Tag: Testing & Evaluation

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Reducing the carbon footprint and plastic waste of LFTs: Evidence-based opportunities

April 5th 2022
Dan Haworth

Dan Haworth 

Head of Diagnostics

Billions of lateral flow tests have been used worldwide during the COVID-19 pandemic – over two billion have been provided in the UK alone. Debate has raged on social media about why the tests need to use so much single-use plastic and how they could be made more ‘sustainable’. The test strip caseworks is a particular source of dismay – why so much plastic to house such a tiny test strip?

With the UK government ending the free distribution of lateral flow tests for the general public – citing a transition from emergency response to longer-term management of the pandemic – now is the ideal time to look more closely at the sustainability of these lateral flow tests, and to seek the data to demystify some of the emotional assumptions being made.

Familiarity with lateral flow testing has certainly increased, as has confidence in their clinical performance. It’s expected that lateral flow devices will be more present in our daily lives post-pandemic – not just for COVID-19 and pregnancy testing but to diagnose diseases such as seasonal influenza and sexually transmitted infections – all from the comfort of the home.

We’ve carried out a high-level assessment to quantify the approximate environmental impact of lateral flow tests and identify evidence-based suggestions for improving their environmental sustainability.

Why do COVID-19 lateral flow tests contain lots of single-use plastic in the first place?

The emergence of COVID-19 was a global emergency, and vast quantities of lateral flow tests were needed urgently. Once developers could produce the right immunoassay chemistry to detect the virus (SARS-CoV-2), it required implementation in a low-cost, low-risk device, that has a mature supply chain – with proven, readily available materials that wouldn’t compromise analytical or clinical performance.

This meant using existing plastic casework designs to retain and protect the nitrocellulose test strip. Plastic is robust, low cost, lightweight, easy to transport, and easily printed for QR codes and LOT numbers. Critically, it’s a consistent material proven for the highest volume manufacturing and won’t interfere with the immunoassay chemistry.

From a performance, cost, and manufacturing perspective, redesigning the product with new materials would have been high risk. Material changes may also have needed significant R&D costs, new capital equipment as well as additional cost and effort needed to demonstrate equivalence and achieve regulatory approval – risking the ability to provide sufficient numbers of high-quality tests, at speed during the pandemic.

Our results: The sustainability of lateral flow tests

But how serious an environmental impact do these tests have? To find out, we broke down a test into its constituent components and weighed them to calculate the approximate environmental impact, using standard emissions factors to calculate the carbon footprint of a single test.

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We focused on carbon footprint (the carbon dioxide and other greenhouse gases emitted during manufacture, transport, and disposal of the tests) and plastic waste (waste that would persist indefinitely if released into the environment) – the two issues that have attracted the most attention around lateral flow tests. A more comprehensive study should consider a broader range of environmental impacts, for example, the use of scarce resources and emission of other pollutants to avoid unintended consequences of any product changes.

Our results reveal:

  • The components needed to conduct the test account for around half of the carbon footprint and around two-thirds of the plastic waste. Packaging makes up most of the rest – as is often the case, a surprisingly high proportion of the total environmental impact
  • The test strip caseworks, which attracts the most comment online, is responsible for around 30% of the carbon footprint and 40% of the plastic waste. While it’s the most significant single contributor to the environmental impacts we evaluated, the large number of other small parts is also significant. Focusing on the caseworks therefore might not be the best strategy for improving the sustainability of the tests overall.
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Lateral flow tests a minor piece of UK healthcare’s environmental impact

To put these numbers into context, we can compare the environmental impact of the two billion COVID-19 lateral flow tests distributed in the UK with the UK healthcare system’s overall environmental impact. We estimate the UK’s lateral flow tests have a carbon footprint equivalent to around 0.5% of the total NHS carbon footprint. This isn’t a trivial amount, but it’s also not the largest single contributor to the impact of the UK health system.

It’s also worth considering the positive environmental impact of a user-administered test on the health system. Conducting a test at home can eliminate the need for an individual to visit a test site, GP’s surgery, or hospital (assuming the clinical performance of the lateral flow test is adequate). Based on estimates from the Sustainable Healthcare Coalition, one lateral flow test has around 5% of the carbon footprint of a single GP appointment and produces a similarly low percentage of non-degradable (plastic) waste.

And that’s before we consider travel. We estimate one lateral flow test has the same carbon footprint as driving 350 metres in an average UK car. So, if you’re driving yourself to a test site or GP surgery some distance away, at-home lateral flow tests compare even more favorably.

If a lateral flow test prevents an individual from transmitting COVID-19 to a vulnerable person, there’s a public health benefit – as well as an environmental benefit – to keeping people out of the hospital. We can all see the discarded waste from home tests, but the less visible impact from energy- and material-intensive medical interventions is often significantly higher.

These approximate figures demonstrate why building an evidence base is vital during product development targeting sustainability objectives – because the results can be unexpected and non-intuitive.

Quick ways to optimize today’s lateral flow tests

Just because waste from lateral flow tests might not be the most urgent sustainability issue for UK healthcare, that doesn’t mean we can’t and shouldn’t do something about it.

We used the ‘avoid/shift/improve’ model to find potential quick wins for lateral flow tests. These reduce the carbon footprint of each test by nearly a third and the plastic waste by almost a quarter – without impacting the fundamentals of how the test works.

