DCA Medical and Scientific brochure 005

Over half a century of design.

Medical and Scientific Overview

Contents

9 Welcome 10 Our Expertise 12 Our Awards 14 Our People 16 Medical device development process 18 Medical and Scientific services 22 Our connected disciplines 24 Research and Strategy 26 Mechanical Engineering 28 Industrial Design 30 Human Factors and Usability 32 Interaction Design 34 Electronic Engineering 36 Software Engineering 38 Prototyping and Evaluation 46 The art of persuasion: Designing devices for patients who don’t want to adhere

62 Designing for uncertainty 74 Designing a connected product around a coin cell 80 How smart do smart medical devices need to be?

106 The future of radiotherapy treatment 116 Beyond compliance. What is the role of human factors in medical device development?

128 Designing products that stand the test of time 158 Our location 163 Contact

Drug delivery 11, 26, 30, 40-45, 52-61, 66-73 Other Medical 32, 34, 84-89, 96-105 Scientific Instruments 19-20, 86-89, 90-95 Consumer Healthcare 120-127, 134-153 Commercial and Industrial 110-115, 154-157 7

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Welcome

Founded in 1960, we are one of the world’s leading product design and development consultancies, operating globally from our campus in Warwick, UK. Since the early sixties we have helped a wide variety of companies design and develop market leading products that users still value every day, ranging from the Stanley knife to the Eurotunnel Shuttle.

Today we focus on building long term relationships with large corporations in four market sectors: ‘Medical and Scientific’, ‘Consumer’, ‘Commercial and Industrial’, and ‘Transport’.

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Our Expertise

We add value by improving the success of product innovation.

We do this through an intelligent approach to design, based on the transparent management of risk, informed decision making, true integration of disciplines and rigorous development processes.

We believe that the outstanding commercial success of the products we help create is dependent ultimately on delivering exceptional value to our clients customers.

We provide the right blend of strategic thinking and pragmatism to deliver our clients’ projects successfully.

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We balance the creativity and the technical discipline needed to achieve commercially successful product innovation.

Every client is unique. To support our clients, we like to understand them, their place in the market and their ambitions thoroughly.

Sanofi SoloStarÂŽ Disposable insulin pen injector

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Design planning Usability and HF Mechanical engineering Industrial design Colour, material and finish Instructional design Graphic design Prototyping Testing and evaluation Production support

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Our Awards

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A multi award winning design and development service.

Multi award winner

Multi award winner

Multi award winner

multi Silver Award Winner

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gold

winner 2015

Multi award winner

Stanley Caplan User-Centered Product Design Award

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Our People

DCA is a collection of over 130 extraordinary individuals. Intelligent, creative and thorough, our people make the difference to our clients’ projects.

They combine to create a vibrant fusion of disciplines including mechanical engineers, electronics and software engineers, industrial designers, usability and interaction experts, researchers, strategists, prototyping technicians and specialist project managers.

Each person is an expert in their own field, but has the curiosity, understanding and flexibility to reach

across traditional inter-disciplinary boundaries. Our organisational structures and team culture encourage this synergistic blending and integration of specialist skills.

Our clients benefit not only from each individual’s depth of knowledge and experience but also from a team whose combined strength exceeds the sum of its individual members’ expertise.

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Medical device development process

Industrialisation Support

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Foundation

Design Input

Design Output

Pre-prototype Iteration

Prototype Iteration

How do you meet the challenge of delivering your new product to market quickly with the right performance and a strong intellectual property position, whilst industrialising robustly and cost effectively?

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4 Production Validation

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Design Transfer

Production Support

5 Design Verification Design Validation

It’s a complex problem, but one in which we have a great track record, with many commercially successful products delivered for clients in the pharmaceutical, medical device, consumer healthcare, hospital equiptment and scientific instrument markets.

An effective development process underpinned by informed decisionmaking is fundamental to our work. If a project is planned and structured correctly from the outset, then key risks can be identified early and managed towards a positive outcome.

Successful medical and scientific device development requires keen attention to detail, with commercial realities meaning that development effort must always be appropriately directed. You can have confidence that our creativity, technical rigour and sensitive design skills will be intelligently focussed to deliver exciting and effective solutions to the challenges you bring.

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Medical and Scientific services

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We offer a comprehensive design service to the medical and scientific industries, with development processes aligned to standards and regulations in the EU and US.

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Microbial Systems CellFacts II Modular real-time cell analysis instrument Design planning Mechanical engineering Industrial design Prototyping Production support

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Fully integrated product development services from initial project direction through to detailed support for industrialisation.

With extensive experience of strategically important and technically demanding projects, our large multidisciplinary development team comprises mechanical engineers, electronics and software engineers, industrial designers, usability and interaction experts, researchers, prototyping technicians and specialist project managers.

We provide fully integrated product development services from initial project direction through to detailed support for industrialisation. Our skills include product development strategy, design research, project planning and management,

intellectual property strategy, concept creation, prototyping, feasibility studies, design auditing, risk management, detailed design, engineering analysis, development testing, usability engineering, design verification, supplier selection and technical support for industrialisation. We can provide a complete turn-key development service, or staged input to a project.

Our design and development service is certified to ISO 9001 and ISO 13485.

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Our connected disciplines

Since our foundation a multidisciplinary philosophy has been the cornerstone of our approach to product design and development.

DCA’s specialists offer robust tools and techniques in every field of product design and development, but it’s the connection between these different disciplines that we believe make us unique.

Our studios, laboratories and workshops have different disciplines working side by side. Our ability to connect and integrate the right disciplines, at the right time, in the right way is the cornerstone of our approach.

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Mechanical Engineering

Interaction Design

Design Research & Planning

Software Engineering

Prototyping

Electronic Engineering

Human Factors & Usability

Industrial Design

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Research and Strategy

Deciding which direction to take a design, or even what to design next, often proves one of the greatest hurdles in product development.

Research and Strategy at DCA exists to inspire and inform these decisions, providing the cultural and user insight on which to build great product strategy and designs.

Practised by a team with diverse experience we use a range of tools to build robust data and rich stories.

No two projects are the same.

We go wide and we go deep, gaining intimate knowledge of the relationship between people, brands, products and their environments.

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Mechanical Engineering

To consistently deliver market leading products you need a world class approach to engineering.

For us, this means employing the best engineers with a wealth of individual and collective experience. It means planning projects rigorously and applying individually tailored development processes during their implementation. It means using cutting-edge tools and techniques to develop and test our ideas.

And it means integrating our engineering thinking, closely with

our other in-house product development skill bases to deliver unified project results.

World class engineering is at the heart of most projects we undertake and provides our clients with the highest probability of success, even with the most technically challenging developments.

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Industrial Design

In an increasingly sophisticated world, external form and visual detailing have become an important expression of the quality and performance of a medical device, or scientific instrument.

The space between medical devices and consumer products has become blurred and market tolerance for poorly executed visual design is low.

In this context we believe industrial design should be informed and relevant. It should be highly creative and push what is technically possible.

Yet there are still some important differences between medical and consumer products. Safety must always be paramount, usability cannot be compromised and longer market lifecycles mean that visual design must transcend short-term fashions and trends.

We achieve this by integrating the industrial design team with research, usability and engineering disciplines and by employing designers who understand strategic context and are passionate about detail.

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Human Factors and Usability

We inform ideas and their implementation through a deep understanding of the relationship between people, products, and their environment.

We integrate human factors and usability throughout the design process, adopting domain-specific regulations and guidance from ISO 62366.

Emphasis is placed on moving beyond compliance to leverage the commercial benefits of more inclusive products and services that optimise system performance.

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Interaction Design

Our multidisciplinary approach delivers product interactions across integrated physical and digital platforms.

In an increasingly connected world, new challenges have emerged in delivering compelling user experiences. Our multidisciplinary approach delivers product interactions across integrated physical and digital platforms that are simple, intuitive and a delight to use.

co-ordinated product experiences.

Whether extending products with digital touchpoints or developing interactions for embedded hardware, we use an integrated approach to create future facing concepts and develop these through to production.

Our team combines interaction, graphic and industrial designers, researchers, electronics hardware and software engineers to develop

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Electronic Engineering

Our electronics team have developed medical devices and scientific instruments with functions ranging from simple automated monitoring to sophisticated electromechanical control, diagnostics and connectivity.

Success in these areas depends on robust requirements definition and careful partitioning of functionality between electronic, mechanical and software sub-systems. The effective management of interfaces and interactions between sub-systems is key, and is greatly enhanced by an integrated team structure.

For this reason our electronics engineers, designers, mechanical engineers and researchers work very closely together from the start of projects to capture, define and translate requirements into effective design solutions.

Whether electronic functions are an inherent part of your new product architecture, or an existing mechanical system needs to be enhanced with new electronic features, we have the skills and knowledge to meet your development challenge.

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Software Engineering

A rigorous approach to software engineering is fundamental to safe, effective and successful medical device development.

Software must be carefully planned and diligently executed, but this does not mean that it has to be slow.

DCA’s agile software development process is fully compliant with IEC 62304, but also draws on years of experience developing code efficiently for the consumer goods and automotive sectors.

