Healthcare Innovation: The Use of Fall Detectors to Detect Unwitnessed Falls and Reduce A Long Lie.

Key

Elderly: Persons over 65 years of age.
A&E Department: Accident and Emergency department.
NHS: National Health Service.
Long Lie: Falls resulting in a person remaining on the floor for one hour or more.
Rhabdomyolysis: Break down of muscle tissue.
Osteoporosis: Thinning of the bones
Polypharmacy: Taking many medications. Can result in medicine interactions and side effects.
FD: Fall Detector
ERD: Emergency Response Device
Orthostatic Hypotension: A drop in blood pressure on standing.
U.S : United States
FDA: Food and Drug Administration
DALY: Disability adjusted life years.
Gyroscope: A device used to measure or maintain orientation and angular velocity.
QOL: Quality of Life.
R&D: Research and Development
BMJ: British Medical Journal
NICE: National Institute of Clinical Guidelines
GP: General Practitioner
OT: Occupational Therapist

Abstract:
Falls in the elderly are a large healthcare burden for the NHS as well as for healthcare systems globally. They account for greater than £2.3 billion per year of UK government spending, with 30% of those over 65 years and 85% of those over 80 years falling at least once every 12 months [1]. The number of injuries associated with falls is set to increase by 100% by 2030 [2], likely associated with increasing numbers of an ageing population.
With an increasing burden of elderly falls the Apple watch has added a FD and ERD. This notifies both emergency services and an emergency contact providing location details and driving instructions to reduce time to treatment. Few studies have been performed examining how this impacts patient outcomes and its potential cost effectiveness for the NHS.

Background and Unmet Clinical Need
The elderly are at risk of falls, and injury following fall, given their increased fragility, osteoporosis of advancing age, chronic co-morbidities such as diabetes mellitus and heart disease, polypharmacy, disturbed vision, muscle weakness and gait disorders. Falls exponentially increase with biological changes [2].
Falls in the elderly are associated with extensive medical investigation, given that falls can result in a wide range of injuries from a wide range of medical or mechanical causes. This is compounded by a more difficult extraction of patient history given memory loss and dementia of increasing age. This reduces the ability of medical staff to focus scans and testing to more likely diagnoses and complications associated with the fall. Traumatic brain injury is most commonly a result from falling [4] and 95% of hip fractures are a result from falling sideways [5]. Both conditions are associated with long term hospital stays, investigation, surgical needs and with high rates of mortality. Although with less emphasis in this age group, sick leave in those who remain in work should also be taken in to account from an economic stand point.
Aside from healthcare expenditure, falls can result in greater social needs. Having a fall increases the ongoing risk of falling [2] and hence reducing the risk of safe independent living. As 5% of falls in the UK community and 10-25% in nursing homes and hospitals result in hospitalisation or fracture [3], finance channelled in to hospital stays and long term rehabilitation is also of consideration. In the UK, national guidance requires that these patients are followed up, assessed and safely discharged from physiotherapy and occupational therapy prior to independent living [6]. Those that are no longer considered safe for this, will need input from carers or assisted accommodation. Increasing government expenditure and demand for services.
Older people are less likely to get themselves up following a fall. A ‘long lie’ may result in rhabdomyolysis, pressure sores, pneumonia, dehydration, with or without acute kidney injury, hypothermia and complications arising from omission of scheduled medication [7]. It can also contribute to mental stress and a reduction in confidence from social isolation and independence.
Overall, the demand is increasing for support surrounding falls in the elderly, reducing a long lie and increasing confidence and ability for people over the age of 65 to live independently. Although injury from falls are inevitable, there are ways for them to be minimised. Ensuring rapid treatment for any injury that is obtained contributes to this and hence reducing long hospital stays and health care expenditure.