They include:

  • Eliminate waste bags. There’s a case for quickly isolating contaminated waste (even given COVID-19 also spreads from infected individuals through the air), but the bags account for around 5% of the carbon footprint of the test. It’s not clear how widely used they are in a domestic setting – there may be a risk-based justification for not including them in the test kit.
  • Package all the test strips in a single foil pouch. Using a single re-sealable pouch to protect the tests from ambient humidity (rather than individually packing each test in a pouch with desiccant) is common in packs of lateral flow tests designed for use by healthcare professionals. However, once opened, the stability lifetime of the remaining tests is affected.
  • Reduce the size of paper instructions. These are important for the effectiveness of the tests and are a regulatory requirement, but account for 5% of the carbon footprint of a test – could they be reduced in size?
  • Eliminate the cardboard sleeve. This packaging isn’t essential to the safe and effective functioning of the test, and it seems likely that the functions it does provide could be achieved with less material.
  • Prefill the extraction tubes with buffer solution. This is already done in some test kits, although manufacturers need to be conscious of moisture loss and the effect on shelf life. However, the separate plastic vial used in the test kit we studied accounts for around 5% of the carbon footprint and plastic waste.
  • Increase the size of the pack from seven to ten tests. This would mean less package waste per individual test. Including ten tests in one pack instead of seven reduces the carbon footprint by around 5% (depending on how many other optimizations are done at the same time). Perhaps a pack of seven tests was originally designed to cover a week of daily testing – but is that how tests are being used in practice?
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Redesign of the test strip caseworks

Looking to the longer-term gets us into product redesign – creating a new generation of the product with sustainability in mind. Doing this can take significant investment since, for medical devices, it’s likely to require new regulatory approval, which is a lengthy and costly process.

A popular idea circulating for lateral flow tests is to minimize the plastic test strip caseworks (without compromising the essential functions of providing a stable platform, and protecting the nitrocellulose test strip). It might be possible to halve the caseworks mass and reduce the overall carbon footprint and plastic waste by 15-20%. This would require significant investment in R&D, production tooling, and regulatory approval hoops to jump through – but could be worthwhile if future demand for tests stays high.

Longer-term options

If we consider that the world may require billions more lateral flow tests over the coming decade, a more comprehensive redesign becomes commercially viable. This could involve stripping the design back to the fundamental requirements for a lateral flow test – flowing a sample through the test strip in a way that is controlled and free from contamination. Current designs take advantage of established components to collect, buffer, and dose the sample – but, at this production volume, it may be worthwhile designing a system from the ground up that is optimized for cost, usability, performance, and sustainability.

Sustainability as a brand differentiator

It’s clear there’s scope to optimize lateral flow tests to reduce their environmental impact – and a systematic analysis reveals options beyond those that might jump out to someone when they use the tests. But it’s essential to put the impact of lateral flow tests in the context of the wider healthcare system, to focus resources where they can have the most environmental impact – and to recognize that, sometimes, the plastic waste people can see helps to avoid more serious, but less visible consequences.

On the other hand, while visible plastic waste from lateral flow tests may not be the most pressing environmental issue facing the healthcare industry, it highlights the growing influence consumer opinion is likely to have as diagnosis and treatment shift from hospitals to homes. And as lateral flow tests become (in the UK, at least) a product people buy with their own money, choosing from a range of options, there may be a competitive advantage for businesses that take note and optimize their products for sustainability.

References
  • Prime Minister sets out plan for living with COVID [Internet]. GOV.UK. 2022 [cited 1 April 2022]. Available from: https://www.gov.uk/government/news/prime-minister-sets-out-plan-for-living-with-covid
  • The Sustainable Healthcare Coalition. Care Pathways Calculator. [Internet]. Sustainable Healthcare Coalition. 2022 [cited 1 April 2022]. Available from: https://shcoalition.org/

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For more information on reducing the environmental impact of lateral flow tests without compromising performance, contact Cambridge Design Partnership.

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Mastering fluid flow to enhance user experience|

Mastering fluid flow to enhance user experience

March 22nd 2022

Ice cream and blood are two things you probably don’t want to think about simultaneously. But both are full of organic proteins and fats and behave differently from a fluid like water when they’re pumped through tubes. Innovators sometimes think about these similarities when creating, for example, a novel ice cream dispenser or device that filters out platelets from donor blood .

How a substance flows is a vitally important consideration for many products, from foods to skincare to medical devices to household paints. Development teams need to keep in mind a wide range of flow behaviors (for example, flow through nozzles, non-Newtonian flow, and foaming) to hit the sweet spot: a positive user experience that makes a product stand out in a crowded market. This means thinking about the science of how liquids and gases behave (fluid dynamics), as well as how the product responds to user interaction.

Look at how the squeezable plastic ketchup bottle differs from the glass bottles that were standard before 1983. The new design completely changed the user experience – no more digging down into the bottle with a knife to get the ketchup flowing again. Things became even easier for ketchup lovers with the debut of the upside-down squeezable bottle – no more awkwardly storing ‘regular’ bottles upside down in the fridge.

Or think about how the experience of washing your hands changed after the arrival of the liquid soap dispenser. Instead of having to share the same bar of soap with others, people can now wash “without the soapy mess”, as Robert R Taylor, who introduced SoftSoap liquid soap, put it, and can take only as much soap as they need.

