DCA Medical and Scientific brochure 004

Medical and Scientific

Over half a century of design.

Medical and Scientific Overview

Contents

7 Welcome 8 Our Expertise 10 Our Awards 12 Our People 14 Medical device development process 16 Medical and Scientific services 20 Our connected disciplines 22 Research and Strategy 24 Mechanical Engineering 26 Industrial Design 28 Human Factors and Usability 30 Interaction Design 32 Electronic Engineering 34 Software Engineering 36 Prototyping and Evaluation 44 The art of persuasion: Designing devices for patients who don’t want to adhere

60 Why we need to think differently about drug delivery device connectivity?

74 How smart do smart medical devices need to be?

80 Why can’t it be more like an iPad, only safety critical?

102 The future of radiotherapy 112 Beyond compliance. What is the role of human factors in medical device development?

146 Our Location 151 Contact

Drug delivery 9, 24, 28, 38-43, 50-59, 66-73 Other Medical 30, 32, 78-79, 84-87, 94-105 Scientific Instruments 17-18, 84-87, 88-93 Consumer Healthcare 26, 116-140 Commercial and Industrial 106-111, 142-145 5

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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

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Silver Award Winner

multi

gold

winner 2015

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, performance and efficacy of a medical device.

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 Deltaflex J Disposable GLP-1 pen injector for Japan Mechanical engineering Industrial design Colour, material and finish 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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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 44

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 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 Canada and across Europe. AllStar® Pro is a new 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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Why we need to think differently about drug delivery device connectivity.

Paper presented on 1st February 2017 60

In many industries, connected versions of existing products are often developed partly because it’s technologically possible to do so at reasonable risk. Highly integrated chipsets, incorporating low power radio communications, offer the capability to add connectivity to legacy devices relatively easily and with an acceptable development and unit cost.

feedback on bugs and instances where the product is a cause of frustration. In the majority of cases, frequent software updates have to be rolled out to fix performance issues based on user feedback.

Products that are well received in the market by early adopters can be redesigned and released as second generation products to encourage mass appeal.

For manufacturers of consumer products, it’s now often considered important to have a connected device to keep up with competition and also to be seen as innovative.

Launching a first generation connected device is an opportunity to explore how users respond to new propositions. Early adopters get treated as, and often brag about being, ‘Beta testers’ providing

These connected consumer devices generally have a short lifespan and can therefore be designed to use the communications technologies and protocols relevant at that time.

Early adopters of some connected devices can be exposed to a number of risks. The best product isn’t necessarily the one that succeeds, which can leave some

A connected device’s online ecosystem may be critical to the usefulness of the product. early adopters having to change horses when their initial choice gets dropped due to lack of commercial success (think VHS vs. Betamax, or Blu-ray vs. HD DVD). Some connected consumer products introduce other potential downsides.

Minimal attention may be paid to wider security issues, seemingly innocuous products, such as a connected doorbell, can provide hackers with access to your home network if the device’s security is easily breached. What’s more, a connected device’s online ecosystem may be critical to the usefulness of the product and if that shuts down, your nice shiny hardware may become a nice shiny doorstop (think Google’s Nest shutting down the Revolv smart home ecosystem). Most connected devices are purchased as products and do not come with detailed service agreements guaranteeing online support for a long period of time.

That said, the consumer product development model is clearly working. This is evidenced by the diverse range of devices coming to the market. What’s more, this development model gets product to market fast, which is essential to gain market share, and maybe establish a new ecosystem.

Article by Tony Smith Electronics Engineer Medical Sector Project Manager Dr D. Jenkins Research Lead Human Factors and Usability This article is based on a paper given by Tony Smith at Pharmapack 2017.

For medical and pharmaceutical devices, connected devices are a very different proposition. To make it to market, new products need to be demonstrably safe and effective.

Regulators demand extensive evidence of this. Likewise, it’s also imperative that medical devices are secure, to ensure both safety and confidentiality. Fears around data

security and privacy are often far more critical than with consumer products. The idea of sharing intimate details of our state of health is incredibly unpalatable.

The resulting security considerations put constraints on the technology selected and increase the development time. This must be offset against flexibility in the underlying communications system to allow support of multiple, often fluid, technologies for exchanging data with the outside world.

