I have been writing about digital health technologies for a while and it is rare for me to mention individual companies or products in my posts. However, the Proteus Digital Health (formerly Proteus Biomedical) ingestible biosensor has ramifications that transcend earnings for the company or a few patents.
It was recently approved by the FDA after having been approved a while ago by the CE of the EU. In summary, this technology is a physiologic sensor incorporated into a medication pill. Stomach juices activate an energy source which is similar to a potato starch battery. The sensor then sends signals to a skin patch electrode which then wirelessly transmits information such as vital signs, body position, and verification of medication ingestion. The information is obtainable to designated persons (caregiver, clinician) via an app. It is, essentially, the quintessential digital technology.
1. This technology is the ultimate medication adherence tool. Medication adherence has been a target of digital health technology development for many years, as it is estimated that up to $750 is spent on care and other expenses on non-adherent patients. From text messaging to digital pill bottle caps, technologies have been trying to come as close to an eyewitness of a person ingesting a medication as possible. This technology leaves no doubt about adherence.
2. This technology represents the crossroads of sensors, wireless, remote monitoring, and mobile. Physiologic sensors, wireless technologies, and mobile apps are the focus of dramatic developments recently. The Proteus ingestible sensor combines all of these features, demonstrating unique elegance and ingenuity.
3. This technology is clinical enough to put it on the radar for physicians. Most medical apps and digital technologies have not been taken seriously by clinicians because they are too simplistic and unproven. The ingestible sensor appeals to the scientific mind as well as addressing real clinical problems. If it is shown to decrease hospital readmissions, perhaps improve workflow, improve outcomes, and have no long-term adverse effects, it will no doubt be welcomed by healthcare providers worldwide.
4. This technology provides a firm foundation for development of offshoot technologies. Like the development of NASA technologies and the ’Star Wars’ initiative in the 80’s, this is a technology which will spawn ideas and developments in a few diverse directions resulting in the development of perhaps unrelated products and services. Examining all the ’moving parts’ of this technology offers to me that kind of exciting promise.
5. It is a technology with market appeal to clinicians first, consumers second. Most mobile apps to date have been targeted at consumers for various reasons. They do not require regulatory approval, they can be mass marketed, and they are not currently beholden to any standards. This technology has gone through vigorous approval processes by multiple agencies, addresses real clinical concerns, and may have a major impact on patient outcomes. So far only a few technologies have gone through this process. These are the technologies which will, by virtue of their potential impact on patients, be the ones to break barriers of adoption of digital health technologies.
One might see why a champion of digital health technologies like me is excited about this product. I look forward to many other digital health developments (Tricorder X Prize contestants, personalized genomic medicine, and others) having the same impact on the healthcare system. It should be noted that I have no financial interest or relationship with Proteus Digital Health.
By Dr. David Scher
David Lee Scher, MD is director at DLS HEALTHCARE CONSULTING, LLC, which concentrates in mobile health technology clinical research design and implementation. A former cardiac electrophysiologist, clinical trial primary investigator, human subject research committee chairman, Medicare advisory committee member, Dr. Scher was also a medical device industry key opinion leader for 20 years.Visit website | More posts by Author
.@vmcombs: Where did the mock-up of the iPhone app come from in your story? Really looking forward to these apps! http://t.co/56Wfyfzf #hcsm
@klickhealth I believe from the company; I will check.
@vmcombs Thanks for checking - other awesome part of story was the sensor powered by stomach acids! http://t.co/UeS0fZ6O #mhealth
What are we going to do with the data? Already I'm following several very interesting discussions on the Society for Participatory Medicine discussion boards where patients are demanding access to the raw data that embedded devices from Medtronics and other companies produce and are getting significant pushback. On another front we have few physicians who want patient generated data in their EHRs even though most patients expect the data from automated measuring devices like Withing's Wi-Fi scale and BP cuffs will be in the record. Are physician's going to spend the money to integrate this type of data into their systems or find the time to even monitor it when they haven't shown an interest in the data that's already out there that could have a significant impact on care today?
Who's going to pay for this? Already the majority of my patients are choosing high deductible plans and asking me to convert brand name to generics so they can afford their medications. They also do modify the administration of prescriptions according to their monthly finances. With this type of technology that "freedom" will be lost and more cost added to care. I could see pharma picking up the tab as it would probably improve adherence and increase utilization ... maybe.
But perhaps a more likely user of this technology might be those companies who already have devices and apps to measure activity (FitBit, Withings, Pedometer, LoseIt, MyFitnessPal.com, etc....). This technology provides even a better way to provide feedback to the healthy user who wants to improve performance.
Finally, I think this type of technology would explode in amateur and professional sports where real-time monitoring is crucial.
But medicine? I'm not convinced Medicine has worked it's way out of the 20th century yet in order to leverage these tools.
@dvoran