Focus by Kinneir Dufort: Engineering Better Healthcare

Focus DESIGNING A BETTER WORLD

engineering better healthcare

A human-centric approach to medical product development

Kinneir Dufort

contributors

Kelly O’Connor

Craig Wightman

Trevor Brinkman

David Eason

GRAPHIC DESIGNER

CDO

Hayley Maynard

INDUSTRIAL DESIGNER

James Holmes

INNOVATION CONSULTANT

SENIOR ELECTRONICS ENGINEER

HEAD OF ELECTRONICS & SOFTWARE

Kerry Briggs

Chris White

Ben Arlett

HEAD OF MEDICAL

PRINCIPAL HF CONSULTANT

HEAD OF ENGINEERING

FOREWoRD The term Engineering is derived from the Latin ingenium, meaning “cleverness” and ingeniare, meaning “to contrive, devise” and is defined by The Oxford English Dictionary as “The branch of science and technology concerned with the design, building, and use of engines, machines, and structures.”

Neither the definition or the derivation adequately describes the practice of engineering at Kinneir Dufort, although the combination of creative ingenuity with technical rigour to design and build, captures something of its essence. For our team, engineering covers a broad range of disciplines including: mechanics, materials, optics, fluidics, mechatronics, simulation, electronics and software, prototyping, project engineering and technology exploration. The healthcare sector provides a myriad of challenges and opportunities for developing new solutions through ingenuity, engineering excellence and application of technology.

What’s missing from the definition above is the human factor, which is so important to all of our work, and particularly so in healthcare. The mix of features in this “Engineering Better Healthcare” showcase how we apply engineering creativity and best practice, whilst always maintaining focus on the needs of the end user during the product development process.

We hope you enjoy this edition of Focus and, as always, welcome your feedback on features to include in future editions.

Craig Wightman CDO craig.wightman@kinneirdufort.com 2

CONTENTS

04

Importance of Requirements

A Guide for Success Outlining how to establish good requirements & reap the benefits

06

Beyond the Battery Powerful Solutions Exploring options powering your next product

08

Human Factors A Holistic Approach

Sharing methods that can add real value to medical device development programmes

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The Year of Engineering A Celebration

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The Art of Engineering A Balanced Approach Utilising a range of tools to achieve successful outcomes

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Development Timescales

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Patients are Doing it for Themselves

A Timely Exploration

D2C Self-Care

Understanding the challenges & requirements in improving time to market

Applying the “Direct-to-Consumer” model to healthcare

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The Power of Colour A Potent Tool

Using colour to drive value in medical devices

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Killer App

Connected Health Exploring whether connected health is the ‘Killer App’ of the IoT?

The KD engineering team share what they love about their vocation

3

Residual Risk

Requirements capture

David Eason

Spend Rate

Importance of

Requirements The Project Management Institute (PMI) cites a failure by enterprise organizations to establish a requirements baseline at an early stage of the project, and a failure to consider the user in requirements, as two of the seven most common causes of project failure [1]. Despite this, many projects still suffer from poor requirements and the very thought of having to tackle requirements is often enough to set the eyes rolling of even seasoned project owners. Spending the time to define the “what we want to do” and not the “how we want to do it” in design & problem solving is hugely beneficial to all stakeholders involved.

Requirements aren’t always easy Requirements capture & analysis is often seen as a purely paperwork exercise, being requested by the regulators. These early phases of work are often overlooked, and often not given the consideration they deserve. It is often the case that people underestimate the value that conversations generated through the development of requirements can create. “Requirements” themselves aren’t a single check list, document or check box to be filled in. They are a multi-disciplinary set of statements that define the product or system you are developing at multiple levels of detail. They need to be managed, maintained and evolve within the project as your understanding and knowledge develops. It can be thought of as essentially capturing the “essence” of a particular problem, along with the user’s needs and applying critical and technical thinking to produce a solution that can satisfy those needs. This takes time upstream in the innovation stages of development and requires probing of key questions to elicit the key attributes and quantify the problem. This applies to multiple disciplines and can help to provide synergy between human factors, engineering and industrial design. The challenge is often convincing the main stakeholders in a project to invest the time upstream on this work.

Depending on the complexity of the project, there may be multiple levels to the requirements, from the user level, product level, system level and then the lower module level and detailed specification requirements. The latter items often originate from the former, and the details will evolve over time. New requirements often get generated in the process, through discovery, exploration, analysis, prototyping and testing, as new questions get raised as

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the project progresses. Whilst requirements for a complex system can take significant time to get right, it’s not the case that this level of detail is needed for every single project. It can often be just as valuable to document the requirements on 1 page of A4, particularly at a very early stage of feasibility.

What are the benefits?

The real tangible benefits are often overlooked when exploring and analysing requirements. In having discussions and thought processes about what user’s really want up front, before any solutions are explored, product requirements naturally fall into place. It is often hard to get away from the “illusion of progress” by creating “looks like, works like” prototypes with limited time and budget. Sweeping assumptions are often made about available solutions, and real innovation opportunities can be missed. Early “form factor” PCB’s and assemblies are often produced, along with software that can “be fixed later on”. Performance is often “TBC” and the design starts early. This is the expensive and often painful route, where multiple iterations are required, and the system is difficult to test.

