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The application of Web 2.0 technologies to patient monitoring and clinical communications offers a new healthcare model that will be essential to the NHS in the coming years. Barnaby Perks, Director of ERBI Medtech, talks to Medtech Business about what wireless healthcare means for the industry.    

Barnaby Perks

ERBI is a not-for-profit membership organisation for international life science and healthcare companies, based in Cambridge. Its 370 members include pharmaceutical, biotech and medtech companies and associated technical and commercial service providers.

ERBI’s report Is the future of healthcare devices wireless? was the result of an ERBI and Cambridge Wireless joint workshop on 4 December 2008, when the region’s biomedical technology and wireless communities came together to discuss the possibilities for wirelessly enabled medical devices.

How are wireless healthcare technologies changing the healthcare model in the UK? Why is this of benefit to the NHS?

There is an increased awareness of the need for monitoring patients.

The practicalities of monitoring patients on a long-term basis have always been a challenge. In the past, typically a home-based patient would need to go to their GP surgery to undergo tests. Now people are taking blood pressure monitors home with them and monitoring their own blood pressure over a period, so that their clinicians can get a view of the patient over a long period rather than just a snapshot in the surgery. You always get a better understanding of someone’s condition if you can monitor it over time. So the driver is that better data can be used to generate information to enable better understanding of conditions, leading to improved treatment.

The benefit of that to the NHS is that it improves healthcare outcomes, but also lowers costs – because you’ll be applying appropriate therapies, and where a therapy isn’t working you can switch to an alternative and monitor its effect by monitoring the person. So more effective treatment and better outcomes should also lead to lower costs.

There’s a further application in the ‘wellness’ arena: people are increasingly starting taking control of their own health, because they have easier access to medical information than before. There’s a relatively well-off and educated group of people who can afford the time to find out about their own health, and are sufficiently motivated to monitor it themselves. These ‘worried well’ individuals are potential consumers of devices that enable them to gather data on their health and either make decisions based on that or put the data into e-health sites such as Google Health, which will process the data and aggregate it with others – thus enabling them to see how they fit into the population, how healthy they are and whether they need to take remedial action.

So there’s the NHS driver and the consumer driver. The latter has a direct effect on the NHS, because if people take better care of themselves they’re likely to need much less treatment for illness.

How does wireless healthcare enable the integration of different technologies (e.g. medical devices and diagnostics)? What are the implications of this for the medtech industry?

The integration issue has two aspects. On one level you have the integration of medical devices with biologics and drugs. That’s a fairly key area: there are a lot of medical devices that have some biological or chemical element to them now, which leads to some regulatory challenges

The other key integration area is one in which wireless technology is an enabler: it’s not really integrated into the technology, but it enables us to move data between different devices. That’s the integration of information management with medical devices and diagnostics, as well as with biologics and drugs. This is critical because now we’re in a position where we have a lot more data – but data in their own right don’t tell you much, you have to process them in some way to give you some information that you can use to develop some kind of decision support. These information management tools need to be integrated with the medical devices. The wireless part of it is just a way of connecting the device to the information management infrastructure.

There are some other implications that relate to how you integrate medical devices into mainstream communication devices. Regulation is a major challenge here. Medical devices are very tightly regulated, and different types of device mean different regulatory hurdles to be jumped. You don’t have that level of regulation in the consumer electronics world: for a mobile phone, a PDA or a digital camera, there’s no regulation beyond basic consumer safety. If you want to test a new model you don’t need any regulatory approval to do that, you can just modify your product and send it out. In the camera industry they even trial new features in the market that way.

With a medical device, however, you have to test every feature before it goes to market: you have to clear all the regulatory hurdles and be sure that the changes you’ve made won’t be detrimental to the patient. If the changes you’ve made to a consumer electronics product affect the user experience, that’s a bad thing in terms of sales but it’s not actually going to hurt anybody – whereas with a medical device, you need to prove the changes you’re making aren’t going to lead to either direct harm to the patient or erroneous data that could lead to a mistaken interpretation.

So how you connect medical devices into consumer electronics is an interesting area. There are three ways of doing it. First, you can integrate the consumer device with the technology for the medical device by licensing in the technology in some way, licensing in components or licensing in a technology-enhanced consumer device, so the onus for getting the device through regulatory approval falls on the electronic consumer device manufacturer. Second, you can license in or implement the communication technologies into the medical device.

Third, you can network the medical device with the consumer device in some way. For instance, if you have a medical device that can communicate with the outside world via a Bluetooth connection that can be used by a mobile phone, you’ve removed the need for regulatory approval of the consumer electronics device, but you’ve got the connectivity you need. You’ve also got some degree of flexibility, because if the consumer device changes more rapidly than the medical device (which is extremely likely) then as long as that communication route is open there’s no detrimental effect on the relationship between the medical device and the consumer device (which is acting as a communications hub).

How can Internet-based healthcare services overcome the difficulties that many users have with major ISPs (unreliable access, poor customer service, etc)?

Internet-based healthcare services highlight how critical universal connectivity is to user experience, because the more we integrate our Internet usage into our everyday life the more important high-speed connection becomes. That’s true in our working lives as well, of course.