With a powerful blend of experience, talent and rigour, our software engineers integrate seamlessly

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with our electronics, mechanical engineering and interaction design teams to deliver products ranging from complex electro-mechanical systems through to more simple, but equally compelling devices.

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Prototyping and Evaluation

Prototyping is at the heart of our business.

Since our foundation we have always had extensive workshop and prototyping facilities in the centre of our studios.

This enables us to explore, test and iterate concepts at increasing levels of resolution throughout a project and is a fundamental part of our product development and risk management processes.

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The multi-billion selling SoloStar ® pen injector is one of the world’s best known drug delivery devices.

DCA partnered Sanofi throughout the development of SoloStar®, applying our rigorous evidencebased approach to all aspects of the design. The result is a device that delivers leading performance in almost every respect. With superior levels of safety and comfort, the pen is sophisticated, yet simple to use.

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Since its launch in 2007, SoloStar® has been adapted for use across a range of therapies and can now be found in almost every market around the world.

Sanofi SoloStarÂŽ Disposable insulin pen injector

multi multi

Design planning Usability and HF Mechanical engineering Industrial design Colour, material and finish Instructional design Graphic design Prototyping Testing and evaluation Production support

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Sanofi ToujeoÂŽ SoloStarÂŽ Disposable pen injector for concentrated insulin Design planning Mechanical engineering Industrial design Colour, material and finish Instructional design Packaging design Graphic design Prototyping Testing and evaluation Production support

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Toujeo® SoloStar® Building on the multi-award winning SoloStar® platform, DCA partnered Sanofi to develop a new range of pen-injectors for Toujeo®, a triple concentrated basal insulin.

dose accuracy tolerance limits are three times tighter than for a standard pen, meaning that doses need to be delivered within a ±0.0033mL window.

Toujeo® SoloStar® contains 450 insulin units, deliverable in single unit increments. Due to the triple-concentrated formulation,

Toujeo® SoloStar® was painstakingly engineered to achieve this exacting requirement and also to provide an ultra-low injection force.

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Sanofi ToujeoÂŽ Max SoloStarÂŽ Disposable pen injector for concentrated insulin Design planning Mechanical engineering Industrial design Colour, material and finish Instructional design Packaging design Graphic design Prototyping Testing and evaluation Production support

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Toujeo® Max SoloStar® Toujeo® Max SoloStar® has a capacity of 900 insulin units, the largest of any long-acting insulin pen on market, and an increased maximum dose of 160 units, selectable in 2 unit increments.

This means fewer pen changes and fewer injections, making life easier for the increasing number of patients on higher insulin doses.

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The art of persuasion: Designing devices for patients who don’t want to adhere

By some estimates, half of patients with chronic medical conditions fail to take their drugs as prescribed.

By some estimates, half of patients with chronic medical conditions fail to take their drugs as prescribed.

For many, this is a conscious decision. Intelligent design of drug delivery devices can help to change this.

Within the context of drug delivery devices, the conventional approach to improving therapeutic compliance is often to think in terms of reminders or dose counters. While these devices have a clear role to play, they only tackle one part of the problem – unintentional nonadherence. They do little to explicitly challenge patients who elect not to take their drugs as prescribed.

The scale of the problem is hard to quantify, but there is evidence that a significant proportion of patients with chronic medical conditions actively decide not to comply with their prescribed treatment; some estimates attribute intentional nonadherence as high as 70% of the issue ².

Published on 17th December 2015 46

There is a consensus that the reasons for intentional nonadherence are complex and often idiosyncratic, meaning that it is unlikely that any single intervention will ensure that all patients take their medication as directed. Systemic solutions are needed that help patients to better understand and engage with their therapy, along with drug delivery solutions that cater for the patient’s emotional, as well as physical needs.

This article will explore what device developers can do to confront these issues within realistic commercial constraints that tend to favor ‘standardized’ device solutions.

The Non-Adherence Problem.

Medication non-adherence is one of the biggest challenges facing health care providers. It is incredibly difficult to determine exactly how many people are affected, or why patients are not taking their drugs as prescribed, however, current estimates from the World Health Organisation 1 are that 50% of patients around the globe, with long-term illnesses, do not take their medications as prescribed. In the USA alone, it is estimated to cost $290 Billion a year 3, cause 125,000 deaths annually, and account for 10% to 25% of hospital and nursing home admissions 4.

Intentional or Non-Intentional?

Unintentional non-adherence is usually related to some form of forgetfulness or confusion. The result is that patients may forget to take a dose, take the wrong amount, repeat a dose, or take the incorrect drug.

Intentional non-adherence, on the other hand, relates to situations where patients are aware of what drugs they should be taking and when. However, they decide that they do not wish to take their drugs as prescribed. This may mean that users fail to take any of the prescribed drugs, end a course

prematurely, or take a different dose to that prescribed.

Ostensibly, the intentional nonadherence challenge is one of behavioral change. One commonly adopted approach is to address this challenge by viewing patients as the problem. Designs then focus on making patients more motivated, preventing them from doing something, or to persuade them to do something else. Fear tactics are one example of this; however, their efficacy is questionable, moreover, they can lead to patient anxiety, often in individuals who have no issues with adherence.

particular situation and decided to depart from the prescribed drug regimen. Like the reasons for non-adherence, the way in which individuals make decisions are largely idiosyncratic. However, there have been many attempts in the past to describe decision making activities. One model commonly used is the OODA loop.

This describes a feedback loop where decision makers observe the information available to them, they then Orientate this information to their own lives and the specific context, Decide which of the available actions they should adopt, and then act.

An alternative approach is to view the patient as a rational decision maker that has absorbed the information provided to them, considered it in the context of their

Learning from decision making theory, it is evident that the presentation of information alone does not change user behavior, rather it is the process

Behaviour Change.

Many people in the drug development and distribution chain also have their role to play in increasing adherence. of interpretation, or orientation, that is key. In order to both gain and maintain user engagement, users need to be able to relate the information provided to their own lives and the specific context of use.

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In many cases, there are opportunities to simplify drug regimens by viewing them holistically and reducing the number of drugs required.

Accordingly a key opportunity in helping users to adhere to their drug regimen lies in the orientate phase of this decision making cycle.

What is clear is that much of the patient information currently provided is often not being read or not being understood. A Danish study 5; found that 40% of elderly patients did not understand the purpose of the drugs they were taking, while only 21% understood the implications of the omission of a drug or dose. This is perhaps unsurprising when viewed in the context of how many drugs some people are taking – with 60% of over 65s in the US taking five or more medications 6.

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A recent study assessing the impact of text messaging on adherence 7; also provides some interesting insights. The study involved 303 participants; half of which received SMS alerts prompting them to take their drugs, while the other half, the control group, received no intervention. The first insight is that the reminders were helpful; in fact 60% reported that they were reminded at least once to take a dose that they may have forgotten.

This is perhaps unsurprising, but validates the assertion that reminders have a role to play in the adherence challenge.

What gets a bit more interesting is what else the study found. When

comparing drop out rates (i.e. those either stopping completely or taking less than 80% of their medication), it is apparent that the drop out rate was considerably lower for those in the test group (25% in the control group compared to 9% of those receiving text messages). Further examination reveals that those in the test group were asked to text back with any concerns that they might have. 15% of the test group reported concerns on at least one occasion, because of uncertainty over the need for treatment, concern over side-effects, or another medical illness. Each case was followed up with a telephone call to address these concerns. This intervention, simply by calling them up and explaining these concerns, resulted in 87% (13% of the test group) resuming treatment.

These findings of this study suggest that actively addressing patient concerns and uncertainty can have a marked impact on adherence rates.

For device manufactures the next logical question should therefore be how can medical devices, and the ecosystems that surround them, be designed to support this.

packaging design will undoubtedly have an impact on the way drugs are perceived, likewise the way drug devices look, feel, sound, taste, and function will all shape perceptions.

What Can Device Developers Do?

Focusing on medical device development, and more specifically products that patients are using to self-manage their regimens, there remains much that can be done.

As highlighted in the text message study, engagement has a key role to play in tackling the adherence challenges. This challenge can be split between gaining and maintaining engagement.

As a systems issue, health care providers are well placed to make changes to adherence levels. In many cases, there are opportunities to simplify drug regimens by viewing them holistically and reducing the number of drugs required. Likewise, the way patients receive their drugs can be simplified, a number of pharmacists are now offering clearly labelled sachets containing all of the drugs a patient should take at a given time.

Many people in the drug development and distribution chain also have their role to play in increasing adherence. Within the marketing team, the way drugs are presented and even named have the potential to impact adoption,

Maintaining Engagement.

The concept of seeking to maintain engagement is often more familiar to device developers, involving topics that are well understood by those familiar with good usability engineering practice. This involves minimizing the impact on patients’ lifestyles.

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Ultimately, the way we design and present information to users should be driven by a clear understanding of the way they orientate themselves with this information.

Common tactics include focusing on: • Convenience and flexibility of use (products should generally be unobtrusive on users’ lifestyles.

Extending the time between doses and flexibility in the timing of doses. They should be transportable, allowing users to use them, and safely dispose of them in a wide range of scenarios.

Patients should be supported in managing their drug regimen).

• Time taken (devices should minimize the time required to set up, use, and safely dispose).

