Focus by Kinneir Dufort: Future Healthcare by Kinneir Dufort

FUTURE HEALTH

Focus DESIGNING A BETTER WORLD

future healthcare A snapshot on future influences around improving healthcare

contributors

CRAIG WIGHTMAN CHIEF DESIGN OFFICER

JAMES HOLMES HEAD OF TECHNOLOGY

KELLY O'CONNOR GRAPHIC DESIGNER

IAN CULVERHOUSE HEAD OF HUMAN FACT0RS

GARY HUNT SENIOR INDUSTRIAL DESIGNER

HANNAH SAGE DESIGN RESEARCHER

FOREWoRD Healthcare Matters. It affects all of us, whether we are in the role of patient, carer, healthcare professional, manager, payer or policy maker. Healthcare is also changing, with increasing demands on systems and new technologies offering potential solutions to challenging issues. At Kinneir Dufort, as a team of designers, engineers, thinkers and makers, Healthcare provides a prime need, and opportunity to exercise our maxim: Designing a Better World. We have, therefore, chosen this subject to explore in this edition of Focus. Around 50% of Kinneir Dufort’s work is in the Medical sector, including drug delivery, diagnostics, therapy devices and consumer healthcare. We believe that human-centred design thinking can address the challenges of healthcare in new, beneficial and valuable ways. We hope you enjoy reading our collection of articles and thoughts. We’d love to hear your feedback to include in future editions. Craig Wightman Chief Design Officer craig.wightman@kinneirdufort.com

Getting To The Point Mega Trends

Are we on the brink of a new era of healthcare diagnostics and point-ofcare testing?

The Human Factor

Can Graphic Design Save Your Life?

Leveraging Human Factors testing to reduce risk, add appeal and create business value.

Delving into the rich history of graphic design and health inspired by the Wellcome Collection exhibition.

Kinneir Dufort Approach

Exhibition Review

Digital Health And Selfcare

Can Product Design Save Your Life?

Five key areas whereÂ selfcareÂ will become increasingly important and prevalent.

As a complement to the Wellcome collection exhibition, we asked our team to suggest products that have been significant in saving lives, or otherwise advancing healthcare.

Why Software Is Hard

Perspective Matters

Digital Health

Design Thinking

Developing medical device software under IEC 62304 and FDA guidelines.

CONTENTS

FUTURE HEALTH

KD Team Opinion

Human Insights

Real Healthcare for Real People. Illustrating three perspectives: the patient and carer, the healthcare professional and the healthcare manager.

Gary Hunt

Getting to the point It is estimated that 70% of clinical decisions are based on diagnostic tests and with the scientific community constantly developing new tests, designed to provide clinicians and patients, with better information about their condition, this percentage is only likely to increase. The majority of these are run in large centralised clinical pathology labs, where economies of scale and quality of results are paramount. However, many of these tests have potential application in Point-of-Care Testing (POCT) situations, where testing can be most effectively performed in emergency situations, doctor’s offices, pharmacies, workplaces and people’s homes. POCT is valuable because it can deliver results in situ and in real-time, immediately closing the loop of diagnosis and therapy decisions. This can be important in emergency and critical care settings, such as emergency room or paramedic, where rapid diagnosis is essential. In doctor’s offices, it offers efficiencies for physicians, where patients can be treated in a single appointment, as well as reducing anxiety and improving convenience for patients. POCT technologies also have an important role to play in developing markets, where 4

Are we on the brink of a new era of Healthcare Diagnostics and Point-of-Care Testing? Pathology labs, Queen Elizabeth Hospital, Gateshead, UK

Point of Care Testing at Franklin County clinic, Rocky Mount, Virginia

POC clinic

FUTURE HEALTH

funding and infrastructure to support the model of large centralised laboratories does not exist. However, there is often a frustration than many innovative, and potentially valuable tests, are taking too long to get to market or are not getting there at all.

Decentralised testing in a military ﬁeld hospital

So what are the key factors to consider in successfully bringing a POCT system to market?

Evidence Based: To gain real traction the test must have proved itself to improve patient outcomes and be justified in hard healthcare economic terms. The path to achieving this evidence is often a long and expensive one, involving clinical trial with devices and test consumables first embodied in production-like form. Carefully considering the pathway to proving the real clinical value of the test should be built into the business plan of the development of any new diagnostic test.

Accuracy & Quality: To be widely accepted, a diagnostic test must demonstrate accuracy and consistency. Lab-based tests have the advantage of the QC procedures that can be realised in the controlled environment of a large laboratory facility. Tests done in remote locations, outside the controlled environment of the lab, have a tough job of ensuring that they are performed to the equivalent level of accuracy and control as those conducted in the lab.

Usability: Point-of-Care tests are often undertaken by non-specialised staff and sometimes by patients themselves. Designing a useable product is not only an FDA requirement to ensure safe use but an imperative to allow users to carry out tasks simply and confidently. It’s important to consider not only the usability of the test itself, but all the elements of the system including: sample preparation, quality control procedures and entry of user and patient information.

Workflow: With different types of users and environmental settings, it’s pivotal to look at workflows. This top level interconnected journey of the patient and Health Care Professional (HCP) needs to be clearly mapped and identified to ensure a seamless integration of any new device into a given system. Considerations should include: • How long does the HCP spend with the patient? • Who takes the sample and who performs the testing? • Does the patient wait whilst the tests are being carried out? These are all critical elements which could affect uptake and device acceptance.

