The comparison I make is with the smart-phone market. People tend to write-off the first generation of smart-phones by characterising them as “bricks”. Actually they weren’t all bricks: some were hand-sized, some had keys down the side, some had a writing stylus, some even had mechanical buttons that pressed onto a touch screen – but they were all different! And that’s the comparison with the wireless medical devices of today, we see a range of different solutions to the same basic question: “What if we could have a wireless hospital?”

I’m going to take a look a three recent product announcements, all broadly in the area of the Digital OR. The trend that I’ll highlight is the technology divergence in this new market.

Firstly, we have GE Healthcare with their wireless enabled Digital Radiography (DR) tablet, a device which transfers X-ray images using Ultra-Wide Band (UWB). The primary benefit to the patient being that a wireless DR tablet can be positioned with greater flexibility to get just the right image.

Secondly, there’s Carestream who have also launched a wireless DR product, but theirs uses one of the latest versions of WiFi (IEEE 802.11n).

And finally, Stryker has announced the use of wireless in a new medical device development for endoscopy. The benefit being to remove cables from the Digital OR whilst still allowing for real-time images to be shown on high definition video screens. And, no surprise here, Stryker has chosen another different wireless technology from the consumer HDTV market, called Wireless Home Digital Interface (WHDI™).

So who’s right, and who’s going to prevail in the market?

Both WiFi and WHDI make use of new technology coming out of the consumer markets, and have cleverly adapted the use for the benefit of patients: however, these technologies both share the same spectrum as existing WiFi infrastructure products and it will fall to the hospital IT department to ensure that access to these radio frequencies is controlled appropriately.

UWB has the unusual feature that it’s radio signals are restricted to be very low power and so don’t propagate through walls; this can actually be a benefit since it allows for a much more predictable deployment, however, there have always been questions about UWB’s reliability in a cluttered environment.

To find out more about Cambridge Consultants and Wireless Medical, look here.

For benefits of remote monitoring to be realized, especially in the case of chronic disease management, the system must be designed such that consumers *want* to use it rather than be forced to do so. This can only be achieved if the end-to-end product development is carried out with the consumers in mind. The devices and tools used for communication must be simple, must seamlessly fit an individual’s lifestyle and must provide tangible near term benefits. Take the recently approved diabetes management solution from WellDoc. They offer mobile phone based software that not only records a user’s blood sugar level, but uses that information to provide intelligent feedback to direct the user’s actions. By engaging users in a meaningful manner and providing guidance in real time, WellDoc is likely to increase compliance and thus positively affect outcomes.

The tremendous increase in health apps for the iPhone is testament to the role a device plays. These apps seem to make people do all kinds of difficult things that they didn’t otherwise do. Why – because people like interacting with the device!! A big cumbersome tele-health hub on the kitchen table makes you feel like a patient and is thus an unattractive proposition. But a “cool mobile, go-with-you gadget” like the Minder is perhaps much more likely to engage and thereby increase compliance.

The Minder is the latest concept in the family of wireless medical devices based on Cambridge Consultants’ Vena platform. It provides Continua Compliant wireless connectivity, receiving data from Bluetooth enabled monitoring devices as well as user inputs and transferring it to the back-end via HL7 messaging on cellular networks. With 2-way communication capability and a simple user interface, it can serve as a low cost gateway for mobile health and wellness monitoring.

Moreover, our human factors and UI design team has taken into account real life use scenarios to develop an intuitive dashboard interface for the Minder that can provide the instant gratification as well as data sharing ability that today’s consumers demand.

See the Minder in action at the Consumer Electronics Show in Las Vegas Jan 6-9,2011

The choice amongst EHR solutions varies just as greatly as the vendors offering them. The field includes dedicated players such as Cerner, Mckesson, multi-product specialists like GE, as well as start ups with innovative offerings. At the recent Xconomy Xchange event, we witnessed a heated debate between two relatively new players – AthenaHealth & eClinicalWorks.  CEOs of both companies made very contrasting points about the benefits of their individual approach and product. While we appreciated the arguments from both sides, the most interesting observation was their seeming agreement that the government’s incentive program for EHRs will hurt rather than help clinical organizations if they get succumb into buying seemingly outdated products just to meet the set deadlines.

Whether this agreement amongst staunch rivals stems from their attempts to take on the big boys or whether clinicians will truly end up suffering due to ill conceived products that were built for billing rather than patient care, only time will tell.

The benefit of electronic records is unquestionable and the idea of incentivising their adoption brilliant, but I often do wonder whether the intended goal of better patient care (at lower cost) will be met. A friend’s recent experience with her physician gave me little confidence – apparently the doc spent less time examining my friend and more time fiddling with the computer (trying to type).