• Complexity of use (devices need to be intuitive to use – matching the cognitive abilities and expectations of the target users).

• Physical effort and comfort (the forces and postures required to deliver a drug need to be carefully considered and controlled).

• Capturing and sharing information on adherence (can the device system communicate progress to the patient, providing feedback and reward? Where appropriate, can the system capture the level of adherence for health care providers or carers).

Gaining Engagement.

Article by Dr D. Jenkins Research Lead Human Factors and Usability Rob Veasey Senior Sector Manager Medical and Scientific Matthew Jones Senior Sector Manager Medical and Scientific This article was originally published on the MDT - Medical Design Technology website

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Understanding the patient’s initial decision making process is central to gaining engagement. This is a topic that tends to receive less attention in standards (e.g. IEC 62366) and guidance documents (e.g. HE75).

Playing the decision cycle described in the OODA loop backwards can reveal some interesting insights.

Explicitly considering the decisions that users are making, and how their specific view of their condition and context shapes this, is critical.

Ultimately, the way we design and present information to users should be driven by a clear understanding of the way they orientate themselves with this information.

In this context, the ‘information’ goes well beyond written instructions. It includes all sensorial aspects of the device that patients are interacting with. The form, the colour, the material, the way it feels, and the way it responds are all information prompts that shape the way users decide whether to engage.

A second opportunity lies in the decision making section of the model. Carefully controlling the options available to the patient can also assist in the process.

Pre-metered doses or treatments in a single pill may help to reduce patients under dosing or overdosing.

There are a number of activities that can help device developers to understand the orientate phase: • Understanding the context (understanding the condition and the system of therapy, considering how and when patients are engaging with this product and other products used in conjunction).

• Developing an emotional connection (Getting products out of the medicine cabinet.

Designers and developers should ask what makes users love and engage with a product and not want to hide it away. There are many lessons here that can be learnt from how traditionally ‘taboo’ consumer products are now packaged).

Even subtle differences in colour can mean separate regulatory submissions – resulting in additional cost and potential delays in getting drugs to market.

• Information that the users can relate to (Devices should be designed to support simple instruction. Instructions should be limited to major points presented using clear, everyday language and photographs or pictograms, covering why they should follow each instruction, along with how).

What does it mean for Standardized devices?

Based on the guidance captured thus far, it is apparent that devices that resonate with individual needs, or certainly the needs of sub-groups of the population are important.

This may be in the form of fun ‘funky’ products for children, or ruggedized products for those who are keen to take part in outdoor pursuits. However, this requirement for multiple variants of the same device presents significant challenges for medical device manufacturers. Even subtle differences in colour can mean separate regulatory submissions – resulting in additional cost and potential delays in getting drugs to market.

The result is that, in most cases, a single product must be found that balances the needs of its diverse user base. This requires detailed

References

1 World Health Organisation report (2003).

Adherence to long-term therapies: evidence for action. ISBN 92 4 154599 2.

2 Reid. K (2012). The Heart Of The NonAdherence Epidemic. Available at http://www. atlantishealthcare.com/news-media/details/ the-heart-of-the-non-adherence-epidemic accessed 06/07/14.

3 CVS Caremark (2012). State of the States: Adherence report.

4 Smith DL. Compliance packaging: a patient education tool. Am Pharm. 1989;NS29(2): 42–45. 49–53.

consideration to ensure that product can be both standard while still meeting the needs of as wide a patient group as possible.

Arguably, the challenge of maintaining engagement is far better understood and well captured in guidance (e.g. HE75). The FDA focus on safety and efficacy seeks to ensure that the physical forces required and the complexity of use is appropriate for the user population. However, the process prescribed in IEC 62366 does far less to encourage explicit consideration of how devices can be optimized to gain engagement.

For that, a different focus is required.

There is a wide range of tools from the fields of human factors and design research that can help to structure this focus. Techniques such as ethnography and semistructured interviews allow device developers to gain a richer insight into the lives of device users.

Furthermore, they can help inform how an emotional connection can be established. In addition, a detailed understanding of decision-making psychology can help structure what information is required, along with where, when and to whom it should be displayed.

5 Barat I, Andreasen F, Damsgaard EM (2001).

“Drug therapy in the elderly: what doctors believe and patients actually do”. British Journal of Clinical Pharmacology 51 (6): 615–622.

6 Belcher VN, et al., (2006). View of older adults on patient participation in medication-related decision making. Journal of general Internal Medicine. 21 (4): 298-303.

7 Wald DS, Bestwick JP, Raiman L, Brendell R, Wald NJ (2014) Randomised Trial of Text Messaging on Adherence to Cardiovascular Preventive Treatment (INTERACT Trial).

PLoS ONE 9(12).

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Sanofi LyxumiaÂŽ Disposable pen injector for GLP-1 Design planning Usability and HF Mechanical engineering Industrial design Colour, material and finish Instructional design Packaging Graphic design Prototyping Testing and evaluation Production support

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The LyxumiaÂŽ pen is an easy to use disposable injector, intended to help people with type 2 diabetes.

It is the product of an intensive, evidence-based development programme focused on improving the injection experience of patients, for whom LyxumiaÂŽ may be their first experience of self-injection.

Providing a device that is not only intuitive to use, but is also comfortable and reassuring was a primary consideration in the design.

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AllStarÂŽ is the first reusable insulin pen produced by a global pharmaceutical company in India.

The pen injector is the result of three years exemplary team work between DCA and Sanofi, with the sole purpose of offering a product that matches the needs of people living with diabetes in India and other developing markets.

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AllStarÂŽ is a state-of-the-art device that is easy for patients to use and also supports physicians in early initiation of insulin therapy, for better glycaemic control and enhanced therapeutic outcomes.

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Sanofi AllStarÂŽ Reusable insulin pen injector Design planning Usability and HF Mechanical engineering Industrial design Colour, material and finish Instructional design Prototyping Testing and evaluation Production support

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AllStar® Pro premium reusable pen injector.

Sanofi have recently launched the AllStar® Pro pen injector in Europe and Canada. AllStar® Pro is a reusable pen injector, intended to help people living with diabetes.

The pen uses replaceable cartridges, providing a convenient option for patients who inject regular doses of insulin. DCA partnered Sanofi throughout the development of

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AllStar® Pro, targeting a product that delivers high quality with efficient use of materials. This important new device is the result of a rigorous development programme, which builds on the award winning AllStar® device platform.

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Sanofi AllStarÂŽ Pro Reusable insulin pen injector Design planning Usability and HF Mechanical engineering Industrial design Colour, material and finish Instructional design Prototyping Testing and evaluation Production support

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Designing for uncertainty.

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Making decisions about the future direction of a product or service is not easy. Not only does it require commercial acumen and technical ingenuity, but it also requires an element of prediction – determining how the product or service will fit the future user and market needs.

The pragmatic middle ground is to base decisions on a grounding of appropriate information, recognising when the information available is enough to progress for a given risk level. Perhaps more critically, the challenge is to ensure that the right information is sought.

Project teams can fall foul of one of two clear traps when deciding on the future direction for a product or service. Some teams limit the information collected, in favour of relying on intuition – progressing the design without a clear understanding of risk, while others collect too much, delaying decision making in a quest for clearer, more unequivocal, information. In the latter, there is a risk that analysis paralysis can set in – where decisions can be repeatedly deferred as additional questions are raised resulting in further research.

While we cannot be certain of the future, we can make educated assumptions. Some assumptions will have high levels of certainty, others less so. Likewise, some assumptions will be critical to the design, others less so. Products stand the greatest chance of success if they are designed based on an explicit understanding of the assumptions that underpin key design decisions along with a description of their robustness and their criticality to the design.

Furthermore, actively monitoring,

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Products stand the greatest chance of success if they are designed based on an explicit understanding of the assumptions that underpin key design decisions. and protecting, those assumptions plays an important role in increasing the likelihood of success.

assumptions that have significant sway on design direction and those with lower levels of certainty.

Assumption-based design

The process can be summarised as follows:

The approach we have been refining over the past few years and describe as Assumption-based design creates an explicit, and auditable, link between the information available, the assumptions that are made based on this information, and design recommendations.

Article by Dr D. Jenkins Research Lead Human Factors and Usability Rob Woolston Managing Director Malcolm Boyd Senior Sector Manager Medical and Scientific

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Record information and insights collected 2. Record assumptions made 3.

Link assumptions to information and capture a rating of assumption confidence

Understanding the links between information, assumptions, and design recommendations is critical.

By linking assumptions to design recommendations, it is possible to understand which assumptions are more critical to the project, and which are less (or even irrelevant).

Likewise, the information that is being used to direct future product recommendations can be explicitly highlighted.

4. Record recommendations made

When a rating of confidence is applied to the assumptions, the approach serves as a structured process for prioritising future research, focusing first on the

The type of information collected will be dependent on the type of product being designed. However, it is likely to include a mixture of factors that can direct innovation:

5. L ink recommendations to assumptions and capture a rating of recommendation confidence 6. Identify critical assumptions 7.

Determine the required processes to confirm and monitor information and assumptions Information

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When a rating of confidence is applied to the assumptions, the approach serves as a structured process for prioritising future research.

