Assisted Living a Market and Technology Review

Assisted Living Technology
A market and technology review

Produced by: Life Sciences-Healthcare and the Institute of Bio-Sensing Technology for the Microelectronics and Biomedical iNets March 2012
w:www.inets-sw.co.uk e:[email protected]

Life Sciences-Healthcare
Innovation2Enterprise
i. ABOUT THE AUTHORS Dr Gugs Lushai - Director and Co-Founder of Life Sciences-Healthcare Limited. Specialist in Business Development and Foreign Direct Investment and New Market Entry – 20 years of Science and Innovation support for Private and Public organisations. Promoting links to international markets. Former Head of Bio Sciences for the UK Government and the South West of England Regional Development Agency. The Life Sciences-Healthcare Ltd Team has over 130 years of Life Sciences and Healthcare experience to ensure accelerated business development success. Our main foci include: Medical Technology, especially diagnostic platforms Pharmaceutical drug development through proof-of-concept and phase 1 development Biotechnology exploitation especially from marine resources Funding especially government and international soft-landing packages Dr Tim Cox - Director of Research and Enterprise of the Institute of Bio-Sensing Technology of the University of the West of England. He has over thirty years experience in government, commercial and academic sectors as a technical leader in the development of silicon based microsensor systems for a wide range of applications. The Institute of Bio-Sensing Technology, based at the University of the West of England, Bristol, is a collaborative venture working with research groups and industry in the UK and worldwide. Together we have a strong track record in bio-sensing technology research, which has attracted significant funding from industry, government, European Union and Funding Councils.

IMPORTANT NOTICE This report has been prepared solely for the purpose of conducting an initial evaluation of the proposed growth opportunities for the Assistive Living Technology (“ALT”) markets on behalf of the South West of England Microelectronics and Biomedical iNets. The report does not purport to contain all the information that may be required for a full evaluation of, or business planning for new and potential commercial growth activity in this sector. Analysis and the market opportunity are from reputable sources and are assumed to be correct at the time of publication.

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ii. CONTENTS i. ABOUT THE AUTHORS ....................................................................... 2 ii. CONTENTS ......................................................................................... 3 1.0 INTRODUCTION .............................................................................. 4 1.1 Top Level Definition: Telehealth; Telecare; Smart Homes; Mobility and Orthopeadic ..................................................................... 4 1.2 Who is the Report for: Users; Providers; Deliverers; Researchers/ Developers ...................................................................... 5 1.3 Why do we need Assisitve living: Physical; Cognitive Barriers ...... 6 2.0 MARKET .......................................................................................... 8 2.1 Market Growth in Europe .............................................................. 8 2.2 Drivers: Rising elderly population; Cost of providing care; Low market penetration; Standardisation of healthcare; Rising demand of personalised care ............................................................................ 13 2.3 Challenges: Limited awareness; Profit margins; Unclear reimbursement models; Price competition ........................................ 15 2.4 Opportunities: Market driven growth; Private Funding; Diversification; Interoperability; Reduction in cost; Shift in demands; Digital communication ....................................................... 17 3.0 ASSISTIVE LIVING TECHNOLOGY .................................................. 18 3.1 Sensor technology: Physical; Chemical; Biological ....................... 19 3.2 Actuators: New materials and devices; Actuators and Devices ... 22 3.3 System Integration: Input; Output; Under development ............ 23 3.4 Wireless Sensor Networks: Home; Body based ........................... 24 3.5 Closed Loop Control Systems: Measurement; Responses; Input. 27 3.6 The Design Process: Bespoke; Inclusive ....................................... 28 3.7 Assistive Robotic Devices: Physically Assistive; Social ................. 29 3.8 Emerging Technologies: MEMS/ Smartphone Apps; Low Powered Wireless; Standardised Platforms ....................................... 30

3.9 Ethical Issues: Patient Interest; Decision Making; Security and Access.................................................................................................. 31 3.10 Regulatory considerations: MHRA; CE; 510K; Standards .......... 32 4.0 FUNDING SOURCES FOR ALT DEVELOPMENT ............................. 35 4.1 European Union (EU): AAL/ Framework programs ...................... 35 4.2 UK Government: Department of Health: NHS (Procurement/ Reimbursement)/ NHIR (i4i); Business Innovation Skills: TSB (ALP; DALLAS; Smart Awards; SBRI; Collaborative R&D)/ Research Councils UK (R&D): EPSRC/ ESRC/ MRC (CASE Awards)/ MRC (LLHW.35 5.0 HOW ARE PRODUCTS CHOSEN, SPECIFIED AND PAID FOR ........ 38 6.0 STRATEGIC COMPANIES ............................................................... 42 Top Five Companies: A&D Medical/ Tunstalls/ OBS Medical/ Tynetec/ Tanita ................................................................................... 42 7.0 ROAD MAP ................................................................................... 44 7.1 Regional Road Map: HEIC-SW (Community Solutions - DALLAS bid); Medilink SW; biomedical and microelectronics iNets ............... 44 7.2 Industry Overview ........................................................................ 45 "Market MapTM" ................................................................................. 46 8.0 RECOMMENDATIONS & CONCLUSIONS ...................................... 47 9.0 APPENDICES ................................................................................. 48 7.1 References................................................................................. 48 7.2 Acknowledgements ................................................................... 49

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1.0

INTRODUCTION Assisted living is perceived differently in various parts of the world and comprises various devices. The devices described by definition below form the basis of the market analysis and revenue forecasting for ‘Assisted living technologies’ (“ALT”) in this study. This study focuses only on the devices “technology” market and briefly describes but does not quantify the services market. The macro-level landscape for ALT in Europe is against a back drop of economies of Europe struggling to reconcile the demand for social care with public funds available, especially after the onslaught of the continuing recession. Therefore, Governments are keen to adopt affordable alternatives that are innovative, technologically advanced and able to address the problem using limited resources and reduced costs in healthcare services. Europe is witnessing an explosion of an ageing population, and this is posing a challenge for the policy makers in terms of social-security systems. Across European countries, the retirement age is rising, putting higher pressure on governments to provide the right living conditions for the elderly population to facilitate the population’s independent living. Along with the increase in life expectancy, there is an increase in the prevalence of mental and physical health ailments among the ageing population. This demographic shift in Europe paves the way for technological innovation to efficiently enhance the living conditions of the aged and physically impaired. Broadband communications, networking capacity, integration of devices and services and other communication capabilities allow multimedia communications between homes and community centres. However, there is a difference in the usage of such technologies among various age groups of end users. Hence, market demand impacts innovation and improvements of technology and together these are an important stimulant for growth for ALT in Europe. It is against this socio-economically weighted background that the nascent market of ALT is in its ascendency.

1.1

Top Level Definitions Assisted Living Technologies has no specific definition and has different meanings in different geographies. For the purposes of this report it implies the use of instruments, apparatus, appliances, or materials, including the software necessary that helps to assist the elderly (people aged above 65), and those who are physically and cognitively impaired in fulfilling their daily activities towards independent lives and an improved quality of life. It is a nascent industry so application and technology is continually being updated and has overlap in definition and implementation. In brief the technology areas/types that are commonly associated with ALT include: Telehealth devices that use information, communication and sensor technologies to monitor and assist people who have conditions. Some examples for these devices are blood pressure monitors and dementia roaming systems. Telecare is the use of information and communication and sensor technologies to provide
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social care and support to people to help them live independently away from the hospitals with settings consistent with their needs. Smart Homes retrofitted homes with automated building controls that are integrated to facilitate least manual effort in domestic tasks, thereby improving comfort and lifestyle, especially for the elderly and disabled. Mobility/Orthopaedic aids to help users to walk or move from place to place. Basic examples include crutches, canes, walkers, wheelchairs and motorized scooters etc., whilst specialist surgical intervention includes dealing with problems that develop in the bones, joints, and ligaments of the human body impacting on the quality of life of the user. It is important to note that a diversity of devices are used in the telecare, telehealth, smart homes and mobility/orthopaedic markets, but only the types that are used for monitoring, communicating and facilitating everyday tasks, i.e. catering predominantly to the elderly population are described in this report. Hence, many devices and surgical interventions including those used for the young and physically impaired are not detailed here.

1.2

Who is the Report for The report is designed to provide: An introduction to some of the patient conditions which may benefit from ALT – current and future. A description of some of the technologies currently available and those under development which form the building blocks for ALT. Users of and markets for assistive technology and the drivers behind these markets. A description of how a patient will be prescribed a particular aid and how the technology will be paid for. Therefore the report will be useful for senior managers considering how to understand the assistive market and also technical, medical and nursing practitioners at the working level. In particular: Companies considering deploying their technology from an existing market, e.g. security, into the assistive market. Companies wishing to understand the spectrum of issues, i.e. medical, social, technical and commercial, involved in developing an assistive product. Medical and community healthcare workers who want to have an over view of current and emerging assistive technologies. Technical experts who want to appreciate how technology can fit into the patient care pathway.

