Lateral flow testing at CDP: A surprising result

May 27th 2021 5 min read

Mike Worth

When we modelled the use of lateral flow testing at CDP we discovered something surprising: there was a high chance we could test everyone every day without preventing a single transmission of COVID-19. This application of mathematical modelling and bioscience gave us powerful evidence on which to base our response, allowing us to direct our efforts where they will have maximum impact: improved ventilation and new air filtration installations in our offices, labs, and workshops.

In common with all businesses, CDP has been closely watching developments in practises, and technology to keep our people and community safe from COVID-19 infections, while maintaining business operations. In the UK, lateral flow tests (LFTs) have been rolled out in a variety of settings over the last few months. These tests have major benefits in that they are low cost, give a result in half an hour, and require no medical expertise to administer. When the use of these LFTs became a possibility here at CDP, our COVID-19 team began drawing up plans for the roll out.

The two key questions were “who to test” and “how often to test”

As a multidisciplinary business with diverse capabilities and specialisms, our people work in a variety of locations and patterns. Most of these working patterns and risk profiles don’t match those of the early adopters of these tests, such as those in clinical and educational settings. As a result, we built a team to analyze the available data and tailor our use of the tests for maximum impact in our particular case. The team was led by myself, a simulation scientist, and my colleague Richard Owen, our Senior Consultant Bioscientist. The team identified the latest bioscience data available on the parameters of COVID-19 and the LFTs, then developed a bespoke Monte Carlo model – used to predict the probability of different outcomes – to model potential infections across the business. We used the popular Anaconda python platform for scientific computing.

What are the key inputs?

COVID-19 infection timeline

A viral infection typically progresses through several stages: when a person first catches the infection, the virus multiplies until they become infectious and often continues to multiply causing symptoms before the immune system is able to fight back and eliminate the virus. LFTs can provide an “early warning” when virus levels start to increase, but before symptoms start.

‘Effective R’ within CDP

We’ve changed our working environment in a variety of ways to reduce transmission potential. If this was 100% effective then LFTs wouldn’t offer any benefit, but we all understand that the measures are instead designed to reduce the risk to the lowest reasonable level. While we have no evidence for transmission on-site, we’re aware of some cases, unfortunately, brought in from the outside community and so we applied a “reasonable worst case” estimate of transmission.

Background population case rate

Clearly more cases of COVID-19 circulating outside CDP would result in more infected people coming onto our site and identification of each one could potentially prevent further infection. We recognized that this value has changed rapidly so we investigated the benefit of LFTs in a variety of scenarios.

Sensitivity: if a person with COVID-19 takes an LFT, what is the chance that it will give an accurate, positive result?

This property of the LFTs on the market is very important. While they can be more than 90% sensitive for symptomatic people, those people should already have isolated and obtained a “gold-standard” PCR (lab) test. When used in asymptomatic populations with well-functioning immune systems, the sensitivity can be as low as 3%. Considering the population demographic in this study compared to our own, our model took a less pessimistic view of LFT performance and erred on the side of higher sensitivity.

Specificity: if a person without COVID-19 takes a lateral flow test, what is the chance that it will give an accurate, negative result?

The LFTs on the market are thought to have a specificity of around 99.5%. While 0.5% might sound low, current estimates are that only 0.1% of the population has COVID-19; therefore the 0.5% false positives actually make up significantly more people than the number that are really infected. This is the source of some controversy as it can cause unnecessary isolation when the case rate is low; however, this risk was not considered a significant problem for us at CDP as we took a “better safe than sorry” approach.

What did we learn from the model?

There are multiple measures for the success of a testing program. In our analysis we simply looked at the number of people becoming infected, and how much this could be reduced by a variety of regimes. We ran the model many times with differing input values to evaluate the impact of testing regimes and understand the sensitivity of our results to the various inputs, which are either uncertain estimates or subject to change over time. In a result that surprised us all, we discovered that in our specific situation the benefit of LFTs is actually very small. Of course, the keywords here are “our specific situation” – by tailoring our model to CDP we gained maximum value for our own decision. However, this model is inherently not a generalized result and is not a valid evidence base for decisions in other contexts. There was a high chance that we could test everyone, every day (totaling thousands of tests) without preventing a single transmission of COVID-19.

What was the outcome?