Economic Case: © NHS

The cost per point-of-care test is likely to be significantly higher than a lab test can deliver. The resultant payback on the total cost of care, based on improved outcomes of a POCT system is often hard to prove, but is essential to encourage adoption by healthcare managers and payers.

drugs. According to the Longitude Prize, a challenge with a prize fund of £10 million, run by Nesta, the UK’s innovation foundation, “Point-of-care test kits will allow more targeted use of antibiotics, and an overall reduction in misdiagnosis and prescription. Effective and accurate point of care tests will form a vital part of the toolkit for stewardship of antibiotics in the future. This will ensure that the antibiotics we have now will be effective for longer and we can continue to control infections during routine and major procedures”. Teams from around the world, seed funded by the Longditude Prize, are currently working on a range of new diagnostic systems for POCT settings. Secondly, new technologies have enabled the reduction in size and cost of testing. Miniaturisation will allow the “lab” to be deployed on small, portable handheld devices and even on the test consumable itself. The availability of improved connectivity, derived from mobile devices, is key to maintaining connection to the central lab information system (LIS), ensuring maintenance of results management and QC procedures. Thirdly, the regulatory landscape for POCT is changing with transition towards a new in vitro diagnostic (IVD) directive, providing clearer classifications and one that is more flexible in response to the increasing pace of technological development. Lastly, and importantly, as healthcare inevitably moves towards a more consumerised model, patient expectations will increasingly drive demand for more immediate and convenient diagnoses of health conditions. Elizabeth Holmes’ ill-fated venture, Theranos, which offered convenient, rapid, fingerstick blood test diagnostics direct to consumers, illustrated the potential of this trend (despite its fall from grace last year) and suggests that new, revolutionary, directto-patient, and point-of-care diagnostics tests, will be a key part of the future healthcare landscape.

Despite these challenges to bringing a POCT to market, there is increasing encouragement and incentives for the scientific, clinical, design and business communities to do so. Firstly, there are important new drivers for POCT, such as the need to tackle antibiotic resistance, much of which has been created by over-prescription of broad spectrum antibiotic © Nesta

The

Human

Factor

Leveraging Human Factors testing to reduce risk, add appeal and create business value

IAN CULVERHOUSE

FUTURE HEALTH

The last decade has seen the role of Human Factors (HF) gather significant attention and pace within the MedTech and Pharma world. A number of high profile key milestones define the progress HF has made, not least of all FDA’s HF Guidance, the revision of IEC 62366-1 and most recently for the UK, the release of MHRA’s own guidance focusing on Human Factors. The identification of user needs and requirement for ensuring the “right product” has been designed (i.e. Design Validation) has been a critical component of Design Controls for medical devices since the introduction of FDA 21CFR 820.30 in 1990 as well as being part of the ISO Quality Management System for medical devices, ISO 13485. Nevertheless, the introduction of guidance focused on HF methodologies has brought without question a greater level of clarity as to how to incorporate HF into a device design. Owing to the fact that FDA’s mission is to “protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices” it stands to reason that from a regulatory perspective, the primary role of HF is to remove the potential for use-related risk. However, HF’s potential impact and return on investment extends far beyond being isolated as a risk management process.

Desire and Engagement

The consumer industry uses a plethora of methods and tools to attract consumers, encouraging the purchase of products which represent lifestyles, trends and aspirational visions of who people wish to become. Consumer products are therefore marketed by highlighting the value and beneﬁt they will have upon our lives; often in an aesthetically pleasing way.

Risk Mitigation

Commercial Risk

Desire + Engagement

The challenge in developing medical devices that people want to use, is that there is no ‘one sizes fits all’. Some users may want a device that looks clinical, professional and typically ‘medical’, whereas others would rather hide the fact they’re having to use medication and prefer the device to blend in: looking almost ‘consumerised’. To illustrate these challenges, take the example of a daily injection device that patients can carry with them. Our past research - which has shown how different patients’ attitudes and desires can vary greatly – suggests that there are a range of user profiles. These can include but are not limited to: the hider, the embracer and the professional. The hider might not want to be reminded that this is medication; they want a discreet device that they can hide. The embracer on the other hand, acknowledges and actively embraces their condition. It’s part of their life that they want to make it fun, even something they’re happy to show off. Finally, the professional. These patients want to be reassured that a medical product looks like a medical product; giving a sense of trust and comfort. Developing and understanding of the breadth and variety of users can seem daunting. However, performing formative studies can be a helpful way to navigate this landscape, and create tangible ways forward. Take for example, a large volume patch pump device, designed to infuse an accurate dose of drug to a patient over an extended duration at home. A traditional formative HF study could be utilised to help ensure the user interface is clear for the patient and not susceptible to potential use-related error or risk. However, in the context of real use, once combined with a drug which potentially has unpleasant side-effects, there is a very real risk that the patient will become reluctant to use the device, not because it is difficult to use, but because their overall experience is unpleasant. Whilst HF can do little to address unpleasant side effects patients may experience when undertaking this treatment, HF can help to understand patient barriers and motivators which in turn can be used to improve engagement and adoption during use. After all, a device which introduces a sense of stigma and embarrassment to the end user is ultimately far more ineffective in fulfilling the intended use than one which has a button that is slightly hard to depress.