Needs

Assumptions

• E xplicit stakeholder (end users, manufacturers, installers, maintainers, etc.) wants and needs

Assumptions are made based on the interpretation of one or more pieces of information.

• Latent stakeholder needs • M arket demands (e.g. regulatory requirements, cost models) Technology • Latest component availability • Current R&D pipeline • Predicted technological innovations and costings (extrapolation of trends) Category trends • D escriptions of current competitor products • I ntelligence around competitor pipelines (what they are talking about coming next) • Patent searches and landscaping Macro trends • Trends from parallel worlds (what is happening in other markets that tend to cascade down) • Broader trends (e.g. attitudes towards disposable plastics, views on cashless transactions)

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As an example, for a given product, a number of information sources (such as ‘voice of the customer’ data and competitor portfolio mapping) may indicate the importance of a connected version of a product, leading to an assumption that a connected variant would be critical to the design.

We can be very confident about some of the assumptions that we make about a product or a service. Others can feel like little more than a guess. As such, it is important to have some way of capturing a description of their certainty, along with a link to the information source(s) used. This creates an auditable trail and allows assumptions to be revisited should the validity of an information source be subsequently questioned.

Recommendations Recommendations can be treated in much the same way as assumptions.

We can be very confident about some of the assumptions that we make about a product or a service, others can feel like little more than a guess.

It is important to record what they are based upon, and the level of confidence in them. The adoption of a recommendation is likely to determine the importance of each of the linked assumptions and, in turn, the associated information elements.

This may lead to further research to confirm the information.

Continuing with the example of a need for a connected device, this is likely to lead to a recommendation to develop a connected variant of a product. However, it may be critical to re-test this assumption throughout the development process to ensure that the product being developed is indeed meeting the needs of the consumer.

Improving the model Once all of the assumptions are listed out, and linked to recommendations and information, it is then important to understand which are the most critical to the success of the product or service.

This allows critical assumptions to be monitored and a focus to be placed on the assumptions that are critical to product success. Critical

assumptions can then be tracked, protected and hedged.

For example, if product success is linked to two core assumptions: that the product will have the lowest cost of goods (COGs) and that the cost will be a key driver in purchase decisions, then it may be critical to monitor competitor portfolios and innovation pipelines (e.g. patent searches) to understand if they are developing technologies or processes that may give them a cost advantage.

Cost advantages can be protected by further reducing COGs through cost reduction exercises (making it harder for the assumption to fail).

It can also be hedged by ensuring that the product has added value to consumers that would allow it to be a viable proposition even if the assumption were to fail (no longer the lowest cost on the market).

nature of the approach provides a clear audit trail for decisionmaking providing a more efficient, transparent, evidence-based process.

This not only helps to guide product development, but it also helps to reduce instances of ill-informed decision-making and analysis paralysis.

This is particularly relevant when initiating a product in the face of uncertainty. Rather than delaying project kick-off in pursuit of further information, this approach can be employed to start the project based on a clear understanding of the assumptions made, resulting in a specification that is refined over time and allowing timelines to be met, while still managing risk and uncertainty.

Conclusions Our experience is that assumptionbased design provides a highly structured approach to product and portfolio planning. The explicit 65

BD Libertas™ Wearable autoinjector for large-volume drug delivery Design planning Mechanical engineering Industrial design Colour, material and finish Prototyping Testing and evaluation

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BD Libertas™ is a wearable injector capable of delivering large-volume and high-viscosity drugs.

In 2018 BD and DCA won a prestigious iF design award and a Good Design award for BD Libertas™. It was developed to administer biologic medicines for various chronic diseases over longer periods of time that cannot be administered through the use of auto injectors. The design prioritizes safety, convenience and usability while delivering high performance

with manufacturing efficiency.

An exciting new device built on a foundation of pharmaceutical company needs, user understanding, and technical robustness, BD Libertas™ is a significant step forward for the safe and convenient delivery of biologics.

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We understand just how deceptively complex it can be to successfully design and industrialise an inhaler or nasal drug delivery device.

Achieving a design that performs consistently across the range of operating environments, is usable and intuitive, copes with foreseeable use and misuse conditions and functions correctly in all component tolerance combinations is a challenge.

It’s a challenge that is magnified by the need to manufacture the device economically in very high volumes and within tight regulatory and delivered dose consistency constraints.

Success demands careful and considered management of the complex interactions that occur

between the device, the primary pack, the drug formulation and the user. This requires a rigorous, yet flexible approach, underpinned with a detailed understanding of the core operational principles of the design and sensitivity for user needs.

Our design and analysis work with global pharmaceutical and device companies includes pressurised metered dose inhalers, breath actuated inhalers, dry powder inhalers, dose counters, intra-nasal delivery systems and regimen assurance devices.

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Bespak Pressurised metered dose inhaler with dose counter Mechanical engineering

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Major pharmaceutical company Combination dry powder inhaler Development of a mathematical model and early design verification to understand the lid foil compensation mechanism for an Inhaler.

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card.

A fresh look at a connected dry powder inhaler (DPI)

Monitoring inhalation technique and patient compliance to support better treatment and outcome driven payments. card. is a new multi-dose disposable DPI technology that combines sophisticated data monitoring with a strong consumer orientated design. The device comes with a re-usable sensor module capable of monitoring orientation, shock/impact and the inhalation profile. These data sets are carefully selected to provide valuable information on the most common use errors associated with DPI’s, allowing users to be given personalised and relevant coaching to improve their own treatment, and encouragement when they do.

Matthew Jones Senior Sector Manager Medical and Scientific

The same data can be used to monitor and demonstrate compliance; not only that they have taken the dose at the right time, but crucially, in the right way. With health authorities or ‘payers’ pushing for a

stronger link between payments to pharmaceutical companies and the health outcomes of their patients, in the near future this kind of monitoring may become a bar of entry for new inhalation devices.

Not just a concept, the fully working sensor module prototype is able to provide real time data to its partner app. It uses a miniaturised processor and sensors of the type that we commonly employ on connected drug delivery device developments. The sensor module manufacturing cost is estimated at $8-9. With a clever approach to power management, the single battery provides a 5 year life without any need for charging or battery replacement.

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Designing a connected product around a coin cell.

There is an increasing demand for “smart” devices that are capable of measuring and reporting on their usage, but are similar in size and appearance to traditional devices that already have market acceptance. This more often than not results in a coin cell battery being deemed necessary to keep the size and cost down. In this article, Richard Gledhill, DCA’s Senior Software Skill Leader, looks at some of the challenges this poses.

Many of the challenges were faced during the development of DCA’s own “Card” connected dry powder inhaler concept. It features a multi-dose disposable inhaler and a re-usable sensor module that attaches to it. The sensor module monitors technique and compliance by measuring orientation, shock and inhalation profile. As a connected medical device, Card needs a long 76

battery life and medical-grade reliability and accuracy. Its single, tiny coin cell must support interfaces to mechanical systems and sensors, a Bluetooth interface to a phone or tablet, and a regular but unpredictable usage pattern.

In Card, the monitoring is started when the patient opens the device; it must then take readings until the inhalation activity has finished.

Card stores the monitored diagnostics such as the inhalation profile in a log on the device. A partner app running on a phone, connected via Bluetooth Low Energy (also known as Bluetooth LE or Bluetooth Smart), is used to visualise and provide guidance on the new data.

When the user’s phone is in range, Card automatically sends the dose diagnostics via Bluetooth so that the user can see the results.

The main development challenges related to the coin cell come from its very limited current capability and capacity.

Challenges such as accurate and consistent mechanical measurement of the flow, the compact physical dimensions and reliable data storage were significant enough in their own right. Adding in the need for relatively power-hungry wireless communications and 5 years of operation on a single coin cell further increases the challenge.

that the transmitter no longer acts like a simple on/off switch and analogue side-effects begin to affect the received light values, making readings unreliable. At this point, a more sophisticated approach is required, such as pre-charging a capacitor to improve the turn-on speed of the LED and make the best use of the pulse length available.

The main development challenges related to the coin cell come from its very limited current capability and capacity. These affect every aspect of the design: physical size, choice of mechanical parts, monitoring systems, data storage, Bluetooth connectivity, selection of microcontroller and other electronics components, even the architecture of the software itself.

Once this problem has been solved, it is possible to take readings and establish the inhalation profile when using Card. Storing the dose information to flash would, in normal circumstances, be considered a relatively trivial exercise. Writing data to flash typically takes 5-10mA, although this is for a very short period of time (usually tens of microseconds), so it can be covered by existing bulk circuit capacitance.

What happens though when the area assigned to record storage in flash becomes full? Normally, a strategy is used of erasing the oldest records to make space for new records; however erasing a sector of flash can take several mA for tens of milliseconds. If this happens fairly frequently, it can use up a considerable amount of power budget. Therefore one potential solution we have explored on Card is to dimension the flash storage to allow storage of enough records such that there is no longer a requirement to erase any flash.

The challenges in detail So what does having such a tiny power source, with such a tiny power budget, actually mean in terms of product development?

Here we take a look in more detail at some of the challenges that arose during our development work on Card and similar projects.