While the flow of some liquids is analogous to water, whose behavior is well understood, other substances behave in much more complicated ways, requiring in-depth analysis work to understand when designing new products. For example, the air bubbles in ice cream make it behave as a liquid foam. Ice cream’s flow will change depending on how you’re dispensing it: Push it at high pressure through a narrow channel or nozzle, and the air bubbles will be compressed, allowing more ice cream to flow through the nozzle at once. When the ice cream is returned to normal pressure, the air bubbles re-expand, and the ice cream returns to its original size. Because of this complex and variable behavior, designing a product to dispense ice cream relies on hands-on experiments… which can mean going through gallons of ice cream before you can create a design that works as intended. Only by conducting these experiments to understand ice cream’s behavior can you build the mathematical model required to effectively develop a high-performance machine.

While it’s a shame to use gallons of ice cream in the quest for a better product, it’s not an environmental disaster. But shipping water-based products around the world does contribute to fossil fuel consumption and climate change. Removing water from laundry detergent helps cut shipping emissions by reducing bulk and making shipping more efficient. But it also dramatically changes how detergent flows and gets used by consumers. For example, measuring out 10 ml more detergent than recommended likely wouldn’t have an impact if you’re using a product that’s mostly water. But being off by 10 ml when detergent is concentrated could make a big difference for your laundry. So, it’s vital to ensure that dispensing is accurate, which requires an understanding of flow.

There are so many flow behaviors that can affect a product’s design. For example, should a container for insecticide include a mechanism to avoid skin contact and spillage? How could a medical device for freezing tumors be redesigned to eliminate vapor locks without the use of heavy and bulky high-pressure gas cylinders? Is there a way to dispense foaming hand soap in a decorative pattern for a premium experience?

Getting the design right for a flowing substance can differentiate between a product that fails and one that creates an experience that shifts category norms and delivers breakthrough consumer delight.

References

Pilot manufacture for drug delivery devices||

Prepare the way: Pilot manufacture for drug delivery devices

January 18th 2022
Jon Powell

Jon Powell 

Head of Manufacturing

Bringing a drug delivery device to a clinical trial is a complex endeavor. You need to keep a handle on multiple moving parts, for example, the active pharmaceutical ingredient (API) development, the regulatory pathway, establishing the supply chain, and labeling. Developing a novel drug delivery device takes things to another level.

Many manufacturers shy away from the challenge, relying instead on proven technologies, so patients and clinicians don’t benefit from the most advanced user-centered design, and pharma companies can’t leverage the competitive advantage new technology delivers.

Here, I share some of the obstacles encountered conducting pilot builds in-house to help our clients bring devices to market – and give four pointers for ideal pilot manufacturing for clinical trials.

Develop your manufacturing process and architecture in tandem

3D CAD makes it all too easy to lose touch with reality and forget that the model on the screen is only an idealized representation. Zoom in 4,000%, and everything lines up beautifully. There’s no gravity, and parts have infinite stiffness, no tolerance, and perfect alignment. But, when you get natural variation in the manufacturing process, results can be disastrous. Components may not even fit together.

Once a design is frozen, making changes is expensive. After it’s passed to a high-volume manufacturer, costs become exponentially higher. Understanding manufacturing processes – and how changes can impact a project’s timeline – is critical for successful delivery. You need to prepare for the supply-chain ‘whiplash effect’: a tiny change at the top of the chain can mean seismic shifts at the end of it. That knock-on is the reason your product development strategy should incorporate pilot manufacture. Pilot manufacture keeps this effect in check by minimizing the volumes involved.

It’s vital to consider the whole supply chain, not just the component manufacturer, but the process equipment partners, filling, packaging, sterilization, and logistics. Each step has requirements to be understood and communicated to relevant parties. By developing manufacturing and assembly processes in tandem with device design, we can be flexible to insights arriving from either direction.

Pick the right partners for success

One of my first jobs was for a major automotive company. In their heyday, they ran the foundries that made the ball bearings for their vehicles. Today, they wouldn’t dream of it. No company does everything anymore. Few organizations would claim to be experts in all areas of drug delivery. Even those that manufacture and fill their own devices rely on external partners to produce the plastic resin and packaging materials and often outsource activities such as sterilization.

Partnering with experts to contribute specific knowledge is a time-efficient way to overcome obstacles in the development pathway. It also unlocks access to cutting-edge equipment and facilities that are expensive to maintain. While developing a breath-actuated inhaler, we engaged an external test house to conduct bio-compatibility evaluations on the device. We may have the skills in-house to perform this testing but maintaining accreditation for an activity that isn’t core to our business doesn’t make financial sense.

Know the limits

When developing a device, it’s essential to explore sources of potential variation. The same goes for the manufacturing process. You can use various tools to do this, but we frequently return to the humble ‘process failure modes and effects analysis’ (pFMEA). The pFMEA is a structured way to consider all the process steps – and how they could go awry. Developing a robust pFMEA ensures the team focuses on the highest risk areas and starts thinking about implementing mitigations.

A key checkbox for each manufacturing process step is if the results can be verified or validated. The US Food & Drug Administration Code of Federal Regulations Title 21 defines verification as “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Many processes can be verified using in-process measurement systems. But several can’t, for example, the joining of two plastic parts by ultrasonic welding. You can’t determine the strength of this weld without destructive testing. The ultrasonic welding process needs to go through process validation to determine the limits within which the process should be operated.

