Catherine Booth, a partner in the Manchester office of IP firm Mathys & Squire looks at the new challenges emerging from the Internet of Medical Things (IoMT).
Nobody can fail to notice the ever-increasing presence of the internet in almost all aspects of daily life, with seemingly everything now having some level of connectivity. Medtech is clearly no exception and in fact, is one of the technology sectors to most embrace the opportunities that IoT brings – with the interconnection of devices and systems via the internet (IoMT). However, innovating in the IoMT world may involve stepping into other areas of technology that are different to those with which the medtech community are familiar, bringing new challenges, new competitors, and the need for a new way of thinking, especially with regards to your Intellectual Property (IP) Strategy.
In recent years, medtech companies have been developing ways to enhance products using the IoT. Just a few examples are wearable monitors that send data to a connected device or to a healthcare provider; smart medications that record how and when they are used and provide feedback for improving efficacy; data tags in manufacturing and packaging to monitor batch quality, shelf‑life, shipping and returns, etc. Each of these, and the many other applications being developed, requires transfer of data between devices.
A mistake I have often seen made in the medtech sector, even by otherwise IP savvy companies, is incorporating known communications technologies into devices without checking whether this is covered by existing IP. Whilst it may seem surprising, there is often problematic IP held not only by known competitors (whose own IP strategy you may be comfortable with), but more frequently by companies with whom you previously did not compete, since many big-name IT companies are now moving into the medtech space, and they may have a very different approach to IP. Should they enforce their IP rights, it can be very costly and damaging to a business, to the point you may have to remove your product from the market, and the accompanying compensation payable to them may be significant.
Therefore, it is important to rethink and modify your IP strategy if you want to take advantage of the IoT. One of the biggest changes I recommend is to consider the IP landscape at the earliest stage in development and as frequently as possible, since the technology sector is very fast-paced (compared with medtech) and new IP can arise even when you think you have cleared a product. Tech companies are extremely prolific when filing IP, so it can often seem like there is a huge amount of IP covering what you want to do and no way through it. However, much of this IP is speculative and unlikely to be valid in broad terms, so its existence does not necessarily prevent you from doing what you want, but you will need clear, practical advice to help you make strategic decisions.
Another aspect that is quite often neglected by medtech companies is filing your own IP. Medtech is generally a very innovative sector, with developments that stand out as being inventions. Therefore, it’s common for medtech companies to see communications technologies as not adding anything particularly innovative to a product and to not seek protection for the new IoMT device. You are missing out on valuable protection that not only can be used to stop competing products, but can also be a bargaining and commercial tool should you find yourself within the IP protection of another company and in need of a licence for example.
Another area that must be considered is data protection, especially with the recent legislation changes such as the EU General Data Protection Regulation (GDPR) which came into force in 2018. How you implement GDPR may lead to IP opportunities and again, commercial opportunities with regards to licensing.
Timely and appropriate IP advice throughout your development cycle is essential. You can spend large amounts and still not avoid the pitfalls, whereas getting it right from the very start can save costs over time. As you are moving into another sector, with big name players that are typically more aggressive with their IP, and whilst it can be daunting, the rewards can be significant. As Facebook’s Mark Zuckerberg said, “In a world that’s changing really quickly, the only strategy that is guaranteed to fail is not taking risks”.
Mathys & Squire is exhibiting on stand F58 at Med-Tech Innovation Expo.