Protecting connected medical devices

The digital health industry has expanded exponentially in recent years with the market for medical devices able to exchange data over the Internet predicted to reach $52.2 billion in 2022. This trend is leading to a paradigm shift in ways of treating patients regardless of where they live. A rapid growth in R&D investment has been closely shadowed by growth in patent applications for connected medical devices. There has been a 100-fold increase in patent filings in this field over the last 20 years, with the top five patent applicants being Medtronic, Philips, Olympus, Fujifilm and Konica Minolta.

A patent protection strategy should begin with protection for the connected medical device itself, with claims targeting unique features of the device. Many connected medical devices are associated with wearable monitoring systems that have data collection, storage, processing and transmission capabilities. Such devices may include biocompatible sensors that can provide real-time continuous measurement of physiological parameters and communicate relevant information to the user, physician or caregiver. Innovative means of forming or incorporating the sensors within a wearable device is one such area that has been subject to a series of patent filings: for instance, the use of flexible substrates and sensor arrays embedded in surgical implants and wound dressings that are adapted to measure and transmit patient specific parameters and biomarkers, as well as associated manufacturing methods. 

A patent application can also cover how the device is used, including how data is communicated from the medical device to another part of a system, perhaps for further processing or analysis. The manner in which physiological data from the user is obtained, processed and transmitted by the medical device (or a connected part of the system) may also be protectable. The patent applicant must tread carefully as in Europe at least a patent cannot be granted for methods of medical treatment or diagnosis using a medical device (even though the device itself is patentable). However, processing steps that do not include interaction with the patient can also be protected. 

Typically the inventive part of a connected medical device will be partly or fully implemented in software. This is patentable in Europe so long as a “technical effect” can be identified which moves the invention away from a purely abstract concept. A particular growth area is the emergence of practical applications of Artificial Intelligence (AI) in the medical industry, which has prompted numerous patent applications. Patent protection for inventions implemented through AI is a fast-evolving field. The European Patent Office (EPO) is at the forefront of this trend. The EPO considers that patents may be granted for the use of AI in connected medical devices, for example, the use of a neural network in a heart-monitoring apparatus to identify irregular heartbeats. The identification of irregular heartbeats is an example of a patentable technical effect.

We also increasingly see patent applications directed to communications security to ensure the protection of any patient data stored, transmitted and/or received by the device. As for any technology concerning the transmission of sensitive data across the internet, privacy is critical. 

A patent strategy for a connected medical device should consider who the patent targets. A claim directed to the connected medical device, and its manufacture, is likely to be the focus to target rival manufacturers and potentially resellers. While it is unlikely that end users of a connected medical device are to be targeted, a method of use where the focus is the transmission of data from the device for processing by a commercial organisation could be claimed. 

Given the size of the market for connected medical devices, the investment required to bring products to market and the relative ease with which many devices can be copied, patent protection should be sought to protect R&D investment. While there are traps for the unwary, valuable protection is available for different aspects of connected medical devices and how they are used.

Richard Gover and Adam Hines, HGF