When communicating with stakeholders, it’s crucial to know the volume limits and have a realistic plan for producing parts representative of the final production process. For example, how many parts can the mold tools make? There’s a trade-off between tool production speed, tool cost, and tool life. Low-cost soft aluminum tools might be ready in two weeks but only suitable for 2,000 shots, whereas a more expensive hardened steel version might take 16 weeks (without validation) but last for over 100,000 shots.

Validating injection mold tools can be a lengthy process. Exploring the process window needs planning and performing multiple molding and measurement runs and subsequent analysis. Companies only want to bear this cost once, so experienced development teams need to hold firm when encountering adverse test results. I know of an auto-injector that showed promise early on, albeit with an infrequent failure observed in testing during development, that was allowed to pass into design freeze. More thorough testing during design verification revealed results that triggered the regulatory application to be rejected. Cue months of tooling validation needing to be reassessed.

Combination products require the delivery devices to be filled or co-packaged with primary containers of the API. Clinical trials complicate this because they need devices filled with the API or safe and sterile placebo. The filling process can be complex, especially when the API is highly viscous or uses technologies such as microspheres to sustain the release of active components over time. You need to factor in time to explore the filling and develop the process settings. Thought needs to be given to the amount of API and placebo available and the lead times for new batches as this can limit the amount of filled and finished devices.

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Not documented? You’re not done.

Understanding the controls needed to manage risk is essential for a manufacturer delivering high-quality, safe, and reliable products. ISO 14971 sets out a best practice framework for managing risk in the context of medical devices. We advise creating a quality control plan that summarizes the production risk mitigation controls identified through risk assessment in a clear, concise format. This control plan also blueprints the actions needed if a specific limit or check is breached.

Anyone who has experienced an audit by a notified body or regulatory agency will recognize their love of records. The mature management systems used by large manufacturers often aren’t available for the short-run low volumes involved at the scale-up stage. Building a bespoke database compliant with 21 CFR part 11 to handle records can be a lengthy activity, particularly when compared with the pace of setting up paper-based systems.

Managing paper records generated by the manufacturing process can be challenging, putting storage and recall burdens on a manufacturer. Companies scan these documents soon after completion to reduce this burden. But the destruction of originals is risky, and the recall and integrity of e-records must be checked before destruction.

Pilot manufacturing helps optimize the journey of a drug delivery device to clinical trial. It’s not without its own challenges, but synchronizing manufacturing process and device design development, partnering with experts, having a plan for producing components that’s representative of the final production process, and keeping a handle on records puts you in a position to maximize pilot manufacturing’s potential.

References

Connect with CDP

For more on how to navigate pilot manufacture and bring drug delivery devices to clinical trial with confidence, contact Cambridge Design Partnership.

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Why testing is vital to product sustainability|

Making it last: Why testing is vital to product sustainability

March 25th 2021

Jonathan Wilkins 

Mark Buckingham 

How long do we expect a product to last? Many sophisticated technology products, such as phones and tablets, are routinely replaced after a few years as specifications evolve rapidly. But what about a chair or a toaster? There are a huge range of products that we only replace when they wear out, but how long will this take, and how do we decide when minor changes add up to justify a replacement? When we prepare new product designs, how do we test to predict whether the lifetime will be months, years, or decades?

The challenges of biomaterials

Many consumer products contain large quantities of plastics derived from crude oil. But there’s increasing consumer interest in products made from bio-based materials derived from plant matter. While bio-based plastics are renewable, many are recent innovations. There may be a temptation for designers to make a direct substitution between a well-established plastic derived from crude oil and a bio-based plastic. Yet the two materials are unlikely to behave on a “like for like” basis. Because of limited service experience, there’s often a lack of data or understanding of how new types of plastics degrade and age over time. As a result, long-term testing and lifetime predictions of bio-based materials is a particularly relevant topic and can begin right at the start of a design project, while still in the materials selection phase.

Designing for the long term

We want newly designed products to have a long service life and to withstand normal rough handling. If we buy a shiny new phone, bike, or car, we expect it to start looking slightly rough and worn after a while, but we don’t want it to break or change color too soon. How do we check for this? We need to think about how the product will be used and how it might fail.

We can look at this challenge in terms of material selection. How do products age under different applications? What types of rough handling will a product need to withstand, and will the result be sudden failure or a gradual loss of properties? How will subtle changes in the appearance of the product over time affect its suitability for continued use? Does it matter if it becomes less glossy or even changes in color? Is it easy to keep clean? Do certain design elements require local reinforcement to prevent early failures at potential weak points? It’s easy to overlook these questions when an existing product is redesigned, particularly if a change in material is proposed.

Even when changing the grade of the same plastic material, such as polypropylene, small variations in the amount or type of fillers and other additives, or the length of the polymer chains, can modify its behavior. We can’t look up a single set of properties for polypropylene as there are a huge number of grades with different characteristics. The impact of even a small change may be to move a design from rugged to marginal, with a substantially increased chance of failure. It’s vital to select specific tests in order to evaluate the risks for a particular application.

 

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Better, or just different?

