The medical device market is in the midst of a transformation. Major high-tech players such as Google, Amazon, and Apple have entered the healthcare sector, bringing a spirit of innovation and powerful software capabilities to a historically hardware-driven industry.
With the rise of mobile technologies and IoT, along with expectations that digital health will continue to scale to a population beyond early adopters, medical device manufacturers have begun investing more heavily in digital health.
Ernst & Young’s 2018 Pulse of the Industry report states that only 16 of the 43 therapeutic devices that received FDA premarket approval for the 18 months between January 2017 and June 2018 had a digital health component or made use of data analytics.
Medical device companies that fail to invest in digital health R&D may have a tough time staying relevant in an increasingly data-driven healthcare sector.
What does 2019 hold for digital health and medical devices? Here are a few developments to watch.
1. Healthcare Data Everywhere
Electronic Medical Records (EMR), diagnostic imaging, and health apps gather oceans of data, and healthcare organizations and medical device manufacturers are just scratching the surface of how to harness and make the best use of that data, as well as how to ensure the security of that data.
Data is expanding our capabilities in the design of clinical trials. In silico clinical trials, which are individualized computer simulations using virtual trial subjects based on human models, use these large data sets in the service of development or regulatory evaluation of both drugs and medical devices.
In silico trials have the advantage of running scenarios millions of times faster than in a randomized control trial, providing developers with applicable data, opportunities to identify potential hazards, and allowing researchers to determine how a device or drug may perform in different hypothetical use cases.
Read the complete article at Bigfootbiomedical.com
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