It’s more efficient to have brainstorming of user and functional requirements, and then, if needed, determine how you will answer the unknowns. Technology demonstrator prototypes can be used to figure out the key attributes of an idea. This then feeds into the detailed specification and provides an easier path to implementation. Verification and validation becomes simpler as your requirements form the basis of your verification plan. Allowing a test-driven development approach to be followed at an early stage, helps to reduce risk and make hand-over and third party review a lot more straightforward. If something can be better quantified, and the constraints understood, e.g. the accuracy and precision required, finding the right solution is easier and there will be no surprises. Retrospective test and requirements analysis, is prone to creating issues down the line.

Everyone knows that the cost of change increases over the period of a development cycle. To offset this, it is anticipated that the risk should reduce as the project develops, having better defined requirements and thus test methods will help to alleviate these costs by identifying risks early.

It is not always easy to get a team to work together and move in the same direction, good requirements provide a common language. Getting more team members from different disciplines and backgrounds also fosters better collaboration and team morale. This then harbours a strong team spirit and gives project stakeholders more ownership in the process, providing a smoother path to success.

The other ma jor benefit is of course to provide a smoother path to regulatory approval, highlighted by the FDA stating that ‘development of a solid foundation of requirements is the single most important design control activity’. Regulatory constraints are valid requirements to introduce in the upstream work, as these can have a ma jor impact on the path taken in development. For example, in BS EN ISO 13485:2016, Section 7.2, customer related processes are defined, such as the definition & review of requirements for delivery and post-delivery, as well as identifying any additional ones that arise in the process. This is not a linear process and there are feedback loops in the process, and some form of so called “solutioning” up front. In the age of easily accessible software and hardware and more connected devices, it is even more important than ever to have a solid grounding in regulatory compliance in a development program.

What constitutes good requirements Good requirements are essentially descriptions of what a system needs to “do” for users. They are not the same as the

specification, but the specification includes the requirements.

They are clear statements that:

1.

Show the users’ needs were understood within a set of constraints

2.

Allow technical performance to be achieved at a system level to satisfy user’s needs

3.

Ensure regulatory requirements are met

4.

Are traceable and testable

5.

Clear, concise and unambiguous

It is best described as the “What” is needed and not the “How” is implemented, and ultimately at the highest level is a common language that can communicate the description of a system between stakeholders of different disciplines and backgrounds.

Requirements should be driven by user’s needs, within any constraints, and not necessarily by developer’s opinions.

However, it is worth bearing in mind that highlighting feasible technologies & solutions early on, given a timescale and budget, is no bad thing and can drive other constraints, such as cost.

It is important to not think of a solution to begin with (e.g. a specific type of sensor, or device) and work backwards to the specification or the fundamental question being asked. What matters at the end of the day is a “black box” that works as expected.

Validation User Requirements

Product Testing

Verification

System Design

Sub System Design

Validation

System Integration Tests

Product/System Requirements

Verification

Validation

Sub System Assembly Tests

Sub System Requirements

Verification Component Tests

Component Level Requirements

Detailed Design

Validation

Design Fixed

Summary Writing good requirements isn’t always easy but developing them early on is well worth the effort. It may require more of a cultural change, rather than purely introducing new process, but there are numerous benefits as discussed. By following some simple steps, the process can be easy: • Introduce multiple team members early in the discussions of a brief or concept & provide them responsibility and a stake in the design.

• Define a high-level language to describe the ideas in terms of “What” is wanted, rather than “How” it is implemented; Start to develop simple statements to describe the functionality in terms of user needs and product function. Identify constraints: cost, space, time, technology, geography, etc.

• Explore and identify key attributes that can describe the required functionality; these could be quantifiable parameters.

• Develop analysis, simulation and performance-based technology demonstrator rigs to probe these parameters and identify the limitations. Test methods can then be developed to validate suitable solutions.

• Maintain the requirements documentation at all levels. The further down a level you go, the more detail is required until ultimately you end up at the technical specifications.

• Avoid ambiguity, “TBD” and similar statements!

[1]https://www.pmi.org/learning/library/seven-causes-project-failure-initiate-recovery-7195

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Beyond Battery All around us but largely invisible, batteries become more ubiquitous every year. Yet with their impact on the environment and the users they serve steadily growing, there has never been a better time to consider whether batteries are the right solution for your next product.

James Holmes 6

Every year, 1.2 million tons of batteries enter the European Union. These batteries not only have a potentially huge environmental impact but, by requiring perpetual charging or replacement, can also be a burden to the very users they are intended to serve. Nowhere are these factors more significant than in medical devices where production volumes often exacerbate the scale of the environmental impact and where users can rightfully expect the most seamless experience in receiving their treatment free from the need to check and replace batteries in the devices on which they rely.