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1.3

Why do we need Assistive living Ambient assistive living technology may be employed to improve the quality of life for patients1 with a wide range of conditions which act as a barrier to quality of life. Principal barriers may be classified as primarily cognitive or physical in nature: Physical barriers: loss of physical function, e.g. lack of mobility or failing eyesight and hearing Cognitive barriers: loss of cognitive function, e.g. memory loss in Dementia. These conditions may also be associated with psychological conditions such as depression. Patients may often also be lonely and experience loss of independence and control. Reductions in cognitive and physical functions may arise from long term life limiting illnesses such as diabetes and respiratory diseases such as chronic obstructive disease (COPD) and asthma. Thus the control of such diseases is also a key part of the assistive environment. Treatments for these conditions may also impact on physical and cognitive abilities with some drug therapies giving rise to an increased likelihood of falls. Hence the total care package not only needs to address physical and cognitive aspects but also other aspects such as medical treatment, loneliness etc., whilst respecting the needs of the patient, i.e. their wish to feel respected and in control. Figure 1 Conditions may be represented as a combination of physical and cognitive impairments of different severity

We could represent a patient’s condition in terms of severity of impairment of the cognitive
1

Here we define patients as the person with the condition and carers as anyone who is supporting the patient. Carers include family and friends and healthcare professionals.
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and physical components (Figure 1). As an example, locked-in-syndrome is a condition in which there could be a high level of cognitive function but an inability to speak, for example as the result of a car accident or stroke. Tracking the movement of the eyeballs is a technology which allows one route, albeit slow, to communicate in the case of total lockedin- syndrome. Some of the common diseases of the aging population are represented in the figure such as, Dementia. This is characterised by the development of multiple cognitive deficits, including impaired problem solving, impaired organisation skills and altered memory. The most common of these is Dementia of the Alzheimer’s Type (DAT) which may have a gradual onset and progressive decline. As the disease progresses, people with Alzheimer’s will need more support and will eventually need help with all their daily activities. The symptoms of Parkinson’s disease include tremor, rigidity and slowness of movement. In the case of Lewy Body Dementia, symptoms include frequent falls in the early stage. Other symptoms may include Parkinson’s type tremors. The intensity of the symptoms may also fluctuate. Assistive aids are being developed to overcome the effects of tremor, e.g. software is available to remove the effect of tremor whilst controlling a computer mouse. It is possible to represent the progress of a patient’s condition as a trajectory in cognitive and physical space. The progress of Dementia could follow a number of possible paths – three are shown in Figure 1. Alternatively a fall victim could suddenly find themselves with a low level of physical mobility whilst maintaining a high level of cognitive acuity. Assistive aids such as a Zimmer frame, wheelchairs and devices to get in and out of a bath could be used initially and then discarded after a recovery period. If the user does not recover, then more permanent aids such as a mobility vehicle and stairlift might also be necessary. The patient might also benefit from technology to alert a carer to a fall or a change in stability of movement patterns. The use of such an aid might also alleviate the fear of a second fall. As described in section 5, the patient will often be assisted by a Team of carers including family and healthcare carers and social services. Key amongst this Team would be Occupational Therapists who are skilled in the use of assistive aids. This Team would use assistive technologies as just one of the toolsets available to support users. The introduction of ALT is always undertaken with sensitivity and discussion. The rapid deployment of an assistive aid might solve one problem whilst emphasising a loss of function thereby leading to awareness of loss of independence with associated depression. As a consequence of the subtleties and diversities of Assistive Living, it is being referred to as “Independent Living” (a term that will likely gain in popularity as it implies release rather than dependence).

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2.0

MARKET The European countries have underlined the importance of using information and communication technology in healthcare primarily to tackle the growing elderly population. Though assisted living is a niche market, it still holds significant potential to grow. Acceptance of this market is high in countries like the United Kingdom, Germany and Scandinavia, which are expected to be the power houses of growth for the ALT market. The current ALT market scenario is highlighted in Figure 2. It is a nascent market in its ascendency, but it has many hurdles to overcome. Details of market growth projections, drivers, challenges and opportunities are described in this section. Figure 2 Schematic of the overall ALT market scenario (2009)

2.1

Market Growth in Europe - special focus on the UK The ALT market in Europe is fragmented with skewed market competition and high growth opportunity. The market was valued at $154.7 million in 2009 and is estimated to grow to $525.7 million by 2015. This growth will be attributable to four major markets and these are respectively Germany, UK, France and Scandinavia (see Figure 3). Figure 3 Pie Chart describing ALT market segmentation (2009)

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Germany and UK contributed more than $94.0 million with market shares of 32.9% and 27.8% respectively, whilst France and Scandinavia made a significant contribution of $47.6 million with market shares of 16.0% and 14.7%. This major contribution was mainly an outcome of high adoption rate and receptiveness for such technologies the high percentage of an elderly population. The other geographies (Italy, Spain and Benelux) made very limited contribution, $13.3 million and market share of 8.6%. This was due to factors such as low penetration of ALT and a relatively low population of the elderly against the respective national totals. Table 1 European ALT market segmentation and projected growth (2007-2015)2
Country
Germany UK France Scandinavia Italy Spain Benelux

% Market
2009 32.9 27.8 16 14.7 4.1 3 1.5 100

Revenue (2007-2015)
2007 $24.7 $20.5 $13.8 $7.8 $3.8 $2.6 $1.5 $74.7 2008 $36.4 $30.4 $20.4 $14.5 $4.9 $3.5 $1.9 $112.0 2009 $50.9 $43.0 $24.7 $22.8 $6.4 $4.6 $2.3 $154.7 2010 $65.5 $55.5 $31.8 $31.3 $7.8 $5.7 $2.8 $200.4 2011 $81.9 $69.3 $39.7 $40.6 $9.3 $6.8 $3.3 $250.9 2012 $100.3 $84.7 $48.5 $50.9 $10.9 $8.1 $3.8 $307.2 2013 $120.4 $101.6 $58.3 $62.1 $12.7 $9.4 $4.4 $368.9 2014 $142.8 $120.4 $69.3 $74.4 $14.7 $10.9 $5.1 $437.6 2015 $171.9 $141.0 $85.8 $90.9 $17.4 $12.9 $5.8 $525.7

The market growth of ALT in Europe (see Table 1) mainly depends on the adoption rate/market penetration rate of these technologies. This in turn is influenced by factors such as receptiveness towards technology, price affordability and product customisation. The market dynamics seem favourable to ATL and are expected to influence a CAGR of 22.6 % between 2010 and 2015. A large number of opportunities are expected to attract new market participants and aid in the market development. Most of the above mentioned revenues are expected to come from countries like Germany, the United Kingdom, France and Scandinavia, which are the big markets for assisted living technologies in Europe. ALT in institutions is widely prevalent due to the large number of community centres in use. Many aged people living in community centres and social care homes enjoy the benefits of personalised and regular care. The assisted living technologies market in institutions was valued at $115.5 million in 2009 and is expected to grow at an average rate of 20.2 % per annum between 2010 and 2015. The healthcare services of Germany, the United Kingdom, France and Scandinavia are again leaders in this market (revenues in millions (market share) respectively: $34.8 (30.1%), $35.1(30.4%), $18.2 (15.8%), $16.8 (14.5%)). ALT in residences The assisted living technologies market is shifting its focus towards homebased services and care. The assisted living technologies market for residences was valued at $39.4 million in 2009. Together Germany, UK, France and Scandinavia are again a huge market for home care assisted living (revenues in millions (market share) respectively: $8.3 (21%), $15.8 (40%), $6.5 (16.6%), $6.0 (15.3%)). The ALT market for residences is expected to grow at a CAGR of 28.5 % between 2009 and 2015 and reach a market size of $177.2 million in 2015. ALT market in the UK The United Kingdom is one of the fastest growing markets in Europe for ALT, as the importance and advantages of these technologies are already recognised by the
2

European markets for Assistive Living Technologies, Frost and Sullivan 2010
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Government. This has resulted in significant improvement in the adoption rate of ALT in healthcare. The market is expected to witness a CAGR of about 21.9 % from 2010 to 2015 and to achieve revenues of $141.0 million in 2015. Comprehensive deployment of pilot projects and government funding (see later) and the elder population growth3 described in Box 1 below are together the reasons behind this market growth, as the government recognises the need for such preventive care for the elderly. BOX 1 The United Kingdom is going through an extraordinary demographic transition. The first ‘baby boomers’
are now drawing their pensions and the number of people over State Pension Age are overtaking the number of children3. The bullets and tables below summarise the situation in the UK (2006): 20.5 million People were aged over 50, up 690,000 since 2002 11.3 million were over State Pension Age (SPA), up 420,000 since 2002 7.2 million women were aged 60 and over 9.7 million people were aged 65 and over, of whom 4.2 million were men and 5.5 million were women 2.7 million were aged over 80, up 220,000 since 2002 Table 2 Population distribution (2006) Country
England Scotland Wales Northern Ireland

Population over SPA
9,462,000 983,000 615,000 284,000

Table 3 Regional distribution of people over State Pension Age (2006) Government Office Region
North East North West Yorkshire and the Humber East Midlands West Midlands East London South East South West

Population over SPA
500,800 1,295,300 962,900 833,600 1,027,400 1,098,400 1,034,700 1,590,000 1,119,000

Table 4 UK population growth projections 2018 Growth over the next 10 years
Over 50s Over 65s Over 80s Tot. Pop. 4.1m (20%) 2.6m (27%) 788k (29%) 5.3m (9%)

2028 Growth over the next 20 years
6.7m (33%) 5.1m (53%) 2.3m (85%) 9.4m (16%)

3

Older people in the United Kingdom - Key facts and statistics, Age Concern’s Policy Unit, 2008
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Figure 4a,b,c (clock wise) describes the Medical Technology Industry sector segmentation by a) Number of Employees, b) companies and c) turnover in the UK (2009). The “stars” describe market segments closely associated with ALT.

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Figure 5a,b,c describing the Medical Technology Industry sector segmentation by UK regions: a) Employees, b) companies and c) turnover (2009)

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Medical Technology (MT) sector in the UK by employees, companies and turnover4 gives an indication of the place of the ALT segment in the overall MT sector. As Invitro Diagnostics, Orthopaedic Devices, Ophthalmic Devices, ICT+E-health, Mobility Access and Implantable Devices are all closely related to ALT, the importance of size and scale for the ALT market segment is demonstrable not only to the national but also the South West regional economy. The sector can be described by 21 industry segments (Figure 4) and 12 significant geographies (mapped by local government zones, Figure 5). In brief an overview by employees, companies and turnover illustrates: Employees: The total employment within the MT sector is just over 52,000, which represents 13% of all EU medical technology employment, second to Germany with 26%. The Top 5 segments for employment contain 41% of all employees in the sector and these are; professional services, in-vitro diagnostics, single use diagnostics, wound care and orthopaedic devices. The ALT market is just after these and employs c. 3500. The employment pattern across the UK geographies shows Yorkshire and Humber as the largest employer within the MT sector, with 12% of the UK total. The South West being described as the fifth, with just under 5000 employees. Companies: There are 2,771 companies (mostly Small to Medium Enterprises, (SMEs)) in the MT sector. The professional services and consultancy sector contains the most companies followed by those providing products in ALT (c. 10% of all companies) and re-usable diagnostics equipment segments. The West Midlands, followed by the East Midlands and the East of England have the highest number of companies in the MT sector, with the South West being 7th in size. For ALT, the top five regions are in order of size: West Midlands, Yorkshire and Humber, East Midlands, South East and the South West. Turnover: The combined annual turnover based on the latest available company information from these 2,771 companies is £10.6 billion (20094). Wound care management, in-vitro diagnostics, orthopaedic devices and single use technology are the largest by turnover, all with just over £1 billion in sales. Between them, these four segments make up 40% of the total UK turnover. According to these figures the ALT market is worth c. £500 million5 a factor of ten greater than that described in Table 1. Ranking the total turnover by regions shows that the South East and East of England have high turnovers, together representing a third of the UK total. The South West is ranked 6th, but this does not take into account the significant turnovers from multinationals trading within the region.