We both verified that each small “cog in the machine” was behaving as expected and validated that the results of the whole model matched reality (we already had a historic dataset for what COVID-19 transmission looked like without lateral flow testing). We also further explored uncertainty in the driving factors, to assure ourselves that the remaining uncertainly in the inputs would not substantially change the outputs. Following this process, the non-intuitive result allowed us to confidently redeploy our efforts onto alternative COVID-fighting initiatives. Following the evolving scientific knowledge, we’ve improved the ventilation of our offices, labs and workshops and installed air filtration to reduce the potential for airborne viruses to move between people.

We inevitably enter investigations with preconceptions, but by applying science to the big decisions we’re able to confidently manage our choices and prioritize our resources to keep ourselves and others safe in this weird world. By combining our expertise in both mathematical modelling and bioscience, we created a team that is more powerful than the sum of its parts, demonstrating the power of mathematical modelling in making decisions.

Women in innovation: Science and Engineering

May 6th 2021 8 min read

Women play a crucial role in innovation and business success at CDP. We’re proud of the critical contribution made by our women colleagues, who lead in diverse areas of innovation including design, research, science, technology, engineering, and human factors.

In this second instalment of our Women in Innovation series, three of our STEM professionals discuss women, leadership, and their role in science and engineering. Caroline Zakrzewski, Alejandra Sánchez and María FM Balson reflect on their work and their career journeys. They aim to share a positive message and empower the next generation of women and girls in STEM (Science, Technology, Engineering and Mathematics). We believe their experiences and journeys can help and inspire many others.

Caroline Zakrzewski

Drug Delivery Devices Scientist

How did you become a scientist?

I always knew that I would be a scientist. It wasn’t clear to me immediately what that looked like, but I also knew that I wanted to help people and improve the quality of their lives – to make a lasting difference. I spent some time in hospital as an adolescent and that experience inspired me to focus on healthcare. I embarked on a master’s degree in chemistry and the synthetic organic chemistry that provided a foundation to many traditional drugs. Having started out analyzing drugs that came out of devices, I then got distracted by the devices themselves – how they worked and how they were made. After a while I backed up what I was learning at work with a master’s degree in pharmaceutical engineering that looked at drug and device manufacture in an industrial setting. It’s one of the great things about science that the tools you are given to harness and focus your curiosity can be applied to so many different areas – you don’t need to decide your whole career at the outset. I’ve had many different jobs that I’ve loved, including this one, and that feeling when I see the devices that I’ve helped to design, test, industrialize, and manufacture on the market and in the hands of real patients never gets old.

How does being a scientist help you make sense of the world?

Science is around us every day, helping with our understanding of the world, from flat pack furniture construction to the perfect recipe for banana bread. In the last year, the healthcare sector has made the news more than ever before as we’ve seen population statistics, data modelling, diagnostic devices, and vaccine development becoming front page news. This has been fascinating for me and it’s helped me to be objective about the current situation, but in equal measure it’s frustrating as much of the media fails to understand the details of what they’re reporting.

Does the world need more women in science?

Yes. I’m a great believer in the power of diversity and representation to drive effective innovation. At CDP we use the experiences of our colleagues across different markets – healthcare, consumer, and industry, to generate solutions to the issues our clients bring to us. Women make up half of the population and it’s important that their voices are considered in product development and particularly in healthcare at all levels. With the benefit to the user foremost in our minds, diverse inputs provide a more widely applicable and robust solution. Without this, healthcare needs of major groups, such as women, are side-lined and left wanting. If you want to make a difference to people’s lives, to find solutions to problems that you see in the world and to be part of a great team doing the same, then science has a career for you.

Alejandra Sánchez

Associate Biomedical Engineer

How did you become a scientist?

I think science chose me. Somehow, I was driven by different events to the point where I find myself today. At least I didn’t have a “conscious plan” to be where I am, but I can definitely say I’ve had decisive role models along the way – family and teachers – that have inspired me, stimulating my curiosity and passion for biology and innovation. Science gives me a deeper understanding of everyday life. It also represents the key element that steers my knowledge into engineered solutions that can ultimately be part of a marketed product in somebody’s hands. I think the best feeling is knowing that my work makes a difference. I also believe science breaks borders and boundaries, you can work in any country you want, the language of science gives you the ability to further understand people from different cultures and backgrounds. This opens so many doors!

Is work/life balance important for gender equality?

Work/life balance is still one of the many unanswered questions regarding gender equality. In my experience – including roles in Argentina and the UK – I’ve always been part of a warm and supportive workforce and life balance hasn’t been a personal issue. However, I’m aware that many leadership positions are not seen as attractive to women, for a number of reasons. For some, the nature of those roles is simply incompatible with non-professional responsibilities, such as caring for children or elderly relatives, which historically have been seen as female responsibilities. Nowadays, these personal responsibilities are better shared among men and women; however, I do think this should be properly addressed if we’re serious about achieving gender equality.