Batteries Bad? Modern batteries offer incredible levels of energy storage in almost every conceivable form factor and are available at low cost in high volumes. In the health tech space, batteries form a key component of everything from blood glucose meters to portable ECGs, connected inhalers and autoinjectors. There is however, no escaping the fact that most batteries contain some level of toxic materials. Each battery type is different but as electrochemical devices, they generally rely on a range of potentially hazardous materials including mercury, lead, zinc, cadmium, manganese and lithium. As a result, regulators are increasingly placing responsibilities on the manufacturers of products incorporating batteries to ensure that they minimise the harmful effects of disposal. This has forced manufacturers to consider battery removal as part of a device’s design, but it also requires users to act when it is time for the device to be disposed. For some potentially low cost, high volume products, the complexity of implementing a recyclingfriendly battery-based design renders them uneconomical.

Cutting Consumption Reducing our dependence on batteries starts with reducing energy consumption. For decades keeping up with Moore’s law has driven processor manufacturers to double processor power every year. In service of Moore’s law, semiconductor manufacturers have continually driven down silicon feature sizes to the point that the some of the latest chips are built with 7 nm processes.

Whilst this trend has enabled enormous increases in processing power, these smaller feature sizes have been combined with features such as dynamic voltage scaling and low power peripherals to deliver huge reductions in the power consumption of processors and sensors.

It’s not just microprocessors and sensors which have received the low power treatment in recent years.

E-Paper, cholesteric and Memory LCD displays require exceptionally low or zero static power to operate. Such displays are ideal for battery-less devices or those with very small batteries but can also offer significant usability benefits; an always-on display means that information is always available to the user with no need to wake the display and no tedious start-up times. This opens up a range of opportunities for medical products such as a digital usage instructions which guide the user through correct use of the device through animated graphics.

The Harvest In 2003 Transport for London launched the RFID based Oyster card as a convenient way to pay for travel on the London Underground. The magic behind the Oyster card was that the card itself contained no power source at all and instead relies on harvesting energy from the ticket barrier when the two were brought together. In 2018 not only are contactless payments ubiquitous, but NFC (a subset of RFID technology) is supported by almost every recent mobile handset.

These developments combined with continually dropping power requirements for processors, sensors and displays mean that some devices can harvest sufficient energy from a smartphone or other RFID source to operate with no internal power source at all.

Connected devices such as smart inhalers which today rely on lithium batteries and Bluetooth radios could instead communicate wirelessly via RFID and harvest the energy they need in the same process.

Here Comes the Sun Solar technology has also long been established as a means of powering small electronic devices and as device power consumption has dropped, the efficiency of solar cells has also increased. Related developments such as increasingly sophisticated DC-DC converter controllers which perform Maximum Power Point Tracking (MPPT) mean that small solar cells are now a practical means of harvesting sufficient energy to power simple sensors and radios even in indoor environments.

Dye Sensitized Solar Cells (DSSCs), such as those produced by GCell are well suited to indoor applications and offer an interesting further advantage in that unlike batteries, they are thin and flexible.

If the Sun Don’t Shine?

There is no escaping fact that in some applications, there is no light or radio energy to harvest. Sometimes only a battery will do. In such cases it may be worth considering a growing range of battery solutions which are specifically designed to be easier to recycle.

There are many companies pursuing greener solutions to the battery problem and some even come with additional benefits such more flexible form factors.

The manufacture of solutions from suppliers such as an Enfucell require far fewer hazardous substances than conventional batteries whilst delivering small amounts of energy in flexible packaging. These characteristics not only make them well suited to unusual form factors, such as in the wearable TempTraq baby temperature monitor, but also make them far more environmentally friendly than conventional solutions.

A promising future for battery-less devices Whilst batteries are undoubtedly an excellent solution for the power requirements of many portable devices, they also present several environmental, regulatory and usability challenges. With energy harvesting and low power technologies continually evolving, a battery-less design is becoming a viable alternative for an everbroadening range of devices.

7

Human

The Human Factors

Factors

Chris White

Multiple methods Holistic Methods for holistic User needs

In the world of medical device development, Human Factors considerations and testing have become an integral part of the product development process.

The US Food and Drug Administration (FDA) defines its role as follows: “For Medical Devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively.” As a result, medical device engineers and designers are very aware of the formal role Human Factors plays in the process but are generally only aware of a few methods used to achieve this goal. Almost all the human factors work requests our team at KD get from our clients are for standard formative and summative (HF validation) testing. However, there are a wide range of other methods, proven to be effective through application in healthcare as well as other industries, which offer the potential for adding real value to medical device development programmes in building a deeper understanding of user needs and usability issues.

CGM

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Showcasing potential methods via diabetes management system To illustrate the need for a more holistic view of user needs, let’s take the example of an Artificial Pancreas system, which is a system of devices worn by people with diabetes that closely mimics the glucose regulating function of a healthy pancreas. This has been a long time holy grail of diabetes care, which recent technological developments have brought within reach.

The connected, body-worn system comprises a continuous glucose monitor (CGM) which measures the patient’s blood sugar levels from a sensor inserted usually into the abdomen or arm. Glucose measurement data from the CGM is processed through a computer-based algorithm and sent to an insulin pump. On receiving the data, the insulin pump, also worn by the patient, will automatically inject the required amount of insulin.