Description of the Innovation
In 1982, William Hormann received the Frankfurt Innovation Prize for producing the first ERD for sick or elderly individuals living alone [8]. A pendent was worn around the neck, and when activated would send an alert message to a selected telephone number. If the telephone was unanswered, no one would be alerted and the message unheard.
In the following 30 years, ERDs have continued to be modernised with increased sophistication and specificity. There are now many ERDs globally which aim to alert of a potentially unwitnessed fall.
World renowned technology company, Apple, have added a FD and ERD to their Apple Watch. The Apple Watch Series 4 has an inbuilt fall detector which links to an application on both the phone and the watch itself [9]. Although fall detectors have been available through smart phones via various applications for some time, notably the Fall Safety Pro [10], this is the first innovation to link the benefits of a smart watch with this technology [9].
A gyroscope inside the watch is able to detect when someone is likely to have taken a hard fall. The watch alerts that the fall detector has been activated and the screen begins a 45 second count down from when the fall was detected. Unless the patient presses the option to confirm that they are ‘OK,’ an alarm sounds notifying nearby people. Simultaneously, the emergency services are notified, along with any emergency contacts stored in the phone via text message, phone call and email. If the GPS is switched on, the person’s location and driving directions are also provided to the emergency contact [9].
The technology is not only made accessible for the elderly, but also marketed in the building industry where workmen are regularly climbing ladders and scaffolding, unaided.
Although fall detectors as an industry do not claim to have 100% accuracy. For instance, an elderly person may slide slowly from the end of their chair or from the toilet, without this being identified by the device as a rapid acceleration. The accuracy of fall detectors as a whole, is still considered high at 95% [7].
Apple.Inc’s innovation can be classified in a number of ways. On one hand, adding the FD and ERD as soft technology to an already existing product, the watch, is an incremental improvement. The business model and technology of the watch itself remains unchanged, yet it is an improvement to an already exiting product. On the other hand, however, merging a watch and an already established technology – in this case, the FD and ERD – does in fact create a new market. Rather than those seeking a FD in isolation, either as a bracelet or pendent, a new market opens for those looking to marry their watch, and the ability to tell the time or make phone calls/receive messages with technology aiming to increase their safety when living independently. This creates a disruptive marketplace.
Some may argue it is an orthogonal innovation, using two existing innovations for use in a completely new way, without necessarily simplifying the technology. Others will argue that it is potentially a mixture of all 3 depending on what market you are analysing.
For instance, the elderly who may not have considered an Apple Watch, may now consider it to be a beneficial purchase. Therefore, a disruptive innovation creating a new user and new business model. Whereas, a teenager contemplating the purchase of an apple watch may consider it more strongly given that it has a new added benefit over other watches; an incremental innovation.
The FD and ERD within the Apple watch is integrative. You are not able to download the mobile application and view data regarding a patient’s fall history without having access to an Apple product. This drives the commercial aspect of the product, though limits its diffusion as a technology application.

Enablers and Limitations
ENABLERS
With a predicted increase in falls of the elderly [2] and with a shift to more chronic medical conditions such as osteoporosis and orthostatic hypotension, all of which become more common as we age [1], the levels of injury secondary to falls is likely to increase. It is well known that following any injury, time to treatment can be a reliable indicator of outcome [7]. This, along with evidence available suggesting that a long lie is detrimental to the patient’s prognosis [7], specifically following a fall, increases the demand for a device that may hold the ability to summon emergency services in this situation. Thus, producing an inflating target market.
The Apple watch currently holds a U.S. FDA approval as a FD and ERD [11], and has other healthcare benefits such as tracking number of steps to log activity levels and monitoring heart rate. Receiving this certification as a healthcare product increases how well it is trusted globally.
FDs and ERDs are noted to increase confidence for those elderly who live independently. This can reduce their levels of anxiety to live alone within the community, reducing demands on carers and provide a financial saving on residential homes. It can also be used as a positive util for the innovation by increasing DALYs. This is of great importance to the patient and drives value within society.
From a policy perspective, as demand increases, so does pressure within the healthcare system. As more falls occur, presentations to the accident and emergency department increase, along with increased admission rates, investigations and treatment costs. This drives a demand for increased efficiency in managing falls, which the Apple watch sets out to achieve.
The Apple watch has the added advantage of aiming to provide equal access to care. Some may live remotely from friends and family or have fewer visitors to check on them on a regular basis (to identify if they had fallen). Ensuring equality in access is important when considering a healthcare innovation in the NHS as it is a mission statement for its operation. Likewise, ensuring quality of healthcare is of great importance. Although the application does not in itself provide care, the quality of their overall care is improved by reducing time to medical intervention.
Apple products may not appear simple or easy to use for the older generation. However, once set up, the FD is considered simple and easy to use. The screen is intuitive and requires no buttons to press, so those with upper limb injuries or arthritic joints should be able to use it without complication. The default setting is to notify emergency services should the user be unable to de-activate the fall, this is a safe, but potentially wasteful setting if notified in error.