2011 is almost here. The race is definitely on. I sure hope it is the patients that win!!

In the recent months, a request has been made to the Federal Communications Commission (FCC),  to allow dedicated usage of the 2360MHz to 2400MHz range of spectrum for medical devices in and around healthcare facilities that transmit patients’ vital signs data (Medical Body Area Networks).   This spectrum is currently used for several other services, including testing the safety of planes.

Against a backdrop of the FCC’s national broadband plan calling for 500MHz to be made available for broadband use in the next 10 years, there are some parts of the wireless medical arena where an outmoded protectionist approach to spectrum utilisation still rears its ugly head.

The benefits of wireless connectivity to the medical sector will ultimately contribute to the nation’s well-being. However, to fit within national plans,  connectivity solutions must make best use of the available assets, which in the case of radio spectrum are very finite. As technology evolves and the methods for accessing spectrum allow for more efficient use, the call for exclusive use of the 2360 to 2400MHz spectrum for Medical Body Area Networks seems to be a retrograde step.

The Presidential memorandum  of June 28 specifically states that “to achieve mobile wireless broadband’s full potential, we need an environment where innovation thrives”.  We believe that moving towards the cognitive principle of using intelligence to provide maximum spectrum utilisation fits much better with the idea of innovating to drive efficiency.  Ring fencing spectrum, rather than sharing, conflicts dramatically with the ethos of what should be a forward looking industry. After all, if we stay with the same old allocation models, we will end up with the same inefficiencies and revenue streams – with no innovation and no net gain. Conversely, there is also no gain in technological change just for the sake of change.  However, introducing new technology that provides better spectrum utilisation and, in turn, generates a greater number of services (for more people at lower cost) does benefit the economy and creates a feel-good factor for the nation.

The wireless medical space already has several tranches of spectrum in which to operate. Ring fencing additional spectrum is in direct conflict with the need for innovation. Innovation in the form of technologies such as Whitespace and cognitive radio access catalyses the drive to more efficient spectral usage. The medical sector, where the application of wireless technology promises to deliver significant benefits, would indeed profit from seizing the advantages that such innovation can provide.

Although tablets and PDAs have been used in the clinical environment for several years, the buzz created recently by the iPhone is quite impressive. I attribute this mostly to the fantastic user interface and the abundance of applications available to help clinicians be more efficient in their jobs. This serves as another confirmation that a device or service which makes life easier can become successful among even the most conservative and non-techie audience.

The question this brings to mind is whether the same devices can become “personal” health hubs for the population at large? Will a well designed smart phone or tablet become the best platform for rapid deployment of Connected Health solutions? Can users, enticed by these “cool” gadgets, be motivated to monitor and track their health data?

There has been rapid evolution along these lines with developments in several key areas in the past few months. Viable commercial cases and business models are beginning to emerge as health insurance companies start recognizing the benefits of engaging consumers and driving them toward healthy habbits using friendly tools.  The uncertain regulatory landscape has led to formation of the mHealth Regulatory Coalition, which aims to address the question regarding the FDA’s role and will hopefully clarify the regulatory approach for the use of mobile phones for health applications.   Finally, low cost, standards based technical solutions are becoming available to support data transmission from monitoring devices via mobile phones.

This brings me to the key question of the day –

Will consumer oriented devices, (e.g. Smart Phones), bring about disruption in  telehealth – a market which has traditionally revolved around expensive & dedicated “telehealth hubs”?

I welcome your thoughts on this very interesting and evolving ecosystem.

Designing a wireless system starts with gathering the requirements, viz.

• What range do you need? Do you just want avoid having to plug your data-logging watch into your computer or do you want to transmit data while you are outdoors on you bicycle?
• How much data do you want to transmit? Just someone’s location every few hours or many patients’ ECG data at diagnostic grade?
• Shall the batteries last for years or are a few hours of operation enough?
• How reliable does the transmission need to be? Does someone’s life depend on it or will you just try again if something fails?