2.2

Drivers Market drivers are factors that induce the market growth in any region. These factors could be anything, which yield a better market expansion and generate high revenues.

4

Strength and Opportunity: The landscape of the medical technology, medical biotechnology and industrial biotechnology enterprises in the UK, Her Majesty’s Government, 2009 5 Eucomed Medical Technology Brief, May 2007

Rising population of the elderly By 2015, there will be 75 million people above 65 years of age living in Europe, putting enormous pressure on the working and independent population. Assisted living technologies are identified as the solution to reduce this social issue on the working population, which will indirectly benefit the economic activities of the respective regions. Figure 6 Schematic of some of the market drivers for the ALT market2

The increasing elderly population is laying more emphasis on preventative medicine and healthy living of the elderly, making the elderly population the most important market driver for ALT in Europe. The increase in the elderly population is likely to drive the need for customisation of product and technology development. Cost of providing healthcare A skewed demographic with an ever increasing elderly population is impacting on the European Governments to invest into affordable techniques that could provide practical solutions to the growing population. These investments are helping bring in innovative techniques to the elderly population that needs assistance with vital daily activities. Low market penetration ALT has not penetrated deeply into the market and low adoption rates are the evidence for this. Current levels of low adoption show the untapped potential of this market making Europe the most lucrative geography for ALT versus North America and Asia. With better marketing and a clearer road map of what is out there and improvisations and customisation of technology, there is an expected increase in the adoption rate. Similarly, innovation in technology and simpler to use and common platforms are likely to make the prices more affordable, which is expected to attract more elderly users to adopt this technology. Current low market penetration levels, due to the market being in the early stages of development, will offer huge opportunities for the market participants. This growth in the market will take place in parallel with the growth of the product development and innovation in technology. The market participants are expected to leverage on this scarce
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competition and low adoption levels to ensure a better market share in the future. Healthcare systems are being standardised across Europe through better legislation and regulatory reform. Especially, important areas of innovation and technical standardisation are being given high importance. Necessary improvement of healthcare infrastructure standards is driving the growth of ALT market by rapidly increasing adoption rates among the elderly. A standardised approach in the delivery of ALT in countries like the United Kingdom (UK) are a having a positive impact on the market. Standardisation of vendor responsiveness to the elderly has developed a trust in the delivery model among the aged, helping the take up and improving adoption rates. The requirement to develop networking standards for ALT is parallel to that of the need to standardise regulation. Such standardisation of technology, equipment and regulations will help in reducing the price of the sensors and the equipment on the whole. This in turn will help in driving the market growth for ALT. Personalised solutions for users to suit their individual demand is a pertinent driver for ALT. Due to increasing age ratios in population demographics and decrease in independent population, there is a growing emphasis on personalised solutions and preventive technologies. The elderly population in Europe is showing increasing receptiveness to adopt technologies that ensure personal safety and easy operation. As assisted living offers complete managed care and personalised services, there is a boost in the growth of the market for these technologies. With increase in population, the managed healthcare services and personalised care are gaining high importance in European countries. The ALT market participants are expected to capitalise on this opportunity to influence the growth of the market. 2.3 Challenges Industry challenges are issues, which influence the industry development and business development of the industry participants. These challenges are economic trends, end-user issues, government regulations, marketing strategies, competitive structure, new opportunities, and market threats. There is limited awareness about the benefits of using assisted living technologies, as the target audience for these technologies is the elderly. There has been no statistical evidence on the benefits of adoption of such technology, making it a weak argument for the market users. Increasing government participation and initial results from the pilot research projects are likely to help the market participants in the future. Current market conditions offer limited market or technology-specific knowledge and information to the end users, making it unattractive for them to adapt to such technology. Awareness levels are likely to improve in the future with improving healthcare standards and reimbursement models. Profit margins in the assisted living technologies markets are low, making it unattractive for the market participants. Low adoption rates, unclear standards and procedures and low growth rate due to the market being in the early development stage are influencing the profitability of the technology and product suppliers.
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Figure 7 Schematic of some of the main market challenges for the ALT market2

The entire value chain will witness higher profits when the market develops into a matured one and develops standards to ensure profitability for the suppliers. This scenario is likely to change in the near future, with improved product development and increasing adoption rates; the receptiveness towards such technologies is expected to make positive projections for profits in this market. High costs in delivering the products to the end user, supply chain management and costs involved in innovation and customisation of products and services are the main causes for low profitability of ALT. Unclear reimbursement models and policies are reasons behind the low adoption rates in Europe for assisted living technologies. Across Europe, there is very limited information on the reimbursement patterns for the adoption of ALT. This situation is likely to improve in the future, with improvement in healthcare standards and clear policies from perspective governments. Assisted living technologies are expected to have clearer reimbursement models as early products establish themselves in the healthcare market. Increasing competition, especially in terms of price. Though there is limited competition due to the low awareness levels currently, the addressable market is low. This leaves very limited scope for the market participants to expand. Price is an important reason behind low penetration, leaving limited room for the vendors to increase the price. Competitive pricing is almost a mandate in this market, affecting the profitability of the market participants from day one.

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2.4

Opportunities Industry opportunities are aspects which will promote the accelerated development of the industry and business development of the industry participants. Government policy and support are central to the accelerated establishment of this new industry. And Europe has been coordinated in its approach with for example the establishment of Ambient Assisted Living (“AAL”) - a joint programme taken up by EU to enhance the quality of life for the elderly through effective use of information and communication technology (ICT). The increase in the elderly population is driving the funding for such initiative, as it not only poses a challenge, but also provides new opportunities for social and healthcare providers. This and national programmes of this type is giving the boost towards investment in ALT and also helping the market to have accelerated growth. There are significant trends that will qualify the growth in this decade2. In brief these are: Market Driven Growth Increased private participation will lead to higher competition, and the free market will drive the growth instead of government-funded projects. Private funding will rapidly increase and overtake the government funds. Diversification Strong market participants will expand into other lucrative regions, and there will be large-scale plans under execution. Interoperability Equipment is likely to become globally interoperable and will use open platform software to enhance connectivity. Reduction in Costs As an outcome of high demand, the cost of equipment is likely to drop by 2020. Shift in Demands There will be a vast expansion in product portfolio and the aged population are likely to change their demands. There will be specific suppliers for the variety of equipment. Digital Communication The ALT market is likely to adopt c.100% digital communication and infrastructure for effective services to the elderly.

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3.0

ASSISTIVE LIVING TECHNOLOGY In recent years, there have been significant advances in many aspects of the technology base required to develop ALT. The drivers behind these major advances have been primarily to address markets other than assistive living, e.g. small sensors for the automotive industry, the detection of chemical and biological entities for defence, lightweight functional materials for aerospace. However, assistive living is now poised to exploit and to benefit from these technologies. The most significant of these include: Lightweight materials with improved engineering properties relative to traditional materials such as stainless steels, e.g. materials containing carbon fibres and new materials containing carbon nanotubes Smaller, cheaper and more sensitive sensors to measure a wide range of physical parameters. For example, accelerometers and gyroscopes developed partly for the automotive industry which are now appearing in products such as the Apple i-phone 4 and Nintendo Wii Imaging technologies, i.e. cameras which detect radiation not only in the visible part of the spectrum but also at other wavelengths, e.g. in the infra red parts of the spectrum to image in the dark and for temperature measurements Sensor devices to measure chemicals, i.e. small molecules, in either air or liquid with increasing specificity and sensitivity, e.g. at the level of sub parts per billion. In the medical field, the most all pervasive sensor is that to measure glucose in blood for the management of diabetes Sensors to measure biological entities, such as bacteria which might cause infection, on surfaces and in blood and water, and also biomarkers which are early indicators of disease, e.g. cancers Sophisticated electronics to condition the signals from the sensors Mathematical techniques such as signal processing and pattern recognition to extract the maximum amount of useful information from a range of sensors with a minimum volume and power overhead. Also the fusion of data from a number of sensors to extract optimal diagnostic information Based on the above technologies, a range of actuators – devices that do things are also possible. These range from the opening of a window for environmental control to an implanted pump to deliver insulin for the control of diabetes (section 3.2) User friendly methods of interfacing between people and technology, e.g. smartphones, haptic displays and voice recognition (section 3.3) Wireless communications that offer wireless connectivity within the home in the home, e.g. to a smart hub and communications technologies to link the home to the outside world, e.g. to a carer or healthcare professional. These include the internet and mobile phone technology (section 3.4)

The combination of sensors and actuators with communications technology offers the
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possibility of closed loop control, either by the user, autonomously or under the control of a remote carer or healthcare professional (section 3.5). The combination of these technologies to produce an effective assistive technology will be most effectively achieved within an inclusive design methodology which puts the direct user and any carers at the heart of the design process (section 3.6). Trialling of a new product at every stage of the development process with users will be central to a production of a device which can be sold effectively into the ALT market. In section 3.7 we describe recent advances in robot technology which offer the possibility of robots to both carry out tasks and also to provide a level of social interaction. In section 3.8, some emerging and potentially disruptive technologies are described. Finally, at the end of the section 3, brief mention is made of ethical (section 3.9) and regulatory issues (3.10). 3.1 Sensor technology A sensor is a device which provides a useful output in response to a specified measurand. Within the assistive environment, we may think of measurands as either physical, chemical or biological in nature: Physical measurands include temperature, movement, pressure and electrical fields. Chemical measurands include glucose in blood, blood gases and volatile organic compounds in body fluids such as breath, urine or faeces. Biological, e.g. the identity and number of bacteria present in a wound and biomarkers in blood for a disease, e.g. biomarkers for cancer or for a heart attack. Some of the measurands of interest to the assistive environment are listed below together with some of their applications in the assistive living market. Sensors for physical measurands. There are now many commercially available sensors for physical measurands. Many of these are MEMS6based (Micro-Electro-Mechanical Systems). MEMS has evolved from the technology used to manufacture silicon integrated circuits. The use of IC technology allows three dimensional structures to be fashioned to tolerances of a few nanometres in silicon and also in a wide range of other materials such as metals for electrodes. MEMS technology now offers sensors for acceleration (3 axis), rotation, pressure and sound (e.g. the microphones currently used in smart phones). The sensors are typically of dimension c. 100 microns (the width of a human hair) and are available in small packages combined with signal processing electronics for a cost of c. $1. The way in which combinations of these sensors may be used to monitor daily activities such as movement, cooking, washing, getting out of bed, exercising and sleeping are reviewed by Hein et al7.