Why connect?

A connected device might send or receive data or control information, interact with remote devices, connect to a server over the internet or just exchange information between the device and a smartphone.

The ability to pass information to or from a drug delivery device opens up a number of interesting possibilities. For example, dose reminders, or sensors to monitor the patient’s condition for side effects or to evaluate the effect of regimen changes.

A connection to a smartphone also offers some other potential advantages. The relatively large, high resolution, display may be a better way of viewing information compared to a device display limited by the size of the product. Having the instructions on the phone can be helpful particularly if these are also available as videos or audio files. The ability to customise these messages to meet the user’s capabilities could be critical (information in the right 61

It is imperative that the data that is collected and presented is relevant, useful and accessible to everyone that interacts with it, whether they be patients, carers, nurses, doctors or payers. language and level of complexity, in a format that can be interpreted).

Links to other online resources (such as peer-to-peer forums, or details on complementary therapies) could also help compliance by educating the patient about their condition and treatment. Such advances, however, face many challenges.

Patients

Carers

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Nurses

Doctors

Payers

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What should connected medical devices do?

It can be tempting to collect and present data simply because it is accessible. However, to avoid data overload, it is imperative that the data that is collected and presented is relevant, useful and accessible to everyone that interacts with it, whether they be patients, carers, nurses, doctors or payers.

Connected medical devices are often promoted as offering additional value to health care professionals by providing richer data on the health and condition of their patients.

However, it is important to consider the time that health care providers have available to respond to the data that is collected on their behalf.

Once multiple connected drug delivery devices start to enter the market, health care providers are unlikely to have the time to deal with a wide range of user interfaces on different device data portals, or the level of data that might be available.

The functionality of connected devices should be informed by a detailed understanding of the conditions that they have been designed to support. One place to start is by considering the use of the non-connected legacy version of the product. Observing and interviewing stakeholders can reveal rich insights.

The international standard on medical device usability (ISO 623661) advocates the use of task analysis to describe current activity. This involves breaking down the activity

into sub tasks, these sub tasks are then themselves broken down until base level operations are reached.

Each base-level task can be examined to assess the demands it places on the user at a sensory, cognitive and physical level.

This usability analysis will often throw up where additional or new information or features may support or reinforce a particular task. This analysis yields data that feeds into a table of information requirements for each task, enabling us to identify feature opportunities.

Unmet needs can sometimes also be highlighted from unexpected sources – such as the #WeAreNotWaiting social media and maker group. These groups of very tech savvy individuals are creating their own connected medical devices, often by combining off the shelf technologies with bespoke open source software.

While they offer exciting insights into unmet needs, the solutions they are developing are only really accessible to those with a detailed understanding of technology.

The open source nature of the technology, and the lack of formal regulation to assess for safety and efficacy, places users at a clear risk.

Thus, it is important to consider the feature set carefully, taking into account all stakeholders needs. A development path should be chosen that will lead to a safe, functional, efficacious and successful product.

That means understanding the stakeholder needs, targeting the correct level of engagement, while not detracting from the core device functionality and not compromising device usability.

One approach is to map out the functionality of the system in a tabular form, allowing a direct comparison to be made between

A typical hierarchical task analysis model 63

One approach is to map out the functionality of the system in a tabular form, allowing a direct comparison to be made between the legacy system and the proposed connected system.

Existing information source Potential new information source

the legacy system and the proposed connected system. The table above is an example that identifies the information required to support each task, highlighting the source in the current system (shown in the blue). Having established the table for the current system, it is then extended to include alternative or additional information sources in the connected system (shown in the green columns) The alternative or additional information sources can then be explored and summarised in a table of potential new features.

Each potential new feature must be assessed and filtered based on the benefits, and potential risks, to the stakeholders. The process iterates because of the potential to introduce new risks but generates a reasoned, useful and safe set of features more likely to give rise to a successful product.

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Conclusions If connected medical devices are to stand the greatest chance of commercial success it is important that: 1. Development is based on a properly structured process aligned to the relevant standards (e.g. ISO 13485, EN 62304, EN 62366, ISO 14971).