Once you know what you want, you can match the requirements against the numerous technologies already available. Chances are, you will find a suitable solution amongst existing standard options e.g. Bluetooth, Wifi, cellular systems of all generations, DECT, near-field communication, etc. You can then use commercial off-the-shelf components to implement it. Sometimes you will have to design your own system, though. One case where you might need to think about your own design is high-reliability patient monitoring for hospitals. Just to give an example on reliability, a typical cellphone network is planned on figures of roughly 95% coverage or a few percent of dropped calls. A hospital grade patient telemetry system often has requirements of less than 1 second outage in 20 minutes. That is less than 0.1%! Of course the law of diminishing returns applies here. Going from 99% to 99.9% involves a disproportionally large amount of effort. For a cellular network operator, the return-on-investment is key and a higher reliability network would cost a lot more but bring little or no extra revenue. For a hospital the foremost consideration should be reliability of the system.
Most wireless systems have been designed for specific frequency bands. Frequency bands are allocated by regulators to individual or multiple users under certain conditions. That means that users of many wireless technologies actually have to share the transmission space with other users. This leads to collisions and sometimes poorly working systems. This might be just annoying when your are trying to listen to your favourite internet radio station over your home Wifi. But it could be outright dangerous if a patient suffers a heart condition and this goes unnoticed because the signal can not get through. Hence, care must be taken when selecting a wireless technology and corresponding frequency band to achieve the require reliability. With more and more wireless devices out there, this will become even more crucial. If you’d like to read more about available frequency bands, have a look at this white paper on which frequency band to utilise for a wireless medical system.

In an ideal world, clinical trial participants would be 100% compliant with the trial protocol, diligently reporting outcomes, and enabling straightforward proof of drug efficacy, assuming of course that the drug is fit for purpose. In real life however, trials significantly over-recruit, as participants often drop off, do not comply with protocol or just don’t bother reporting data. Compliance with paper reporting ranges between 11-20%. Moreover, correlating efficacy with compliance is a real challenge.

In the last decade pharmaceutical companies began embracing technologies such as Electronic Data Capture, which has somewhat streamlined data collection. However, the process is still far from automated and does not provide actual compliance information. Tracking participant compliance to established protocol, providing regular reminders for medication regimes, and automatically transferring data to a designated secure server, could significantly reduce clinical trial costs and could even speed up regulatory approvals and time to market.

The good news is that all this feasible today and the necessary technology is readily available.  The answer lies in wireless sensors embedded within drug delivery devices. Cambridge Consultants’ first unveiled the Connected Inhaler concept at the RDD conference in 2009. The concept uses our Continua compliant Vena platform and demonstrates how wireless connectivity and availability of data can enable  new business models centered on the patient.

This year at RDD, we demonstrated how the same connectivity solution could be added on to existing devices solely for use in clinical trials, without affecting drug delivery performance, drug stability or regulatory complexity.

Our ongoing discussions with a variety of partners is strong evidence that it won’t be long before the leaders break through the traditionally conservative mindset of the drug delivery devices market and forge ahead with such innovative solutions. The race is on to determine who will be first but it will be more interesting to watch how quickly the ‘fast followers’ are able to catch up.

Rather than develop new standards, the Alliance has taken the pragmatic approach of setting guidelines that mandate the use of existing standards in combination to achieve end-to-end interoperability. For example, the Version 1 guidelines mandate the use of the Bluetooth Health Device Profile as the wireless transport and IEEE11073 as the data layer. This approach ensures that devices from different manufacturers can be used by the same application. In 2009 the first six devices passed successfully through Continua’s certification program.

Cambridge Consultants has been leading the way in enabling its customers to achieve Continua certification.  Our Vena protocol stack implements the full Version 1 guidelines, and was first to achieve Bluetooth HDP certification.  Since then it has been deployed by a number of our customers including A&D Medical, who were first to achieve Continua certification for both their weight scale and blood pressure meter products.

So where next for the Alliance?

The Continua Health Alliance now has a number of certified devices already in the market, and more products are on their way. A major next step will be to demonstrate system roll out and deployment in the hands of the consumer.  For this to happen, the Alliance is concentrating on two major steps:

The first step involves existing telehealth services transitioning to the Continua standards.  There are significant incentives for telehealth providers to adopt the guidelines, as providers will then be able to purchase devices from multiple manufacturers, supporting a single interface which will reduce overall system cost and complexity.

The second step is to stimulate adoption of the standards in the mobile phone sector. With its selection of Bluetooth, Continua paved the way for a wide range of health and fitness services to be offered via mobile devices, and in 2010 we should see the first handsets that will enable developers to launch new health services.

Beyond the immediate product launches, the Continua Health Alliance is also generating extensions to its guidelines to address high volume consumer products.  These extensions exploit the introduction of Bluetooth Low Energy, and ZigBee to address in-home networks for independent living.

Challenges and pitfalls - Confusing the consumer

In its quest for interoperability Continua offered the hope that any product with a Continua Certified logo would be able to communicate with any other Continua Certified product. It is becoming increasingly clear that this wont be the case. Even with the version one guidelines not all devices support both wired and wireless connection, so you would at least need to look for the Bluetooth and USB logos as well. Then the list of device types began to grow so a device certified today could not support all future device types. With the introduction of an increasing number of technologies (e.g ZigBee) this picture is getting more confusing.