Measuring physical characteristics such as pressure changes might be accomplished by using an optical transmitter and receiver which results in a pulse train that can easily be read by a microprocessor.

Counting the pulses allows calculation of the pressure change and therefore the inhalation profile of pressure over time. However, running an optical transmitter such as an LED continuously takes more current than the battery can provide. Pulsing the transmitter with bursts of energy is a welldocumented solution, with these pulses potentially being extremely short. However this only works until the pulses become so short

current-hungry, bursty nature – the data is transmitted in tiny bursts of energy lasting only microseconds, but each burst of energy requires a significant current of many mA, which is more than the battery can comfortably supply. This can generally be managed by the use of suitable capacitors between the battery and the RF transmitter chip. However this brings with it its own problems. Leakage current through these capacitors can drain the battery in the background.

Therefore it is critical to manage the amount of data transmitted via Bluetooth to limit the number of capacitors and consequently the cost, PCB space required and background current drain.

Data transmission on a power shoestring

The Bluetooth Low Energy wireless protocol is designed to assist the development of such low power systems, but there are still a number of challenges when using it at this level of available power. For instance, making Card discoverable to phones involves a high rate of data packets being transmitted, advertising Card to any nearby Bluetooth device.

It may be that the default advertising packet rate is so high that the current limit available from the battery is exceeded and the system resets. However, set the rate too low and the device either becomes incompatible with some Bluetooth phones, or takes unduly long to be discovered by a phone causing time-outs or failures.

Once the measurements have been stored, this data must be sent from Card to a paired mobile device such as a phone. Once again, the tiny current capability of a coin cell presents more challenges.

The inability to supply much current is well documented as being troublesome when used to power radio transmissions, due to their

A further complication is that repeated pairing with different phones or tablets may result in an area of flash containing the bonding information needing to be repeatedly erased.

If this issue is not handled, it will further reduce the battery life.

One possible solution that suited our requirements for Card is to redirect storage of the bonding information 77

to a less energy-intensive storage medium, such as an area of RAM that is maintained when the device is not active, or an area of EEPROM. "Sending that much data too fast could drag the battery voltage down, so intelligent throttling of the flow of data may be required."

Similarly, care needs to be taken when transmitting (relatively) large amounts of data. Sending a single dose record may only be a small number of bytes, but synchronising Card with a user’s new phone without the full dose history on it could easily result in a few thousand records being requested from the phone, meaning many thousands of packets are exchanged between Card and phone Sending that much data too fast could drag the battery voltage down, so intelligent throttling of the flow of data may be required.

The user interface – a simple led It might be deemed desirable to alert the user that the Card device needs to synchronise with the user’s phone – perhaps by flashing an LED. This seems so simple, yet with 78

the coin cell’s voltage varying between 3.0V and less than 2.0V, a simple arrangement may not work, particularly if, as was the case with Card, a DC/DC step-up convertor is not appropriate due to inefficiencies, energy losses and parts cost. It may be necessary to pulse the LED using a charge-pump system, for instance, and varying the pulse duty cycle and speed depending on the battery voltage. Even lighting an LED, then, can be a challenge.

Fast start-up times from ultra-low power modes To achieve the battery life required for a disposable device such as Card, the microprocessor must require an incredibly low current while the device is not in use – generally a microAmp or less. This means in most cases that the device is effectively coming out of reset each time, rather than a standby mode, meaning that it has to go from a standing start to taking the first measurements within a very small amount of time. For a mechanically-activated start which could be triggered when movement

is just beginning, such as when a Card user opens the device and begins to inhale, this could literally be measured in milliseconds.

This is challenging across a range of temperature, stability and startup requirements and will be an important factor in the choice of microprocessor.

Bookending the battery’s life - the early years and the twilight years On top of these core functional requirements, there are considerations for what happens at the very start and end of the device’s lifespan. Programming on the production line could use up the coin cell’s valuable energy unless carefully handled, as could programming configuration, serial numbers or security parameters into flash.

Perhaps more of a problem is what happens as the battery comes to the end of its useful lifespan. Its nominal (unloaded) voltage may still appear reasonable – perhaps still more than 2V – but as soon as any current is drawn from it, it may drop significantly, potentially

To achieve the battery life required for a disposable device such as Card, the microprocessor must require an incredibly low current while the device is not in use – generally a microAmp or less below the minimum operating voltage of the microprocessor which is typically around 1.7V for many architectures. Similarly, as the battery voltage drops, references and ranges for analogue inputs may be affected, together with anything driven from the battery directly such as the optical transmitters and receivers used for the Card dose measurement. Any switched-mode power supplies will have to work harder to generate stable voltage supplies, further increasing the load on the battery and exacerbating the problem. Energy-intensive operations such as Bluetooth transmissions and pairing may need to be slowed down or even disabled.

If such low-power occurrences are not handled gracefully, various parts of the system including the microprocessor may spontaneously reset or misbehave – hardly appropriate for a medical device such as Card.

And finally, one last thought.

What about when the device is sitting on the shelf, in between manufacture and first usage?

One option is, of course, to have a small strip of pull-tape between the battery and its contacts, but this could be problematic due to IP rating constraints. It might also be necessary to have some data retained from manufacture, such as a real-time clock value. In either case the current drawn must be virtually zero before first use.

complete connected device such as Card which involve a coin cell are likely, therefore, to actually revolve around the coin cell itself. This is a fundamental difference to designing devices with larger battery packs or a permanent power supply.

Our considerable experience in this area means that we solve many of the problems above on a regular basis – and many more that aren’t covered in this article, such as the differing behaviour of supposedly identical coin cells, temperature, transportation and storage effects, oxidisation layers within the coin cell and so on.

Looking forward, this area is likely to become even more challenging and exciting as Bluetooth begins to be replaced in some situations with ultra-low power cellular network access through technologies such as NB-IoT and LTE-M (also known as LTE Cat-M1). Could we see a coin cell powering these devices?

As battery technology and cellular technology evolve towards each other, we wouldn’t rule it out.

"What about when the device is sitting on the shelf, in between manufacturer and first usage? ...it might be necessary to have some data retention from manufacture, such as a real-time clock value."

Article by Richard Gledhill Senior Software Skill Leader

The power of first-hand coin cell experience All aspects of the design of a 79

Major pharmacutical company Intra-nasal spray device Complex tolerance analysis Detailed mathematical modelling Computational fluid dynamics

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Aptar Pharma Dolphin Intra-nasal spray device for vaccine delivery Mechanical engineering Prototyping

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How smart do smart medical devices need to be?

The devices we use on a daily basis are getting smarter. Devices that were once ‘dumb’ are now fitted with a range of sensors allowing them to work out what is happening around them, and how they are being used. For example, the latest generation of toothbrushes are able to determine when, and for how long, we are brushing our teeth. What’s more they can also evaluate our brushing technique, telling us if we are pressing too hard, or spending too much time in one region of our mouth.

Published on 8th March 2017 82

Augmenting everyday devices with sensors, microprocessors, communication technologies, and algorithms provides the possibility to allocate tasks that were once the responsibility of the end-user to either a microprocessor and

software programme or another human elsewhere. Automation can offer a clear benefit by taking on the tasks that humans often perform poorly at, or would prefer not to engage in. Activities like continuous activity monitoring, or providing timely reminders may be better allocated to a microprocessor.

That said, it is important to remember that automation also comes at a cost. In the majority of cases, the same functions still need to be completed; however, they are simply passed from a human to a microprocessor or another human.

Where data collection and decision making is distributed, it is imperative to ensure that the necessary communication is possible and assess the frequency and costs of this.

For consumer devices, the latest technology is frequently used as a marketing driver.

Smart products are often proposed as greater value that a non-connected version.

For consumer devices, the latest technology is frequently used as a marketing driver. Smart products are often proposed as greater value than a non-connected version. This often comes with the promise of ability to control objects in our home remotely, or closely monitor what is happening and respond accordingly. From a commercial perspective, products are often made ‘smart’ in an attempt to encourage users into a wider ecosystem of products or services and collect rich and valuable data on user behaviour. In some cases, there is a strong push to upgrade products to smart devices without explicitly considering the additional benefits for the consumer.

While the value of these connected smart products is not always immediately clear to all of us, the demand is often unquestionable.

Well-considered and well-designed connected devices have the potential to optimise the allocation of function and improve the

overall system’s performance in terms of efficacy, efficiency, safety, inclusiveness, satisfaction and flexibility.

For medical devices, adding intelligence to the device is often cited as a significant opportunity for enabling more patients to take control of their therapies. The idea of reminding users when to take their drugs, and recording what was taken and when, is clearly appealing.

Likewise, the ability to collect rich, often continuous, data on biometrics (e.g. heart rate, blood glucose levels, blood pressure) can be invaluable. This has the potential to allow patients the ability to manage conditions in the home that once had to be handled by HCPs. Similarly, it provides HCPs with a more robust evidence-base with which to make diagnosis and track patient conditions.

Given these inherent advantages, there is a clear appetite to develop connected medical devices, albeit

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Effectiveness

System Performance

Flexibility

Satisfaction

with some reservations about their implementation.