How can we foster the next generation of women leaders in science?

Education is the key. Diversity of thought provides space for creativity and innovation; this is what we need at all levels, from board and senior level executives on down, to better understand a problem and tackle it for optimal results. I’d love to see a greater promotion of inspirational women in STEM to much wider audiences. Everyone in a STEM class at school should be taught of the outstanding women that made a difference in these fields, thus encouraging young girls into following this incredible path. We should also get more companies into schools to show how creative and exciting the industry is and capture young minds.

How can women and girls start a career in science/STEM? Why is this important for the world?

STEM careers are often referred to as the jobs of the future, responsible for driving innovation, inclusive growth, and sustainable development. However, gender disparity in this space remains alarming. Until recently, different myths have been spread by word of mouth and even in academia, arguing first that women were biologically less capable and now that they’re simply less interested in STEM. I’m happy to say that both have been proven wrong, by scholars at Harvard University (for more information access the study and the science article from Slate), and that there is nothing about STEM that precludes female participation. Understanding how crucial it is to take part in STEM fields now, will allow us to take action and play a part in building our tomorrow.

María FM Balson

Consultant Biomedical Engineer

How did you become an engineer?

I’m extremely lucky: I’ve had a broad education, parents who fed and encouraged my curiosity, and excellent teachers. I have always loved languages, philosophy, and the sciences. If I could, I would study everything. I cannot, so I chose engineering.

I really like that von Kármán quote: “Scientists study the world as it is, engineers create the world that never has been”. I love that idea and, honestly, I think I won the lottery. In my job, I get to be a scientist whenever I encounter a new problem – I have to learn as much as I can about it, as quickly as possible – and then I put on my (metaphorical) engineering hat and work with extremely talented people to solve that problem.

I’m particularly interested in applying engineering principles to the solution of problems in biology and medicine, whether that is designing medical devices, modelling healthcare interventions, or improving access to contraception. Also, I have a terrible soft spot for Excel and Python, so if those are involved, even better.

What do you think of the assumptions and stereotypes connected to women in engineering?

Professor Tim Minshall sums it up really well in this TED talk: too often, when people think of engineering, they think “men, hammers, spanners, boots”. This, while sometimes true, is a very narrow and outdated view of engineering, which is a rich and evolving field as broad and diverse as any academic discipline. At its heart, engineering is the application of scientific principles to the solution of problems in any and all areas of life, from feeding the world’s growing population to reversing climate change.

Now, more than ever, we need STEM professionals. We need a larger and more diverse talent pool. We need to attract more women and minorities, then train them and retain them. This is a complex endeavour, and requires work on many fronts. One of these is outreach: engaging with the wider community to change their perception of science and engineering, from “hard, boring, and not for me” to “exciting, accessible, and world-changing”. I’m heartened to see all the great outreach that happens in Cambridge, coming from both the University and the local technology firms. I urge all STEM professionals to get involved in these types of activities and to continue expanding their reach into underserved areas. It’s not always easy and can be disheartening at times, but it really is worth it.

What can we do to empower women in STEM?

What a great question, and how difficult to answer! The first thing, as ever, is recognizing that there is an issue and that it needs to be fixed: we need more STEM talent urgently, we need a more diverse workforce, and there are barriers preventing women and other underrepresented groups from joining and advancing in the profession.

Many people (often men, but not always) are unaware of the extent of the issue and cost of ignoring it – they do not realize that inequality is holding us all back. It leads to missed opportunities and carries a very real social and economic cost. Therefore, the first step is education: educating ourselves and others on the value of diversity and the importance of working towards an equitable workplace and society.

Next comes the difficult task of untangling the problem: gender inequality is a very complex issue, deeply tied into cultural expectations, societal norms and economic incentives. And it’s a vicious circle: inequality breeds inequality. For example, women earn less than men on average, so they are more likely to take extended leave for childcare than male partners (to minimize lost earnings) and so they miss out on experience, raises, and promotion, which then widens the income gap even further.

Thankfully, a lot of great research has been done into the roots and ramifications of the problem, as well as concrete steps we can all take to address it. I hope to explore some of these in a future blog, but for now, I’ll leave you with a book recommendation: Women Don’t Ask, by Linda Babcock and Sara Laschever.

If you missed the first blog in our Women in Innovation series, you can find that here.

Incisive action: Cutting the carbon footprint in surgery

April 22nd 2021 6 min read

Kiron Athwal

Insight and Strategy Consultant

Hear us out: the pandemic has stretched world health services to their limits, but it may also be paving the way toward a greener future for healthcare.