By extending the focus of HF beyond a task-based risk reduction tool, it can help to deliver devices and experiences which address user needs on a richer level. The next time you think about planning a formative HF study, ask yourself, could we expect the same set of results if the user spent more than an hour using the device? What if they had to use it over a simulated duration akin to the intended use of the product? Commercial Risk In addition to helping support increasing desire and engagement within device design, HF tools such as Contextual Inquiry (CI) can add significant business value in helping to identify potential areas of commercial risk. CI traditionally generates a detailed model of the tasks specific users need to perform within a given environmental setting. CI draws upon observational techniques combined with opportunistic interview questions to help develop a deeper understanding behind peoples’ behaviours and actions. Traditionally, these task models are used to formulate the basis of a uFMEA through a Hierarchical Task Analysis and the definition of User Profiles within a use specification. Our experiences of conducting CI in clinical and home-use settings has shown that the value extends further and can help to redefine the commercial pathway of a device programme that may follow. The semi-longitudinal nature of a CI study can help to undercover implicit decisions related to device use that are otherwise unobtainable through spoken discussion or interviews. Learnings which relate to motivations and behaviours can help feed into marketing and positioning strategies, ensuring the messaging behind a device reaches those most influential in the decision-making process for adopting a device for use. 7

DIGITAL HEALTH & SELFCARE Five ways in which we will increasingly be looking after ourselves

Craig Wightman

FUTURE HEALTH

“Healthcare has been the last major industry that hasn’t been touched by technology in terms of productivity and consumer adoption in the way so many other industries have” So noted John Sculley, hi-tech investor and former Apple CEO a few years ago. Observing the activities of major healthcare players such as Philips Healthcare, Johnson & Johnson and GE Healthcare, as well as tech giants such as Google and IBM with its Watson Health arm, it’s clear that interest is high in leveraging digital technologies to create new solutions in healthcare. However, despite the activities of established corporates and startup entrepreneurs alike, the perennial challenge of healthcare funding and stretched resources, combined with the restrictions imposed by regulatory frameworks, has meant that the impact of technology in creating new solutions in healthcare, has been almost imperceptible in comparison to the pace of change in other areas. Whilst governments, health authorities, regulators and healthcare companies continue to seek to ﬁnd ways to square the circle of increasing costs and increasing needs, it seems clear that we, as consumers – or patients in health-speak – must and should take more responsibility for managing our own health. Healthcare businesses and brands, whether public sector or private, need to work harder and smarter to make health more relevant and compelling to our everyday lives – not just when we are ill. Here are ﬁve ways in which digital tools will increasingly allow us to look after ourselves, heralding a new era of self-care:

01. SELF DIAGNOSIS The digital infrastructure for transformative self-diagnostics is already here, in the form of: 1) Wearables sensing activity, heart rate and behaviours 2) Smartphones providing communication and computing power 3) AI systems interpreting the data and delivering targeted results We are already seeing a “second” wave of wearable tech solutions focused on healthcare including Clincloud’s stethoscope, Alivecor’s Kardia ECG and Bloomlife’s pregnancy monitor, all providing professional quality diagnostic tools enabled by the power of consumer smartphones. Just as signiﬁcant is the growth of on-demand triage diagnostic services, providing new ways for consumers to access health advice and diagnosis, avoiding the delays of getting doctor’s appointments, or unnecessarily clogging up Accident and Emergency departments. Babylon Health’s service, combining real doctors with AI-backed digital tools is already ﬁnding its way into the mainstream by providing the NHS 111 triage service in parts of London, and is proving popular.

The CliniCloud Stethoscope is a world ﬁrst, designed speciﬁcally for home use

Providing access to real doctors, backed up by AI-powered digital

Smart self-monitoring during pregnancy and labour

Alivecor Kardia Medical grade electrocaridiogram in 30 seconds delivered straight to your smartphone © Alivecor

Smith & Nephew PICO Advance woundcare for hospital and home care settings

02. SELF THERAPY We will continue to see a trend towards patients self-administering and self-managing their own therapies. Examples include growth in ever more sophisticated auto-injectors and other drug delivery devices, and systems such as those from Kinneir Dufort clients Ambicare with their Ambulight PDT skin cancer therapy and Smith & Nephew with their PICO advanced woundcare systems. These systems are allowing previously hospital-based treatments to be delivered by patients in their own homes. Key drivers for self-therapy are cost, as well as limitations on staff and other hospital resources. In the area of diabetes care, where self-therapy is practised by millions of people around the world, the holy grail of a closed-loop self-diagnostic and therapy system, combining continuous glucose monitoring (CGM) systems with insulin pumps, is now within our reach, technologically. The challenge is now to make these “automated pancreas” systems sufﬁciently accurate, reliable and safe to prescribe. However, some diabetes patients, hungry for new solutions to better manage their disease, are taking matters into their own hands. The #wearenotwaiting movement encourages tech-savvy people with diabetes to fashion homemade artiﬁcial pancreas systems by hacking their insulin pumps and combining with CGM systems and digital diabetes management tools. Although at the fringes of consumer/patient behaviour, this underlines the desire amongst patients to take matters into their own hands and encourages medical device companies, as well as the regulatory bodies, to keep pace with patient expectations.

#wearenotwaiting Automated pancreas created using hacked insulin pump and Continuous Glucose Monitoring system © Dana Lewis

MySugr app for managing diabetes Accu-Chek Connect System Connected Diabetes Care: blood glucose meter, app and online portal

Propeller Health Smart sensors for asthma and COPD inhalers © Propeller Health

03. SELF MANAGEMENT OF CHRONIC CONDITIONS Chronic conditions, such as diabetes, respiratory conditions, heart disease and cancer, offer great opportunities for improved outcomes as well as consequential reduced cost burdens, through effective used of digital tools in self-management. In this area, there is a strong recognition that device/data ecosystems backed up by AI can provide valuable personalised health management advice. The challenge is often in capturing manually entered data points. Devices such as Propellor Health’s smart sensor attached to existing inhalers is an example of a digital enabler, but more important and challenging aspects are how to capture data related to diet, health events and mood. Here, the most successful solutions will be those that best engage and empathise with patients. Examples include the MySugr diabetes management app, created and run by people with diabetes, for people with diabetes and recently acquired by Roche, and the Omada system, which combines connected devices, health coaches and smart tools to help achieve behaviour change. Another opportunity in this space is the potential for engaging personal, family, friends and wider social networks to support patients in self-management of their conditions.