6 7

Fundamentals of microfabrication and nanotechnology , Marc J Madou (2011). A Hein et al, Monitoring systems for the support of home care, Informatics for Health and Social Care, Vol 35, p 157 – 176 (2010).
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Table 5 A selection of the physical measurands that may be used in assisted living
Measurand Temperature Acceleration Examples of use Environmental control for comfort in a smart home; Human body core temperature Fall monitor – rapid acceleration and a ‘crash’; Movement of limbs in assistive living or for orthotics; Control of a powered wheelchair Blood pressure; Pressure pads under a bed to monitor movement Stability control system for mobility scooters; Fine control in robotic systems Implanted measurement of ECG for pacemakers; Measurement of EEG and ECG from outside the body. Microphone to detect sound as a monitor and also for speech input of commands; Microphone for cochlear implant To measure light levels to decide when to turn on lights and close curtains; To monitor movement, e.g. by interruption of a light beam Cameras are available for daylight and night time operation (infrared); Machine vision systems can provide significant information ranging from simple movement to an analysis of facial expressions.

Pressure Rotation, orientation Electric fields / potential Sound / acoustic Optical radiation

2D and 3D images

Sensors to measure chemical measurands. Some of the chemical measurands of importance in the assistive living environment are listed below. Table 6 Chemical measurands of interest in assistive living technology
Measurand Vapour Example Carbon dioxide levels for environmental control. Levels of carbon monoxide in breath. Head space analysis of body fluids as a possible way to diagnose disease or infection. Measurement of carbon monoxide to warn of burning food or fire. Measurement of methane to warn of gas leaks. Glucose level in blood Cholesterol levels Blood gases for medical diagnosis, e.g. in intensive care. Oxygen in blood via pulsed oximetry.

Small organic molecules in solution Gases in solutions

The technologies to measure gases at high concentration, e.g. carbon dioxide and carbon monoxide are mature. Pulsed oximetry is also available as a commercial product. Current technology developments include the production of electronic noses to measure vapours at low level, e.g. in the headspace of body fluids. Invasive glucose sensing in which a small drop of blood is analyse using a biosensor is well established. New technologies are being developed to non-invasively measure glucose levels, e.g. by absorption of infrared radiation of a specific wavelength.
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Sensors to measure biological measurands. Table 7 Biological Measurands of interest in assistive living technology
Measurand Hormones Viruses Bacteria Proteins Examples Insulin – important in diabetes; Measurement of thyroid related hormones. Norovirus – gastroenteritis; Testing for specific strains of influenza Food spoilage; Infections in wounds; General infections, e.g. for diagnosis of sepsis or a respiratory infection. Markers for infection, e.g. c-reactive protein – a general marker for infection; Troponin – to assist in diagnosis of a heart attack.

Much of the technology currently in use to measure biological measurands is based on laboratory equipment and is not currently in a form for home use. Exceptions include devices such as lateral flow devices for pregnancy testing. There are currently significant research programmes to develop bio-sensing technology for point of care (POC) testing and for home use. This technology will undoubtedly allow home testing for a wide range of biomarkers and sources of infection in the near future. See, for example, papers in the Royal Society of Chemistry Journal: Lab on a Chip8. Summary of sensors. Many sensors are already being used in assistive technology. With the exception of blood glucose testing, these are currently mostly physical in nature, e.g. fall monitors. In the near future, new products will be appearing for home use: Point of care tests for the diagnosis of infections and infectious disease. Patient friendly systems to measure biomarkers for the management of long term chronic diseases with a minimum of intervention from clinicians, e.g. chronic obstruction pulmonary disease (COPD). Body worn devices, e.g. contact electrodes for ECG monitoring. Implantable wireless devices for diagnostics and therapy. Activity sensors for monitoring exercise regimes, e.g. detailed measurement and recording of compliance. Sensors integrated into clothing – the outputs from the sensors may be either stored for later download or wirelessly communicated to a hub.

8

http://pubs.rsc.org/en/journals/journalissues/lc
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3.2

Actuators – devices that do things Actuators are defined here as devices that do something – usually in response to an electrical input. Within ALT, they traditionally comprise: motors to open and close windows for environmental control in a smart home electrical motors as used to drive and control wheelchairs and for stair lifts relays to switch household appliances on and off in robotics, a wide range of actuators are used to give movements to give fine control of assistive devices, e.g. for self-feeding New materials and devices are giving rise to new actuator technologies: Piezoelectric materials which move in response to the application of a voltage offer compact actuators, e.g. for haptic feedback and for vibro-acoustic interfaces with the user. Early piezoelectric devices were mostly made from rigid ceramic materials. Electro-active polymers are flexible materials which change shape or size in response to a voltage, e.g. polyvinylidene fluoride (PVDF). Such materials are being developed to address the challenge of producing artificial muscle type devices for assistive applications. Micro-technology, e.g. based on MEMS, is spawning a range of micro-actuators such as pumps and valves. These are finding applications in drug delivery systems, e.g. for insulin and complete miniaturised lab on a chip systems (LOCs) for point of care diagnostics7. LOCs offer the potential for complete micro-analysis systems to take in a small sample and analyse it for a variety of analytes, such as bio-markers for a disease or infection. Combining actuators with sensors offers a further level of sophistication in actuator functions. Examples include: Collision avoidance control for wheelchairs. Measurement of acceleration and rotation of a wheelchair allows control of actuators to stabilise any undesired movement. This technology is also widely used in the automotive industry. Measurement of bite pressure on a spoon for a feeding robot. Electrical inputs to the human nervous system can also result in actuation of muscles, e.g. for functional electrical stimulation (FES). In this way, the body’s own actuators can be used, e.g. where neural pathways have been lost due to a stroke or accident which caused a spinal cord injury. As examples, FES is used to treat foot drop in neuro-prosthetic devices and also to restore bladder and bowel function.

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3.3

System Integration: Man Machine Interface The user will need to interact with the assistive system to: Input information and instructions Receive feedback, instruction and social interaction. The communications interfaces will need to be designed to match the cognitive and physical skills of the individual user and the complexity and type of information that is to be transferred. Methods of input which are available and under development include: Speech input: a microphone combined with signal conditioning and speech recognition software is needed. This could either be for free speech or for a defined set of instructions. The microphones could be incorporated into sensor motes placed around the house or worn by the patient Non speech input, i.e. pre-defined sounds could also be used. Gestures and movements – these could be recognised via camera systems or by movement sensors, e.g. by a worn accelerometer. For computer systems, input could be via a keyboard, mouse or touch screen. Handwriting recognition. Tactile sensors which mirror the behaviour of the receptors within the human hand Haptic technology which gives feedback to the user. The touch of the user is measured using e.g. pressure sensors. Feedback is then given via actuators based on, for example, piezoelectric materials. Some of the output methods include: Visual displays on a screen Acoustic outputs – these are preferred by many patients. These could be either speech or non-speech. Tactile – e.g. vibration of the skin to alert the patient to a forthcoming event or as a reminder. Light – patterns, intensity or hue are used to represent different results or events. For example a reminder to take a medicine or that it is time to eat or have a drink. Video input and output can provide a very important level of social interaction to alleviate a feeling of isolation and loneliness. Visual communications can also be effective in a noisy environment. Boll et al9 describe the use of a range of stimuli to communicate a reminder to the patient, e.g. to prepare a meal or to take a medicine. The techniques used include vibrotactile devices, sound – both speech and non-speech, and lighting effects.

9

S Boll Development of a multimodal reminder system for older persons in their residential home, Informatics for Health and Social Care, Vol 35, p 104 – 124 (2010).
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Some techniques under development include: Brain Computer Interface (BCI): electrical signals representing cognitive activity in the brain (electroencephalography) are detected using non-invasive electrodes placed on the scalp. Implanted arrays of microelectrodes which physically record the isolated activity of individual neurons are also being developed. Such direct interfacing with the central nervous system may offer solutions for those with severe neurological disease (See Figure 8). Figure 8 Micro needle array for direct neurointerfacing

3.4

Wireless Sensor Networks Advances in wireless communications combined with low power sensors have in recent years led to the emergence of truly wireless networks of sensors10. As an example, Vergados11 discusses many of the issues in implementing such a system in an assistive environment in the ‘INHOME’ project. The integration of both sensors for health monitoring and sensors and actuators for the control of appliances such as washing machines is discussed. A recent review by Bal et al12 provides details and references to a number of projects developing smart home technologies are A variety of communication hierarchies are also discussed. Home sensor networks. Wireless technology allows sensors to be placed anywhere in the home, including on moving objects such as exercise systems based on Ninetodo’s Wii devices, and also to be worn by the patient as they move around the home. A body area sensor network is also shown on the patient which collects, processes and transmits data from wearable and implanted sensors.

