Medical companies are modifying how their devices are being used to address the need for safe physical spaces between coronavirus patients and healthcare providers. Large scale medical companies, including Medtronic, ResMed, and GE Healthcare, are being prompted by the FDA to create and quickly distribute remote programming and monitoring abilities for their devices to reduce the risk of frontline worker’s exposure to COVID-19. Chief executives of these companies have indicated that the changes are here to stay. The FDA is likely to tighten restrictions on these products in the future. Therefore, companies are encouraged to get their data and information together now for post-pandemic use.
Last month, GE Healthcare partnered with Microsoft to launch a new remote monitoring software for hospitals. It provides an enterprise-wide view of patients on ventilators to help doctors identify those who could go downhill. Also last month, Medtronic partnered with Intel to launch a remote management setting for the Puritan Bennett 980. This feature allows healthcare workers to adjust the machine’s settings from a distance so that they don’t have to be in close physical spaces with infected patients.
According to Metronic’s CEO, Geoff Martha, the company worked closely with Intel to introduce these changes in only a matter of weeks as the need for safety among healthcare workers is prudent. Martha stated that while remove monitoring abilities were important before the pandemic began, they are not critical to keep both the patients and healthcare workers safe. He stated that the company is seeing hospitals talk about making remote capabilities a standard point of care. He continued by saying that if and when hospitals make these changes permanent, Medtronic is prepared to supply the marketplace with the necessary devices to accommodate the growing need.
According to Jim Hollingshead, head of ResMed’s sleep department, the company quickly launched into action to provide its customers with remote monitoring options for coronavirus patients on ventilators. The company announced earlier in the quarter that they were creating a cloud-based remote monitoring software for Lumis bilevel devices and ventilators across Europe. This technology gives healthcare workers the ability to access repository information about their patients through smartphones or computers. Healthcare workers can also change some of the device settings on the Lumis remotely by using the software. Hollingshead stated that the technology would soon be available in the United States. He stated that it has allowed doctors to take their patients out of hospital beds in countries such as Spain and Italy where intensive care units were maxed out and be monitored remotely instead, freeing up space.
Hollingshead stated that the coronavirus has caused medical device companies to look outside the box to adapt to the pandemic. He sees a place for many of these remote devices and software systems as the pandemic ends, too. Hollingshead stated that he wants the company’s cloud-based technology and remote monitoring to assist in the care and treatment of all chronic diseases. He stated that if you can monitor a patient remotely, it will make the patient experience more positive.
ResMed recently announced the debut of its MaskSelector, which is a digital tool that can be used to help fit masks remotely. It creates a personalized recommendation based on the patient’s facial measurements and sleep patterns. A healthcare worker can use MaskSelector to provide a HIPPA-compliant one-time link that is sent to the patient through text or email. The patient then needs to answer a set of questions and enter three measurements of their face into the portal. The software uses the patient's answers and recommends one of ResMed’s masks along with an alternative mask based on models and sizes available. Hollingshead stated that the online service will help doctors who need better options to remotely fit and select masks for patients during the pandemic when social distancing is crucial. However, he thinks that this technology will benefit healthcare providers long after the pandemic is over.
Similarly, Medtronic and Martha are considering M&A deals and other types of investments in remote settings for its line of products. Martha stated that the company is going to be making more investments in remote technologies for their products and business model. This may include remote monitoring of devices, remote programming of devices, remote case support, digital medical education, and more. When the promotion was announced back in November, Martha told the company’s investors that they planned on getting more aggressive with tuck-in M&A. He also noted that the company wanted to make a great amount of these deals.
Despite the negative impact that the coronavirus has had on Medtronic’s first-quarter, the company is looking to take advantage of any opportunities created in the healthcare field for permanent devices. Martha stated that the company is in position to increase its acquisition and merger activities during this uncertain time. The company is looking for deals of all sizes, according to Martha, but they prefer those in the medium billion dollar range as they have a bigger impact on the company’s growth rate.
At least for now, the FDA is widing its acceptance of devices, products, and software that accommodate remote monitoring. Ventilators are not the only products available that can be flexible with their uses to accommodate remote capabilities. In April, the FDA approved guidance and an emergency use authorization for the expansion of remote monitoring and manual control of infusion pumps. This would allow healthcare workers to care for and monitor COVID-19 patients without having to physically enter their room.
According to Randy Prebula, head of the technology and medical device department at Hogan Lovells law firm, some of these products may become a permanent part of the healthcare field after the pandemic ends. The FDA has been extending its approvals to allow for the use of medical products that were otherwise unauthorized. The agency is also approving the use of unapproved or uncleared medical products as long as they meet certain criteria, such as when there are no other options available. Prebula stated that the FDA has made it clear that when the pandemic is over, some of these approvals will be revoked due to safety reasons. He stated that he tells their clients that are involved in this area that is a perceived risk. He also recommended to them that they think about gathering data and other information that would be needed for their product to become available for use when there is no longer a public health emergency.
Prebula recommends that medical companies start to have FDA discussions now regarding these issues before the pandemic is over. He stated that companies should not wait to talk about the future of their products and how they can be transitioned into the post-pandemic era. In regards to FDA regulations after the coronavirus pandemic ends, Hollingshead agreed that it’s a good idea to collect data during the public health emergency to support product filing with the FDA when the time comes. He stated that the normal course of events would involve filing for a clearance against a predicate or doing some type of trial to provide evidence about the product. However, he thinks that the FDA may extend approvals based on real-world evidence from how the products were used during the pandemic. This is also a good time for companies to work on perfecting their products and services so that they can be adapted into the post-pandemic market.