare is so expensive, to a world based on calculus and certainty, which will bring enormous efficiency gains. To make that that real for you: Think about what Yahoo did by putting advertising on the internet, which is nice. They lacked efficiency though because advertisers were paying for page views. Then Google came along and said 'Advertisers don't want to pay for page views, they want to pay for customers.' We should get paid when somebody buys something and the price of the service is tied to the value of the transaction not the price of showing a page view. That's a calculus-based business, not a statistical business."
Thompson said Proteus plans to bring a similar mindset to healthcare: "What we are saying to healthcare systems is: 'We aren't going to sell you drugs. We aren't going to sell you devices. We are selling you the outcome you want to buy, and that we can measure with our system. And if we don't deliver it, you don't pay for it.'"
Thompson was careful when describing his companies ongoing partnerships with pharmaceutical companies. While the company has been known to work with companies like Novartis and Otsuka in the past, he didn't name current partners other than to say: "We have been particularly pleased with our progress with our pharma partners, particularly in the context of our work with the FDA. What you should understand here, is that we have received clearance for our medical devices in 2012, and reached agreements about how fully integrated digital drugs would be reviewed and then cleared and approved by the [FDA]. Those pathways are unfolding in ways that are very appropriate and very good for our industry."
MobiHealthNews has noticed a relatively steady stream of FDA 510(k) clearances for Proteus Digital Health's platform over the years, and Thompson explained that the clearances are steady because the company is iterating like a technology company, not like a medical device company.
"Different parts of our platform are continuing to iterate," Thompson said. "Some of the most important work we have done with these agencies is help them understand what technology cycles look like and how quickly they iterate... One of the unique aspects of our company is that we are creating medical grade, FDA-cleared products, with all of the quality standards that, that implies but within the framework of a consumer product roadmap. The technology world moves quickly -- batteries get smaller, radios get more power, chips become more powerful and have more functionality."
So, why the UK? One reason: Thompson said that in the past several years the UK has seen the shuttering of more than 20 pharmaceutical manufacturing facilities because pharma is in a period of significant decline.
"What I am doing here is taking advantage of massive investments in manufacturing and other infrastructure that will enable me to significantly accelerate and deliver digital medicines," Thompson said. While the company already has the manufacturing capability to punch out thousands of sensor-enabled, ingestible tablets an hours, he said they are "looking to create a facility in the UK that will probably be able to create 10 billion units a year."