10

C F Garcia-Hernandez et al, Wireless sensor networks and applications: a survey, Int. J. Comp Sci and Net Sci, vol 7, p264 - 273 (2007). 11 D Vegados Service personalisation for assistive living in a mobile ambient healthcare-networked environment, PersUbiquitComputVol 14, p 575-590 (2010). 12 M Bal et al Collaborative smart home technologies for senior independent living: a review, Proc of the 2011 th 15 international conference on computer supported cooperative work in design, p 481-488 (2011).
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Figure 9 Schematic of a wireless sensor and actuator network in the home

The output from these sensors is routed wirelessly to a base station which in turn may be connected to a PC which is then the gateway for onward transmission outside the home, e.g. via the internet or via a wireless communications technology. The information from the sensors may be displayed in a form which is useful to the user via an appropriate graphical user interface (GUI). Actuators may also be present in the system and be wirelessly linked to the base station. The actuators will be able to carry out operations as instructed via a wireless link under the control of the PC. The information may also be transmitted outside the home for consideration by a healthcare professional, a carer or relative or via a monitoring service. This may result in a decision to carry out a task via remote use of an actuator in the home. Figure 9 depicts a home network and shows three distinct types of sensors: Sensor motes which are now available to measure a variety of physical parameters. Cameras – these may be hard wired to the base station or connected wirelessly Sensors worn on the body (a body sensor network) which may measure a wide range of physical, chemical and biological measurands. A sensor mote will incorporate sensors, a microprocessor, memory and a wireless transmitter. Sensor motes are available for a wide range of parameters13, e.g. acceleration, rotation, temperature and sound. Wireless communication may be via protocols based on IEEE815.42, e.g. Zigbee. This is often the most power hungry part of the sensing process. Thus, a mote may be configured to process the signals on the mote and to wirelessly send an ‘OK’ at regular intervals, only sending significant data when an alarm event is detected. The use of energy harvesting techniques will also contribute to the power budget.

13

MEMSIC offer a range of MEMS sensors packaged into mote format (http://www.memsic.com/products/wireless-sensor-networks.html - accessed 9 March 2012).
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Body sensor networks14 offer the possibility of measuring not only a range of physical parameters such as movement but also physiological parameters to monitor the state of health of the patient during the course of the day. The sensors may communicate directly with the base station, e.g. via protocols based on IEEE815.42 (e.g. Zigbee). Alternatively, the information from each of the sensors may be collected via a local processing unit, such as a PDA. The data may be stored in the PDA for later download to the PC. Some sensors which might be incorporated into a body sensor network are shown in Figure 10.

Figure 10 Sensors that might be incorporated into a body sensor network Sensors may be integrated into worn clothing, be in contact with the body or actually implanted in the body. As an example: for cardiac monitoring: blood pressure, heart rate, respiration rate, ECG, EEG, blood oxygen levels and movements could all be monitored. The development of small wearable and implantable sensors is currently a major research topic, e.g. an implantable or non-invasive blood glucose measurement. (See for example the Glysens website15). Other issues to consider in the deployment of wireless sensor networks are: Encryption will be required to ensure security of the data, both within the home and also for transmission of patient information via the internet Safety of the system during a failure event, e.g. a power cut or failure of the internet 3.5 Closed loop control systems

14

Medical applications of wireless body area networks, P. Khan et al, International Journal of Digital Content Technology and its applications, Vol 3, p 181 – 193 (2009). 15 http://www.glysens.com/products/products.htm
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The wide range of sensors, actuators and communications technologies can be used in combination to provide a hierarchy of control loops of increasing levels of intervention and sophistication as shown in the flow chart in figure 11. Measurement only. The only component is a sensor(s) which takes the measurement(s). The sensor could be under the control of the patient, e.g. a blood glucose sensor, or be autonomous, e.g. a wireless mote. The output from the sensor might be displayed for the patient to see or could be recorded within the home for later analysis. The data could also be sent outside the home for storage on the patient’s record or for assessment by a healthcare professional or carer.

Figure 11 Hierarchy of control methodologies within an assistive environment.

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Figure 12 Blood Glucose Sensor Measurement and response within the home: once the sensor measurement has been taken, action could be taken based on the outcome of the reading. The output from the glucose sensor could be fused with other information, e.g. activity levels and past and planned food intake to recommend a particular insulin dose. The patient might self administer the insulin. This could also be done automatically via a remotely operated insulin pump. Environmental control could be achieved in which a window is opened by an actuator to control the temperature and levels of carbon dioxide as measured by appropriate sensors. Response to sensor inputs is controlled from outside the home. Here the information from sensors is sent outside the home, either to a carer or a healthcare professional. The information may be collected for later analysis. A decision may be made immediately or at a later date based on this information. Some events, e.g. a fall, might result in a phone call to check ‘all is well’. If the call is not answered then there would be an urgent visit to the house. Remote operation of actuators is also possible, e.g. to turn off an appliance or water from an overflowing sink. There is now an increasing range of functions which can be activated remotely.

3.6

The Design Process – Inclusive Design Briefly two distinct approaches to producing assistive devices include: The bespoke design of assistive devices for patients with particular cognitive and physical impairments. The inclusive design of mainstream products which are accessible to as many users as possible. Bespoke design. Important aspects to consider in the bespoke development of assistive products include: Involving the patients and users through the design, development and trial process. The challenge to be addressed needs to be clearly defined in conjunction with users at the outset. Information on this process can be found on the Helen Hamblyn Centre

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for Design, Royal College of Art website16. Some products designed in this way are also described on the Bath Institute of Medical Engineering (BIME) website17. Making assistive products attractive, so that the user is not immediately labelled as disabled. Sometimes they can become fashion items in their own right. As an example, the Novo Nordisk Novopens18for insulin delivery come in a variety of attractive designs which are matched to a spectrum of users. Inclusive design. The British Standards Institute (2005) defines inclusive design as "The design of mainstream products and/or services that are accessible to, and usable by, as many people as reasonably possible ... without the need for special adaptation or specialised design." The inclusive design process thus involves understanding user diversity variation in terms capabilities, i.e. physical and cognitive, and their needs. Inclusive design will aim to understand and address as many of these aspects as possible. The end product should be functional, usable and aesthetically pleasing and also commercially viable. In this way mainstream products will then become available which address some of the needs of an assistive living environment. An inclusive design tool is available at reference 19 to assist in understanding this process.

3.7

Assistive Robotic Devices Robotic devices are being used increasingly to assist patients with impairments across a significant part of physical / cognitive spectrum20. Robots can in particular provide: Assistance with physical tasks – providing assistance particularly across a wide spectrum of physical impairments. A degree of social interaction. Physically assistive robot. Assistive robotic arms (ARMs) are being developed by many companies with six degrees of freedom with end grippers, for example Exact Dynamics21. ARMs can be mounted to the side of a wheelchair for general manipulation. Control can be affected by an eye, mouse, shoulder movements and an electromyography system, i.e. electrical signals produced by skeletal muscles. Such devices can help with daily tasks such as washing, cleaning teeth and feeding.

16 17

http://designingwithpeople.rca.ac.uk/ http://www.bath.ac.uk/bime/ 18 http://www.novonordisk.com/diabetes_care/insulin_pens_and_needles/novopen_4/default.asp 19 is www.inclusivedesigntoolkit.com – a number of inclusive designs are also described at this site. (accessed March 14 2012). 20 S W Brose et al, The role of assistive robotics in the lives of people with disability, American Journal of Physical Medicine and Rehabilitation, p 509 – 521 (2010) 21 http://www.exactdynamics.nl/site/
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There are a number of feeding systems which can increase a patient’s autonomy and can offer fine control to people with high tetraplegia, see for example ‘My Spoon’22. Sophisticated wheelchairs are now available which respond to a variety of controls including the use of a joystick, voice recognition and eyeball movements (in development). On board sensors reduce the chance of collisions. Wheelchairs are also available that can climb stairs. Cameras on a robot can also be very useful – for monitoring exact details of the patient interaction. It will be very important to be able to turn off the camera for privacy reasons. Social interaction. Robots can provide a level of interaction with feedback. For example, AIST23 in Japan have developed a therapeutic seal which has tactile, position, optical and acoustic sensors. It responds to being stroked and to speech and sounds from the patient. It was shown to improve brain activity in some patients with dementia. Robots can provide personalised cognitive assistance and companionship, e.g. to people with various forms of dementia. They can play games that stimulate the mind and also suggest activities, e.g. physical exercise or that a meal or drink should be taken.

3.8

Emerging Technologies Many emerging technologies have been described in the preceding sections. It is, however, interesting to list here just a few of the most significant and potentially disruptive new technologies and approaches from each section. Micro-sensors, e.g. MEMS, which can be widely deployed around the home. Implanted or non-invasive sensors for glucose blood measurements and interventions (See Figure 13) Small devices to measure biomarkers in the patient’s own home for early disease diagnosis. Direct interfacing of sensors and transducers with the central nervous system for both sensing and feedback applications Low powered wireless technology to link sensors and actuators distributed around the home and also worn by the patient to a remote site. Closed control loops allowing remote control of actuators based on useful information from a range of sensors. A design methodology that puts the patient at the heart of the design process. Robots to help with a wide range of daily tasks whilst maintaining dignity. An integrated suite of technologies which can provide some level of social interaction to address some of the issues of loneliness. It is essential that all of these and other advances are viewed within a sympathetic environment which puts the best interests of the patient at the centre.

22 23

http://www.secom.co.jp/english/myspoon/ (accessed 14 March 2012). www.parorobots.com
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No section on disruptive technologies would be complete without a mention smart phone and computer tablet technology (See Figure 13). As an example, one group have used smart phones as an interface between wearable health sensors in a smart garment and a health professional’s website24. One author reports that there are already in excess of 7,000 cases of smart phone medical apps25.