There are many perfectly sensible drivers for changing materials, including cost or weight reduction, improvement in properties or sustainability. In each case we seek to improve, but have we unwittingly introduced a new way in which the product might fail? If the appearance or feel of the product has changed, might it be used differently? If it appears to be stiffer and more rugged, is it OK for me to push it harder? Have we considered how to test the product design to take all possible failure modes into account? If the customer could misunderstand how to use the product there’s an increased chance of unanticipated rough handling.

If we design a product to have a long lifetime, we also need to take customer preferences into account. Until recently, there were drivers to replace products simply because they look a little old and tired. But much greater awareness of environmental issues has encouraged customers to continue to use well-liked older products until they fail, and to consider repairing them to enhance their useful life. Whatever nature can create, nature can also degrade. So, if we consider replacing a synthetic plastic with a natural material, then it may be biodegradable under the conditions of use and so it may fail in new and unexpected ways.

Mechanical performance testing is always a good place to start. As well as testing the finished product, additional trials on small pieces, or “coupons”, of the component materials will highlight any changes in properties after environmental aging. For many regulated applications, such as medical, food packaging or toys, there are specific mandatory tests, for example measuring levels of extractable or leachable materials. But in a novel design it’s often other, non-mandated tests that show up how a particular product might fail. It’s then the responsibility of the designer to investigate and mitigate the possible failure modes in a new product. Key tests will show up early signs of wear, damage or other aging and it may not be necessary to test the item to destruction.

Taking it outside

If a product is to be used outdoors or at high or low temperatures, the risk of failure must be checked over a wide range of conditions. Artificial weathering environments with water spray and UV light mean we can quickly predict the impact of many years of outdoor exposure. As well as possible changes in mechanical performance, the stability of color and other aspects of appearance can also be tested. For example, we expect the paint on a car to begin to degrade only after many years.

Specific environments will put additional stresses on some types of materials. The salt in a marine environment or the sand in a desert may cause wear much more quickly. Beneath the hood of a gas-powered vehicle, the components will be exposed to high temperatures and oil, fuel, and other fluids. Materials used in aircraft, high voltage systems and nuclear power stations also need to perform reliably in very specific ways.

Standing the test of time

Long-term subtle changes can be difficult to detect. For example, many plastics undergo creep when subjected to loads and specialized test regimes are needed to detect when substitution with a stiffer material is necessary. Exposure to fluids can also cause long-term changes, particularly when plastics slowly absorb the fluid and become softened and distorted.

If a product is designed to last for decades, for example if it’s installed within a building, then we need to carry out accelerated aging evaluation to test how its properties will perform over this period. One response is to apply the rule that the rates of chemical changes increase with temperature in a predictable, mathematical way.

By storing samples in ovens at a range of elevated temperatures and testing them periodically, we can build a picture of how the same material will perform over decades at room temperature. This methodology is often termed the Arrhenius approach. For example, it may allow us to predict behavior after 10 years at 20°C in only around six months, by accelerating the testing at 60°C. We can even immerse the accelerated test samples in fluids if we want to simulate use in wet conditions, for example in food or beverage applications.

A route through the maze

With appropriate experience in design, material selection and evaluation, it’s possible to devise a new product and to put together a suitable test plan. The data generated can be applied to provide confidence that a new design or a change of material will lead to a product with a long lifetime. After all, when we like a pair of shoes, we want them to wear out slowly, and there’s no reason why the same can’t apply to our favorite products.

Testing times

Testing times: adapting user insights research for a new era

May 21st 2020

Ben Kelsey 

Andres Barrera 

As COVID-19 related distancing threatens established methods of engaging with consumers and patients, Ben Kelsey and Andres Barrera reflect on how to support innovation projects with ‘hygienic’ user research tools and techniques!

The ability to travel and observe how people live in their cultural context is a privilege, and an asset to a researcher’s toolkit. It enables us to elicit the insights that can develop new commercial strategies, and it allows our design and technical teams to create the new products and experiences that deliver critical benefits. So, a global pandemic would, at least on the face of it, seem a high barrier to the ‘day job’.

However, to preserve the global economy, businesses must and will adapt, therefore products and services must also evolve and reinvent themselves for this new environment. The emotional rollercoaster that many families are currently experiencing will certainly influence their behaviour, and understanding this may offer a valuable insights into potential long-term changes in habits and attitudes that will provide innovation opportunities in the future.

Our broad tool-kit and research expertise has developed over the last ten years to include both physical and remote insights capture and validation methods. The challenge is knowing the right tools to use and having the experience to deploy them to maximise results. No one tool is perfect for every task because the research objectives and budgets can vary significantly, but the starting point is that there is much to be gained, and little to be lost, by a learning engagement with your future potential customers.

As long as travelling to users’ houses is prohibited by the need for social distancing, traditional ethnography is impractical. However, online ethnography can go some way to replace it. Users can self-facilitate their interview, creating a series of short recordings on their smartphones across a series of scenarios which have been pre-defined by the moderator. This enables researchers to gain a valuable visual, narrated snapshot of respondents’ lifestyle, behaviour, shopping environments and product usage.

