The need to create safe physical distances between healthcare workers and COVID-19 patients is prompting medtechs to modify how their devices are used.
Spurred by regulatory flexibility from FDA, companies like GE Healthcare, Medtronic, and ResMed have developed and rapidly deployed remote programming and monitoring capabilities for their devices to help frontline providers reduce exposure to the deadly virus. Executives say many of the features are likely to become permanent.
GE Healthcare, partnering with Microsoft, last month introduced new remote monitoring software to provide hospitals with an enterprise-wide view of ventilated patients and to help identify those at risk of deterioration.
Working with Intel, Medtronic last month launched a remote management capability for its Puritan Bennett 980 ventilator to allow providers to adjust the breathing machine’s settings outside of intensive care units and away from patients.
Medtronic CEO Geoff Martha said the company's work with Intel brought a product to market "in a matter of weeks," speaking to investors on Thursday during a conference call.
While remote programming and remote monitoring capabilities were important before the pandemic, Martha contends these kinds of features are now critical.
“We’re seeing hospitals talk about making that standard of care. If, and I’d say when, that happens, we are well, we are the best positioned in the marketplace for that,” Martha boasted.
Jim Hollingshead, president of ResMed's sleep business, told MedTech Dive it pivoted quickly to provide customers with remote monitoring of COVID-19 patients on ventilators.
Earlier this month, ResMed launched cloud-based remote monitoring software for ventilators and Lumis bilevel devices across Europe, giving clinicians access to respiratory information via computers or smartphones. Healthcare providers can also change some Lumis device settings remotely using the technology.
“It has allowed patients to be taken out of hospital beds” in countries such as Italy and Spain where ICUs were overwhelmed, and to be remotely monitored instead, Hollingshead said, also noting use in the U.S.
Hollingshead said COVID-19 has accelerated adoption and sees a vital role for connected devices in a post-pandemic world.
“What we want to do is to use our remote monitoring and cloud-based technologies to virtualize care across all chronic diseases,” Hollingshead said. “If you can monitor a patient remotely, you can make the patient experience so much better.”
Last week, ResMed announced the availability of MaskSelector, a digital tool for remote CPAP mask fittings that creates personalized recommendations based on a patient’s sleep attributes and facial measurements.
Hollingshead argues the online service will ultimately help clinicians who need better remote capabilities to fit and select masks for patients during the current environment of social distancing, but he sees it as proving valuable long after the pandemic ends.
For its part, Martha said Medtronic is considering M&A deals and other forms of investment in remote capabilities for its products.
“We’re going to be making [more investments] in remote capabilities of our product and of our business model, quite frankly. [Whether] it’d be remote programming of devices, remote monitoring of devices, remote case support, digital/medical education and things like that," Martha told investors last week.
FDA wields EUA broadly, for now
Ventilators are not the only medtech products provided with regulatory flexibility during the public health crisis to accommodate remote capabilities.
FDA issued guidance in April and an emergency use authorization earlier this month aimed at expanding the remote monitoring and remote manual control of infusion pumps, so that providers can manage the care of COVID-19 patients without physically entering their hospital rooms.
Randy Prebula, head of the medical device and technology practice at law firm Hogan Lovells, believes that some of these products will become permanent components of the healthcare landscape after the public health emergency subsides.
FDA has been wielding its EUA authority to allow the use of otherwise unauthorized medical products, or unapproved uses of approved or cleared medical products when certain criteria are met, including those with no available alternatives. However, he warned the agency made it clear that when the emergency is over, the EUAs will be revoked.
“We tell our clients routinely in this area that irrespective of where you are in a risk profile, it’s wise to be thinking about what data you need to gather and what type of submission your product would go through if you wanted it to be available when the emergency no longer exists,” Prebula told MedTech Dive.
Prebula recommends medtechs start FDA discussions now on these issues. Companies shouldn’t wait to “lay the groundwork” for how their products will transition into the post-pandemic phase, he said.
With an eye toward regulatory OK following the COVID-19 crisis, ResMed’s Hollingshead sees the value of data collected during the pandemic to support a potential product filing with the agency.
“The normal course of events would be you would have to either file for a clearance against a predicate or you’d have to do a trial of some sort to provide evidence,” Hollingshead said. “The FDA may decide that real-world evidence from the crisis would be sufficient.”