2. The needs of the various stakeholders are understood.

3. A reasoned, useful and safe feature set to implement is established at the start of the design process and revisited throughout the development of the device.

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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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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 74

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 76

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. 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.

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.

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

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.

A smart approach to smart device development 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.

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).

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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Why can't it be more like an iPad, only safety critical?

Improving user experience is an increasingly cited motivation in medical device development. To develop experiences for medical devices that match users’ expectations an approach is needed that can mirror the pace of iteration and experimentation seen in consumer devices. The challenge, however, is that this approach must continue to meet the needs of a controlled medical device development process. This article discusses the role of interaction prototyping in bringing rapid iteration, and design exploration within the constraints of safety critical device development.

Published on 31st March 2016 80

It’s a question that most people working with medical devices will have faced, ‘why can’t it be more like my tablet or smartphone?’ It

can be very tempting to dismiss the question, and explain away the differences, by pointing out that the medical devices are safety critical and, thus, must be developed in a different way. However, if we are to gain the engagement with medical devices we all hope for, it’s important to understand what we can learn from large tech companies and consider how this can be applied to the rather different world of medical devices.

The number of interactive medical devices is unquestionably growing.

With processing power being used to tackle technical, safety and convenience challenges, the importance of usability within medical devices is becoming well understood. This growth of awareness has been accelerated

The core argument being that users are likely to be more engaged with a device that they like using.

by regulators mandating a structured human factors and usability process.

Coupled with this general awareness of the need for usability, there is also a growing trend for patients (and to some extent untrained carers) to take greater control of their health care – often taking more responsibility for monitoring their condition and administering treatment.

The US Food and Drug Administration (FDA) is clear that medical devices need to be demonstrably safe and effective before they can go to market. Alongside this clear need to explicitly consider safety and effectiveness, the importance of user satisfaction or user experience is continuing to gain traction. The core argument being that users are likely to be more engaged with a device that they like using.

User acceptance of any device is often set not only through direct interaction but also through expectations set in other devices.

Perhaps the greatest expectations are set by the devices that we use most often – our smartphones and tablets.

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

The user experiences (UX) created for mobile devices and online services have grown out of tools, platforms and approaches that encourage experimentation, building on ideas in an environment in which ‘failure’ is not only survivable, but a metric used to select the most appropriate concept. Ideas can easily be sent out into the market to see if they gain traction (eBay and facebook both expanded from niche positions to global success), sites and apps can live in permanent Beta, and powerful frameworks can be built upon to facilitate rapid iteration and evolution of ideas – quite literally survival of the fittest and rejection of the weak.

It is, in this environment, that the experiences driving user expectations have been generated.

The environment that medical devices are developed within is, necessarily, quite different and the consequences of failure range up to and include fatalities. Medical device development requires controlled and documented procedures that result in the production of validated code,

and where development cycles of years rather than weeks is the norm. However, this does not mean that users necessarily appreciate these constraints or, even if they do, forgive poor quality experiences.

To develop experiences for medical devices that match users’ expectations, we need to leverage the benefits of the interaction design tools and development environment that drive consumer device experiences, and apply these to a controlled medical device development process.

The role of interaction prototyping.

One of the interaction design approaches that can be leveraged to bring rapid iteration to embedded medical device design is interaction prototyping. The term ‘interaction prototyping’ covers a range of methods that pull together hardware and software user interfaces to enable rapid exploration, evaluation and iteration. Techniques can range from Paper Prototyping, Wizard of Oz (simulating functionality – the classic example of this is IBM’s simulation of speech recognition), hacking together of different components using miniature computers (e.g. Arduinos) or embedding small touch screens in prototypes to very quickly create models that are apparently functional from an interaction perspective.

In applying these tools to the development of novel interactive medical devices at DCA, we have seen the following four key benefits: 1. Seeing something sooner 2. Integrated iteration 3. Improved communication and stakeholder buy-in 4. Reduced design changes during formal development.

These benefits can be explored in the context of a development cycle in the figure below. The diagram shows the ‘traditional’ medical device development process in grey with the activities of hardware and software design in green and blue respectively.

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2. Integrated iteration interaction prototyping bridges the gap between hardware & software.

