How Device Makers Can Take Healthcare "Beyond the Pill"

Print 10 February 2015
Medical Devices and Diagnostic Industry

In the aftermath of the frenzy of JPMorgan Healthcare Conference that concluded mid January in San Francisco, the life sciences industry is taking stock of the themes emerging for 2015 and beyond.

One thing is clear: Pharma’s commitment to “beyond the pill” has never been so apparent.

Each and every pharma company seems to have formed a division or a strategic team to explore new services around patient compliance, population health data and furthering connectivity for improving patient management.

Ultimately whether a drug succeeds in the market will depend on the overall need to reflect better outcomes and an end-to-end solution in patient care. Pills don’t collect data [unless they are embedded with the Proteus Digital Health chip] and this gap represents an opportunity for devices and wearables. This is the sweet spot of convergence between pharma and medtech that device entrepreneurs and executives should be striving for - to be at the center of the end-to-end patient care solution.

Here are a few ways to achieve that:

Data Sourcing from Wearables 
For pharma to go beyond the pill and provide connected health solutions, they need real world patient data. Even with the prevalence of the electronic medical record, clinical patient data is hard to capture without medical devices that monitor heart rate, respiration, blood glucose or other parameters.

A Fitbit device or quantified-self applications are useful tools but moving the needle on patient outcomes means that it is critical that clinically-meaningful or actionable data be captured.

Better Connectivity and Interoperability 

Several medical device companies today offer proprietary patient management solutions and analytics from patient data generated by their proprietary devices. For example, there are several cardiology management platforms to capture rhythm management data for enhanced cardiac patient management.

However, pharma and providers need a better way to move into an “open architecture” environment to capture all sources of data off of several different devices, regardless of manufacturer.

The device industry has been built on competitive barriers that include proprietary cord and connector configurations and closed data transfer protocols that inhibit the ability to get real-time patient data on one common system. Payers have pieces of this data in claims format; providers have pieces in the EMR; and device companies promulgate closed systems.

That needs to change. Like it or not, interoperability is coming – the Office of National Coordinator – released a draft document on Jan. 30 to further the goal of achieving nationwide health IT interoperability by 2024. FDA also plans to publish guidance on interoperability. Device companies can become leaders in the move to open up their data for better patient care.

Regulatory Savvy on How to Connect Devices to Patients 

Device manufacturers have a huge edge over any other industry or nontraditional healthcare players (including pharma, Google and Apple) in navigating the FDA approval pathways at CDRH for the wearables or general device category.

Medtronic, Abbott, GE and J&J have the shown how to achieve FDA approval for the use of data from devices, although these are proprietary platforms. This ability can be leveraged into transforming their position in the care management paradigm. We are seeing promise in cardiology and diabetes with players such as Cardiocom and Glooko. CardioCom, which Medtronic acquired in 2013, has a remote monitoring solution to monitor heart failure patients and alert physicians if symptoms worsen.

Glooko is a mobile diabetes management solution that allows patients to sync data on their blood glucose meters to their mobile device as well as input nutritional data through a companion app. Healthcare providers can see trends mapped out through dashboards and can use that to make clinical decisions about the patient’s care.

Providing Data At Physician Visits 
According to a survey on physician satisfaction conducted by the AMA, physicians yearn for more, not less, interaction with their patients and would like to have lab results and monitoring data in report form before the patient visit.

Putting the physician-patient visit as the target for wearables/devices data can create tremendous value. If data from all medical devices and wearables could be consolidated, it makes it easier for physicians to assess patients’ compliance with drug regimens. It can also enable titration of prescriptions where physicians can adjust doses until desired results are reached.

Overburdened physician practices could become more efficient if the provision of data is timely and consistent. This would allow them to spend more time and give more attention to their patients.

For example, an endocrinologist now must digest dozens of different report formats from insulin pumps, CGM and glucometers, each one proprietary. The industry can clearly improve upon this with a new paradigm.

A new healthcare marketplace demands that previous silos between pharma and devices, between payors and providers and vendors be broken down. A new era of convergence is emerging and in it, device makers can prove that they are the backbone for patient data management systems.

Let the device industry be front and center in the comprehensive solution set.

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