The vision of one logo guaranteeing interoperable health and medical devices is no longer a reality. What the continua logo will now offer is a set of tools that enable the development of health services.

So what would my prescription be?

The Alliance will not introduce a new transport unless its members identify a new use case that cannot be met by an existing transport. This is not enough to limit the confusing growth of wireless technologies that Continua could end up supporting (NFC WiFi?). The Directors need to provide some steering and act to ensure that they meet their goals of simple interoperability.

The Alliance has done a good job of overcoming the hurdle of interoperability. They are working with the FDA to clarify any regulatory concerns, so the only major hurdle that stands in the way is revenue.  The biggest challenge for companies entering this market is working out how they will get paid. Is this an area where Continua can help?

As a result we have developed telehealth hub solutions that minimise the hardware cost, and minimise complexity. As you may have seen from my previous blog posts on the overlap with Health2.0 I believe that the simple and invisible solutions are often the best.

A number of recent developments seem to show a trend toward expensive PC based devices for the delivery of telehealth services. This includes the announcement last week of the first Continua certified telehealth manager - a Panasonic toughbook tablet PC.  Silicon provider Marvell last week also launched a tablet PC focused on telehealth. These solutions are similar to the Intel Health guide product shown below – essentially a low end PC with touch screen interface. As a result they are expensive items that are not going to fit the cost sensitive world of healthcare delivery.

There are some lower cost systems from providers such as Tuntstall, Bosch, and imetrikus, but even these solutions are relatively expensive.

It is challenging to create a low cost product that is attractive and simple to use. As I mentioned in my previous post Vitality RX seem to have produced an attractive system.

One example of how to do this successfully is our client Clipcomm. They have used our powerful Bluetooth development tools to create an attractive low cost hub for telephony. The Bluetooth phone adapter shown below enables users to route landline calls to a Bluetooth headset. It has a simple user interface, and connects to your existing phone line.

If only telehealth hubs were so simple – watch this space….

The truth is I struggle with these terms myself. When creating the content for Cambridge Consultants Wireless Medical web pages I can never be sure which of the terms will be relevant to our customers. While there may be some subtle distinction to the originators of these terms they largely describe the same overall concept. The application of communications technology to the health sector. I believe that the industry and the public would benefit from some clarity of message.

Last year we conducted a survey of Healthcare experts that found 40% were not familiar with the term connected health (results presentation here as a PDF). This figure shouldn’t be too surprising given the range of terms that are being used by experts. Some of the confusion is introduced by a range of conferences, trade publications and market reports which distinguish themselves from the competition by creating terms that describe a niche within a niche. Another reason to create these new terms is to distinguish from history. Telemedicine is a term that has been around for a long time, but as a result it is often associated with a dated technology. New market entrants often look for a more exciting description of their technology.

Adding to the confusion the FCC published its national broadband plan (large PDF link) in which they examined the Healthcare needs for telecoms systems. On page 200 they attempt to define the terms used but appear to have introduced one more term – ECare.

So I have added some context and links that may help:

Telehealth: The broadest term to describe the application of telecoms technology to the improvement of health. This is most often associated with remote patient monitoring – the collection of health data in the home or on the move, and often associated with non clinical applications e.g fitness or wellbeing.

Telemedicine: Telemedicine is the use of communications technology to exchange medical information from one site to another. Most commonly associated with remote consultations via video conference, or remote diagnostic services. The leading organisation in this area is the American telemedicine association.

Mobile Health: Mobile health or mHealth is specific to the use of mobile communications networks for the provision of health services. Typical applications include text message appointment reminders and education programs or pharmaceutical authentication.

Connected Health: Connected health is a term that is used primarily in the US, an more recently Europe. The distinction from telehealth appears to be the focus on health services that reduce cost, but it still focuses on remote monitoring, and the impact of comms technology on health. The term is connected to the Partners centre for connected health in MA USA.

Health 2.0: Health 2.0 is the application of web2.0 technologies to the provision of health services. Primarily associated with the work of Matthew Holt, and the Health 2.0 conferences. Historically focused on bay area startups in health search it now has a wider focus overlapping with telemedicine. (My intro to Health2.0 PDF presentation)

Other associated terms: Telecare, E-care, ehealth, assisted living, romote patient monitoring, wireless health, wireless medical, healthcare unbound.

This is my interpretation of the terms, and there will be different opinions. I’m sure I’ve missed other definitions.  Which ever term you use there is significant growth predicted in the market – With such similarities shouldn’t we rationalise this confusing list of terms?