LIMITATIONS
The apple watch is innovative by combing an everyday object such as a watch with potentially lifesaving technology. Yet there is a lot of competition. ERDs have been on the market since the 1970s with FDs emerging soon after. There are now various different types which suit a variety of users. If someone already has access to one, it reduces the impetus to seek another.

Recently the Fall Safety Pro application, for example, is available free of charge for download to most smart phones [10]. This works as a modular innovation, unlike the Apple watch, which increases its accessibility. The Fall Safety Pro works similarly as a FD and ERD. Although a smart phone is not attached to the user in the same way as a watch would be, and that it is not FDA approved, some may find this is as a comfortable draw back in exchange for a cheaper (free to those already with compatible phones) and more readily available product. However, the reliability of the fall detector will be limited to the gyroscope technology within each smart phone.

The use of a smart phone or watch with the FD may actually be a factor reducing how competitive it is. With many self-confessed technology phobic individuals over the age of 65, it may encourage the use of further simplified versions of the product which harbour larger screens or larger buttons for those with reduced vision and/or dexterity. For example, an ERD which is worn as a simple button on a pendent which the patient presses upon falling.

Although it may potentially be assumed that the Apple watch is more superior than its competitors with increased sophistication and intuitive technology (a helpful cognitive injustice for Apple products, secondary to a lengthy reputation as technology world leader [12]) there is no evidence to support this. Although the NHS receives pressure for healthcare technological innovation and is now partnering with technology companies such as Google and Deep Mind’s [13], there remains an economic pressure to reduce costs and prove cost effectiveness.
With a debt of £1.851 billion end of financial year 2015/16 [10], evidence is required to show not only the improvement in outcomes, but also how this is an overall cost neutral or cost saving innovation. Currently there is little data to support the use of the Apple watch in this setting and no data to support its superiority over competitors. Data exists to demonstrate the use of FDs, but they are very difficult to test in real life situations (usually tested in simulated settings) making the data that exists largely ‘academic.’ The NHS could support R&D around FDs and ERDs in more real life scenarios, but this yet again requires an injection of capital and a long time period to test and analyse data, which may deter decision makers from doing so. The technology may also be out of date once research is completed.

Adding to this, the elderly population are often considered to be innovation laggards [15]. Thus predicting that the product may find it more difficult to jump the translational gap successfully from innovation in to adoption.

Many other versions of ERDs work on a monthly contract. Although they have little start-up costs, if any at all, the device will continue to charge the consumer on a monthly basis. On one hand, the Apple watch can be considered to be a cost-effective purchase. If used for a long time, the watch may calculate to be cheaper than a long term monthly instalment plan. In addition, it harbours many other benefits such as the ability to send text messages, phone calls and monitor other health related data such as heart rate and sleep activity.
On the other hand, technology is constantly evolving and healthcare knowledge continuing to expand. The Apple watch may not be considered the most reliable product in one year’s time, or potentially not be needed following a new medical/surgical intervention, or even death of the individual. Thus deeming the watch an expensive purchase for use over a short time frame and less cost effective.