Connects patients to doctors via computer, tablet or phone in the comfort of your own home

Ambulight PDT Portable skin cancer treatment

FUTURE HEALTH

04. WELLBEING AND PREVENTATIVE CARE A key challenge for society is to encourage us, as humans, to maintain healthy lifestyles and to think about healthcare before we get ill. The ﬁrst wave of wearables enticed us to maintain more active lifestyles, but, from a business perspective, this has been hard to sustain, with even major players like Jawbone failing to make their consumer wearables business pay, resulting in liquidation in July this year. To succeed, like market leader Fitbit, a key target will be the insurance and workplace health and wellbeing schemes, where a sense of community, as well as the prospect of lower premiums, will provide a key element of motivation. One notable development in wellbeing, has been the growth of systems designed to support mental health. Often previously ignored, an increasing acknowledgement of its importance has led to the growth of meditation and mindfulness app Headspace, as well as Pear Therapeutics’ specialist digital application and medication systems for treatment of stress, anxiety and other disorders.

Pear Therapeutics Combined medication and digital therapy for treatment of stress anxiety and addition disorders

05. TELEHEALTH AND ASSISTED LIVING Although in use for many years, telehealth now looks set to generate more significant traction through the greater prevalence and affordability created by smartphones. Whilst the benefits for providing connected care for our ageing population are obvious, the use of telehealth services to significantly augment, or even largely replace, the physical GP visit seems likely. Services such as HealthTap and Doctor on Demand point the way towards a new smartphone-enabled consumer-driven future for accessing healthcare services. © HealthTap

These ﬁve areas offer huge potential for innovation and for creating a new, more consumerised healthcare market. The challenges of safety and compliance imposed by the medical regulatory framework remain, but the opportunities made possible by new digital technologies of enhanced patient/consumer experiences and better clinical outcomes, are too inevitable and valuable to resist. The coming years will see a consumerdriven transformation in healthcare. Craig Wightman, CDO at Kinneir Dufort was speaking at the 2017 Digital Health World Congress, London. 11

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FUTURE FUTURE HEALTH HEALTH

Why Software is Hard ...and how to make it easier Developing medical device software under IEC 62304 and FDA guidelines.

James Holmes

As the sophistication of medical devices continues to grow, software is becoming increasingly fundamental to an ever-expanding range of products. Delivering effective products to the market quickly whilst still meeting the requirements of US and European regulators requires a fresh approach to medical device software development. The exponential advancement in consumer technology kick-started by the smartphone over a decade ago, has trained consumers to expect much more from the products they use. Whilst many medical device manufacturers are keen to provide improved user experiences and leverage the latest technologies, it can be hard to balance ‘pushing the envelope’ with achieving regulatory compliance whilst simultaneously meeting budgets and timescales.

Conversely, consumer technology companies are increasingly interested in adding more ‘health’ functionality to their devices in an effort to maintain growth by targeting more sustainably high-value product offers. This leads them ever closer to considering medical regulatory compliance. Apple’s CEO Tim Cook has publicly stated that despite his company’s desire to expand into the health space, it would never put a device such as the Apple Watch through the medical device regulatory approval process out of concern that it would hold back innovation. How then can we help to bring the user focus and pace of innovation seen in the consumer space, to the world of medical devices? Fresh and new thinking is required in order to balance the need to innovate quickly with the structured and rigid approach required to achieve regulatory compliance.

User

Planning

requirements

Sprint 1 architecture

detailed design

Review/ design updates

Breaking medical software development into short cycles of iteration and evaluation

Prototype early

The right process

Innovative solutions which are intuitive to use can be key to a product’s success, but the formalised procedural medical development process can be stifling to innovation. Early stage prototypes when used appropriately can help in formulating requirements and architectures which are both robust and appropriate, helping to minimise costly changes later in the development process. High level programming languages and the widespread availability of powerful library code mean that software and user interfaces can be prototyped, just as easily as prototype parts can be 3D printed.

Whilst medical device regulations for software are explicit in the phasing of development and required design inputs and outputs, they do not mandate a specific development lifecycle.

Rapidly building early stage prototypes ensures key product assumptions can be tested up front and also allow formative human factors studies to be conducted; enabling refinement of the user experience well before expensive development work is undertaken. 11

FDA guidance and IEC 62304 may be interpreted as implying a rigid “waterfall” process, but an Agile approach to software development activities can also meet regulatory requirements. By leveraging the Agile development methodology, our electronics and software team at Kinneir Dufort have been able to respond more reactively to the natural evolution of products during their development, supporting the need to respond to change whilst ensuring regulatory compliance. By tackling the development phase of medical software in ‘Sprints’, functional (though incomplete) aspects of the code can be seen by stakeholders as the code base evolves, rather than in one block at the end of the project. This not only increases the engagement of all those involved in making the product a success, it also ensures that any changes which need to be made can be identified as early as possible.

