2020 has been a highly impactful year for the medical device community as companies face new challenges from the coronavirus pandemic. With a reduction in elective surgeries, pushes to meet demand for ventilator manufacturing on significantly shorter timelines, and more rapid issuance of EUAs becoming more commonplace, in 2021 medical device companies will need to stay on top of trends moving toward remote medicine and wearables for monitoring purposes, perhaps considering M&A to do so.
2021 Medical Device Trends
TREND #1: Remote Medicine is Gaining Momentum
In the past, US physicians have observed barriers to telehealth, with major concerns tied to a history of uncertainty around reimbursement and insurance coverage. However, the 2020 coronavirus pandemic has made remote medicine more important, more relevant, and more accessible than ever, as reimbursement has become more widely accepted. Telemedicine has also become more accessible in part because of the increase in wearable med devices, allowing doctors to measure patient health parameters such as heart rate and respiration remotely. For example, Philips was granted 510(k) clearance for a biosensor to help clinicians remotely observe a patient’s heart and respiratory condition, highlighting how remote monitoring is likely to become more common in 2021.
While remote monitoring devices are helping to push telemedicine forward, using devices remotely may change the way that practices decide to make med devices purchases. For example, patients may currently use med devices, such as a holster heart monitor, away from an office temporarily but return it soon after receiving a diagnosis. Making medical devices to be used for longer term remote monitoring will likely rely on their ability to consistently access the internet and connect with the doctor’s office. This type of remote health application also increases the need for strong cybersecurity measures, especially since medical devices may now come in the form of software to improve connection and compatibility with wearables. Medtronic even recently developed a mobile app to help connect pacemakers to patients’ smartphones to help them better use health data for remote monitoring.
An increase in the popularity of telehealth could affect geriatric medicine in a particularly unique way. In the past, these patients may not have considered remote medicine to be a viable option, but as accessibility increased during the pandemic, they may be more likely to move forward with more of a 50/50 split between telehealth and in-person appointments. However, if half of check-in appointments become remote, this may affect the quantity of medical devices that need to be purchased for a practice, such as weight scales for example, in balance with devices that can be used for telemedicine. This highlights considerations for medical device companies as we move into a more remote-focused 2021.
The percentage of visits by telehealth among health centers in the U.S. dropped from a peak of 53% in late April to only 31% in August 2020.
Trends #2: EUAs are Becoming More Commonplace
Because of the coronavirus pandemic, in 2021, FDA emergency use authorizations (EUAs) are likely to continue becoming more common, especially in comparison to most companies’ practice of initially making requests for 510(k) clearance. In the past year, these EUAs have been implemented for factories and ventilators, with Resmed achieving 24 and Philips achieving 12 respiratory device modification approvals eligible for EUAs in late March 2020. EUAs have also allowed established medical device manufacturers to create rapid tests for COVID-19 preventions and invitro diagnostics. The EUAs have helped medical device companies increase availability and speed for diagnostics, while still providing a level of quality and safety. With outdated regulation policies dating back decades, the ability of EUAs to reduce hurdles for medical device manufacturers hoping to move more flexibly may become more of a foundational model coming out of the pandemic.
Due to COVID-19, in May 2020, there were 17 EUAs for ventilators, with the most (6) going to Resmed.
Contributions by Courtney Loughran