It is suggested that reducing hospital stay following a long lie and reducing those needing facilitated living arrangements would reduce NHS expenditure. If so, would a high end product, with few targeted health applications, but potentially encouraging increased use by its versatility, work out much more cost effective than a more simplified/cheaper FD with ERD? There is currently no data to calculate this.

Implementation Strategy (Economics and Policy):
As the theory of economic development becomes more outdated, which suggested that entrepreneurs are the driving force of innovation, there is a shift to suggest that innovators tend to research the market for opportunity prior to designing their products. It is likely therefore that Apple.Inc produced the Apple watch with FD and ERD following identification of a population demand. It undoubtedly appears to offer tangible benefits to both healthcare providers along with its consumers, even if these are difficult to measure. However, this compatibility does not directly link to either its use in accepted medical practise or within a UK health policy.
There are a number of implementation strategies that are likely to assist with this. One ‘push’ method would be to encourage the public themselves to purchase the Apple watch and then educate health care professionals to make use of the data stored within the FD. This would require a lot of mass media marketing and public education about the product with no guarantee of high volume diffusion and adoption.
An alternative ‘pull’ strategy is to encourage NICE to update its guidelines, making use of the Apple watch and used within national policy. Although timely and difficult to encourage, if accepted by NICE, it would mandate diffusion in to the market by making the Apple watch a requirement in certain individuals deemed at risk of falls.
Ideally there would be elements of the two above methods. The former to capture those who would like to feel more confident living alone but who do not fulfil an ‘at risk’ criteria, and the latter to ensure those that are at risk are exposed to the product and take benefit from its use.
An injection of capital is required to fund this process. This finance may be provided by the innovator themselves (Apple.Inc in this instance), a venture capital firm (a less likely investor until the concept of the product is proven and hence associated with a reduced risk) and/or the government.
Research is an important first step to support validity of the innovation. Including information regarding:
a) Efficacy
b) Relative advantage over other FDs and ERDs.
c) Cost effectiveness of product versus savings in hospital expenditure and social care needs.
d) Intelligent calculation of the DALYs increased from use of this product, with a consideration of individual patient feedback from a psychological and emotional perspective on QOL.
Having this data, and any other data that scientifically supports the product’s benefits to patient outcomes will reduce the time taken to diffuse the innovation in to the market, especially as this innovation is within the highly regulated healthcare sector, with increasing demands for evidence based policy and medical practise. Hospitals may choose to conduct this research ‘in-house’ and create a local policy, but when conducted at a national level, it increases the magnitude of outcome and increases the opportunity for nationwide policy change and incorporation in to NICE guidelines.
The time taken, and finance required to conduct viable studies at this level should not be underestimated and could create a very large translational gap from innovation to adoption.
Without the evidence from clinical trials however, the product solely relies on adventurous early adopters and positive dissemination through peer groups, along with more active dissemination through Apple.Inc marketing campaigns. This may be successful in isolation but is a risky strategy. The Apple watch FD and ERD are unlikely to be accepted by medical professionals, hence not taken seriously as a medical device in the UK (despite U.S. FDA approval), making a critical mass of adopters difficult to obtain.
Although research is important, it must be transparent to populate demand. Publishing findings throughout a wide variety of communication channels and through a wide variety of mediums e.g. through trusted medical journals such as the ‘BMJ’ and in more readily available social media posts and newspaper publishing such as ‘The Daily Mail,’ will encourage circulation throughout medical professions and lay individuals alike. This assists in generating a demand from the public on to healthcare providers and also provides clinical staff with reassurance of its scientific foundation for use. This is especially important when encouraging key clinical opinion leaders to represent the product and stand by its use, without fear of putting their reputation at risk.
Along with clinical champions, an incredibly important frontline behaviour is to create time and resource to educate both consumers of the Apple watch FD and ERD and the medical professionals, such as GPs, A&E staff, geriatricians and allied healthcare professionals such as OTs, who will interact with them. This can be challenging to achieve. Medical professionals alone will vary in location and level of interest in the product.
For nationwide implementation, time, staffing resource and financial resource need to be calculated and met by researchers and health economists. Sadly however, many healthcare innovations fail to be launched successfully secondary to the demands required for both R&D and for a successful innovation strategy such as that detailed.
For a product such as the Apple watch, it is likely to succeed in the private market given the strong reputation and image of Apple Inc, despite whether policy makers take an interest in its potential benefits as a public healthcare innovation for the NHS. Unless data supports its cost effectiveness within the healthcare industry and against its competitors, it is unlikely to be adopted as a national intervention for the elderly at risk of falls. With R&D being costly and time consuming, it is likely the UK may await data from overseas, such as the USA, to observe the Apple Watch’s FD and ERD’s impact on patient outcomes and the response from users and medical professionals, before considering direction of scarce resource towards its nationwide implementation.