This is a great example of a hugely beneficial, yet highly complex device which combines diagnostics and drug delivery devices in an intelligent, connected system. For the user, this presents a wide range of physical, cognitive and emotional challenges to achieve safe, compliant and comfortable use.

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We take a look at potential human factors methods that could be used to improve our understanding of end users throughout the development of the system we have described.

1. Expert reviews:

2. Digital contextual inquiry:

Often overlooked as a technique, an expert review of a system can identify a wide range of potential usability issues very early in the development process. The ‘expert’ could be an experienced user or even a usability expert but should not have been involved in the system design.

Contextual inquiry involves the observation of end users interacting with a particular device, system or process in a real-world environment.

It is commonly used as a tool to understand the needs of the user and to identify design opportunities.

Reviews can be carried out in a number of ways, e.g. a cognitive walkthrough where the ‘expert’ looks at the steps required to complete specific tasks and identifies issues.

A cognitive walkthrough can be done at an early conceptual stage or on fully developed prototypes.

Another example is a heuristic evaluation that takes a more holistic and less task-based approach. Here, a usability practitioner will evaluate a system against a set of recognised usability principles.

Both these techniques have merits and can be done relatively quickly and cost-effectively during early stages of device design. In our example this sort of approach would be especially effective for the pump interface and any data that might be presented back to the user.

Insulin Pump

Whilst Contextual Inquiry is becoming more popular as a research method, it’s traditional form can be laborious and costly to execute effectively. There are also often barriers to accessing patients and healthcare professionals, especially for rare diseases, infection control and geographic location.

There are a variety of digital approaches that can help solve these problems.

Remote user testing is becoming a quick and cost-effective approach that can be adopted to get deep insights in to user behaviour. In its simplest form, video calls can replace traditional interviews potentially allowing a snapshot into a real use environment. Welldesigned diary studies, utilising photos and videos from smartphones, can achieve great results when searching for real-life insights during longitudinal studies.

Provided they are carefully designed, utilising digital techniques for contextual inquiry and ethnographic studies can yield rich data.

Data of this nature will need careful analysis to synthesis the finding, often requiring interpretation from subject-matter experts.

This technique can be used to gather data on long-term use of the system, such as adherence and behavioural changes in line with product familiarity.

3. Cognitive workload tools: Cognitive workload assessment is a tool that is used to measure the mental effort required of an individual when completing specific tasks. There’s a plethora of approaches to measuring cognitive workload from subjective

questionnaires through to tracking heart rate during tasks using wearable sensors. The key watch outs for any kind of measurement is that none have been shown to capture the whole picture and as such, multiple methods should be adopted and compared.

Additionally, many of these approaches are intrusive (perhaps requiring sensors to be placed on the subject) and are therefore not always suitable for application in a real-life device use.

Using a good suite of workload tools during real-world device use, spikes in workload can be identified and associated with specific tasks or contextual factors. With this information design changes can be made to reduce cognitive workload and improve the user’s experience. This method is suited to complex systems and for our example might be best applied to assess the tasks required during initial setup and familiarisation with the system.

4. Experience prototyping: This is a tool made popular by the service design sector and includes the simulation of an experience to elicit more lifelike feedback from a user. Human behaviour is very easily influenced and accurate representations of systems and use environment can help ensure the participant in a study reacts as naturalistically as possible.

Typically, this involves props and role-play, alongside prototypes, which can be used to create a simulated use environment, often during the development of the actual device.

Experience prototyping may even include the use of ‘actors’ to play additional roles during device use such as a scrub nurse during a surgical procedure or a patient for a care giver to administer medication to. The key influencing factors for user behaviour need to be carefully considered; for example, something as inexpensive and simple as the presence of sterile gloves for the user to wear might change the approach a user takes. In the example here, you may only have a working prototype of one element of the system but blockmodel ‘props’ of varying levels of fidelity to represent the rest of the system could help create a full system experience.

No medical device is used in isolation - there is always a context of use: other devices, environmental influences, user experience levels and distractions. Medical device systems are also becoming more complex, with end users having to take more responsibility for their use and management. Taking a holistic approach and using a range of methods to uncover the factors that influence user behaviour and identify where design changes could enhance the user experience can have an important role to play in helping medical device designers and engineers develop better, more successful, user-centred products and systems.

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Mike Gray

For me, engineering is about creating new things that make the world a better place. I love the diversity; from submarines and satellites to the everyday inhaler, the same principles and practices are employed to overcome challenges of all shapes and sizes.

Chris Jones

My dad was a biochemist, and he spent all his time doing blood work. I got interested in software/electronic control because I grew up seeing what he was doing and inherited his electronics.

Ben arlett

I was drawn to engineering by the desire to create better products through a fundamental understanding of how things physically work. What makes it more interesting is the interplay between different disciplines and the teamwork and creativity required to deliver truly breakthrough products. All this provides a steady stream of fresh challenges.

The Year Of ENGINEERING We want to celebrate the fact that 2018 is the Year of Engineering! We asked some of our KD engineering team to share what they love about their vocation and why they do what they do...

