23 October 2012

The challenges for medical device interoperability

Hospitals have complicated and connected technology ecosystems. Few places have such a diverse array of machines, skills and information, all attempting to coexist in a stressful decision making environment. Each department has an array of devices and a staff with highly specialised skills.

Information on patients and their treatment must flow seamlessly through this ecosystem, across more than one hospital and, potentially, between hospitals and the home. And this needs to be sustained throughout the patient's life for treatment and care to happen in an effective way. Modern hospitals are filled with complex machines and the bar is set high for their safe and effective use. Taking a device to market is an increasingly complicated task.

One example is the potential for an ambulance to download data. Ambulances feature ever more equipment to allow patients to be treated quickly, but it would be even better if information on their condition could be relayed to the hospital. Unfortunately, these devices were not designed with this in mind and retrofitting them can be difficult and expensive.

Interoperability

Interoperability could be defined as 'the ability of medical devices and healthcare systems to interact seamlessly with each other to enable better outcomes'. The goal is not only to do things faster, but also to achieve better outcomes for patients.
This can be achieved by the adoption of standards, so different devices from different manufacturers can communicate. Devices must connect securely across the hospital's ecosystem and through telecoms systems into the home, allowing information to flow. The goal is to reduce the variability in workflows for a given treatment so a positive health outcome can be achieved at the most optimal cost.

The data under consideration is largely that representing the patient. This data not only needs to be accurate, but also to be in the right place at the right time, delivering the required detail for a person or another machine to understand it and act upon it. Data is ubiquitous, but the lack of interoperability is making it hard to take advantage of this information and improve patient safety.

For example, it has been demonstrated in intensive care that the ability to synchronise xrays with the patient's breathing cycle improves image quality. Unfortunately, interconnecting and synchronising these devices automatically is not possible today.

Another example is a safety interlock and alert system that could stop the flow of pain medication from an infusion pump if a patient showed signs of respiratory distress. Sadly, we are locked into a risk averse world, where interconnecting these types of devices is considered to be an additional integration burden that no device manufacturer wants to tackle.



Barriers

The list of stakeholders is long: governments and providers, physicians and device manufacturers, standards organisations and patients. Each can benefit from greater device interoperability, but there are many barriers to adoption.

Although efforts are being made to regulate medical devices by health delivery organisations and regulators, there is no strict enforcement for interoperability. While there are necessary guidelines and standards, lines are drawn as to where the box starts and ends and therefore interoperability is not strictly regulated or enforced. Companies, therefore, can get away with the lowest common denominator of interoperability.

Another important dynamic is the network effect, whereby a small network that connects to a large network gains massively and disproportionately. Incumbents in healthcare systems do not have the incentive to interoperate with other companies' devices as it may erode their market share. A few players dominate the market and, in specific hospital chains, even fewer players dominate the device ecosystem.

Thirdly, most medical device companies have been vertically integrated, so the concept of standards and componentisation has been restricted to their environment. Intervendor interoperability means pushing interoperability a level down – to their suppliers.

Interoperable software standards should be implemented no differently than basic communication protocols. The same holds true for connected components – companies should encourage their suppliers to buy components that are prefabricated and integrated one level down in the value chain.

Progress

Progress is being made, despite these barriers. Health delivery organisations are starting to realise the huge costs incurred and are pressing vendors for interdevice interoperability. The US FDA, along with other standards bodies, is pressing suppliers and hosting medical device interoperability workshops that encourage greater collaboration in the testing of devices. Also, government health agencies and large healthcare providers are working with some telecom and networking companies; and telecom providers can be highly effective at enforcing standards.

There are many interoperability standards bodies which, at a very high level, can be separated into regulated (hospital) and unregulated (consumer or home) types. As an example, the Continua Health Alliance has defined IEEE11073 medical device communication standards for personal healthcare, such as individual personal telehealth devices ranging from blood glucose meters to thermometers. More than 70 devices have been identified under this umbrella standard, which allows compact devices to connect via USB and Bluetooth, with the goal to monitor patients reliably and remotely.

Other standards address different environments or ensure messages are formatted in the right way, so an alert on an infusion pump gets to the intended recipient. The goal is always to get the right data to the right place at the right time in the right level of detail, so it can be acted upon.