References

[1] N. I. o. C. Excellence, “Falls in Old People; Assesing Risk and Prevention,” June 2013. [Online]. Available: https://www.nice.org.uk/guidance/CG161/chapter/introduction.
[2] C. M. a. I. P. Raul Igual, “Challenges, issues and trends in fall detection systems.,” Biomed English Online, no. 12, p. 66, 2012.
[3] W. H. C. J. P. P. Jager TE, “Traumatic brain injuries evaluated in U.S. emergency departments Academic Emergency,” Academic Emergency Medicine, vol. 2000, pp. 134-40, 1992–1994..
[4] Centre For Disease Control and Prevention, 10th February 2017. [Online]. Available: https://www.cdc.gov/homeandrecreationalsafety/falls/adultfalls.html. [Accessed 17th November 2018].
[5] R. LZ, “;Falls in older people: epidemiology, risk factors and strategies for prevention.,” Age Ageing, vol. Septemer, no. 35, pp. 37-41, 2006.
[6] D. C. Tidy, “Prevention of Falls in The Elderly,” 3rd July 2006. [Online]. Available: https://patient.info/doctor/prevention-of-falls-in-the-elderly-pro. [Accessed 19th November 2018].
[7] C. M. M. S. K. Kimberly Charlton, “Perspectives of older people about contingency planning for falls in the community: A qualitative meta-synthesis.,” PLOS one, vol. 0177510, 2017.
[8] Essence, May 2018. [Online]. Available: https://blog.essence-grp.com/panic-button-advanced-pers-solutions-providing-extra-layer-care/. [Accessed 25th November 2018].
[9] Apple Inc., 30th October 2018. [Online]. Available: https://support.apple.com/en-us/HT208944. [Accessed November 21st 2018].
[10] Itunes, “Fall Safety Pro,” [Online]. Available: https://itunes.apple.com/gb/app/fallsafety-pro-safety-alerts/id870864283?mt=8&ign-mpt=uo%3D4. [Accessed 2nd December 2018].
[11] A. Krueger, “Food and Drug Adminstration Federal Agency,” 11th September 2018. [Online]. Available: https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180044.pdf. [Accessed 25th November 2018].
[12] K. Korostoff, “Top 10 Tech Leaders,” 11th November 2006. [Online]. Available: https://www.networkworld.com/article/2301142/infrastructure-management/top-10-tech-leaders.html. [Accessed 20th November 2018].
[13] S. Neville, “Surgeon Aims to Inject Fresh Thinking of Tech on to NHS.,” 2018 November 20th. [Online]. Available: https://www.ft.com/content/5736df28-d82a-11e8-aa22-36538487e3d0?shareType=nongift. [Accessed 5th December 2018].
[14] NHS Confedartaion, 14th July 2017. [Online]. Available: https://www.nhsconfed.org/resources/key-statistics-on-the-nhs. [Accessed 1ar December 2018].
[15] B. O. Anna Essen, “Laggards as Innovators? Old Users as Designers of New Services & Service Systems,” International Journal of Design , vol. 5, no. 3, pp. 89-98, 2011.