Medical Devices Meet Consumer Electronics

Revolution in healthcare delivery

A revolution in healthcare delivery is on its way. Advanced semiconductor technology is transforming the medical services market by enabling a new generation of technology solutions that leverage the economies of scale of consumer electronics, while delivering the robustness and medical compliance normally associated with expensive capital equipment. At the forefront of this new generation of healthcare technology is an entirely new way of monitoring the human body-wirelessly, intelligently and at low cost. Breakthrough silicon technology is enabling the development of new wireless devices, with its application across a vast array of healthcare management scenarios. Intelligent microchip-sized wireless body monitoring systems are set to enable a wealth of new healthcare applications, offering quality of life for users and providing critical physical, bio-chemical and genomic data for healthcare professionals.

The New Wave - Pervasive and personalised healthcare

Demands on healthcare throughout the world are changing. As a result, there is now huge demand for new systems which improve productivity, cut costs and support the shift of healthcare from hospital to the home and community settings.

The global demographic trend towards ageing populations, coupled with less active lifestyles and fast-food diets, is leading to higher probability and earlier onset of chronic conditions such as Type 2 diabetes and cardiovascular diseases. This, in turn, is translated into a substantial increase in the proportion of resources required for a long-term, continuous care and a growing burden on healthcare infrastructures. Today, 75-80 per cent of healthcare expenditure is spent on chronic diseases, placing an unsustainable strain on healthcare providers' resources including hospital beds.

With healthcare budgets already overstretched and few care takers-professionals and non-professionals-being available to meet the increased needs, forecast additional demands are simply unsustainable using current practice. Continuous monitoring has shown to enable more effective treatment of chronic disease, deliver improved patient outcomes and reduce the requirement for hospital visits and admissions. With the prevalence of chronic conditions set to escalate in coming years, the ability to harness non-intrusive, proactive healthcare monitoring and 24x7 diagnostic and intervention capabilities-at acceptable system cost levels-is becoming a key priority for healthcare providers.

Converging on a new vision

The impetus for the emergence of the new global digital medicine market is convergence. Digital information standards now enable X-rays and scanned images to be stored, retrieved, communicated and analysed using Picture Archiving and Communication Systems (PACS).

The development of interoperability standards for Electronic Medical Records (EMR) is also opening the way for greater patient / physician access to data and the provision of patient choice. Through interoperable EMRs physicians, pharmacies and hospitals can share patient information and deliver timely, patient-centred and portable care.

In parallel, the ubiquity of wireless and mobile cellular networking is driving the clear trend for 'unwiring' the healthcare world and the increasing demand for mobile-based solutions, both in general ward hospital environments and in out-patient and care home scenarios.

Now, disruptive semiconductor technology is enabling all these convergent trends to come together and create a nexus for major innovations in treatment, diagnostics and intervention. The transfer of this ground-breaking technology allows the advantage of economies of scale that semiconductor industry now enjoys to be passed onto healthcare markets for the first time.

Intelligent wireless body monitoring - Platform for a digital revolution

Health research has shown that our bodies are not constant. Nearly every physiological process fluctuates with our internal circadian rhythms; the body's temperature, immune function and hormone levels vary according to the time of day or night. In addition, many diseases have daily rhythms, with symptoms more severe at certain times. As a result, taking data at single set time points provides limited insight into a condition or an individual's overall health status. A growing recognition and understanding of the body's sensitivity to time-of-day helps in improving the efficiency and safety of drug delivery.

In every healthcare scenario, the ability to continuously-and remotely-acquire data necessary to undertake a more holistic clinical assessment of an individual is the key to defining highly personalised treatments and delivering improved outcomes.

New ultra low-power system-on-chip technology lies at the heart of the digital medicine revolution. This technology enables a new generation of low-cost, non-intrusive wireless vital signs monitors that can continuously monitor multiple vital signs in real-time, allowing healthcare providers to remotely monitor patients via standard mobile devices such as PDAs and cellphones. With the ability to deploy simple, reliable and affordable remote body monitoring devices, whole new areas of the medical services market are being created, including point-of-care diagnostics, tele-monitoring and the ability to self-manage chronic conditions. For healthcare professionals, this innovation is opening a completely new window on patient physiology enabling unprecedented levels of analysis and unlocking entirely new areas of knowledge and understanding into disease progression, diagnosis and therapies.

Intelligent wireless infrastructure for healthcare and lifestyle management

New ultra low power system-on-chip technology is enabling a new generation of low-cost, non-intrusive body-worn wireless vital signs monitors for medical and professional healthcare applications. This breakthrough technology provides the complete wireless infrastructure to allow healthcare providers to remotely and intelligently monitor the human body in real time, via standard mobile devices such as smartphones and PDAs. The technology provides an intelligent data acquisition platform and a complete integrated solution for patient care - enabling the ubiquitous monitoring of physiological inputs from ambulatory and non-ambulatory patients, in both general ward and out-patient or telecare scenarios.

Together with appropriate external sensors (for example, electrodes, 3-axis accelerometers, temperature sensors, pressure sensors, strain gauges, amperometric sensors and so on), this platform technology allows continuous, intelligent monitoring of multiple vital signs-such as ECG heart rate, body temperature, respiration and activity level-in real time allowing earlier detection and prediction of adverse events such as heart attack, falls or hypoglycaemia.

Powered by low-cost thin batteries, body-worn monitors can process and extract key features of the data and intelligently integrate it into an electronic medical record (EMR) via a base station device using a power-optimised wireless operating and networking system. For healthcare professionals, this delivers unprecedented possibilities for proactive monitoring and improved quality of care at dramatically reduced cost. Traditional healthcare models are simply not able to offer this level of continuous care except in expensive ICU settings. This new technology unlocks a higher quality system of individualised patient care throughout the treatment and diagnostic cycle-from the hospital ward to the home.