Spr

FUTURE HEALTH

r Needs Validation Testing

Verification Testing

Sprint N

rint 2 Review/ design updates

Integration testing

Review

System Integration

Release

Number of sprints can be determined by scope and scale of the challenge

Use your tools Development frameworks and tools play an important role in maintaining compliance whilst minimising overheads in the development process. In particular, the results of software unit verification and integration testing must be documented for some classes of software component. By applying tools such as an automated test framework, a tool developed by the Kinneir Dufort software team, we are able to not only reduce software test cycle times but also more efficiently produce verification documentation in accordance with IEC and FDA guidelines. It’s not just the tools used, but how they interact. By tightly integrating software configuration management, automated test and bug tracking systems, traceability can be maintained at a highly granular level with minimal time consuming overheads and far less opportunity for human error associated with paper based systems. This allows developers to spend more time focused on producing creative solutions and less time updating documentation.

Innovation and the Changing Regulatory Framework Regulators are now responding to the challenges of fast-moving software products. In a move last month, as part of its Digital Health Innovation Action Plan, the FDA announced that it has created a pilot programme to speed the regulatory pathway for digital health products. Medical product manufacturers and software developers selected to participate in the pilot programme include: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Roche and Samsung. Launching the initiative, FDA Commissioner Scott Gottlieb noted: “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an 12 individual product.” Despite the efforts of regulators to keep up with the rapidly evolving landscape of digital technology, IEC and FDA guidelines will undoubtedly continue to place significant requirements on manufacturers to maintain safety and efficacy standards. However, with effective early stage prototyping, the correct development process and use of the latest development tools, safe and effective software can be brought to the market without having to sacrifice the opportunity to innovate. 15

Can Graphic Design Save Your Life? Exhibition Review

Kelly Oâ&#x20AC;&#x2122;connor

FUTURE HEALTH

If you were dying from heart disease will one of Saul Bass’s posters cure you? Perhaps not, but advances in medicine, education and public health can all be attributed to masters of Graphic Design. The Wellcome Collection’s exhibition Can Graphic Design Save Your Life highlights the role design has played within healthcare.

Looking back to the 16th Century, when a trip to the barbers for a quick shave included half price offers on limb amputation, it’s easy to see that medical sciences were somewhat overlooked back then. It wasn’t until Andreas Vesalius started paving the way for anatomy and surgery that things began to change. Before Vesalius, physicians were still practicing medicine discovered by Galen, whose writings made waves 1300 years ago… Along with artists, Vesalius created detailed illustrations of anatomy for medical students to complement live human dissections which were previously prohibited. This was a real breakthrough in education as people started to understand how the body worked. Handing the torch from barber to surgeons, knowledgeable in anatomy, undeniably saved lives. Fast forward 300 years when early infographics identified and explained causes of disease and infection. Dr John Snow presented an illustrated map that traced the outbreak of cholera in the 1800s which pointed to contaminated water tanks rather than the previously believed “foul smells”. Florence Nightingale used a similar approach when showcasing the impact of hygiene on death rate. This visual communication of data persuaded governments and other medical professionals to adopt handwashing and other good hygiene practices to be part of the norm. Even before the practice of graphic design existed, words and images were integral to communicating public health messages in the battle against infectious diseases such as the plague. During the 20th century, graphic design was used extensively to bring an understanding of healthcare to the masses, using simple graphics disseminating technical and scientific messages. More recently graphics have been prominently used in campaigns promoting AIDS awareness, the dangers of smoking and reducing hospital infections through good hygiene practice. Bold typography and visual concepts give authority to the campaigns to inform and inspire behavioural change. In 2014, Stephen Doe created a mural in Liberia explaining the symptoms of Ebola visually, specifically aimed at a country where many are illiterate and there are over 30 languages spoken. In this context, good design should be accessible to all as understanding disease and symptoms may just save your life! As Abram Games, prominent British propagandist graphic designer succinctly captured in his famous maxim: “Maximum meaning, minimum means”. Today we can see infographics playing a role in wayfinding throughout hospitals and pharmaceuticals. Pearlfisher’s Help Remedies packaging for New York City-based boutique pharma company seeks to reduce design to the bare minimum with the symptoms, rather than the drug ingredients being made more prominent, ensuring immediate recognition of what you might need to fight your illness.

Here at Kinneir Dufort, we understand the importance of graphic communication IFU (instructions for use). Having conducted many IFU usability studies over the years, it is clear how a slight miscommunication of words can have a potentially serious impact to the user. Often, pharmaceutical companies are restricted by cost and so the less information that needs to get printed, the cheaper the print. In an ideal world, IFU’s would have simple diagrams to explain how to use a product. Done well, this would minimise any confusion in terms of wording and could actually translate across languages. As they say; “A picture paints a thousand words”. Integrating into a tech-savvy 21st century, we can see the way graphic design is fusing with technology to help save lives. The mosquito killer billboards by Brazilian agency NBS, entices mosquitos with scent and light which then traps and kills the mosquito. In a time when the Zika virus and other mosquito-borne diseases are a huge concern, this pioneering technology might help eradicate disease in the future. Furthermore, the technology is made available under creative commons licenses to encourage proliferation of the design to benefit areas around the world.

So in short, can graphic design save your life? Yes, this curation at the Wellcome Colection suggests it, and demonstrates that graphic design isn’t just about decoration and marketing, sometimes it can be the difference between life and death. Can Graphic Design Save Your Life? runs until 14 January 2018 at the Wellcome Collection, 183 Euston Road, London NW1 2BE

Can Product Design Save Your Life? As a complement to the Wellcome exhibition, we asked our team to suggest products that have been significant in saving lives, or otherwise advancing healthcare. Here are a selection of our nominated examples:

Epipen

Smartphone / Smartwatch

Philips Lifeline

In a world where the prevalence of severe allergic reactions is increasing, this lightweight, portable device, introduced in the 1980s, enabled emergency injection of epinephrine to those suffering from anaphylaxis. It required minimal training, enabling the patient or bystanders to administer the drug at the point of need rather than relying upon the timely arrival of emergency services.