Today, it is estimated 3.5 billion people around the world have a Smart Phone1. So these digital methodologies can access populations and user groups with greater ease and speed than face-to-face methods including ‘hard to reach’ populations in a way that was not previously possible. Furthermore, remote research allows the moderator and the observers to gather the insights captured within the participant’s natural environment; allowing the participant to be more relaxed and more instinctive behaviour to be observed, with sessions scheduled around the participants’ daily routine. At a practical level this can enable recruitment of wide diversity, both by geography and consumer segments, typically at a lower cost that physical field observations.

Our research and insights team is made up of a variety of subject matter expert backgrounds, including psychology and anthropology, science, and design. The objective of our work, whether for consumer or healthcare markets is always to creater a better, and more intuitive experience. Human Factors and Usability trials are another research activity that has been impacted by COVID-19, and this service has also benefitted from a creative approach and constantly expanding tool-kit to ensure client’s critical path healthcare development programmes remain on course as we switch to remote methods.

How we run online remote usability testing

There are three key questions we ask partipants which measure product desirability and usability:

“Does it fit in with the way I do things?”

One way we explore this is by gaining feedback on product workflow using storyboards or demonstration videos and animations which can be shared online. These tools are great for communicating assumptions and quickly learning whether they resonate with users and reflect how they do things. Study material can be shared prior to the session or presented to the participant during it.

“Can I understand how to use it?”

Gaining feedback on visual design and the hierarchy of information helps to validate mental models embodied in the design. This can be done using images, walkthroughs and interaction simulations to explore specific user interface features, i.e., interpretation, legibility, navigation, etc.

Each step of the user experience can be explored with the participant to determine their understanding of the device state and asked what they would do next.

“Am I able to physically use it?”

We can obtain richer feedback on physical interactions by posting test packs to the study participants. These might include, for example, handling models or low-fidelity prototypes, and briefing materials, which can be used in a range of ways – both moderated and unmoderated, depending on objectives.

3D printing is a great tool for this. We can print and finish a ‘looks-like’ model, and a 3D-printed headset allows them to video the encounter with their phone. We have also, as a matter of course, been including a personal hygiene pack and instructional information on measures to minimise virus contamination risks.

Participants are encouraged to ‘think out loud’ and walk through the overall experience with the device. This footage is then used by the research team to ask follow-up questions via video calls, to better understand use challenges or frustrations.

Heuristic analysis

Some tools avoid the need for usability testing with real users at all. One is heuristic analysis; an evaluation method which draws upon the collective knowledge and experience of a team of expert interaction designers and usability engineers to evaluate a device or concept against a set of pre-agreed criteria. This can also be expanded to consider capability loss or through exercises such as “walk-in-my-shoes” or using capability loss simulations. It provides a powerful empathetic solution when the target users are hard-to-reach, rare patient groups or are part of a niche consumer population.

Data logging

An approach we have pioneered at CDP is the use of data loggers hidden in prototype products, a service we call diialog. This allows a subject to receive a prototype device or packaging sample and naturally engage with it in their day to day routine in trials lasting up to a month, when it is eventually returned. At this point we download the stored data and analyse it to understand how the subject actually used the product.

This digital technology has been deployed successfully on research devices ranging from drug delivery systems to vacuum cleaners, both in concert with, and without a written diary.

As experienced researchers, we all know that there is no perfect single test method – but when faced with very diverse innovation challenges, the starting point is always collaborating closely with our clients to fully understand their objectives, and a broad and evolving toolkit to call upon! As an end-to-end innovation partner, we understand the importance of asking the right questions in order to uncover the right evidence to craft the right solution that is both desirable and safe for the user.

With a return to widespread physical in-home research some way off, you may be wondering how you are going to maintain your NPD critical path; whether you are in the early ‘explore’ phase of an innovation programme, or needing a decisive validation test result, if this feels like your current situation we would warmly encourage you to get in touch for a chat about your current research challenges, and some of the latest options that may be open to you.

References:

1. https://www.statista.com/statistics/330695/number-of-smartphone-users-worldwide/

Mars Petcare – smart-pill illustration

CDP create a remarkable ‘smart pill’ for Mars Petcare

August 13th 2019

A team from Cambridge Design Partnership has created a ground-breaking ‘smart pill’ to gather crucial nutritional information to help develop innovative new pet foods.

CDP scientists and engineers worked with the world-renowned Waltham Centre for Pet Nutrition on an electronic pill to collect food samples inside the canine gut during digestion.

“It was certainly an unusual request and a major challenge,” says Will Bradley, who led the project for CDP. “Mars Petcare wanted to find out more about how dog food is digested, with the aim of improving their pet food. So they asked us here at CDP for help.”

“They needed samples of partially-digested food that they could gather in complete safety for the dog.”

Part of Mars, Incorporated, Mars Petcare has a portfolio that spans pet nutrition and health through brands including ROYAL CANIN®, WHISKAS® and PEDIGREE®. For Mars, CDP created a smart pill about the size of a grape that a dog could easily swallow.

“We gave it a sensor so that it knows when it has left the acidity of the stomach and entered the first part of the intestine,” explains Will. When it is correctly located the pill opens and takes a food sample, using a miniature piston-type mechanism. “This needs to be absolutely foolproof. The pill then closes, to contain and protect the sample as the pill moves through the remainder of a dog’s digestion.”

CDP was approached by Mars Petcare to bring to life an idea for intestinal sample collection in dogs. CDP created the pills at its laboratory in Cambridge, which were trialled at the WALTHAM Centre for Pet Nutrition in Melton Mowbray, the global pet research centre for Mars. There were many studies and iterations needed to refine the design.