Rebecca Nelson In the development of most products there will usually be that one point where you can see the theoretical being proved out by a physical rig; often after several iterations of development and sometimes failure. It would be hard for any other career to match the satisfaction of these moments and then, eventually seeing these products being used in the real world. Being able to influence products which will have a positive impact on people or sustainability is what drove me to become an engineer but enjoying the work itself is what convinces me it was the right choice.

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Josh Leddra

When I was at school, I remember seeing an electric wheelchair struggling to negotiate the cobbled Bristol pavements. I couldn’t help but try to solve the problem in my head, but lacked the knowledge and experience of how to turn my idea into reality to actually help that individual, which was incredibly frustrating. This year I got the chance to do that by working on an advanced bionic prosthetic device, that allowed me to see first-hand how my engineering contribution improves people’s lives. Watching an amputee walking normally whilst wearing the device I have worked on is all the motivation I need to tackle bigger and harder projects.

Marissa Gotsell I always had a desire to pursue a career where creativity, design and problemsolving were at the forefront. Engineering provided the opportunity to fulfil my desire while shaping the world into a better place. From diagnostic devices to prosthetic limbs, we are the driving force that brings concepts to life.

The Art of

Engineering At KD, the focus of engineering is always on designing a better product. This is a process that starts with understanding what better really means, and then uses tools from many areas of science and technology to achieve that objective. It is often easy to start with the solution rather than the problem and our definition of ‘better’ becomes limited to optimisations of what has gone before. Standing back from the solution and thinking about the problem allows the engineer to use the full range of tools available. This is often an area where a design agency can challenge, by thinking about a problem afresh, or bringing ideas and technology from other industries to unlock a step change in performance.

At KD, the starting point for any optimisation is a fundamental understanding of the mechanisms at play. This normally takes the form of a mathematical model and is key to understanding in which direction to move a design in order to achieve the desired performance. This kind of model can be validated through the application

of a range of different tools and at KD our approach is to identify the right tool for the job, rather than sell any one particular approach. These tools can include rapid prototyping and experimentation or analytical tools such as Finite Element Analysis and Computational Fluid Dynamics.

These provide insight into performance at a specific design point, or can be used to explore design sensitivities by testing different geometries. Digital tools in particular are becoming ever more powerful and easy to use and because of this they are invaluable for scenarios where experimentation is difficult or even impossible due to sensing, materials, cost or timeline constraints. They can also feed into risk management and product reliability processes such as FMEA to make these tools more accurate and valuable in themselves.

Ben Arlett

over the life of the product. Again, a true understanding of the mechanisms in your design will highlight variables that will be sensitive to change, and this is where the digital tools augment but don’t [yet] replace the need for the fundamental understanding which is what brings an engineer closer to the design.

The final design becomes a balance of many variables, including the industrial design, user interface, product performance, materials, manufacturing techniques and reuse / recyclability as well as scoping the development to fit with the available development time and budget.

This is where the ‘art’ of engineering lies – at the centre of it all we still rely on the human engineer, using the tools at their disposal to strike the right balance and ultimately design a better product.

It is also a good practice to think about a design, not as a fixed design point, but as a product that will vary based on the tolerances of components and assembly, as well as something that may change

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Development TimeScales And Speed to MArket As technology has enabled us to have more awareness and control of our own healthcare, this ongoing push towards consumerisation of health brings many challenges for device manufacturers; the most obvious of which is speed of market. We are now all used to being able to order a product and have it delivered within 24 hours or having software glitches on our smart devices resolved as soon as we have found them (if not before). The line in terms of consumer health has been blurred with the release of devices which connect to our smartphones, giving patients data on conditions which previously would have required a healthcare professional to collect and interpret. Every Medtech and Pharma company from small start-ups to the global conglomerates have vision statements which centre around improving patients’ lives, so, if that is our intention how can the medical sector which is notoriously slow and clunky, keep up with consumers demands?

The trend for consumerisation of health is not necessarily new but is gaining steam and visibility through communities of patients who are taking matters into their own hands. Daibetes patient group #wearenotwaiting have hacked devices to stream data in real time and have even developed a homemade artificial pancreas. Whilst these solutions are not all regulated and therefore may pose significant risks to the patient, they are meeting users’ needs in a way that the existing 12

‘regulated’ product is not. The uptake of such DIY systems clearly validates the user needs for such systems with real world use cases. It highlights what a rich source of data post market surveillance could provide if it was collected, managed and analysed properly. Many manufacturers fail to leverage the value of PMS data to inform user needs, merely because the manner in which it is collected constrains the value by asking the wrong questions.

Requirements capture is often rushed through or requirements are not fully defined at an early stage to allow ‘progress’ to be shown. However, this is ultimately short sighted and increases the risk of encountering problems later in development. If you need to provoke the user or challenge a business case, a demonstrator, or minimal viable product (MVP) can be invaluable, especially if built in very short timescales and at relatively low cost. By understanding the requirements of your product, this allows you to prioritise prototypes and MVPs to highlight what is essential to the user and your business, reducing unnecessary time being spent on non-critical elements. This can provide focus for a multidisciplinary team, especially when key decisions about functionality are being made.

