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WEARABLE REMOTE MONITORING TECHNOLOGY – MOVING FROM INNOVATION TO ADOPTION According to a Frost and Sullivan report, the number of patients who are remotely monitored will grow

annually by 48.9% and reach more than 36 million in the next five years. In addition, AARP Health

Innovations@50+ ranks “vital sign monitoring” in its top three markets for health innovation technology.

Given these statistics, it is not surprising that there is both innovation and investment in remote

monitoring technologies to track multiple parameters such as respiration rate, pulse, hydration,

temperature or blood pressure, while incorporating patient-friendly features, such as small size, passive

measurement and unobtrusive design.

However, despite the interest, wearable remote monitoring devices have failed to gain traction among

healthcare providers in a significant way. This is partly because they struggle to deliver on important

features, like accurate measurement of key parameters, ease of use, clinical utility or even wearability.

But also they have yet to figure out how to integrate the data they capture into the healthcare

continuum in a meaningful and useful way. And finally, they are unable to conclusively prove significant

value to payers, which limits their adoption.

Certainly, wearability in an aging or ill population is an issue. Devices which adhere to or rub against the

skin can create skin degradation, particularly in a patient who has poor blood and oxygen flow, which

are common characteristics of the elderly and chronically ill. Small patches and wrist bands can be

difficult to don and doff, and are easily lost or misplaced, by patients with poor eyesight, memory and

dexterity. Dementia patients can potentially tear off adhesive patches or wrist worn devices.

In addition, parameter measurements must be accurate if they are to be used by a health care

professional. Newer technologies, in their rush to be small, unobtrusive, multi-parameter and high tech,

struggle to capture clinically accurate data in a patient who may or may not be obese, and who could be

moving or sweating or even turning frequently in a bed.

The data captured must also be clinically useful, which means it needs to be stored, analyzed and served

up to a provider in a way that he/she can use to impact clinical outcomes. For example, a basic scale,

equipped with a Bluetooth device which allows it to communicate to a home health nurse, has been

shown to capture early fluid retention in CHF patients, and allow simple interventions that prevent

exacerbation. It remains a challenge, however, to communicate vitals and metabolic data to busy

primary care practices with varied technology infrastructures in a way that they find accessible and

useful.

Perhaps most importantly, the business model for these technologies remains unclear. What is the

value of these technologies and how best to demonstrate that, and to whom? The costs of these

technologies will be weighed against the savings they create in the care continuum, and unless they can

prove economic as well as clinical value, they will not be reimbursed.

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For these reasons, medical device and diagnostic manufacturers should be wary about designing to

endpoints that are technologically intriguing but have little medical or economic value. Rather, in early

stage development of wearable remote monitoring technology for clinical use, they should be guided by

the 5 “P”s, Purpose, Patient, Parameters, Providers and Payers.

5P Analysis

PURPOSE – What are the goals for the device and what are the key unmet needs in the

market/disease/patient population that it seeks to address? Is it to track specific parameters so that

they can be analyzed by the patient or the provider? Is it to track compliance with medication or

activities? Is it to alert the patient or provider to specific changes so that interventions can be

undertaken to prevent escalation of an event? Should it track location or position? A true

understanding of the most useful purpose of a device prevents both under and over-design errors,

and results in an optimal value proposition designed to meet the needs of the market.

PATIENT – What are the patient’s capabilities and limitations? Is the patient a child or adult? Is it likely

that they will have vision issues, or mobility constraints or small motor limitations? Will discretion be

important? Will the patient be sedentary or active? It is critical that the design fit the patient, their

capabilities and their lifestyle to optimize both compliance and usability. Makers of software

designed for the elderly, for instance, recognize that the ability to double click with the index finger

diminishes over time, and therefore program alternative selection methods.

PARAMETERS – What is being monitored and what level of frequency and accuracy is required for

optimal health and economic utility? Does the parameter need to be measured periodically or

continually? Is the tracking of concurrent events e.g., activity level or meals, required? The

parameters that are critical to include must be very well understood upfront so that measurements

and data capture support the optimal purpose of the device.

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PROVIDERS – Provider input is essential for clinical adoption, and often overlooked. An understanding

of how the data can best fit within the provider’s practice, level of training, treatment paradigm and

technology resources is key to designing both the device and the surrounding analytics and service.

First, it is crucial that the data, and particularly the analytics, meet the providers’ criteria for

optimum clinical utility. Do they want a longitudinal analysis at regular intervals, or do they only

want it for use during a patient visit? Or do they just want an alert so that they can intervene before

a patient’s condition worsens? Is the data for use by the physician, or by the nursing staff, or both?

Should it feed into an EMR? All of these are important decisions that can make or break a device’s

adoption by providers. And finally, manufacturers of devices need to understand the varied

technological infrastructures of the provider landscape so that they pre-resolve issues around

compatibility and interoperability, and comply with both accessibility as well as privacy

requirements.

PAYERS – Wearable remote monitoring devices must demonstrate the value of their technology to

payers. This means developing the business case by proving the ability to reduce specific hard costs

like hospitalizations, ER visits, medications and other interventions, and then setting the price to

optimize adoption. The payment hurdle is significant. Traditional payers have shown little interest in

reimbursing wearable remote monitoring; CMS for instance slashed reimbursement by over 30% for

remote cardiac monitoring in 2009 and has only recently allowed it to creep upward again. Further,

in post-acute settings like skilled nursing and home health, where remote monitoring has the

potential to supplement over-stretched labor, margins have fallen precipitously and any additional

cost is severely scrutinized. Without compelling health economic evidence, traditional payers as well

as evolving payer-provider organizations will continue to resist funding these technologies.

In the end, wearable remote monitoring devices will not succeed because they are novel, small, multi-

parameter, Bluetooth or non-invasive. They will only gain adoption and revenue if they are based on a

strong clinical and economic value proposition derived from a deep understanding of the optimal

purpose, the patient, the parameter(s) requiring measurement, the providers and the likely payer.

Catherine Ellis Anne Smart

Director Director

212 901 6928 212 901 694

catherine.ellis@navigant.com anne.smart@navigant.com

navigant.com/LifeSciences