The samples that are collected will be used to analyse the way various nutrients are absorbed during digestion. “The scientific understanding of this whole process had basically stalled for decades,” explains Mike Cane at CDP, who has worked on the project for the past 18 months, “because no one could retrieve these samples without invasive surgery to the dog.”

Working with animals is not straightforward, Mike admits: “At all times, there were such high welfare standards. An independent observer was on hand whenever we worked with the dogs. If any dog was looking uncomfortable they would intervene to stop that day’s trial. They really do pride themselves on the way the animals are treated there.”

Once the pill passes through the dog and is excreted, it is retrieved and the data from it is collected. “The data from the trials has been analysed by the lead scientist from WALTHAM, David Wrigglesworth, who will soon be publishing his findings in peer-reviewed scientific journals,” explains Mike.

In addition to surviving the rigours of a dog’s digestion, the pill can also be tracked on its journey. “Once it was clear that the pill worked well, Mars Petcare asked us if we could also find a way of knowing accurately exactly where it was as it passes through the dog,” says Mike. “So we also devised a special interactive coat worn by the dog which picks up a radio signal from the pill.”

The smart pill is so unique that it has been patented by the team.

“Here at CDP, we’re very proud of our achievement,” says Will. “I feel sure that it will enable Mars to create innovative new pet foods for many years to come.”

For further information and media enquiries, please contact: media@cambridge-design.com or call 01223 264428

ablation-catheter-technology-cardiology

CDP and Kings College London develop innovative steerable catheter to treat cardiac arrhythmia

August 4th 2016

Innovative design and technology consultancy Cambridge Design Partnership has worked with King’s College London to develop a novel steerable catheter which King’s researchers had designed.  The catheter is designed to improve the treatment of cardiac arrhythmia – a range of conditions which can lead to stroke or heart failure that affects 2 million people a year1 in the UK alone.

The new steerable, micro moulded catheter enables targeted delivery of radio frequency energy to specific points in the heart tissue for corrective treatment. Compared with traditional catheters, the new device has been designed to be quicker and easier to manoeuvre into the correct position, improving the accuracy of positioning and minimising damage to healthy tissue, which should improve success rates of the treatment.

Cambridge Design Partnership won a four-way competitive bid to further develop the device created by King’s College London, involving helix-shaped interlocking tubes that would allow improved steerability and greater compatibility for robotic control over other catheters on the market. The team at Cambridge Design Partnership successfully refined the initial design, enabling the device to meet key regulatory and biocompatibility requirements, whilst ensuring suitability for commercial manufacture. Through CDP’s experience of developing highly technical medical devices, the team was able to miniaturise the design to allow improved space for the delivery of ablation energy and irrigation. The new catheter design is also assembled from micro injection moulded sections, incorporating features that enable the device to be built on an automated assembly line at reduced manufacturing cost.

Matt Brady, head of Medical Therapy, Cambridge Design Partnership, said: “The steerable catheter is an extraordinary product, with innovative features that enable corrective treatment to be delivered to very specific areas of the heart. By enabling greater accuracy and quicker treatment time, we believe it is possible to preserve more healthy heart tissue, and increase the success of the treatment. It’s been hugely exciting to be involved in this joint project with King’s College London and use our expertise to bring such an innovative product one step closer to commercial use.”

Professor Kawal Rhode, Professor of Biomedical Engineering at King’s College; London, commented: “We have been delighted with the results of Cambridge Design Partnership’s work on this project. The team was chosen for the strength of their existing experience in developing catheters across both start-ups and global corporations.  We were very pleased with the engineering approach and practical improvements that they managed to incorporate. They delivered fully moulded parts, and specified other components and the assembly route which fully met our aspirations for the project.”

King’s College London is now undertaking extensive lab testing of the catheter device, with clinical trials expected to be take place in two to three years.

1 Arrhythmia

For further information on this project, please email: hello@cambridge-design.co.uk

For Enquiries to King’s College London:
Please contact Dr. Rob Glen, King’s Commercialisation Institute
Robert.glen@kcl.ac.uk 020 7188 6209
Kings Commercialisation Institute

New connected wearable device helps medics save lives in disasters and on the battlefield

August 6th 2015

Innovative technology and design consultancy Cambridge Design Partnership today announces that it has developed the world’s first wearable device designed to measure and monitor the vital signs of multiple trauma patients for emergency response in disasters and battlefield situations.

The First Response Monitor is designed to help medics monitor both heart rate and respiratory rate. Respiratory rate is often neglected by automated monitoring systems and has been described as the ‘forgotten bio-sign’, as many existing wearable monitors focus on heart rate alone and those that do measure respiratory rate have low accuracy or are difficult to use in an emergency situation. However, the benefits of accurately monitoring respiratory rate are clear, and when combined with other parameters – such as heart rate and body temperature – can indicate life-threatening conditions such as sepsis.

When designing the new compact device, Cambridge Design Partnership interviewed a range of army medics about their needs and challenges in multiple casualty emergency situations. An unmet need was identified for a low-cost device to bridge the gap between manual methods of vital signs measurement – which can be laborious and challenging amidst the noise and stress of a disaster or on the front line – and more expensive patient monitoring systems.