Figure 13 New Emerging Technologies 3.9 Ethical Issues The deployment of assistive technology should always be in the best interests of the patient. It is not always straightforward to discern the best interests of the patient, especially when they are not able to express an opinion through either a cognitive or physical impairment. It is essential that a holistic approach is taken to assessing the appropriateness of an assistive technology. Issues that might affect the patient include: The use of assistive technology, whilst helping with a physical or cognitive challenge, might also lead to a feeling of inadequacy and heighten the feeling of loss of a particular capability. There may be a feeling that being seen with an aid, e.g. a stick or frame may cause viewers to label the patient as old or inadequate. Such feelings might in turn contribute to psychological conditions such as depression. The patient should be involved in the decision process as much as possible and their views should be paramount. They will want to feel in control. The technology may represent an invasion of privacy, e.g. the use of cameras. The user will probably want to turn the sensors off and also not to be monitored during some activities or in some rooms of the house. One of the issues is who makes the decision when the patient is not able to do so themselves:

24

M Boulos et al, How smart phones are changing the face of mobile and participatory healthcare: an overview, with example from e-CAALYX, Biomedical Engineering Online, 10:24 (2011). 25 Kailas A, From personal phones to personal wellness dashboards, IEEE Pulse vol. 1, 57-63 (2010)
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The Mental Capacity Act26 provides a framework to empower and protect people who may lack capacity to make some decisions for themselves. The Mental Capacity Act makes clear who can take decisions in which situations, and how they should go about this. Anyone who works with or cares for an adult who lacks capacity must comply with the MCA when making decisions or acting for that person. Issues such as Deprivation of Liberty may also need to be considered where appropriate27. Relatives and friends should also act in the best interests of the patient. Security and access to any data that is generated should also be considered: Patients and their carers should be informed what data is being collected, how it will be stored and who will have access to it. An appropriate level of encryption will be required for wireless and other methods of data transmission.

3.10

Regulatory considerations Regulatory reforms. Regulations pertinent to ALT are undergoing significant changes to make these comprehensive and effective to the end users. Currently, the ALT market is mostly governed by regulations that were laid down for the use of IT and communication in healthcare. These policies tend to become obsolete for ALT as the market progresses into growth stage. Regulatory assessment and amendments are currently in early stages of development as the market growth is nascent. The main issues are that there is a lack of clarity in policies and reimbursement models within organisations such as the NHS. Notably, a robust combination of regulations is soon expected to govern ALT market in Europe. There is also a sense of uniformity that is likely to set in the region for assisted living techniques. Lack of uniformity is likely to be removed by the developments such as joint programmes being developed through EU programmes such as Ambient Assisted Living (AAL) and national programmes such as DALLAS. This will induce uniformity in the regulatory set up as well. Devices in general may have four steps to consider before market entry: MHRA approval: The Medicines and Healthcare products Regulatory Agency (MHRA28) regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering. Assistive devices may be classed as medical devices in which case the Medical Devices Directive (93/42/EEC (MDD)) will apply. Many of the ALT devices will probably be classed as Class I devices: non-invasive devices for which the regulations are the least stringent. The Active Implantable Medical Devices Directive (0/385/EEC (AIMDD)) may also apply. For point of care diagnostics devices, the In-vitro Diagnostics Directive ( 98/79/EC (IVDD)) will apply. Manufacturers and distributors are licensed directly by MHRA. Medical devices are approved by private sector

26
27

http://www.justice.gov.uk/protecting-the-vulnerable/mental-capacity-act

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_080718 28 http://www.mhra.gov.uk/Howweregulate/Devices/Registrationofmedicaldevices/index.htm
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organisations called 'Notified bodies'. Their approval is needed before a CE mark can be put on the device, though the manufacture of low risk devices is simply registered with the MHRA. The MHRA audits the performance of Notified Bodies. However: when a product is on the market and in use, there are more similarities than differences in the ways medicines and devices are regulated there are similar systems for receiving reports of problems with products and similar ways of issuing warnings if problems are confirmed after investigation there are also similar systems for inspection of manufacture to ensure that companies are complying with regulations, and similar ways of enforcing the law if that proves necessary. Further information on how we regulate medicines and medical devices is available. CE approval: Conformité Européenne, CE marking29 is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area (EEA, the 27 Member States of the EU and EFTA countries Iceland, Norway, Liechtenstein), as well as Turkey. This also applies to products made in third countries which are sold in the EEA and Turkey. BIS approval: the British Standards Institution30, is a non-profit organisation that develops and publishes standards that oversee virtually every aspect of modern society. BSI Group has grown into a leading global business services organization providing standards-based solutions in more than 150 countries. Headquartered in London, United Kingdom, BSI is the United Kingdom's national standards organization and the UK’s representative in the European CEN and the international ISO and IEC. BSI is now the world's largest certification body. It helps organizations improve their quality and performance, reduce their risk, manage and protect their reputations, and help them be more sustainable. Another accreditation that manufacturers might apply for is the British Standards Institute’s Kitemark31. FDA 510K approval32 (US only): Each person who wants to market a Class I, II, and III device intended for human use in the U.S., for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements. A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence (SE) means that the new device is at least as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate
29

30 31
32

http://ec.europa.eu/enterprise/policies/single-marketgoods/cemarking/downloads/further_information_en.pdf

http://www.bsigroup.com/en/Assessment-and-certification-services/ http://www.bsigroup.com/en/ProductServices/Medical/CE-marking-for-medical-devices/

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/prem arketnotification510k/default.htm
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has the same technological characteristics as the predicate or has the same intended use as the predicate has different technological characteristics and the information submitted to FDA; does not raise new questions of safety and effectiveness demonstrates that the device is at least as safe and effective as the legally marketed device A claim of substantial equivalence does not mean the new and predicate devices must be identical. Networking architecture and standards. Implementation of standardised platforms for greater efficiencies and interoperability are going to be key to the success of ALT proliferation. In particular: Assisted living devices have various possible networking standards, including body area network (BAN), local area network (LAN), metropolitan/wide area networks (MAN/WAN). Assisted living can be provided through any of the network mentioned with both wired and wireless equipment. The industry is looking to develop integrated home hubs, which combine functions of various assisted living services like that of smart homes, telehealth and telecare. This is likely to reduce the development and integration cost of the equipment. Experts suggest that individual hubs for separate applications can be connected using open platform software; later in the long term, these can be combined into integrated hubs. Security is the biggest concern while designing the networking architecture. Especially data security in the case of wireless networking. Wi-Fi technology is increasingly gaining prominence in healthcare, especially, in the case of patient monitoring. There is a gradual shift towards enabling interoperability of assisted living equipment; this will soon change the standards of networking architecture. However, to efficiently enable this, there is a demand to manage the public IP networks, which are likely to form the platform for large-scale deployment.

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4.0

FUNDING SOURCES FOR ALT DEVELOPMENT Opportunities range from small-scale single company projects through to large-scale multiyear multiple partner collaborative projects. A particularly useful source of information is the report from the Department of Health: Research and development work relating to assistive technology 2010-201133. This provides a complete list of AT research and development activities, together with a list of funding agencies and perspective programmes. Foremost amongst these are: EU Funding, e.g. via the Framework Programme UK Government funding Department of Health (DoH): o NHS funding via the National Institute for Health Research34. Department of Business Innovation and Skills (BIS): o The Technology Strategy Board35 o The Research Councils, in particular the EPSRC36 (Engineering and Physical Sciences Research Council) and the ESRC37 (Economic and Social Research Council); collaborative initiatives such as the MRC’s LLHW38 (Life Long Health and Well Being) programme and NDA39 (New Dynamics of Ageing Programme) There is also a comprehensive list of organisations which fund assistive technology on the FAST website40. Calls currently open for funding are listed elsewhere 41. Advice on assistive device development can also be obtained via Devices for Dignity42 which provides awareness of the NHS, access to clinicians, advice on regulatory issues and advice on applying for grants. European Union Framework Programme Funding. Information on EU calls can be found via the Cordis website43. A good source of information is the UK National Contact Points44. Strategically, as mentioned earlier there is Ambient Assisted Living (“AAL”). AAL is initially set up from 2008 to 2013. The programme´s planned total budget is €700 million, of which c. 50% is public funding - from the AAL Partner States

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http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_127996.pdf http://www.nihr.ac.uk/proposals/Lists/NIHR%20Calls%20for%20Proposals/Current%20Calls.aspx 35 http://www.innovateuk.org/competitions/competitionsearch/search.ashx 36 http://www.epsrc.ac.uk/funding/Pages/default.aspx 37 http://www.esrc.ac.uk/news-and-events/news/15706/funding-opportunities-for-201112.aspx 38 http://www.mrc.ac.uk/Ourresearch/ResearchInitiatives/LLHW/index.htm 39 http://www.newdynamics.group.shef.ac.uk/ 40 http://www.fastuk.org/atcommunity/rdfunders.php 41 http://www.fastuk.org/research/fundingopportunities.php 42 http://www.devicesfordignity.org.uk/ 43 http://cordis.europa.eu/home_en.html 44 http://www.innovateuk.org/deliveringinnovation/internationalprogramme.ashx

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and the European Commission - and c. 50% is private funding from participating private organisations (e.g. enterprises)45. For updates on these and further funding opportunities contact the biomedical and microelectronics iNets who can direct you to stakeholders supporting these programmes. UK Government (DoH and BIS) National Institute for Health Research (NIHR) ‘commission and fund NHS, social care and public health research that is essential for delivering our responsibilities in public, health and personal social services’. The routes to funding are described on the NIHR website46. For example the i4i Programme is an NIHR research programme that provides investment in, and improved identification of, promising healthcare technologies in order to accelerate the development of new healthcare products for the 21st century. It also funds translational research, extending between basic research and pre-clinical trials or health technology assessments. For more details go to47. Technology Strategy Board - some of their key programmes include: Assisted Living Platform Special Interest Group48. Smart Awards (previously Grants for R&D) Small Business Research Initiative (SBRI) Collaborative R&D49 is designed to assist the industrial and research communities to work together on R&D projects in strategically important areas of science, engineering and technology - from which successful new products, processes and services can emerge. The scope of the collaborative R&D competitions has recently been expanded to support large collaborative R&D projects and smaller projects approved within faster timescales. These may vary with specific competitions and funding limits are specified by individual competitions but generally include: o o o Feasibility studies – small projects lasting for a maximum of one year and often less than £100k; up to 75% funding Fast-track projects - projects lasting no longer than 18 months and having a maximum total cost of up to around £200k; up to 50% funding Larger Collaborative R&D projects – projects of around a few £100k to £m’s to last up to five years; funding mainly for applied R&D; up to 50% funding

These projects must be industry led and in general include partners. Academics may be partners but are not necessarily required to form a consortium. The Competition Brief and the Guidance for Applicants state the levels of funding available.