Recognising the need for fast, iterative prototypes in this space, the team at KD have developed a “digital

prototyping framework” comprising a “vanilla” suite of sensor and communications hardware, a flexible cross-platform app prototyping tool, cloud data access, and an interactive control and status dashboard. This proven connected ecosystem can be flavoured and tailored to a range of project needs, allowing new solutions to be build, tested, evaluated and iterated at rapid pace.

Understanding what your product actually has to be able to do at an early stage will also allow more accurate planning and risk mitigation to be put in place whilst it is still relatively easy to make changes to your product. This is especially important if you are developing a device which is likely to need regular iterations once it reaches the market; something which is particularly relevant to any medical device which includes software. Whilst changes in medical devices need to be carefully considered in terms of risk and will therefore need to be verified and/or validated, if considered as a requirement from the start of the program, iterations such as software upgrades can be completed in a much more efficient manner.

Updates to software and release of connected devices are a hot topic for everyone, including regulatory bodies. In 2017, the FDA announced their Software Pre-Cert Pilot programme as part of their Digital Health Innovation Action plan. Their intention

is to pre-certify manufacturers, so they will apply the necessary control when releasing new versions of software instead of having to complete lengthy regulatory submissions and allow them to respond to real world performance. The launch of Pre-Cert 1.0 is planned for Dec 2018 for the companies selected for the pilot. So, whilst we wait for these changes to be implemented across industry, it’s worth remembering that this change in approach by the FDA has been driven by pressure from both consumers and industry. This combination of opinions, which has now been harnessed, could be leveraged to identify other areas for improvement.

Change is often slow in big organisations but it is in all of our interests, as consumers, to use our buying power and influence to improve time to market for devices which really meet our needs.

Kerry Briggs 13

Helsinki Children’s Hospital

© HUS/MATTI SNELLMAN

The Power of

Colour

There are few product aesthetics more predictable than medical devices, with their pale grey or white canvasses accented with blue or green. It is driven into our psyches with repeated vigour and there are very few exceptions of note.

If we think about colour as an ingredient to the product design recipe, it is incredibly impactful and powerful but is often underexploited and more than likely considered too late in any development programme to have any meaningful impact.

Here we consider how to harness and recognise the power of colour…

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self-care and home health. Our homes are the new battleground for the medical industry and the overlapping currents of consumer electronics, fashion, homewares and clinical healthcare all blur to forge new opportunities in the way that we have to communicate and contextualise usability and functionality in modern product design. The previous paradigms of stark, clinical aesthetics, so fitting of hospitals and laboratories, are remarkably alien in our homes. Today, the expectations for such products are more aligned and judged against the same trends and aspirations of products from brands like Sony, Apple and B&O.

Colour is hugely emotive. We all express our opinion of colours with subjectivity and loaded emotion. We use words like ‘love’ and ‘hate’ to talk about colour. So why – in a field as emotionally driven and linked to human feelings as closely as medical product design is – do we see such little experimentation and variety? Colour can, in an instant, deliver an immediate impression of functionality, approachability and gender to name but a few of many.

It can be tactically and perfectly used to shift these expectations and impressions to suit the need.

In parallel with context, our colour work needs to fully understand the user group. We live in a world where millennials have finally grown up and baby boomers refuse to grow old. Attitudes are shifting, and outdated stereotypes have been annihilated to the point where a misplaced colour cliché may not only alienate a generation, but very possibly the generation you hoped you’d targeted. Many are deliberately buying and consuming outside their demographic or age group and often actively shun those items specifically aimed at them, so it is a wary path we tread as we craft and curate the palettes we choose.

The role of colour in modern healthcare design is rapidly changing, particularly when placed in the context of the rise of

Colour design and decision making does have its natural pain points. Due to its inherently subjectivity, it can be difficult

to push decisions through management chains and timescales can also be intensely challenging. Medical devices have notoriously longer development programmes, in part because colour proposals may need to be verified in human factors testing where they have an impact on correct understanding of use, and selected colours may be subject to biocompatibility testing. With this in mind, and with an ever-greater deference to faster moving consumer electronics colour trends, it is important to ensure that colour trends are accurately monitored for longevity and robustness and are not likely to be too transient or fashionable to be applicable to slower-moving, longer lifespan products. A broad understanding of the societal and cultural influences on colour enable products to simply fit better within our homes and our lives.

Whilst colour may often appear superficial and a final veneer to reinforce brand values or provide simplistic choice, curated colour design is as difficult to navigate as it is impactful. Colour selection is often a key driver in addressing fundamental user needs in an increasingly complex world of blurred boundaries. It may be regarded as something of a dark art, but if it is well researched, sympathetically curated and well executed it can be the most powerful tool you never knew you had.

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5 Š Ari Seth Cohen

1. Mira Fertility Tracker Clinically-proven ovulation and fertility tracker 2. Tim Zarki: Hue Inhaler A concept for a multi dose inhaler that is meant to make a bold statement instead of being a source of self-consciousness.