The lightweight, robust and low-cost wearable biometric device not only monitors patients but collects and transmits data in real-time, enabling the medic to care for a greater number of casualties, providing more effective casualty triage to deliver improved patient outcomes.

The small device clips onto a patient’s nose and monitors breathing rate and heart rate, giving ‘at a glance’ indication of both parameters, and this data is added to a trends graph showing how these measurements have changed over time. This enables the medic to focus their efforts on providing care rather than taking measurements but also enables the care giver to understand how the patient’s condition has changed over time. The data can then transmitted using Bluetooth low energy to a smartphone app or tablet, enabling other data analyses such as multiple patient triage or situational awareness across the group.

Although the device has been primarily designed with first response medics in mass casualty incidents in mind, it has applications in many other fields – such as civilian medicine where additional monitoring of conditions has demonstrable benefit in patient outcomes, wellness monitoring and within sports for training and performance monitoring. The technology can also be developed to provide a low-cost solution for low resource healthcare settings.

Speaking about the new development James Baker, Partner, Cambridge Design Partnership said: “At Cambridge Design Partnership we’re always looking for ways to find a solution to a clear, unmet need. With the First Response Monitor we’ve combined our expertise in wearable connected devices with our extensive medical experience to develop a technology for effectively measuring breathing and heart rate. The monitor can help save lives in a variety of environments and we’re really keen to speak to partners about developing the potential applications further.”

Why validate concepts? Ask the Wonderful Wizard of Oz

June 15th 2015

Lucy Sheldon 

Head of Human Factors

The Wonderful Wizard of Oz, written in 1900 and adapted into the well-known film, is a fantasy story that culminates with the revelation that the almighty wizard is in fact just an old man, who has been creating an illusion that he is a great and powerful force. All of the other characters in the story believe he is a wizard, and so their reactions to him – up until the point that the truth is revealed – are genuine and valid, psychologically, anthropologically, and sociologically.

It’s not just wizards that can make illusions, and produce genuine responses in people. ‘Wizard of Oz’ testing is a design methodology wherein an experimenter simulates the behaviour of a new product, device, service or business proposition. Particularly effective for this are what’s known as ‘acts like’ prototypes – which are created to act or behave as though they are the real product without having to look like or function like the real thing. These ‘Wizard of Oz’ prototypes allow innovative organisations to discover how users interact with a product, device or service that doesn’t yet exist. Sometimes this is done with the participant’s prior knowledge, as is common during the piloting of new websites or business ideas online, and sometimes it’s done with a degree of secrecy to manage participant expectations and encourage natural behaviours.

The aim of Wizard of Oz testing is to validate concepts so that organisations can prove their potential and learn enough to maximise potential at an early stage of development. Potential RealisedTM, Cambridge Design Partnership’s end to end innovation capability, aims to maximise the return on investment in product innovation. A key step in delivering this outcome is optimising the product or service concept through user and stakeholder research and concept validation.  Wizard of Oz testing is a key tool to achieve this.

Why validate concepts?

Get in early
Through the development process the cost to make changes increases exponentially, resulting in delays to your development should you discover anything you wish to change later down the line. And if you haven’t shared interaction realistic models with users and key stakeholders early, any problems associated with how users interact with a solution won’t be apparent until it is too costly to change them. Development resources are expensive to squander on ideas and interactions which are not right.

In addition to this, as the risks and costs of change increases, so does your team’s aversion to risk.  And so, the only opportunity to innovate through interaction effectively is during early stages in development.

Create facts and evidence
Designers are not users; neither are marketing departments, engineers or human factors specialists. In order to generate facts about what users really want and need, not what development teams think they might need, evidence from primary research with users should be prioritised over opinions from everyone else.

In a recent project Cambridge Design Partnership worked with a surgical device manufacturer to put non-functional handling models in front of surgeons early in the design process. Requirements based on the assumptions of the development team were eliminated and new, more important features were added, from identifying actual user interface requirements. This was done in parallel with technical R&D work prior to formal design control so didn’t add to the timeline of the project and created traceable evidence for user interface requirements and customer requirements, focusing the development resources.

Allow people to interact with, and contribute to, your vision
Users might not be designers, but by allowing them to interact and contribute to your ideas within the context of a well-designed research programme they can contribute to your vision. People can’t ask for what they don’t know is possible, their imaginations and desires are bound by their experience, so they accept inadequacies and deficiencies in their environment as normal, unless they know that an alternative could be available.

Create a shared vision
Clearer device visions save time and money through predictable and timely development programmes. Arm your teams with all they need to get the device designed and built in the right way first time by taking a lead from primary stakeholder and end users to create clearly defined requirements and a collective vision.

Release the true value in your usability team
The stick, rather than the carrot, has driven an increase in usability practice within medical device companies, under the watchful eye and even direction of the compliance team. For consumer product organisations usability testing often comes too late in the development process to explore game changing yet potentially risky interaction approaches – and it is often too late for even minor changes in direction should interaction issues be uncovered.

But there is opportunity to get more than regulatory compliance and minor tweaks from usability processes and methodologies and these opportunities can only be realised if usability and interaction design teams are involved in concept creation. The benefits include delightful user experiences that improve brand loyalty, user centred devices and services which improve outcomes and empower patients and carers, and a reduction in training and support costs.

Read more about our Potential Realised innovation process.