45 46

http://www.aal-europe.eu http://www.nihr.ac.uk/research/Pages/default.aspx 47 http://www.ccf.nihr.ac.uk/I4I/Pages/Home.aspx 48 https://connect.innovateuk.org/web/assisted-living-innovation-platform-alip 49 http://www.innovateuk.org/deliveringinnovation/collaborativeresearchanddevelopment.ashx
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Research Councils. These are not generally viewed as a funding source for companies. However, much early-stage research is funded by the various Research Councils. By their nature they only fund academic research although there are still opportunities for company involvement. Some projects are larger-scale collaborative R&D where companies fund their own involvement (in-kind or actual cash) but leverage research council investment in the academic partners’ work. Most research councils (including EPSRC, MRC, BBSRC) also offer Industrial CASE (Collaborative Awards in Science and Engineering) studentship opportunities whereby they part fund the cost of a PhD student working on a company focused research project. Awards are allocated via competition. More detail on the various forms of industry engagement and research exploitation support is available at the individual research council websites accessible from50.

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5.0

HOW ARE PRODUCTS CHOSEN, SPECIFIED AND PAID FOR The goal of this section is To describe how a particular set of assistive aids is suggested for a particular patient. How the purchase and maintenance of the technology would be paid for Figure 14 describes some assistive aids which can be used to address challenges which arise during the progress of a disease resulting in the progressive loss of physical and cognitive abilities.

Figure 14 Assistive aids to address the cognitive / physical spectrum. The devices shown in the figure include: Memory aids to remind the patient to undertake a particular task such as to take a medicine - for patients with mild cognitive impairment. Following sensors, e.g. pressure pads to track a patient with a higher level of cognitive impairment. Sensors to detect if the patient has had a fall. Eye tracking devices for a patient with total locked in syndrome. Assistive robots to help with tasks and with social interaction. Electronic controllers which allow a patient with high cognitive acuity but considerable physical impairment to operate television, telephone and environmental controls such as windows, heating and curtains. In addition to addressing cognitive and physical needs, technology is now available and under development for the management of a range of medical conditions in the patient’s own home.

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These include: Cardiac conditions: measurement of blood pressure and heart rate; coagulation monitors for self-management of anti-coagulation therapy, biomarker measurement to warn of myocardial infarction, wearable wireless ECG – in development, Diabetes – glucose monitoring, insulin pumps (implantable), implantable and noninvasive glucose monitors are under development. COPD and asthma: peak flow, blood oxygen – already available, point of care systems to measure biomarkers to warn of an exacerbation – in development The patient and carers could then decide to use an assistive technology via a number of distinct routes: The patient independently decides to source and purchase an aid. This is more likely to happen for the case of low levels of impairment. Advice might be sought from a retail outlet, the internet, a friend or a healthcare professional, or from a charity such as the Alzheimer’s Society. The patient is supported and advised by one or a Team of interdisciplinary healthcare professionals including one or more of clinicians, physiotherapists, occupational therapists and social workers. This team may be accessed via a variety of routes. There are many scenarios which will cause an individual to seek assistive technology. Each of these will involve different levels of interaction with health professionals and be associated with different levels of urgency.

Figure 15 Possible care pathway following a stroke or serious fall

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Case I – as a result of a major trauma: as shown in Figure 15, a fall or stroke victim will probably go initially to an acute hospital and will engage with a wide range of health professionals who will provide a high level of support. Rehabilitation may then take place via intermediate care, e.g. in a community hospital. The Team including occupational therapists, physiotherapists and social workers will offer expert advice in a complete package of assistive care. This technology will be required at very short notice and there will be little opportunity for the individual to engage in the selection procedure. Often the patient’s family will also make an impulse purchase of assistive devices. Case II - The above approach is hospital centric due to the initial major incident. An alternative scenario is where a patient may visit a GP after some minor falls. The GP may then refer the patient to a Falls Clinic where the cause of their falls will be investigated. Long term management might include the suggestion that assistive technology would be useful. Care would then be managed by occupational therapists and community health workers, e.g. community matrons or nurse specialists. Case III: Individuals with long term degenerative illnesses such as Alzheimer’s, a respiratory disease such as COPD or diabetes will have more time to be involved in the identification and purchase of assistive technology. Advice will be available from GPs , specialist consultants, OTs and social workers. The level of assistance and the type of devices required will change as the condition changes. Case IV: Well aging people: Individuals undergoing the normal ageing process may also seek assistive technology to improve their day to day life. Senses will gradually lose their acuity and loss of mobility will be experienced. Advice may be sought from healthcare professionals or the device might be purchased directly from a specialist retail outlet or via mail order or the internet. The players involved in specifying assistive aids are: The patient themselves – the needs and opinions of the patients should be paramount Family who are caring for and about the patient Healthcare professionals such as Occupational Therapists, clinicians and the community healthcare Team. Occupational therapists are often key decision makers in this process. Care homes and sheltered housing are also increasingly specifying and purchasing Assistive Technologies, e.g. a pressure pad to detect when someone gets out of bed and stands on a mat near the bed or in the bathroom.

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The way in which the selected assistive technology is paid for currently varies from region to region with the UK. The Darzi report: High Quality care for all: The NHS Next Stage Review51: (June 2008) contains the visions that: Every primary care trust will commission comprehensive well-being and prevention services , in partnership with local authorities, with the services offered personalised to meet the specific needs of their local populations. Ensure that everyone with a long term condition has a personalised care plan. Pilot personal health budgets giving individuals and families greater control over their own care, with clear safeguards.

A number of services in the prevention package may be commissioned by the patient themselves through personal budgets or direct payment. For example, they may pay for a personal assistant to carry out personal care and support services such as footcare, or purchase telecare devices. Information on personalisation is available on the Department of Health website52.

51

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http://www.dh.gov.uk/health/category/policy-areas/nhs/personal-budgets/
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6.0

STRATEGIC COMPANIES Top five companies: The ALT market maybe nascent, but a number of well established and new electronic precision engineering companies have been able to develop products on engineering know how. These are described in brief here (The Table overleaf lists more of the leading industry players). A&D Medical / LifeSource manufacturers blood pressure monitors and other home health care products for home and professional use. Models include automatic, manual, ambulatory, kiosk style and accessories including stethoscopes. The company has established itself as a leader in home health monitoring technology through the development and introduction of a variety of unique products. A&D’s LifeSource blood pressure monitor line has garnered numerous industry awards. Recent product introductions include: the LifeSource digital thermometers, personal scales, stethoscopes, and Ambulatory Blood Pressure Monitors. A&D built its reputation by manufacturing innovative and accurate measurement tools for business, industry, education and health care. Tunstall is a leading provider of telecare/telehealth solutions. Operating in more than 30 countries and employing over 1,200 people, Tunstall supports 2.5 million people around the world. Tunstall's business philosophy is to provide healthcare technology and services that enable anyone requiring support and reassurance, such as older people or those with long term needs, to lead an independent life with dignity and reassurance. OBS Medical is a medical device company which supplies patient monitoring and mobile-based software solutions to hospital wards, primary care practices, and pharmaceutical companies running clinical trials. Originally a spin-out from Oxford University, Oxford BioSignals Ltd, it developed a range of monitoring algorithms across a variety of applications. In 2009, the industrial arm of the business that arose from the broader implementation of the technology was sold to Rolls Royce. In the same year, the company merged with t+ Medical Ltd and to strengthen the technical capabilities and focus on the development and expansion of their medical device products and services. As a result of the merger, the company was renamed OBS Medical Ltd. Tynetec has over 30 years’ experience in the design and manufacture of Warden Call Systems, Telecare & Telehealth Solutions, Access Control Systems and Wireless Nurse Call Products. Products and R&D design come from Blyth, Northumberland. The company supplies equipment to hundreds of Local Authorities and Housing Associations and now with the recent acquisition of AidCall (Healthcare Division), the organisation is expanding its operation through the sales of Wireless Nurse Call Systems into the Hospital and Care Home Markets. For the last 40 years of its 63-year history, Tanita's core business has been the manufacturing of precision scales. Today, Tanita is looking beyond scales to products that enable consumers to monitor their own health. Based on medical evidence linking excess body fat to heart disease, diabetes and certain cancers, Tanita introduced the world's first integrated body composition analyzer/scale to the professional markets in 1992. Tanita developed the world's first scale plus body fat monitor for home use in 1994. Backed by extensive clinical research and an independent medical advisory board, Tanita's accuracy, innovation and durability are
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trusted worldwide. Table 8 Some of the leading companies in ALT

Company Name A&D Medical / LifeSource Tunstall Healthcare OBS Medical Ltd Tynetec Tanita CareTech AB Robert Bosch Healthcare Chubb Community Care Possum Ltd Telbios

Web Site
http://www.lifesourceonline.com http://www.tunstallhealthcare.com http://www.obsmedical.com http://www.tynetec.co.uk http://www.tanita.com/en http://www.caretech.se www.bosch-telehealth.com www.chubbcommunitycare.co.uk http://www.possum.co.uk/ http://www.telbios.it/en

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7.0

ROAD MAP Regional Road map. It is only when you understand the sheer scale of the problem that you start to see the need for ALT and the challenges involved in implementation. The Health Innovation Education Cluster for the South West (HIEC-SW) was asked to look at how to deliver self care and self management at scale. It is estimated that up to 2 million people in the SW are living with a long term condition53. They are not the only ones who can benefit from assistive technology; family and informal carers also play a key role. There are perhaps 70,000 NHS staff involved in providing care not to mention people involved in social care and housing. In short this is a society and community issue affecting all of us. Projects and services dealing with only a few hundred people, involving only a few professional staff will never lead to a fundamental improvement in care. The problem though is that most services are provided by relatively small organisations and many of the good ideas and new services are emerging from start ups and SME’s. There is not enough in the market place for consumers to ‘get it’ and get on with it. What we need is an environment where these problems can be tackled. The Technology Strategy Board (TSB) initiated a competition called Delivering Assisted Living Lifestyles at Scale “DALLAS” (see BOX) as the culmination of a £23 million, 5 year research and development programme to address these issues. HIEC-SW entered the competition and has formed a team called Community Solutions to create the environment where SME’s and statutory and voluntary organisations can work together with citizens to create these new services. We will know in May whether our efforts have been successful. What is clear is that to be effective assistive technology needs to be considered as part of overall service design. It needs to be conceived as a consumer driven service that enables people to have choice, to feel connected and in control of their life and to play a full role in their community. This means thinking about the customer experience and business model at the same time as the product and service offering. Many people have complex needs and therefore want a coordinated and coherent approach and that is what we are trying to engineer. The role of the Government (through programmes such as DALLAS) and local networks such as Biomedical and Microelectronic iNets and a new Medilink SW will enable and support the accelerated growth of the application of ALT. From a Community Solutions perspective HIEC – SW is committed to playing a part in making ALT provision a scalable reality.