Preliminary hardware design specification

Requirements capture 3. Improved communication & stakeholder buy-in.

1. Seeing something sooner interaction can be brought forward to support requirements capture.

Preliminary software design specification

1. Seeing something sooner.

2. Integrated iteration.

The first benefit is that interaction prototyping tools and approaches can be applied very early in the design process – where the costs of change are much lower and before the product requirements have been finalised.

The second benefit of incorporating interaction prototyping in the development process is that the hardware and software interfaces are iterated together, rather than considered as separate elements.

This is critical as the two interfaces are interrelated. The hardware sets constraints on the software design early in the design process, and changes to the hardware architecture can rapidly become both expensive and slow to implement. At the same time, the requirements of the software user interface impact the inputs, outputs and screen real estate required from the embedded hardware. Early integration of mock-up or prototype hardware and software elements of the interface enables an iterative development process where user feedback can be incorporated throughout the development cycle, and design challenges can efficiently

Interaction prototyping can be pulled upfront in the development process to inform requirements capture and communicate design intent. Prototypes can be rapidly created and evaluated with users to explore the extents of what could be possible, challenge assumptions and test constraints. For instance, should a device have a touchscreen? Does it need to be multi-touch, or have haptic feedback? How will it work incontext? The principle of interaction prototyping is to rapidly ‘mock it up’ and try it out, building an evidence base to inform device specifications.

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be tackled early using both hardware and software as integrated solutions.

3. Improved communication and stakeholder buy-in.

Clear communication is not just important for gathering user feedback. It is not uncommon for medical device development teams to come from a range of backgrounds, interaction prototyping can help to encourage communication between the hardware and software development teams, with prototypes providing a common reference for stakeholders from a variety of backgrounds to engage in the project.

4. Reduced design changes during formal development.

Exploring and iterating a design idea using interaction prototypes allows early insights and discovery of user feedback that will help identify and define the desired user interface experience. Investing in

Interaction prototyping activity Hardware design activity Software design activity

4. Reduced design changes during formal development.

Formal developments begins Continued device development

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

early interaction prototyping can help reduce the UX changes later in the formal design development process. This is particularly valuable as changes to design late in the development process are typically costly, cause delay and require very rigorous implementation and validation to avoid potentially hidden safety issues.

Summary.

If the quality of user experience of medical devices is expected to try to keep pace with that of consumer products, innovative approaches are, unquestionably, required. As discussed, the key differentiator between these markets is the tolerance of failure. As such, the pool of methods that can be borrowed from the consumer market is, necessarily, reduced. Interaction prototyping is just one of the approaches prevalent in consumer device design that, when applied considerately, can be leveraged to

tackle the challenges of interactive medical device development.

As an approach, it can support building an evidence base for decision making. Furthermore, it allows experimentation and exploration, supports stakeholder alignment, and integrates usability and acceptance feedback throughout the development cycle. Set within the context of an integrated approach to device development, it can be an exceptionally powerful tool; facilitating evidence-based experimentation and flexibility in the early stages of the development process.

To keep pace with the consumer market and optimise usability, it is increasingly becoming essential to adopt such an approach for interactive medical device design.

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Tissuemed Tissuebond Applicator and 180 Light Source Light activated surgical sealant system for cardio-vascular surgery Mechanical engineering Industrial design Prototyping

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Malvern Panalytical MorphologiÂŽ 4 and MorphologiÂŽ 4-ID Detailed automated imaging particle characterisation instrument range Industrial design Visual brand language Colour, material and finish Interaction design Usability and HF Graphic design 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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P&G Hair colour measurement Point of sale ‘hair colour analysis’ device Design research Usability and HF Mechanical engineering Electronic hardware Software support Industrial design Colour, material and finish Prototyping Testing and evaluation Production support

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P&G Hair friction comb Point of sale ‘hair damage analysis’ device Design research Usability and HF Mechanical engineering Electronic hardware Software support Industrial design Colour, material and finish Prototyping Testing and evaluation Production support

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The future of radiotherapy.

In 2017 at the 36th ESTRO meeting (European Society for Radiotherapy & Oncology), Elekta introduced Elekta Unity, the only magnetic resonance radiation therapy (MR/RT) system that integrates a (1.5 Tesla) MRI scanner with an advanced linear accelerator and software.