The role of smart phones Smart phones have become the middleman in our relationship with the majority of the smart devices we interact with. Most smart consumer products take advantage of the advanced processing power, storage capacity, and relatively large, high-resolution, screens of our smart phones. By connecting these smart consumer devices to the ‘supercomputers’ in our pockets, the connected devices themselves can be kept relatively simple and cost effective.

For consumer products, shifting the ‘intelligence’ to the app (running on the smart phone) has a number of clear advantages.

1. It reduces the bill of materials 84

Safety

Inclusiveness

cost of the smart device in terms of processing power, memory, and display.

2. It allows systems to be updated easily (via updates to the smart phone app) without having to make changes to the device.

3. User interfaces and even functionality can be highly customisable.

4. The smart device app can exchange information with other apps on the phone to gain greater contextual understanding (e.g. location, weather, calendar, health apps).

For medical devices, however, the picture is somewhat different, as different constraints are placed on the system. The two most obvious differences are:

1. The requirement for regulatory approval.

2. The development time of a medical device.

The impact for smart medical devices is that one has to question if the model used for consumer goods, where the intelligence resides in the app, remains fit for purpose. The advantages of a lower bill of material cost remain appealing; however, new challenges are introduced.

Firstly, the challenge of proving that the software is safe and effective is far more demanding if the software sits within a complex operating system. For any app, running on a mobile phone or similar, controlling a medical device it would need to be demonstrated that the function of the app and data integrity cannot

What

When

Where

Whom

How

The intuitive answer is that medical devices need to be smart, much smarter than their consumer counterparts.

Article by Dr D. Jenkins Research Lead Human Factors and Usability Paul Draper Senior Sector Manager Medical and Scientific This article was originally published on the MDT – Medical Design Technology website

be corrupted by the operating system. Phone and tablet operating systems tend to have major updates every 12 months with numerous smaller updates throughout the year.

Each of these updates may require the app software to be updated.

Furthermore, each time the app software is updated the system will need to be assessed for new risks and may need further regulatory approval.

A smart approach to smart device development

With medical device development timelines covering multiple years, it’s unlikely that the operating system or even the smart phone, that the medical device is designed to work with at the start of the project will be the same as the one at launch.

It is far more likely that there will be multiple changes of phone operating systems throughout the development process. What’s more, given the long development time and the high investment, medical devices are often expected to remain in the market for longer than consumer devices.

An understanding of the information requirements should underpin the design of the system. This involves determining what information is required, when it should be displayed, where in the system, to whom and how (in what format).

Thus, the intuitive answer is that medical devices need to be smart, much smarter than their consumer counterparts. Allowing them to be far more independent of the phone they may be connected to.

Any interaction with smart phones and tablets needs to be carefully considered. Ideally any integration with a phone would be non-critical to the function of the medical device, reducing the regulatory approvals burden for the app and phone.

Just like all connected devices, the first stage of developing a smart medical device should involve a detailed consideration of its purpose and the potential value of the connected system, above the legacy non-connected system. An explicit consideration should be made for the end-user and each of the stakeholders in the system.

In summary, the architecture of a connected medical device should be informed and driven by a combination of stakeholder needs, technological capability, appropriate risk, and the ability to gain and maintain regulatory approval. If a decision is made to allocate some tasks or functions away from the user to a ‘smart’ device, in the majority of cases, it makes sense that the intelligence lies in the physical device rather than the app.

Apps can often offer a secondary view of this information; however, the regulatory overhead is likely to be reduced if the processing takes place on the device.

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Provalis Diagnostics in2it Point of care diagnostic system for HbA1c measurement Mechanical engineering Electrical hardware Software development Industrial design Interaction design Prototyping Testing and evaluation Production support

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Malvern Panalytical Zetasizer Ultra and Zetasizer Pro High-resolution particle sizing instrument range Industrial design Mechanical engineering Visual brand language Colour, material and finish Interaction design Usability and HF Graphic design Prototyping Production support

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Huntleigh Healthcare Hydroven Flowtron Compression therapy pump Usability and HF Industrial design Colour, material and finish Prototyping Production support

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Depuy Surgical Jig Tibial Jig Design research Usability and HF Mechanical engineering Industrial design Instructional design Packaging Graphic design Prototyping

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Medlogic Liquiband Surgical adhesive applicator Usability and HF Mechanical engineering Industrial design Prototyping Testing and evaluation Production support

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Elekta Unity MR-linac system Design strategy and planning Human factors and usability Industrial design Interaction design Mechanical engineering Prototyping

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Note: Elekta Unity is a work in progress and not available for sale or distribution.

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The future of radiotherapy treatment.

Millions of people worldwide benefit from radiotherapy every year, and the treatment cures more people than cancer drugs. Dan Jenkins and colleagues describe a project in which human factors played a critical role in the design of new equipment that delivers the therapy to patients.

Every so often, an opportunity arises to design systems that are truly transformative. Often as the result of the introduction of a fundamentally new technology, these revolutionary systems allow new tasks to be conducted or they allow existing tasks to be completed in a new way.

The design of new systems opens exciting possibilities for human factors practitioners. It also brings up concerns and challenges as it’s difficult to predict how a new 108

technology system will shape future work. Observing current behaviour on legacy systems provides just part of the picture.

Elekta Unity, the first high-field MR-linac, is an example of groundbreaking technology because it overcomes the technical barriers that have hindered the integration of precision radiation therapy by combining magnetic resonance (MR) imaging with a linear particle accelerator for highly targeted, real-time radiotherapy. Fast moving, electrically charged particles are strongly influenced by a powerful magnetic field, so keeping them on track while near an MRI seemed like an impossibility before research found breakthroughs. It’s now a system that is being used by clinicians in healthcare institutions around the world.

The new MR-linac allows the exact location of tumours to be identified during treatment delivery.

The new MR-linac allows the exact location of tumours to be identified during treatment delivery. MR imaging provides radiotherapists with a much clearer description of the location of a tumour than is possible with more conventional computed tomography-based systems which use x-rays. What’s more, MR imaging is particularly adept at differentiating soft tissues making it especially relevant to tumours in the abdomen; the location of 65% of tumours. This increased confidence around the location of a tumour allows cancer cases to be treated with radiotherapy that was previously not viable because of the location of nearby critical tissue. The greater confidence in the location of dose delivery also opens the possibility of treating with fewer instances of higher doses.

The right tools for the job Human factors practitioners have the skill and toolsets to help frame the design and its base architecture at the earliest stages of development where the objective is also to inspire and inform the design. Most explorations of human work draw on the same core data collection approaches: 1. O bservations in a naturalistic setting (the ‘real world’).

2. Observations in a lab setting (simulations or user trials).

3. Interviews.

4. Self-reporting.

5. Literature reviews.

For revolutionary systems, observing and documenting current work (using descriptive models), or work as expected (using prescriptive models as described in standard operating procedures; SOPs),

only provides part of the picture.

More formative tools, such as cognitive work analysis, are required to describe how work could be conducted.

As such, there is much that can be learnt from using a range of different tools. When new tools are introduced to a discipline, there’s often the tendency to compare them to more traditional approaches, highlighting the limitations and weaknesses of these established approaches. While this is an important part of discussing the value of the new, it can result in a complete rejection of the old – akin to ‘throwing the baby out with the bathwater’. In practice, it’s often advantageous to draw on the relative strengths of each of these method types.

In the case of Elekta Unity, a mixed methods approach was established that sought to learn from current work as prescribed using SOPs, work as disclosed via interviews, current work as done through observations, and future work as imagined using formative modelling, all at the earliest stages of the design process, seeking to maximise the value of the full toolkit.

This involved drawing from the same core sets of data collection approaches and analysing them with a diverse range of tools.

The core data set was informed by studying several different areas: the current use of legacy equipment, Linacs using CT imaging across seven treatment centre visits spread across North America, South America and Western Europe; observations of over 360 patient treatment sessions; after-hours walk-throughs; over 50 stakeholder interviews; and extensive literature reviews.

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Image credit: The Royal Marsden

The core methods used to process this data can be broadly segregated into descriptive and formative approaches.

The descriptive approach Radiotherapy is typically a highly structured process that follows a well-rehearsed workflow. As such, Hierarchical Task Analysis (HTA) was a fitting backbone for the descriptive analysis. In the first instance, we used HTA to explore the variability in workflows, or work as done, by exploring the observed differences between treatment locations such as lung, prostate or breast, and geographic location, as well as treatment centre types, such as a large teaching hospital with many Linacs and a large radiotherapy department to regional cancer treatment centres with a single Linac and a small team. It soon became apparent that the variability was relatively limited. Where it did exist, it tended to be at the detailed ‘leaflevel’ of the task model or in the detailed ‘plans’ of the HTA. Given the limited variability and the relatively close match between 110

work as prescribed and work as done, HTA proved to be a valuable approach. The main advantage of HTA was its large range of extensions, such as Critical Path Analysis and Link Analysis. The core model provided a common task description that could be explored in greater detail.

the system, both from a physical, manual handling, perspective, using a tool called REBA or Rapid Entire Body Assessment, and from a cognitive level predicting opportunities for ‘error’ using TRACEr or Technique for the Retrospective and predictive Analysis of Cognitive Error.