53

Sasha Karakusevic, Director of Health Innovation Education Cluster SW (HIEC SW) www.hiecsw.org.uk
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BOX 2 Delivering Assisted Living Lifestyles at Scale (DALLAS) A total investment of up to £23 million is being made in the UK-wide DALLAS programme – Delivering Assisted Living Lifestyles at Scale. This comprises an £18m investment by the Technology Strategy Board and the National Institute for Health Research, with a further £5m contribution from the Scottish Government, Highlands and Islands Enterprise and Scottish Enterprise. DALLAS will establish three to five communities of 10,000 people each or more across the UK, of which one will be in Scotland. These will show how assisted living technologies and services can be used to promote wellbeing, and provide top quality health and care, enabling people to live independently – including a preventative approach. We aim to unlock new markets in social innovation, service innovation and wellness, enabled by technology, and show that technologies and services can be made available at a sufficient scale and cost to enable independent living. The competition will help to grow the assisted living sector and position UK companies to take advantage of increasing global demand for assisted living goods and services.

Industry overview see Figure 16 The ALT market place is a nascent market with high growth potential (CAGR 22.6%) and an estimated current value of about $310 million (2012). It is a market where the patient or user needs alongside provider focus on medical economy are driving growth. Assistive Living may be more popularly called Independent Living and this focus on quality and customer driven need will shape regulatory policy and device uptake and establishment. One of the greatest barriers to growth will be reimbursement models for market entry. The best opportunities for new devices will be where they are not stand alone but are easily connected to developed and standardised platforms. It is more likely that standard platforms with a suite of applications will be adopted either in service provider institutes or within the personal user space (home or at work). This interoperability or “platform” approach will be central to accelerated growth. Government focused funding and support has already reviewed this issue and started to support activity that will help manage this gap in the market. Regulatory provision and standards will work to make this more important. There is already a strong ALT product pipeline and continued R&D activity in established high growth companies (most of which are of SME status) and research establishments. Importantly the ease of use of ALT products and their ability to be accessed, i.e. through new standardised platforms will be important to development. In the South West of England HIEC –SW and the “Community Solutions” approach will help form a framework for engagement with support from TSB and NHIR coordinated funding. Partnering through the iNets will allow access to transitional research and innovation in the local geography and supported by a new Medilink SW will be able to encourage local industry to collaborate.

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Figure 16 Schematic of Assistive Living Technology Industry Road Map

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8.0

RECOMMENDATIONS & CONCLUSIONS There are many technologies emerging and under development to address some of the many cognitive and physical challenges faced by patients who are wanting to lead an independent life in their own homes. These technologies will increasingly form part of a personalised care package to address the complete spectrum of their needs. When developing ALT products, it is important to appreciate that these must fit into an integrated care package rather than regarding them as stand-alone devices. Recommendations. What is required to help current and emerging ALT flourish is: Innovative business models to capitalize on business opportunities Development of a concrete market for assisted living services to increase uptake Refrain from complexity for the benefit of the users It is important to show the cost benefits of ALT technologies to move pilot programs to the mainstream – this will accelerate the transition from pilots to commercially viability and help to attract large scale investment. This is a gap being filled by TSB driven initiatives Service providers are continually trying to offer differentiated services for the end users; technology solutions are fragmented and diverse, these will need to become more integrated at the location of care and fit for purpose. Interoperable platforms or better integrated platforms are fundamental to successful uptake. Conclusions. The ALT market is in its development phase and is likely to grow rapidly (CGAR 22.6%). This growth will be attributed to factors that are captured and well documented in this report (see summary in Figure 16). Figure 17 below summarises the opportunity and challenges to overcome. Figure 17 Overview of ALT market opportunity and trends2

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9.0 9.1

APPENDICES References
1. Here we define patients as the person with the condition and carers as anyone who is supporting the patient. Carers include family and friends and healthcare professionals. 2. European markets for Assistive Living Technologies, Frost and Sullivan 2010. 3. Older people in the United Kingdom - Key facts and statistics, Age Concern’s Policy Unit, 2008. 4. Strength and Opportunity: The landscape of the medical technology, medical biotechnology and industrial biotechnology enterprises in the UK, Her Majesty’s Government, 2009. 5. Eucomed Medical Technology Brief, May 2007 6. Fundamentals of microfabrication and nanotechnology , Marc J Madou (2011). 7. A Hein et al, Monitoring systems for the support of home care, Informatics for Health and Social Care, Vol 35, p 157 – 176 (2010). 8. http://pubs.rsc.org/en/journals/journalissues/lc 9. S Boll Development of a multimodal reminder system for older persons in their residential home, Informatics for Health and Social Care, Vol 35, p 104 – 124 (2010). 10. C F Garcia-Hernandez et al, Wireless sensor networks and applications: a survey, Int. J. Comp Sci and Net Sci, vol 7, p264 - 273 (2007). 11. D Vegados Service personalisation for assistive living in a mobile ambient healthcare-networked environment, PersUbiquitComputVol 14, p 575-590 (2010). 12. M Bal et al Collaborative smart home technologies for senior independent living: a review, Proc of the 2011 15th international conference on computer supported cooperative work in design, p 481-488 (2011). 13. MEMSIC offer a range of MEMS sensors packaged into mote format (http://www.memsic.com/products/wireless-sensornetworks.html - accessed 9 March 2012). 14. Medical applications of wireless body area networks, P. Khan et al, International Journal of Digital Content Technology and its applications, Vol 3, p 181 – 193 (2009). 15. http://www.glysens.com/products/products.htm 16. http://designingwithpeople.rca.ac.uk/ 17. http://www.bath.ac.uk/bime/ 18. http://www.novonordisk.com/diabetes_care/insulin_pens_and_needles/novopen_4/default.asp 19. is www.inclusivedesigntoolkit.com – a number of inclusive designs are also described at this site. (accessed March 14 2012). 20. S W Brose et al, The role of assistive robotics in the lives of people with disability, American Journal of Physical Medicine and Rehabilitation, p 509 – 521 (2010) 21. http://www.exactdynamics.nl/site/ 22. http://www.secom.co.jp/english/myspoon/ (accessed 14 March 2012). 23. www.parorobots.com 24. M Boulos et al, How smart phones are changing the face of mobile and participatory healthcare: an overview, with example from eCAALYX, Biomedical Engineering Online, 10:24 (2011). 25. Kailas A, From personal phones to personal wellness dashboards, IEEE Pulse vol. 1, 57-63 (2010) 26. http://www.justice.gov.uk/protecting-the-vulnerable/mental-capacity-act 27. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_080718 28. http://www.mhra.gov.uk/Howweregulate/Devices/Registrationofmedicaldevices/index.htm 29. http://ec.europa.eu/enterprise/policies/single-marketgoods/cemarking/downloads/further_information_en.pdf 30. http://www.bsigroup.com/en/Assessment-and-certification-services/ 31. http://www.bsigroup.com/en/ProductServices/Medical/CE-marking-for-medical-devices/ 32. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotifi cation510k/default.htm 33. http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_127996.pdf 34. http://www.nihr.ac.uk/proposals/Lists/NIHR%20Calls%20for%20Proposals/Current%20Calls.aspx 35. http://www.innovateuk.org/competitions/competitionsearch/search.ashx 36. http://www.epsrc.ac.uk/funding/Pages/default.aspx 37. http://www.esrc.ac.uk/news-and-events/news/15706/funding-opportunities-for-201112.aspx 38. http://www.mrc.ac.uk/Ourresearch/ResearchInitiatives/LLHW/index.htm 39. http://www.newdynamics.group.shef.ac.uk/ 40. http://www.fastuk.org/atcommunity/rdfunders.php 41. http://www.fastuk.org/research/fundingopportunities.php 42. http://www.devicesfordignity.org.uk/ 43. https://connect.innovateuk.org/web/assisted-living-innovation-platform-alip 44. http://www.innovateuk.org/deliveringinnovation/collaborativeresearchanddevelopment.ashx 45. http://www.rcuk.ac.uk 46. http://www.nihr.ac.uk/research/Pages/default.aspx 47. http://www.ccf.nihr.ac.uk/I4I/Pages/Home.aspx 48. http://cordis.europa.eu/home_en.html 49. http://www.innovateuk.org/deliveringinnovation/internationalprogramme.ashx 50. http://www.aal-europe.eu 51. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_085825 52. http://www.dh.gov.uk/health/category/policy-areas/nhs/personal-budgets/ 53. Sasha Karakusevic, Director of Health Innovation Education Cluster SW (HIEC SW) www.hiecsw.org.uk

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9.2

Acknowledgments The Authors would like to thank the following colleagues and contacts who have been supportive in compiling this report and generating stimulating discussions around the topic (listed in alphabetical order): Dr. Praminda Caleb-Solly, UWE (assistive robots) Mrs. Christine Fear, UWE (maintaining the health and well-being of older people) Dr. Sasha Karakusevic, Director of Health Innovation Education Cluster SW Dr. Mokhtar Nibouche, UWE (wireless networks) Mrs. Sharon Webb (Occupational Therapist)

END March 21th 2012

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