Connected Medical Devices: Bridging the Gap (A Recap)

According to Michael Sullivan, BCC Research senior editor and presenter at the event, a key takeaway for this market is that everything in healthcare that can be will eventually be connected.

 

“Connectivity is the new method to improve care at a lower cost, and it also is the new method and platform for analytics,” Sullivan said. “Analytics is the next wave of value—I believe—for a lot of segments in healthcare.” 

 

• Nearly everything that can be connected will be in healthcare
• Regulatory guidelines are a mixed bag, both helping and slowing growth
• The need for analytics will drive interoperability across devices and platforms
• Security concerns will continue to slow market momentum 

While the market is growing at a fairly robust compound annual growth rate (CAGR) of 10%, security concerns and inhibitors from government regulation, especially in the U.S., is limiting this growth relative to other internet and connectivity trends.

 

“We have positive signs that the FDA recognizes connectivity and including it in their nomenclature for dealing with medical devices, but the control and stringent guidelines for what a medical device has to prove before going to the market is still there,” Sullivan said. Further complicating the market are major security concerns and a lack of ability to fully address these concerns in the connectivity community.

 

Some of the greatest opportunities and also greatest challenges are in bridging the gap between consumer self-service, such as fitness wearables, and medically necessary devices.

 

Due to the different functions of these devices, each is subject to different regulatory standards with medically necessary devices being highly regulated for accountability, control and accuracy. In contrast, consumer self-service devices are easy to use, but a lack of regulatory standards and methods to ensure accountability and accuracy limit their widespread use in the medical community for the diagnosis and treatment of disease. Because of this lack of regulation, Sullivan characterizes the latter market as the “Wild West” because virtually any company can enter the market with any product at any time.

 

“Not many companies are interested in working the gap—something that appeals to consumers but works within the regulatory environment,” Sullivan said.

 

In the market for devices that are medical necessities, Robert G. Hunter, BCC Research Senior Editor, Life Sciences, provided the case example of remote patient glucose monitoring. With the prevalence of diabetes growing each year, there are several opportunities to integrate connected devices in diabetes treatment with remote patient monitoring.

 

In addition to CGM devices, there is a growing market opportunity for diabetes management software. Diabetes management includes the data presentation and the interface with the devices—pulling data from the meters, pumps, pens and logbooks. Management software allows users to share their data with multiple entities, including the care team.

 

• Amidst 1000s of health-related apps (general health, exercise, wellness and diet)
• Numerous players (diabetes device companies, start-ups, open-source services, app developers)
• Reality that healthcare apps are often used sporadically or not at all after a period of time.
• Healthcare apps that get the most usage lean toward having a clinical component 

“There are thousands of health-related apps, but the reality is that people use them a little but then not so much,” said Hunter. “In order to drive behavior, we are finding through software layers that it’s about getting the clinical component. It’s about bridging between health and wellness and the clinical part.”