3. Dot. Braille Watch The first braille & tactile smartwatch 4. Mickael Boulay: Measuring less to Feel More A concept blood glucose meter for diabetic users 5. Withings Thermo Smart temporal thermometer

Hayley Maynard

INDUSTRIAL DESIGNER

“

83% want age-neutral & inclusive brands that are the most modern & relevant The Age of No Retirement, 2016

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Patients

are doing it for

Themselves

“Healthcare has been the last major industry that hasn’t been touched by technology in terms of productivity and consumer adoption in the way so many other industries have”, so noted John Sculley, the former Apple CEO and now an active investor in health tech startups.

He’s right. Compared to the multitude of ways we use digital technology to book hotels and airline seats, or manage our bank accounts, the way we access healthcare services feels stuck in the past, and fails to take advantage of the resources that exist in us, as patients, and the powerful technology we carry around in our bags and pockets.

But things are changing. The regulatory bodies (and, in particular, the US Food and Drug Administration), who many cite as the primary reason for the slow pace of technology adoption in healthcare, are actively taking steps to speed up the regulatory pathway for software approvals and are actively encouraging the adoption of innovative solutions which leverage digital technologies. The recent statement from Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren is significant. In it, they note: “Owing to digital advances, we’re experiencing a reimagination of health care delivery. Consumers are now empowered to take more control of their own health information to make better informed decisions about their medical care and healthy living. These advances enable better health outcomes for patients.”

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Craig Wightman

“

Our message today is clear - we want software developers to create new, innovative technologies that can help consumers take control of their health FDA statement 12 Sept 2018

Important current developments include the electrocardiogram feature included in the Apple Watch 4 and now approved by the FDA as a medical device. One interesting new development has been the adoption of Direct-to-Consumer (DTC) models to provide patients with the tools to undertake diagnostic tests which would have previously required a hospital or clinic visit.

Interesting examples of this range from genetic testing kits such as 23andMe where saliva sample devices are posted to patients and sent back to the lab for analysis, to systems which use a combination of available camera and other technology in smartphones and tablets to capture diagnosis remotely by patients in their own homes. Solutions like these can dramatically bring down the cost of test and increase the reach of preventative healthcare.

© Skin Analytics

© Skin Analytics

Trevor’s Experience For many people the discovery of an abnormal mole marks the beginning of an extremely traumatic experience. The first thing many will do is search online for a diagnosis where invariably there will be many references to melanoma detailing how dangerous and aggressive they are and why it is vital to see a doctor as soon as possible. The process of making an appointment, seeing a GP, being referred to a specialist and finally the diagnosis can stretch out over weeks if not months which if it is a melanoma can have serious implications not to mention the stress of waiting.

Utilising “patient power” to undertake part of the diagnostic and therapy process can yield many benefits including reduced time and cost, increased patient engagement and faster throughput of testing, but places new demands on the system and service. So, what are the important things to consider?

Skin Analytics have developed a solution that dramatically reduces the timeframe of diagnosis by using AI and a direct to consumer model. Their process cuts the time taken to make an initial diagnosis and/or referral from what could be weeks to a mere matter of days.

Packaging and presentation:

A diagnostic device is sent directly to your home which consists of a smartphone, microscope and cradle that connects the two.

As a user you are walked through the process of using the device to capture images of the mole by a combination of a physical IFU and app-based instructions. Once the images are captured these are then sent directly to Skin Analytics for analysis by their AI, for us a follow up call with the outcome of a referral to a dermatologist came through the very next day. From the initial call with Vitality, our health care provider, to referral took 4 days and as there was no need to visit the GP we were able to carry out the ‘procedure’ from the comfort of our own home to fit around our schedule.

What are the interaction points of the system, so that the patient feels informed and reassured by the service?

In this instance the benefit of a rapid diagnosis combined with the convenience of having everything delivered to our home was a breath of fresh air. From this experience if I was given the choice as a patient between spending time in a waiting room or ‘doing it myself’ I would most certainly opt for the latter.

Trevor Brinkman

How will the equipment and consumables be packed, to ensure they arrive safely but also make sense to the patient when it arrives?

Patient engagement:

Distribution and delivery: How will the equipment be delivered or collected by the patients? Will the packaging fit through a letter box? What is the method for repacking and returning?

Usability and compliance: To eliminate risk and ensure validity of the test or therapy application, the system needs to walk the user through correct and safe usage with intuitive device design and suitable instructions

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Is Connected health the

Killer app

OF the internet of things

James Holmes 18

With the internet of things (IoT) market expected to continue to grow at an annual growth rate of 28% [1], the IoT is set to transform many industries but it is arguably the digital healthcare space where it is set to have the biggest impact on improving the world around us.

Spurred on by this growth, consumer technology companies are eager to capitalise and continue to flirt with products aimed at the healthcare space. So, what are the key opportunities and challenges for consumer technology in the world of medical devices and what will be the technological developments that have the potential to revolutionise healthcare?

(Smart)Watch this Space At its launch in 2014, the Apple Watch was touted as having a wide range of features including taking calls, sending texts, workout tracking, getting notifications, navigating and viewing photos. Four years on and Apple’s focus for the Watch is all about health. From detecting falls and alerting emergency services to identifying signs of Atrial Fibrillation to capturing ECGs directly on the watch. Apple has even FDA cleared some of these features signalling another step in the trend for consumer technology companies branching out into the more heavily regulated medical space.