The temporal nature of the task was explored by assigning average baselevel task times recorded from over 350 observations to each sub-task in the HTA. Critical Path Analysis was then used to identify areas in the task flow that offered the greatest potential for efficiency savings.

The formative approach

Link analysis was used to time map the tasks in a spatial setting of a plan view of a typical treatment and control room. This revealed opportunities to optimise the layout of physical controls and objects that healthcare professionals and patients interact with, as well as the location of physical and digital information displays.

The HTA model also proved valuable in evaluating the safety of

At a more formative level, tools from cognitive work analysis were used to explore how work could be conducted. Hierarchies were constructed to explore the relationships between the physical objects in the system such as new and existing technology, and the higher order systems values of efficacy, efficiency, safety, inclusiveness, satisfaction and flexibility. Decision ladders were used to describe how information across digital displays, documentation, staff interactions, the physical environment and the verbal and nonverbal patient cues was currently being used to guide treatment sessions and to explore how it could be used in the future. The flexibility,

Human factors helps frame, inspire and inform a design at the earliest stages of development.

variability and resilience of the system were also explicitly explored.

Inspiring and informing design

Article by Dr D. Jenkins Research Lead Human Factors and Usability Malcolm Boyd Senior Sector Manager Medical and Scientific David Gilmore Director of User Experience at Elekta

The purpose of this detailed analysis was to inspire and inform the design of a vision for the future at the infancy of the project. This vision was created six years before the first patient was treated with the system; the intention was to form a basis for the detailed design that was technologically grounded and evidence-driven. Some of the notable features of the design, such as low table top or ‘couch’ that the patient lies on, were informed by anthropometric datasets and manual handling assessments of those assisting and positioning patients.

Engineered safeguards were inspired and informed by ‘error’ predictions and carefully considered against their impact on system resilience.

The approach also provided a detailed description of the information requirements of the system. This ensured that the right information was displayed, in the right place, at the right time, to the right people, in a suitable format that

complements information drawn from human interactions and the physical environment.

The output was a three-minute video describing a vision for the patient experience for the future system, backed up by detailed reports.

This formed the target for a fullscale development programme that resulted in the design of Elekta Unity, the world’s first high-field imaging MR-linac, that was used to treat its first patient in September 2018, ushering in a new era in the battle against cancer.

Author affiliations Dan Jenkins leads the research team and Malcolm Boyd is a Senior Sector Manager at DCA Design international. See www.dca-design. com. David Gilmore is Director of User Experience at Elekta. The Elekta Unity project was awarded the 2018 HFES User Centred Design Award, a 2018 iF Design Award, and a 2018 Good Design Award.

See www.elekta.com

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Published on 27th January 2016

Beyond compliance.

What is the role of human factors in medical device development?

The profile of human factors in medical device development has increased significantly, largely due to it playing a critical role in gaining regulatory approval for a medical device. However, for many, the focus on demonstrating safe and effective use can dominate the project involvement for human factors professionals. This article discusses how human factors tools and techniques can also help to define how to develop products that outperform their competition.

To be successful a medical device needs to overcome two challenges.

Firstly, it needs to make it to market, and secondly, it needs to offer a recognisable advantage over its competitors.

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Challenge 1: Making it to market.

IEC 62366 is an international standard that outlines how human factors should be integrated into the process of medical device development. As compliance with the standard is critical for regulatory approval, the introduction of the standard has served to increase the salience of human factors within medical device development. So much so, that failure to adequately document the involvement of human factors is seen as a clear project risk.

Regulators such as the FDA focus on safe and effective use. The preferred method for demonstrating this is the simulated use test. This test involves putting the product in the hands of

Human Factors tools and techniques can also help to define how to develop products that outperform their competition.

representative users and asking them to perform a set of predefined tasks. The test represents a clear barrier to project success.

At best, failure means project delays and additional costs for design modifications, at worst; it results in the cancellation of the project and substantial financial losses. Accordingly, it is clearly understandable why such an importance is placed upon it. This focus on simulated use tests, and on safe and effective use, helps to ensure poorly designed products are kept off the market. What it doesn’t do; however, is explicitly seek to understand how the users feel about the device, nor does it seek to understand how the device performs in relation to its competitors.

Challenge 2: Establishing a competitive advantage.

Whereas the first challenge, making it to market, posed the question is this acceptable for end users, the second challenge posed is more ambitious as it also strives to be better than its competition.

But what does better mean? Most people involved in the medical device development process would like to think that they were in the business of making better devices. However, the interpretation of ‘better’ is likely to change between the diverse range of stakeholders. For those intimately involved in the manufacturing process, such as production engineers, there is likely to be a keen focus on the cost effectiveness of the devices. For others with a market focus, the emphasis may be on commercial viability.

Systems thinking.

We can learn a lot about how good a medical device is by thinking of it as part of a system. At the most basic level, this system includes

the medical device and the patient.

However, it could also include other people, such as healthcare professionals or carers, or other artefacts such as other devices, drugs, training materials, instructions for use, apps, etc. Additional values such as efficiency (how long it takes to setup the device), usability (how easy it is to use), and flexibility (how well the product fits the range of different lifestyles of its target population).

Measuring performance.

The system’s values can serve as an excellent vehicle for comparing a proposed medical device against the product it is planned to replace, or its direct competition. Likewise, by thinking in more abstract terms, it is also possible to make a comparison with other types of devices or therapies used to treat the same condition. To aid these comparisons, it is advantageous if the differences in performance can be quantified.

This is where the use of human factors tools and techniques comes in.

Efficiency.

One of the most common techniques used within human factors is task analysis. This involves describing each of the core tasks that a user must conduct with a device. For example, this may include, unpacking, reading instructions, preparing the device, administering a dose, and disposal.

Each of these high level tasks is further decomposed until a series of base level task steps is defined (e.g. rotate dial, slide button forward).

The number of task steps alone is often a useful indication of the efficiency of a device and its complexity of use; however, more detailed assessments can be made by coding each task step. Time data can be used to provide a description 119

Planning, preparation and rigorous study design is key to gaining valid insights as is using a representative sample of the intended end users.

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of efficiency. Likewise, task steps can be represented on spatial arrangements using a tool called link analysis. For example, for medical installations this can be used to predict the number of operator footsteps required in a typical day.

Usability.

The usability, or inclusivity, of a design can be assessed in a number of ways. A useful starting point is to consider each of the task steps against three aspects of human performance. (1) Sensory – the ability to see, hear, feel, smell or taste the device. (2) Cognitive – the ability to understand the device and remember how it works. And (3) Physical – the strength and dexterity required to use the device.

There are a multitude of tools that can be used to quantify usability.

Anthropometric datasets can be used to describe the percentage of a given population that would be excluded from use by the size of a product or the force required to actuate it. Likewise, data on those with sensory capabilities can also be used to determine how many users would be excluded by certain colour choices or text sizes.

Flexibility.

Standardisation is a clear challenge for medical device developers.

Even subtle changes to colour may require a separate regulatory submission. Accordingly, a single device system (e.g. device, labelling, packaging, IFU, training aids, support mechanisms) is often required to meet the many different ways of using the device.

Imaginative solutions are required to build flexibility of use into the device system without introducing the burden of additional regulatory overhead.

Safety.

Article by Dr D. Jenkins Research Lead Human Factors and Usability Paul Draper Senior Sector Manager Medical and Scientific This article was originally published on the MDT - Medical Design Technology website

concern. Accordingly, a structured and systematic approach to error prediction is needed. From a human factor standpoint, one starting point for this is at a task based level.

For example where tasks such as dialling up a dose step can be subject to errors of omission, performing too much, performing too little, or performed in the wrong direction, etc.

Effectiveness.

Simulated use trials provide a very useful indication of the influence of human factors on the effectiveness of a device – that is the ability of users to operate the device without impacting its efficacy. Planning, preparation and rigorous study design is key to gaining valid insights as is using a representative sample of the intended end users.

What should the role be?

So returning to the question posed in the title, what should the role of human factors be? The introduction of IEC 62366 makes it clear that the first challenge of demonstrating safe use is a minimum requirement.

Human factors is not simply a tool for regulatory compliance. The vast majority of medical devices operate in a competitive market, and while the product selection may not always lie with the end user, usability and system performance are increasingly shaping purchasing decisions.

Accordingly, the definition of system values and their quantification plays a critical role in informing the project direction and setting commercial, as well as regulatory, expectations for the device. Beyond compliance, the end-to-end integration of human factors tools and techniques in the design process is critical for designing a commercially successful device.

Observations of representative users play an important role in assessing the safety of a device; however, the unsafe acts that can be considered are limited to those that can be observed. Given that medical devices can be manufactured in billions, and misuse can have adverse effects, low frequency errors are of obvious 121

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Designing products that stand the test of time.

The passage of time has a significant impact on the products we interact with – some products are like fine wines, they simply get better with age (or at least we perceive them to), others become outdated, or redundant as time passes, or the signs of use make them tatty and undesirable.

For many of us, some of the most cherished objects that we interact with are the oldest. They are perhaps the things that we have grown old with and formed memories around, such as a family table or a favourite mug. Others may represent specific events – such as a gift of a watch or an item of jewellery.