In the integrated health environment, where people are carrying devices and measuring markers on their bodies and identifying conditions, the Internet health sites are the key to managing the data. As I said earlier regarding the integration of information management with medical devices, if you don’t manage the data then you don’t get any useful information. The internet health sites can help you to manage your data, to turn it into useful information that the ‘worried well’ can use to manage their condition rather than just seeing a list of numbers.

Also, we can aggregrate data to get much better population statistics on the general condition of people and the onset of illness. We have to be careful in doing that, of course, because the subset of people who use these systems is fairly small and you’d need fairly wide usage to draw any good conclusions from aggregated data. But clearly the people who are funding these sites believe that there will be some value from these data.

I think the problem highlights the importance of connectivity, and is yet another reason for industry to communicate the strategic national importance of having a well-connected society.

How will the impending years of severe restrictions on NHS spending affect the prospects for wireless healthcare in the UK?

The OLS Blueprint positions the NHS as a commercial driver that should stimulate innovation by adopting new technologies, with the view that these new technologies can both improve healthcare outcomes and reduce costs. Of course, the commercial world adopts new technology all the time to reduce its costs and improve its productivity. So if we can demonstrate now that adopting a new technology can improve health outcomes and reduce costs, then there is an opportunity here.

However, it all depends on the ability of the industry to influence the NHS, and particularly the Strategic Health Authorities. If they see adoption as a key driver for them to reduce costs, then clearly they will do that; if they see adoption itself as an additional cost, then we’ll see a shrinking window of opportunity. It’s really down to the ability of the commercial sector to influence the strategists of the NHS that this is a real opportunity to improve value.

What are the main challenges that companies offering wireless healthcare services need to overcome? How can they best achieve this?

Clearly, uptake by the NHS is the biggest challenge of all. A key aspect of the innovation agenda within the NHS, driven by the Darzi review, is the adoption of new technologies to deliver the services in different ways. If you can persuade the NHS at the strategic (SHA) level and at the hospital level of the value of this, then adoption can be an enabler – but the challenge is how you achieve that, how you make new technology seem an opportunity rather than just a cost.

Regulation is always a challenge. The group that came to the event that generated our report was split between medical device people and wireless technology people. The wireless technology community showed a clear aspiration to get involved in the healthcare arena – but a lot of them were concerned by the regulatory environment, because was an unfamiliar situation. My experience is that when most people become suppliers of medical devices, that is just something they get used to: they have to understand the regulations and work within them. But it means they have to work differently – it rules out things like market-based testing, as we said before. There are enhanced safety requirements, and that means that you end up with slower and costlier development. The technology is never quite as cutting-edge. It’s better tested, it’s more reliable, it’s more robust, because that’s what the regulations require.

Clearly there are issues to do with wireless connectivity – within the hospital environment in particular. That’s changing now, but it was very restrictive in the past, and finding the right standards and the right frequencies to communicate between devices in the hospital environment is still a challenge. As soon as there is acceptance of the need and then standardisation, that will become less of a headache.

The data management problem will be difficult to solve. At present, where patients have wireless devices that they use several times a day or wear constantly, and you get data feeds from these devices back into a data centre or the GP surgery, even if you have a number of patients at once the data feeds you’re getting in are fairly small, because you’re taking a device home and you’re logging data, there won’t be that many data points and relatively few people are under those sort of regimes – whereas if this becomes rolled out more widely, we’re potentially going to see very large volumes of data coming into these centres, and the infrastructure and process to manage and interpret those data is something we’re just not doing at the moment.

Patient compliance is another challenge. It’s very easy to make someone comply with a regime when they’re in the hospital or if you only do tests when they are in the surgery, but if someone’s actually going home with a device, making sure they’re using it properly and therefore giving you valuable data is a difficult problem. We know that patient compliance on drug taking, for example, is often quite weak. The engagement of taking a device home and using it on an ongoing basis should promote compliance, however. If you feel responsibility for something and have an interest in it and are seeing personal benefit from gathering those data, then compliance should be easier.

In terms of the design of the devices, there’s a balance to be struck between the simplicity of the interface (which helps to make sure that people will actually use these devices) and the complexity of the outputs you’re providing. That’s quite a major issue for a lot of these devices, particularly when you consider some of the groups in society who will be using them. The ‘worried well’ are likely to be in their 30s to 50s, well educated and able to understand these things; but when you’re dealing with people who need ongoing monitoring from a GP surgery, they are likely to be people from a lower socio-economic group, and certainly people who are older and may be less familiar with new technology and ideas.

There’s also the challenge of skilled installation and service for homecare technologies. If people are taking medical devices home for use and problems arise, you will need a network of people who can deal with those issues. It may be possible for the patient to bring a device back into the surgery to be fixed, but that may not be appropriate. You may need skilled teams to install and service various components.

Finally, having a business model that will work, so that the companies that supply these models can turn a profit on them, is always a challenge. Clearly there are a number of telehealth companies in the UK, and those business models are being developed. We’re at the final stages of that – but there’s a lot more experimentation and experience needed before we can decide on the best business models for this new form of healthcare. 

For further information, please contact ERBI at medtech@erbi.co.uk or 01223 497400, or visit www.erbi.co.uk.

A key aspect of the innovation agenda within the NHS is the adoption of new technologies to deliver the services in different ways. If you can persuade the NHS at the strategic (SHA) level and at the hospital level of the value of this, then adoption can be an enabler – but the challenge is how you achieve that, how you make new technology seem an opportunity rather than just a cost.

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