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Through intelligent and pioneering design, Elekta Unity combines the best of both worlds to create a new paradigm for cancer care and provide extraordinary potential for ‘hard to treat’ cancer.

In 2012, as part of a wider engagement, DCA worked with Elekta to create a future vision for the industrial design and usability of Elekta’s MR-linac system, recently unveiled as Elekta Unity.

sites worldwide, over 90 hours of observations (approximately 360 treatment sessions) and over 50 in-depth interviews with health care professionals, thought-leaders and system stakeholders. As well as providing a grounded, aspirational, vision for the Unity system, the broad evidence base and detailed design language has informed the development of a number of other projects within Elekta.

The extensive project drew on DCA’s full service offering. The future vision was informed by a detailed evidence base and grounded with collaborative technical review.

A body of evidence was collected from visits to seven treatment

“It was a real pleasure for DCA to work with Elekta’s project team on such an exciting and game changing development. Throughout the engagement Elekta clearly demonstrated a commitment to evidence based decision making,

placing the needs of the patients and health care professionals firmly at the centre of their vision for the future of radiotherapy, affirming Elekta’s position as a world leader in their field”.

Rob Woolston (DCA - Managing Director)

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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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Haigh Sluicemaster SOLOÂŽ Bedpan macerator Mechanical engineering Industrial design Prototyping Testing and evaluation Production support

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Watson Marlow Qdos 30 A range of peristaltic pumps Electronic hardware Software development Prototyping Testing and evaluation

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RTS Lifesciences Smartstore Laboratory based compound storage system Mechanical engineering Electronic hardware Software development Industrial design Prototyping Testing and evaluation Production support

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Sunrise Medical Sunrise mobility scooter Mobility Scooter Mechanical engineering Industrial design Exterior styling Prototyping Testing and evaluation

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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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Challenge1: 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

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

the hands of representative users and asking them to perform a set of pre-defined 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.

(how easy it is to use), and flexibility (how well the product fits the range of different lifestyles of its target population).

Challenge 2: Establishing a competitive advantage.

Efficiency.

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

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.

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 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 113

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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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 Sector Manager Medical and Scientific This article was originally published on the MDT - Medical Design Technology website

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 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 115

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RB Scholl Pedi Perfect Wet & Dry Waterproof and rechargeable electronic foot file Design research Industrial design Visual brand language Colour, material and finish Packaging Prototyping Production support

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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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LifeFuels Smart nutrition bottle Industrial Design Mechanical Engineering Prototyping Colour, material and finish

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GSK Sensodyne mouthwash Bottle and dosing cap Design research Usability and HF Industrial design Visual brand language Packaging Prototyping Production support

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gold

winner 2015

GSK Toothbrush Sensodyne toothbrush Design research Industrial design Visual brand language Colour, material and finish Prototyping Production support

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GSK Aquafresh Kids Kids toothbrush Design planning Design research Usability and HF Industrial design Visual brand language Colour, material and finish Prototyping Production support

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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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GSK Dr. Best Vibration Electrical toothbrush Mechanical engineering Industrial design Prototyping Packaging Production support

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RB Veet Easywax Electrical roll on wax applicator Industrial design Visual brand language Colour, material & finish Packaging Prototyping Production support

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RB Clearasil perfectawash No touch face wash dispenser Design planning Usability and HF Industrial design Visual brand language Colour, material & finish Packaging Prototyping Production support

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Unilever Axe / Lynx Deodorant body spray Usability and HF Mechanical engineering Packaging Prototyping Testing and evaluation Production support

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gold

winner 2015

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Unilever Degree motionsense Deodorant stick Usability and HF Mechanical engineering Packaging Prototyping Testing and evaluation Production support

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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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GSK Flonase Flonase nasal spray packaging Packaging Prototyping

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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.

Contact

DCA Design International 19 Church Street Warwick UK CV34 4AB T +44 (0) 1926 499461 E medical@dca-design.com www.dca-design.com

Rob Woolston Managing Director Rob Veasey Senior Sector Manager Medical and Scientific Chris Langley Senior Sector Manager Medical and Scientific

www.dca-design.com