The Smartphone in your pocket and the Smartwatch on your wrist are increasingly likely to save lives, such as in the recent case of James Green from Brooklyn NY who received an alert from the HeartWatch App on his Apple watch which proved to be an early warning of a pulmonary embolism.

Perhaps not as immediately lifesaving as some other home safety products such as smoke detectors, the Philips Lifeline, and other home monitoring systems can be a crucial life saver for an elderly person who has fallen down and can’t get up. With connected technology providing easier and lower cost access to smart monitoring features, systems like these will play an increasing part in saving lives of elderly people living independently in their homes.

Russell Beard: Head of Design

Tony Wood: Senior Quality Manager

Lewis Wood: Design Engineer

Prosthetics Limbs

Pacemaker

Other than being a great showcase for inclusive participation, one of the great successes of the Paralympics has been to change attitudes towards disability. The design and technology of advanced prosthetics has had a hugely beneficial influence on both the life enabling functionality, as well as the social perception of prosthetics for everyday use. Not a life saver, but certainly a life enhancer.

Pioneered by companies such as Medtronic, implanted pacemakers are precision works of electronic and medical engineering, designed to provide electrical impulses to the heart muscles to regulate its beating. With moderm versions including defibrillator functionality, these, now commonplace, devices have become everyday lifesavers.

Craig Wightman: CDO

Merle Hall: CEO

Blister Packaging and Pillpack Service The ubiquitous blister pack provides protection and convenient dispensing of millions of life-saving medications every day. Pillpack’s new online pharmacy service, provides monthly home delivery of medications, conveniently sorted, labelled and packed in easy-to-open pouches.

Chris Althorpe: Senior Design Consultant/ Hayley Maynard: Designer

FUTURE HEALTH

Automated External Defibrillators (AEDs) A medical device with specific ability to save and even restore life, these systems need to be designed for use by quite literally anyone. The circumstances around their use will normally be stressful, panicked and need to support successful use by untrained people who have never used one before. Sadly, and challengingly, AEDs now also need to incorporate resistance and prevention of abuse and misuse through vandalism and criminal behaviour.

Ian Culverhouse: Head of Human Factors/ James Darios: Design Researcher

Aquatest Funded by the Bill and Melinda Gates Foundation, and led by The University of Bristol, the Aquatest project was formed to create a device and system for testing and quantifying drinking water quality in remote locations, without access to power, laboratories or skilled users. The resulting product, developed by Kinneir Dufort in partnership with the University of Bristol engineering team, has been pilot tested in 10 countries, providing valuable data helping to target life-saving improvements in water quality.

Phil Walsh: Head of Engineering

Bristol Maid e-Clean Hospital Bedside Furniture Responding to government calls for action to reduce growing rates of healthcare acquired infections such as MRSA and C-Difficile, the NHS and The Design Council set a challenge to designers and manufacturers to create new solutions to the problem. Partnering with NHS supplier, Bristol Maid, Kinneir Dufort re-imagined the hospital bedside cabinet, making it easier and faster to clean and maintain, improving hygiene and making it simpler to use for both staff and patients.

Craig Wightman: CDO

K1 Auto-Disable Syringe

Cycle Helmet

Ambulance

One of the biggest barriers to advancing healthcare is consumer behaviour, intentional or unintentional. Design can play a powerful role in shifting behaviour – anything from improving compliance to fundamentally changing healthcare practice. The K1 auto-disable syringe, invented by Marc Koska is a great example of this. A simple but effective solution, the K1 syringe is similar to standard syringes but has an auto-disable function which means it cannot be used more than once. The K1 syringe has had a huge impact in reducing the spread of blood-borne diseases like HIV and syphilis, particularly in Africa, and has been instrumental in driving the World Health Organisation’s global campaign to eradicate the problem of the dirty needle, which is responsible for the deaths of 1.3 million people worldwide every year.

If you were to peek into the KD garage you’d see a plethora of bicycles, underlining Bristol’s status as a UK cycling city. Our road networks are becoming ever stretched and traffic is a bigger issue than ever before, it’s a common problem across the UK, if not the world.

Designed to cope with a multitude of different scenarios, today’s ambulances pack a huge amount of technology into a small space. First response is critical in emergency cases so the development of ambulances from purely being for transportation to being a mobile emergency room has saved countless lives. Reversing the text of AMBULANCE on the vehicle’s front so it can be read in the rearview mirror of a car, is a stroke of genius too!

Kate Dowler: Head of Research

With a growing number of cyclists on the road and naturally more accidents, the humble cycle helmet can claim to have saved significant numbers of lives. Despite voices that claim helmets are a barrier to entry, a survey published in the Guardian last year, based on a study of 64,000 cyclists globally, claimed that wearing a helmet reduced the chances of fatal head injury by 65%. With roughly 6.6million people riding bikes once a month in the UK alone, that’s potentially a lot of lives saved...

Gary Hunt: Senior Designer

Sunny Panesar: Medical Portfolio Manager

GP Endocrinolgist/ Consultant

Child/ Elderly Patient

Adult Patient Care Giver

Dietition/ Nutrition Type 2

Diabetes Specialist Nurse Type 1

Nurse Educator

Perspective

Matters Real Healthcare for Real People The healthcare system in any market is a complex beast. There are multiple stakeholders with different needs and agendas. Overlay that with the issues of funding and insurance and it’s clear that designing healthcare products and experiences requires a deep understanding of multiple user needs. It’s important to gain empathy with the different people and users, whether they be patients, carers, healthcare professionals, administrators or payors. It’s critical to have a detailed understanding of the issues they face and what’s important to them as users. 20

Hannah Sage

By adopting a human centred approach, we’re able to listen, learn and ultimately design solutions that address the needs of these multiple stakeholders. Our team regularly talk to users and it always helps to establish user personas, to bring to life their stories, based on real-life experiences. Here we illustrate three perspectives: the patient and carer, the healthcare professional and the healthcare manager. These are based on interviews with real people, although names and photographs have been changed to protect privacy.