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Other cherished objects may be viewed as just better, reminding us of simpler times. For me, this list

includes hand tools inherited from my grandfather and a watch from the 1950s. They may also include vintage furniture, motor cars or steam engines. These products often represent a simplicity, a focus on craftsmanship, and a commitment to use materials in a way that would be cost-reduced out of modern massproduction processes.

The modern drive for connectivity and smart products has undoubtedly influenced the lifespan of products.

Moore’s law tells that processing power doubles approximately every two years, it is therefore easy to see how products are soon left behind, particularly if the ecosystem they are connected to is keeping pace with the latest technology. This results in smartphones that were once state of the art, becoming almost unusable

The best classic cars are those that look like they could have rolled off the production line yesterday.

five, or so, years later – often not as a result of the product itself degrading, but simply their failure to keep pace with the systems that they connect to.

A shorter product lifespan may be music to the ears of some retailers, as it allows more products to be sold. However, in many industries, such as public transport design or complex medical devices, products need to last for many decades in order to present a viable business case. Even where the business case does not demand it, an environmental conscience might. Furthermore, most product designers are also motivated to design things that will last – the cherished objects of the future.

This then begs the obvious question – how do we design products that stand the test of time? To develop products that last, and continue to be appreciated, we need to understand the impact that the passage of time will have on them. Both at a physical level (the physical behaviour of the product), as well as an emotional one – the relevance that the product has to those interacting with it.

Physically standing the test of time The best classic cars are those that look like they could have rolled off the production line yesterday.

They represent a snapshot of the past – they have almost no sign of wear and no modifications.

Conversely, our expectations for a period property are quite different.

We expect these to have been modernised – retaining period features and charms, but embracing modern living and comforts (e.g. central heating, open-plan fitted kitchens, and en-suite bathrooms).

From a physical perspective, there are two core approaches to managing the passage of time, (1) to design products so that they are resistant to changes due to time and the impact of wear, or (2) to design products that grow old gracefully, celebrating their signs of usage, and adapting to fit the changing context of use.

Article by Dr D. Jenkins Research Lead Human Factors and Usability

Patina is a word used commonly in design circles; it is used to describe the, often visual, signs or use and wears on a material’s surface.

Think of the much-loved leather sofa or, or perhaps a pair of jeans, that look better after being used and appreciated. Or perhaps more fittingly, the pair of shoes (or slippers) that, not only look better but actually mould to our feet – becoming more comfortable. A traditional wok is another good example. Not only does the product look better after many hours of use, the food actually starts to taste better when prepared in a well-used and well-cared-for wok (part of the reason non-stick versions are often avoided).

However, the idea of visual signs of use (patina) can be highly subjective.

It may be celebrated for an intimate object such as items of clothing, however, they may be less well received for a communal object such as a train.

Interestingly, the idea of physical change as a result of usage does not necessarily translate directly to digital services.

At an emotional level Engagement with a product typically comes from developing an emotional connection to it.

This emotional connection may be formed in a number of ways. Its value may be linked to the way it was acquired (or first encountered) – creating a connection to someone involved in that process (a gift from a loved one) or a moment in time (a purchase on a special holiday or trip). Alternatively, its introduction may represent an investment in time and resources. The ‘IKEA effect’ is a cognitive bias in which consumers place a disproportionately high value on products they have, in part, created (See Norton et al 2012).

This phenomenon is well researched and understood, but it is limited to the start of the experiential journey.

Just like our relationships with people, not all strong bonds are formed upon first meeting. Others are formed based on gradually building trust. Others still stand the test of time almost through attrition, because they adapt to fit changing requirements and needs – they remain relevant by changing their value proposition to fit the given environment and context.

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At a systems level At a systems level, the whole idea of developing a relationship with a physical object may be called into question. In many markets, it could be argued that we are moving away from a connection to products towards a connection to experiences or brands – physical objects simply have too many constraints to adaptation – limiting their ability to remain relevant. Continuing with this argument, any given artefact (or product) is simply an embodiment of the brand that can be replaced or upgraded. For example, we may build a very strong and meaningful connection to a particular brand of smartphone, but be very happy to trade in our current model for the latest and greatest version every year or so – as the relationship is more with the service than the artefact itself.

That said, it’s fair to say the counter-argument against this disposable-culture is growing stronger. Environmental concerns are becoming far more mainstream.

Furthermore, the role of the physical artefact in a meaningful relationship is becoming far clearer. In our haste 132

to embrace the clear advantages of the new, digital aspect of a brand ecosystem, we were, perhaps, too keen to disregard the merits of the lasting relations with physical highlycrafted objects – and the multisensory experiences that they bring.

It is argued that these physical relationships are key to lasting engagements. This can be evidenced by large brands, such as Google, Amazon, and now Facebook, who once lived exclusively in the digital world, investing in developing physical products. The physical assets representing not only a multi-sensory experience but also a commitment to an ecosystem.

Doing it…

So how do we design physical products that remain relevant and have the potential to become the cherished objects of tomorrow?

The simple answer is that “it depends…” the most appropriate solution will be dependent on the specifics of the project and the context of use. However, it’s fair to say that it will involve a consideration at a physical, emotional, and a systemic level.

Accurately predicting the future requirements of a product requires predicting the future. While we may not have a crystal ball, we do have structured processes to anticipate future use. There is much that can be learnt from looking back and exploring the variability of use in the past (over time) as well as exploring the variation in use today (between use cases).

Where products are relatively simple and have experienced little change in their use (such as hand tools), perhaps the simplest option is to look back in time and emulate the qualities of the cherished objects of the past. A return to more traditional materials and manufacturing techniques may create niche but viable business propositions – as long as the value, over much cheaper mass-produced alternatives, can be communicated.

We are currently seeing a resurgence of more traditional tools such as brass razor handles that offer an alternative to single-use devices.

For physical products, that experienced greater variability in the ways that they are used, to stand the test of time, they need to remain

Investing in early interaction prototyping can help reduce the UX changes later in the formal design development process.

relevant as the world around them changes. In most cases, this means adapting. Products that change their value proposition based on their environment and context of use; have the potential to create a greater level of engagement. Just like the sympathetically modernised period home, they perhaps retain the charms of a particular era or aesthetic but remain relevant to any given movement in time.

even repaired with ease over time (by opening the casing and inserting new ‘cartridges’, each of which has been designed as a product in their own right).

This results in a product that is flexible to the user’s requirements and to new technologies that will become available as time progresses.

Explicitly considering future use, and adaption, at the time of design is critical to this process.

By understanding the past, current and future variability, along with far less transient human values, products can be developed that remain relevant.

On a digital level there are six customisable ‘smart buttons’ that adorn the front of the product and feel like piano keys beneath your fingers. These smart buttons can be programmed to perform a range of functions based on the user’s requirements allowing personalisation more common with a digital app while retaining a physical connection to the product.

Our recent work with Linn on the Selekt DSM Network Music Player is one such example of this.

The result is a product that has been designed to last, at a physical, an emotional and systemic level.

The product has considered the passage of time in two main ways. At a more physical level, the product has been designed to be fully configurable, modular and upgradable. Allowing new functionality to be added at point of purchase, or upgraded and 133

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DCA wins innovation award at CES 2018.

LifeFuels new smart nutrition bottle launched at CES 2018 and became a CES Innovation Award Honoree for the second time.

Designed by DCA for LifeFuels, this revolutionary smart nutrition bottle helps users understand how much water they should be drinking throughout the day and allows the user to prepare nutritional drinks on the go. Launched on 8th January at CES 2018, the world's largest technology show, LifeFuels has been

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awarded the CES Innovation Award Honoree 2018 for Sports, Fitness and Biotech.

The system is made up of three parts: the bottle itself, the FuelPods and the LifeFuels app. The user selects three FuelPods, then inserts them into the bottom of the bottle.

Using either the app or the button on the bottle, the user can dispense precise servings according to their taste and nutritional goals.

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gold

winner 2015

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GSK Aquafresh milk teether Teether for soothing and cleaning Design research Usability and HF Industrial design Visual brand language Colour, material and finish Prototyping Production support

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gold

winner 2015

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Alternative Packaging Solutions (APS) MiniMist Long duration spray pump Mechanical engineering Industrial design Prototyping Testing and evaluation

APS MiniMist An innovative alternative to traditional aerosols.

DCA has helped APS to develop MiniMist, a new spray device which provides a great alternative to traditional aerosols and other spray dispensers.

than aerosols whilst remaining cost competitive. MiniMist’s spray characteristics and visual design are easily customizable to suit different brands and product categories.

MiniMist is able to produce a continuous spray without any chemical propellants, resulting in a significantly lower carbon footprint

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Mรถlnlyke Biogel Gloves Packaging Surgical glove packaging Design research Usability and HF Industrial design Packaging Prototyping Testing and evaluation

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3M Versaflo M-Series Headtops Range of faceshields, hard hats and helmets with integrated respiratory protection Design planning Design research Usability and HF Mechanical engineering Industrial design Prototyping Testing and evaluation Production support

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Our Location

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From our campus in the historic town of Warwick, England, we serve clients internationally to develop products that reach markets around the world.

From Birmingham International Airport Travel time 25 minutes From London Heathrow Airport Travel time 1 hour 30 minutes

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Helping clients achieve success through great product design.