Healthcare providers continue to assume increasing amounts of risk in care delivery. This has major implications, not just for providers and patients, but also vendors in IT, diagnostics, therapeutics and devices. If providers assume risk, why shouldn’t their vendors?
We’re already seeing this to some extent in emerging health IT companies. Most health IT innovation discussions revolve around driving value through population health, big data analytics and patient engagement. But many of these startups fail to any generate revenue until they prove the value of their solution through improved outcomes or reduced costs.
Life sciences companies, on the other hand, still generate all of their revenue in a fee for service (FFS)-like model. The more implants implanted, the more arteries unblocked and the more pills prescribed, the more these companies are rewarded, even if it’s the same patient receiving their third implant. The life sciences industry is still in the “sick care” business as opposed to the “health care” business.
How can life sciences companies transform from their traditional FFS business model to a new model that assumes risk and drives accountable care? How can they demonstrate value on a per patient basis? How can they re-shape their businesses to be more consistent with new care delivery models? Data.
Risk cannot be assessed without the measurement of data. It’s impossible to understand the efficacy of a treatment for a given patient if the outcome isn’t assessed in a granular, measurable way.
Today, efficacy data for treatments is typically captured at discrete points in time. Usually this happens when the patient sees the physician and the physician records a data point in the patient’s siloed electronic health record. Moreover, life sciences companies are only formally held accountable to data captured during clinical trials. After a treatment receives FDA approval and is commercialized, life sciences companies hardly understand how their treatments are performing in the wild.
THE INTERNET OF HEALTHY THINGS…WITHIN PEOPLE
The road to better measurement of product efficacy may lie with embedded sensors. These sensors would capture data 100 or even 1000 times per day, rather than weekly or monthly during physician office visits.
For pharmaceuticals, that likely means pairing sensors with pills and capsules to measure specific changes in chemistry and its effect. In some cases, these sensors could even be ingestible! Imagine after taking medication, the medication itself could measure and report against the key indicators it’s supposed to effect. Companies like Proteus Digital Health are developing some of the core IP in this area already, and have plans to license to their technology to other pharmaceutical manufacturers. In the future, cholesterol-lowering statins are paired with a sensor to measure both the target of the drug (the HMG-CoA reductase enzyme crucial to cholesterol production) and overall cholesterol level. Then this data is reported back to the care team in real time.
Google Contact Lenses monitor glucose levels in real-time. With an always-connected passive monitor, diabetic patients could learn about the peaks and troughs of their insulin throughout the day and better manage their diabetes.
In the medical device world, one could embed sensors right into the device. For example:
Many pacemakers already contain sensors to adjust electrical impulse to match heart rhythms and conditions accordingly. What if that data were tracked historically and tied to particular events (e.g. meals, activities, stress)? Patients would be able to understand how their heart is reacting to their lifestyle.
Or what if the recipient of a total knee replacement also received accelerometers within that implant to measure motion and gait? The patient’s physical therapist could use this data to adjust the rehab schedule and long-term data could be used to assess the success rate of the implant, surgeon and physical therapist. Then aggregating that data could then be fed back to the device manufacturer so they could better understand how their device affects patients.
ON STORAGE OF “CONNECTED HEALTHCARE” DATA
Once a medical device captures data, the information could be transmitted to the cloud seamlessly. Patients wouldn’t have to remember to prick their fingers and go to the doctor to see how they’re doing. Just as businesses can take a pulse on themselves through dashboards and data, soon patients will be able to track and manage their health through measurable data in real time.
As patients better understand the impact of their treatments, they’ll react, creating virtuous cycles for effective treatments and vicious cycles for ineffective treatments. Patients will rightfully demand a new implant at no cost if their implant is shown to be statistically inferior to what they otherwise should have received.
CONCLUDING THOUGHTS
Accountability has profound implications for the life sciences industry at every layer of operations. The entire product development, regulatory and commercialization strategies need to be re-thought around accountability. The most lucrative therapies will be those in which patients can clearly see and feel the benefits of the treatments.
Software is eating the world. Life sciences companies will need to embed intelligent software into their products and connect the local devices to proprietary cloud-based services. This will require massive changes in the development processes.
Regulatory processes will change. Perhaps the most important question to answer as a result of the regulatory process will evolve from, “Is the treatment safe and effective?” to “For whom is the treatment safe and effective?”
But commercialization strategies will change the most. The most successful life sciences companies won’t rely on providers as much to manage on-going success with a given therapy. Life sciences companies will employ data scientists to identify trends and patterns proactively. The data models will need to account for dozens, if not hundreds of variables. There is simply no way providers will be able to make sense of this data on a per-treatment basis so these companies will need to get more involved and develop a (even perhaps automated) direct relationship with the patient.
Healthcare is finally on a march towards accountability. And although it’s been a painful march, the march continues. The effects are slowly permeating throughout the healthcare ecosystem at every layer. It’s often said that un-innovative industries are that way because that’s what their customers demand. Hospitals have traditionally been FFS, but are transitioning to assume risk. Thus, it’s only natural that their vendors will be forced to do the same, although they may be kicking and screaming along the way.
Kyle Samani is the Founder and CEO of Pristine, a company based out of Austin, TX that’s delivering the next generation of telehealth communications through Google Glass.