FUTURE FUTUREHEALTH HEALTH

Sarah & Anna:

The Patient Story

For Sarah and her husband, their daughter Anna’s diagnosis was a long and painful one. It took several months, multiple GP appointments, incorrect diagnoses and a few A&E visits before their 10-month-old baby was ﬁnally diagnosed with Type 1 Diabetes. Anna’s symptoms started off small; an incessant need to drink cups of water, far too much for a small baby. She’d scream for no reason and constantly suffered from nappy rash.

“People said she’d grow out of it, but I knew something was wrong” In one A&E visit, Anna was slipping in and out of consciousness searching for her mother, despite being cradled in her arms. She then fell into a diabetic coma and lay unconscious in intensive care for three days before making a full recovery. After a few days in hospital learning how to inject a baby with insulin, and prick Anna’s heel to test her blood, Sarah and her husband were passed over to the care of their local Paediatric Diabetes Specialist Nurse team.

“Clare is a lifeline… she’s the single most, and biggest amount of support we’ve had… without Clare, I dread to think” Eight years on, life is settling down into a gruelling routine of blood glucose checks, insulin doses and carb counting – endless numbers and calculations leaving little mental space for anything else. It’s had a massive effect on Sarah’s life, leaving behind her career after Anna was born, only recently returning to work part-time. The emotional strain is challenging; doubting calculations, waking throughout the night, every night, to monitor Anna’s condition and feeling riddled with guilt if blood sugar levels stray too much. Always fearing the worst Sarah never travels more than 45 minutes from Anna.

to her and being forced to grow up fast, asking questions like ‘will I die?’ if her insulin pump fails. She quickly came to the realisation that her body was completely reliant on the machine. Technology has helped ease some stresses by providing the tools for better and more intense management, achieving better control and longterm health outcomes. Now Anna’s getting older, “she’s understanding how her body’s feeling and she can check her CGM (continuous glucose monitoring) levels herself”. Future blood glucose meters will connect to smartwatches which could revolutionise Anna’s care.

“She’ll be able to check and monitor her sugars in a way that suits her… She won’t be in a vulnerable position where people judge her or stare” It’s comforting that Anna will have a sense of freedom with this tool. While, as a parent, Sarah is then reassured by being able to monitor Anna’s diabetes with an app on her own phone.

Hey Sarah, Here’s Anna’s latest stats

Blood Glucose

121

mg/dL

Next check: 12pm

Hey Anna! Have you checked your blood sugars?

“If something happened and I couldn’t get there… well, I have to be there” It’s been emotional for Anna too, ﬁrst questioning why this happened 21

“It’s time default mo hospital an improveme do

The Healthcare Professional’s Perspective Clare’s Story Clare, a Paediatric Diabetes Nurse Specialist, describes her role in the community as “taking a family along the journey of a child with diabetes” by providing round the clock care and advice. It’s about empowering patients and their carers to manage a life with diabetes. Clare and her team create a holistic package of care, tailored to the individual child and family’s needs. With the child at the centre, support expands to the outer spheres of their inherent support system – family, friends, school and even after-school activities. “It’s trying to look at everything going on for that child, not just the diabetes”. The team recognise that life events impact a child’s care and that support must vary accordingly. “We focus on the diabetes but also consider the effect and implications that the rest of life has on it”. For example, if a family has just been bereaved it is inevitable that this will have an effect on everything else in their life and their ability to manage the diabetes. Being proactive is key, as is learning to manage the needs of the whole family. If parents are separated, the team will travel to both homes and listen to their worries and questions. Choice of language can help ease tensions by ensuring children don’t feel judged if their management isn’t perfect yet. “We don’t call them (blood sugar) tests anymore but checks… young people and children may also feel judged by it, as if it’s a test that they can get wrong or right”. Choosing a device for diabetes management can be a balancing act, ensuring the child and both parents buy into the treatment and are happy to take on the challenges associated with it. It is here where new technology can cause discord in families. Parents are keen for everything to be perfectly controlled but children don’t always want to be permanently connected to a device or feel judged because they are wearing one. It is this part of Clare’s role where it is key to 22

highlight the positives and the negatives of each treatment type. “When there is disparity between what child and parents want we just have to talk it through to come to a resolution… it has to be right for everyone”. Technology can also help healthcare professionals more readily identify patterns, and adjust treatment as a result. With the NHS increasingly focussing on better outcomes for children with diabetes, following the introduction of the Best Practice Tariff (introduced in the UK in 2012-13 to provide an annual payment to support the treatment of all children and young people under the age of 19 with diabetes), Clare and the team welcome the support of increased technology and the progress that comes with it. There is some recognition that devices don’t suit everyone but for those it does, it can be transformative. Even for those it doesn’t suit, “new pieces of tech can often be good for re-engaging and create an interest and a drive”. They are, therefore, often a valuable tool for both healthcare professional and patient in the crucial area of motivation and engagement. However, achieving a more sustainable healthcare change is the challenge and that’s where technology isn’t quite able to provide all the answers and teach families everything they need to know. It’s clear to see that despite the hard work, it’s a role Clare loves: “It’s a job that can really make a difference… if you can help families manage well, it has a lot less of an impact on day to day life than it could do”.

