As proven by the ongoing COVID-19 pandemic, Medical Devices, and other medical technologies continue to serve essential roles in our healthcare system. Face masks to limit the spread of the virus, in vitro diagnostics tests to identify infected persons, and ventilators to support critically ill patients are examples of our reliance on these gadgets. In addition, the pandemic accelerated the emergence of digital health technologies, such as Software as a Medical Device, at-home diagnostics, and numerous wearables that allow for remote data gathering and monitoring while also emphasizing their necessity.
As users and regulators become more accustomed to these technologies, this industry is expected to develop. Despite a drop in demand for medical equipment used for elective treatments during the COVID pandemic, the domestic medical device industry is predicted to revive in 2021, with a 6.1 percent compound annual growth rate. In 2023, the worldwide medical device business is expected to reach a total value of $603.5 billion.
Moreover, lenders must recognize governmental monitoring of the Medical Devices business and the enormous impact such oversight may have on a device manufacturer’s performance from the beginning of the device’s lifecycle to the end. FDA has broad statutory jurisdiction in the United States to regulate everything from face masks to ventilators to diagnostics.