A Voice for Health It’s not just Apple exploring the medical market, last year Amazon ran a competition with pharmaceuticals company Merck, offering a prize of $125,000 for the best use of Alexa in the treatment of diabetes. Since then, the Alexa team has a new Health & Wellness subdivision charged with making Alexa ‘more useful in the health-care field’, and most clearly of all, Amazon teamed up with JPMorgan and Berkshire Hathaway to create a brand new fully independent employee healthcare company. It’s strikingly easy to see Amazon’s interest in this area.

In the UK, Public Health England have used Amazon’s Alexa platform to, for the first time, deliver NHS-approved breastfeeding advice to new mothers via a voice assistant service. Public Health England point out that providing information in this way is quick and convenient to users and is available to support day and night, especially at those times when healthcare professionals aren’t readily available.

Earlier this year, Suki, a health tech start-up, raised over $20 million in series A funding to expand their digital assistant technology. Suki is designed specifically for doctors and aims to alleviate some of the administrative burden of being a healthcare professional. Suki sits in the examination room and is there to take notes as the doctor

conducts an appointment, allowing them to spend more time talking to patients and less time typing notes into a computer. Punti Soni, Suki’s CEO suggested to Techcrunch earlier this year that Suki’s ultimate aim is to redesign the whole healthcare technology stack, and obviously see that this starts with patient access and data.

Big Data Leveraging the scale of consumer technologies brings the double benefit of driving down the cost of access for the user, whilst making more data available for the service provider. This extra data can be used to train more accurate algorithms which could mean smartwatches which are more accurate in identifying health conditions or digital health assistants which deliver more sophisticated responses.

This scale isn’t without its challenges though, last year Google’s DeepMind was found to have broken privacy laws during the development of their Kidney Injury diagnosis system. Sparking a very public debate about ensuring that innovation does not come at the cost of eroding the fundamental rights of patients. Google’s latest move to wholly absorb Deep Mind’s health division has again forced the internet giant to defend its decision to privacy advocates and only time will tell whether the public will ultimately come to trust such large corporations with such personal information.

One of the key enablers for a revolution in healthcare is to have full access to and ownership of our own healthcare data. Whilst electronic health records (EHR) widely exist, they are often clunky to use and disliked by the healthcare professionals that use them. Most importantly, they are rarely made accessible to patients because they exist in a siloed, non-interoperable series of verticals, owned by different organisations: doctors, hospitals, health authorities, insurance companies and EHR providers.

Blockchain technology has the potential to join the dots of EHR systems, allowing patients to access and own their data, and would allow any physician or other third party with a valid interest to securely access relevant, comprehensive and updated data about our health.

The Myth of the Killer App With over 250,000 health and fitness apps available today, it’s clear that there is no shortage of interest in the search for the killer app. However, healthcare needs, as well as the enabling technologies, are too inter-connected for there to be a silver bullet solution. Perhaps the real killer solution lies in a convergence of connected technologies and data systems that provide patients, healthcare professionals and administrators with a transformed healthcare system that meets the needs of tomorrow.

[1] https://www.forbes.com/sites/louiscolumbus/2017/12/10/2017roundup-of-internet-of-things-forecasts/

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Dates in our diary DDL: Drug Delivery to the Lungs Conference 12th – 14th December 2018

We’re looking forward to returning to DDL 2018 to hear the latest in medicines for inhalation. DDL is an annual forum for scientists, academics, clinicians, regulatory and industry specialists, consisting of five themed sessions, presented by experts in the field of inhalation.

We hope to see some of you there! Find out more… https://aerosol-soc.com/events/ddl2018/

Pharmapack 6th – 7th February 2019

Kicking off in 2019 in Paris, Pharmapack is a dedicated Pharmaceutical Packaging and Drug Delivery event. Playing host to over 400 exhibitors and 5,000 attendees, it’s the place to go for updates on latest trends, developments and regulations impacting the industry. Find out more… https://www.pharmapackeurope.com/

2nd Annual Formulation & Drug Delivery Congress USA 18th – 19th March 2019

This two-day conference programme brings together hundreds of industry professionals from across the USA and further afield, to discuss areas including molecule drug delivery, formulation strategies and new drug delivery systems. Find out more… https://www.oxfordglobal.co.uk/formulationusa-congress/

WIRED Health 26th March 2019

This year, WIRED Health is challenging the health industry to transform; bringing together leading technologistics, entrepreneurs and innovations who shape the health industry today. This conference will cover topics from immunology to neuroscience; ageing to AI – all the while fixated on the fascinating innovations that are rapidly changing patient care. Find out more… https://www.wired.co.uk/event/wired-health

CIEHF Annual Conference 29th – 1st May 2019

Join the leading industry body for Human Factors, CIEHF, as it celebrates its 70th birthday in 2019, and hosts what is sure to be another excellent Annual Conference. New this year, will be a day of learning and development CPD masterclasses, alongside the conference programme of keynote speakers, focussing on topics such as design, occupational health, technology and behaviour change.

Find out more… https://events.ergonomics.org.uk/event/ehf2019/

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