“It’s a job that can really make a difference… if you can help families manage well, it has a lot less of an impact on day to day life than it could do”

e to change the odel of going to nd technology ents are helping o this.”

FUTURE HEALTH HEALTH FUTURE

The Healthcare Manager’s Perspective Debbie’s Story “It’s time to change the default model of going to hospital” notes Debbie, Director of Operations at Community Health, a social enterprise body involved in a wide variety of community health initiatives. Recognising the value that technology improvements can provide, she adds: “It [technology] encourages self-care and patients only need to get help when they’re outside their parameters and they need extra assistance”. The use of technology has been driven, in part, by the growing complexity and number of patients. There is no longer enough capacity to manage patients’ healthcare the way it has been done historically. The NHS is recognising that increased expenditure now, on devices like CGM (Continuous Glucose Monitoring), could lead to huge cost savings later, with reduced hospitalisations resulting from scenarios like mis-managed diabetes. The Governments ‘Best Practice Tariff’ (BPT), introduced in 2013, echoes this understanding by recognising the need to support children with diabetes earlier to ensure long term savings. It is supported by research showing that good diabetes control at a younger age triggers a metabolic memory which allows the body to better manage diabetes on its own. On the contrary, poorly managed diabetes leads to devastating effects for the patient and huge financial implications for the NHS. This drive is not just financially practical or better for long term health outcomes but it’s also about improving quality of life and giving patients the independence to live with a long-term condition. As Director of Operations for Community Health, Debbie works across all three healthcare sectors: adults, children and prisoners, looking at clinical pathways and the whole healthcare system. The idea is to identify an area where small improvements could be made that have a beneficial knock-on effect further down the line. For example, a high amputation rate can be positively affected by helping provide high risk patients with access to better education and regular specialist check-ups. For Debbie, this means her days are spent carefully scrutinising current services to identify ways to do it better, even if that means spending more money in the short term. The Community Health organisation is often involved in small scale pilots or trials to test out new ideas and incremental improvements. With success in pilots, it’s possible to scale these services up across a wider region with support from the local commissioner. Unlike the NHS, funding in a social enterprise can be spent where they believe it would be of most use and any surplus can be put back into the system to fuel further growth. NHS funding is often tied to a specific area, a major “pain point” or area of need. However,

Debbie and the team have the ability to address that same pain point by tackling it at an earlier stage of the pathway. Looking at the bigger picture in the healthcare system can get complicated but Debbie isn’t working alone. Fellow directors help oversee the three sectors, as and when needed. They’ll regularly conduct ‘temperature checks’ with the management teams in each sector to understand the main issues they’re facing. In turn, these sector teams are responsible for assessing clinical risk and patient safety issues. Reporting to the Senior Management Team – Debbie and her fellow directors deliver an overview of the priority issues and ultimately have the decision on some of the more widespread topics. Eventually their work is then fed up the chain through Government where, with luck and funding, recommendations are adopted and positive changes implemented into ofﬁcial directives and legislation.

Key Take-Outs

With multiple stakeholders driving healthcare in today’s society, designing a medical product can feel like a hugely complex mineﬁeld. Taking an empathetic approach, grounded in user stories from different perspectives, is a great starting point for designing solutions to these complex challenges. From a Design Research perspective, our three key take-outs are: 1. Listen and Observe It’s vitally important to get out and meet the people that you’re designing for. What people say and what they actually do, can be very different. This can be evident even if they’re talking you through a step by step process whilst doing something totally opposite, right in front of you. 2. Think Visually Draw a diagram identifying the key players and their relationships. Healthcare systems are large and complex and it always feels like a new player jumps in the mix just as you thought you were beginning to understand it. A diagram will help keep your focus and your attention on the right people for the product or problem you’re dealing with. 3. Test Ideas Translate insights into design recommendations as soon as possible, then embody them as sketched ideas or basic prototypes and test them with users. It’s vital to understand your users and how that should inﬂuence the design of the new product, so it can positively impact the user’s experience. 23

Coming up… Digital Health World Congress, London 29th - 30th November

Focusing on digital healthcare technology conference, the Congress serves as a forum for medtech, mobile, IoT, and IT and covers medical and mobile technology including ehealth, mhealth, telehealth, telemedicine, genomics, and healthcare IT. www.digitalhealthcareworldcongress.com

Drug Delivery to the Lungs Conference (DDL), Edinburgh 6th - 8th December

DDL is an annual forum for scientists, academics, clinicians, regulatory and industry specialists involved in developing medicines for inhalation, including ﬁve themed sessions given by experts in the ﬁeld of inhalation. www.aerosol-soc.com/events/ddl2017

Pharmapack, Paris 7th - 8th February

Europe’s dedicated Pharmaceutical Packaging and Drug Delivery event, Pharmapack, invites over 400 exhibitors and 5000 attendees for 2 days of exhibition and conferences, to gain updates on the latest trends, developments and regulations impacting the industry. https://www.pharmapackeurope.com

Wearable Technology Show, London 13th - 14th March

The biggest event for wearables, AR & VR, IoT and connected technology returns to London next March. Two days of conferences, expert speakers, an award ceremony and exhibition. www.wearabletechnologyshow.net/home

International Symposium on Human Factors and Ergonomics in Health Care, Boston 26th - 28th March

This International Health-Care Symposium oﬀers leading human factors experts, pharmaceutical and medical device companies, biomedical engineers, health-care providers, FDA representatives, and patient safety researchers the opportunity to share knowledge and ﬁnd solutions for issues and challenges in health-care. www.hfes.org/Security/ContentPages/?Id=22

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