Vertical integration can work in narrow markets or where the entire device has IP that adds value. But fewer companies can make this approach work. In the health market, most of the electronics and control architecture that go into devices ranging from low power insulin pumps to complex imaging devices can be designed outside and bought off the shelf. A classic example is the TCP/IP stack; 15 or 20 years ago, this would have been written internally and the standard interpreted in a way for easy implementation. Today, most companies will obtain a stack from an OS vendor, including all the appropriate required certification such as IPv6.



Interoperability

To ensure interoperability, three forces need to come together. Enforcement, regulators, healthcare delivery organisations and standards bodies must come together and increase the pressure on companies to comply with the standards. Secondly, there needs to be an incentive system through which a device manufacturer can 'score points' for designing an interoperable system that works with those of competitors. This is an area where CTO organisations within large companies have been proactive and are starting to insist on interoperability. Thirdly, companies need to stop thinking vertically. Interoperability is not where the innovation exists; this happens at the application layers and it is where revenues lie for device manufacturers. Companies should also insist their suppliers implement the appropriate standards.

Wherever they are in the chain, people will pay for better outcomes. So there is a significant market opportunity in creating the middleware to implement these evolving standards, enabling innovation in treatment applications. The recipe is simple – find the ecosystem, find the suppliers and partners with the same or better quality metrics and push the standards, focus on solving new problems and actively seek out partners. Collaboration is the new competition – particularly in the connected health ecosystem.

Author profile:
Ken Herold is Wind River's lead medical engineering specialist.

Author
Ken Herold

Supporting Information

Downloads
45693\P27-28.pdf

Websites
http://www.windriver.com/

Companies
Wind River UK Ltd

This material is protected by Findlay Media copyright
See Terms and Conditions.
One-off usage is permitted but bulk copying is not.
For multiple copies contact the sales team.

Do you have any comments about this article?


Add your comments

Name
 
Email
 
Comments
 

Your comments/feedback may be edited prior to publishing. Not all entries will be published.
Please view our Terms and Conditions before leaving a comment.

Related Articles

X-ray detector on plastic

Researchers from Holst Centre and imec have demonstrated the first ever X-ray ...

Sensor market back on track

Emerging markets such as the Internet of Things, wearable electronics and the ...

Electronics dissolve on cue

Researchers at Iowa State University are the latest to shift their focus to the ...

Smart pump for the heart

Around 160,000 people in the EU require heart transplants every year. About 600 ...

Wearable electronics

Problems with the heart can be relatively common but, because they can present ...

Zeno robot smiles back

The autistic spectrum is sometimes, mistakenly, thought of as a gauge on which ...

Using Linux in medical devices

This whitepaper explores the issues that software developers and medical device ...

Adapting to the extremes of rugged design

Ruggedisation and reliability are key requirements for a wide range of embedded ...

The real solution to fake parts

The high tech supply chain is more vulnerable to counterfeit components than ...

High CV X5R MLCC series

AVX has added new capacitance values to its high CV X5R MLCC series for mobile, ...

Modular power supplies

While engineers are increasingly looking to simplify power design, often by ...

Audio receivers from Molex

A new family of balanced armature audio receivers has been introduced by Molex.

Future World Symposium 2014

29th - 30th April 2014, Twickenham Stadium, London

BEEAs 2013

9th October 2014, 8 Northumberland, London

Engineering Materials Live!

22nd-23rd October 2014, Jaguar Exhibition Hall, Ricoh Arena, Coventry, UK

Self-destructing electronics

Researchers at Iowa State University have created transient electronics that ...

DLP 0.45 WXGA chipset

Learn all about the features and benefits available to developers with the DLP ...

Electronics Design Show 2013

Take a look at some of the highlights from the 2013 Electronics Design Show and ...

Cutting the mustard

In the past ten days, three clients have presented their new designs (an ...

Bionic lenses and rabbits

A Terminator style bionic contact lens has been developed by researchers in a ...

Bullish optoelectronic market

When New Electronics reported the growth of the optoelectronic market in June ...

Gregg Lowe, Freescale

Freescale's new ceo tells Graham Pitcher that, while he's not 'dancing' yet, ...

Rick Clemmer, ceo, NXP

Rick Clemmer believes high performance mixed signal is just one of the sectors ...

Henri Richard, Freescale

Freescale's chief sales and marketing officer tells Graham Pitcher that he's ...