For patients, this transforms the opportunities for lifestyle-compatible, personalised healthcare as well as better therapeutic outcomes.

The key enabling benefits of new platform technology

Gathering real-time information, not raw data

• On-chip signal processing to intelligently extract critical information from sensors

Ultra-low-power

• Patented AMx technology coupled with low-power radio and intelligent information handling results in non-intrusive, continuous monitoring

Low-device cost

• Ultra low-power and low voltage operation leads to devices powered by simple, low-cost "printed" batteries

End-to-end system

• Provides the low-power radio link from the patient to the telecommunications network and into the healthcare provider's database/system

Wireless Body Monitoring Infrastructure

In a Wireless Body Area Network scenario, one or more devices can continuously monitor key physiological parameters on the body. These small body-worn monitors can capture, dynamically process and filter 'problem' event data-such as irregularities in heartbeat or blood pressure-and report it wirelessly to a basestation device plugged into a PC, PDA or smartphone via an ultra low-power short-range radio telemetry link (much lower power than alternative short-range technologies such as Bluetooth or ZigBee). The data can be further filtered and processed by application software.

Using ultra low-power advanced mixed signal processing algorithms, these devices requires only a very small, low-cost battery, enabling them to be body-worn with complete freedom of movement. The system can be incorporated into a wide variety of lifestyle-compatible form factors depending on market application and requirements. For example, a disposable monitor-offering days' to week's lifetime and requiring no battery change-or a non-disposable body-worn device.

End-to-end Solution - Towards management of care by exception

Toumaz and Oracle Corporation are currently working together to link real-time vital signs information acquired by the Sensium system to the electronic patient record, using Oracle's Health Transaction Base (HTB)-an information system designed specifically for healthcare markets and integrated with the first international standard for storing and sharing health information: the Health Level Seven Version 3 (HL7 v3) Standard.

The integrated end-to-end system will allow key physiological data taken from multiple patients-both in general ward and out-patient care settings-to be integrated with existing health information systems, thereby becoming a total patient care package and clinical repository of data. In the general ward environment, vital signs data is transmitted either to the bedside monitor (in the case of non-ambulatory patients) or, for ambulatory patients, to the nearest basestation via the ultra low-power wireless link. Data from multiple basestations is then delivered over Ethernet or WiFi to the software-based server, which can be integrated seamlessly into the existing hospital IT system or database.

In telecare or home monitoring environments, vital signs data is acquired from the mobile patient and transmitted to a standard mobile device (cellphone or PDA), which acts as a network node. From there, it can be sent over the standard cellular network to the server before being integrated into the hospital IT system. All acquired data can then be made available to hospital staff via the nurse's station or wirelessly to a doctor's PDA or Mobile Clinical Assistant (MCA).

First metre healthcare - System architecture for Wireless Body Area Networks

By converging the IT system onto the individual and bringing the network into the 'first metre', intelligent integrated platforms are creating a unique opportunity for the development of end-to-end telemedicine and health information systems that can meet the rapidly growing need for analysis and decision-making based on real-time data-offering the potential to deliver greatly improved healthcare outcomes at dramatically reduced cost.

As a platform technology, this technology provides a viable cost model for long-term, preventative care that is also compatible with patient lifestyles, ushering in a new era of healthcare opportunities. The ability to continuously and wirelessly monitor makes 24-hour observation and analysis of an individual's response to treatment possible, supporting recalibration of dosage quantity and timings. In future scenarios, by allowing two-way flows of information (for example, an uplink of raw or processed data and a downlink of requests or activation signals), intelligent wireless body monitoring platforms could offer further use in closed loop systems to control drug delivery and maintain key physiological parameters, such as blood pressure, within an optimum range. Adaptive treatment responses are crossing into other fields such as pharmocogenomics, which holds the promise that one day drugs might be tailor-made for individuals, or adapted to each person's environment, diet, age, lifestyle and genetic make-up.

Personalised healthcare, boundless possibilities

As witnessed by the digitisation of the telecom industry, convergence creates unimagined technological opportunities. Today, popular social networking sites such as MySpace and Facebook are already changing the human fabric of the Internet. This evolving social networking model may even open the way to new healthcare dimensions in the future. Aggregating data from these sites or search engines like Google, and making this available or accessible from, or within, EMRs could see the emergence of new online communities that enable people to select medical therapies, personal training or recuperation programmes, and even access lifestyle or rehabilitation mentoring partners.

With a growing focus on low-cost preventative care models, demand for personalised healthcare and continuous body monitoring is set to experience exponential growth. We could well see the emergence of a new breed of service provider organisation set up specifically to deliver integrated patient information and bio-sensor network monitoring services to the professional healthcare and wellness market. These services could incorporate a wide range of solutions, including monitoring, clinical data or alarm services, links to dedicated call centres or SMS and email functions.

Developments in wireless body monitoring are already changing attitudes and assumptions about health and healthcare delivery. The ultimate goal is for ill health to become largely predictable and capable of being managed, with the focus on prevention rather than symptomatic or event-driven therapeutics. This technology is now providing the platform for healthcare professionals to work in an embedded matrix of information, with patients becoming partners in managing their own health.

As we move towards this digital medical future, the trends are very clear: the market opportunity created by a merging of the consumer electronics and healthcare industries is vast; and this is certainly just the beginning of a global healthcare revolution.

Trademarks

Toumaz Technology Ltd. retains title and ownership of the following registered trademarks: Sensium® the Toumaz® logo; and AMxT