Care Management First, Research Second

As 2015 comes to a close, we are in the middle of a huge surge of healthcare innovation. As Rock Health reports, digital health venture funding has continued to grow and it is on track to surpass the $4.3B raised in 2014. 

Representing over 10% of that figure is a combination of hardware and software companies that help track health and in some cases, manage disease; companies that develop wearables and biosensing technologies raised over $89M in 2015 and in 2014, companies in a similar category, Digital Medical Devices, raised $312M (1).
 

As a result of this funding, new technologies are being developed to modernize the way health is measured and medicine is practiced. With these breakthroughs it is no surprise that stakeholders across the healthcare ecosystem are interested in putting these technologies to work. EPIC can now integrate data from a suite of wearables, there are countless weight management programs that combine data from Fitbits and Bluetooth enabled scales, and specialists are exploring the use of devices that capture condition specific metrics in conditions ranging from asthma to epilepsy. Although nascent, there is a lot of buzz around the use of these new devices and their adoption is encouraging.

As physicians accept these new care management technologies, their utility in clinical research should not be overlooked. In fact, it is this type of real world data that is often sought after as it represents a patient’s day-to-day life. Here are a few samples of devices (all FDA approved) designed for care management, but perfectly suited for the remote collection of data in a clinical study:

  • Cohero Health – designed to help manage asthma patients, their mobile spirometer is designed to remotely track over a dozen of lung function measures
     
  • VitalConnect – theHealthPatch ® MD biosensor is design to remotely capture cardiovascular measurements for use in the home, hospital, and across other care settings
     
  • iHealth – a simple to use blood pressure cuff, paired with smartphone-based instructional videos enables the easy collection of blood pressure data in the comfort of a patient’s home


Why can’t we just hand out Fitbits?

Although these new devices provide significant data collection potential, incorporating biosensors in a clinical study is not as simple as asking subjects to wear pedometers. Devices vary in the volume and granularity of data they can produce and these considerations influence both the selection and configuration of the technology. Simply counting steps or producing other summary activity measures is very different requirement than detecting a gait disturbance or movement disorder.

Data management is another important consideration.  Consumer tools lack the controls and security that are required for both data integrity and patient privacy in a health care setting.  Devices designed and validated for real time monitoring may lack the reporting capabilities expected for a clinical study. That challenge has to be balanced against the importance of working to improve the concordance of measures used in clinical trials versus clinical practice.

At Koneksa Health, we help our customers to strategically plan and use customized software solutions to ensure that new biosensor technologies are successfully deployed. We know that remote biosensors will continually improve and look forward to 2016 bringing an increase of their inclusion in clinical research. 


By Matt Cantor, VP of Business Operations at Koneksa Health