When thinking of healthcare today, you probably picture the huge pressures on overworked healthcare staff and the scramble for hospital beds. What you may not have thought about is that hospitals in many countries have adopted innovation that inadvertently introduced ‘greener’ treatment. For example, the need to perform ‘virtual’ consultations has reduced patient travel to and from practices. In April 2020; within weeks of COVID-19 hitting the UK, 71% of all GP visits were remote, compared to 25% in April 2019.

“A single operation can have the same carbon footprint as driving 2,273 miles in an average sized gas-powered car.“

Before COVID-19, the UK’s National Health Service (NHS) produced 27 million tons of CO2 equivalent annually, which accounted for 5% of all UK carbon emissions. To combat this, in October 2020 the UK government announced plans for a greener NHS: net zero carbon emissions directly from the NHS by 2040, and its supply chain by 2045.

In the context of COVID-19, this is an ambitious goal even if we were able to sustain the kind of CO2 emission drops witnessed during lockdowns. The forced shutdown of elective surgery may have reduced hospital carbon footprints, but this has been at the expense of patient care and can’t continue. Further ahead, the NHS will be caring for an increasingly ageing population, putting demands on provisions which will lead to increasing energy and resource consumption.

The operating theater has extensive electricity needs, powering equipment, heating, ventilation, and air conditioning, and is three to six times more energy-intensive than the rest of the hospital. This electricity reliance coupled with anesthetic gas and the need for single-use equipment has a significant carbon footprint. Chantelle Rizan, a Fellow of the Centre for Sustainable Healthcare and currently undertaking a PhD to identify carbon hotspots in surgery, found that a single operation can have the same carbon footprint as driving 2,273 miles in an average sized gas-powered car.

So, aside from upgrading hospital buildings and moving to renewable energy supplies, the UK government must explore ways to make surgical practice more sustainable in order to hit the NHS net zero targets. This won’t be easy.

Virtual clinics have helped with triage (deciding severity and service allocation) and surgical follow-ups, but it’s difficult to plan surgery without examining the patients face-to-face. Any changes must avoid extra red tape and be economically viable for healthcare services. Advances may have trade-offs between short-term losses (retraining) and long-term gains (reducing hospital stays or complications). Most importantly of all, sterility must be maintained at all costs. Here’s a new mantra to repeat: green only if clean.

We’ve recently been exploring the challenges facing surgical providers in embracing sustainable change. In our ‘Circularity in Context’ article we considered circularity filters to ensure future products and services become carbon neutral. This philosophy of circularity, maintaining the value invested in materials and products, has applications in healthcare but may also come into conflict with other imperatives, such as sterility.

Before joining CDP I spent time working closely with orthopedic surgeons, observing procedures in the operating theater first hand, showing me where improvements could be found. Innovating in the surgical space is a complex and nuanced area, where first-hand knowledge of the sector is key. Surrounded by a team of engineers, designers, researchers, and healthcare-savvy innovators at CDP, we’ve applied the filters for circularity to identify areas in which circular approaches could provide significant advantages.

Short-term wins

There are many ways to reduce the cradle-to-grave carbon impact of surgical equipment, while engaging clinicians and being financially attractive to health service procurement. Layer upon layer of plastics and non-renewables are used in sterile packaging for implantable devices. If we can’t fully move away from these packaging conventions because of safety and transportation requirements, can we source materials from low-emission supply chains and use local production and assembly for more efficient, less carbon intensive shipping and distribution?

Delivering care with convenience and guaranteed sterility has tended to result in single-use equipment, but we are seeing signs of returning to reusable equipment which is reprocessed between uses. Reprocessing patient drapes, laparotomy pads and intravascular catheters are being used to reduce waste so long as sterility and accuracy can be maintained and improved cleaning cycles reduce energy and water usage. Reprocessing of instruments has been driven more by cost concerns rather than sustainability, but this hints at the potential economic benefits of reprocessing beyond complex instruments. This could be further bolstered if the hospital can receive reimbursement for reprocessing an instrument instead of purchasing a new one.

There will always be cases where single-use equipment is a necessity for sterility or convenience, or where a Life Cycle Analysis shows this to be the most environmentally friendly approach. We can still streamline these sets so that rarely used kit is not disposed of even when it hasn’t been used, as is often the case once a set is opened in theater.

Long-term innovation

Given the need to develop better treatments and the burden of evidence needed to establish safety and efficacy for devices and systems, the healthcare industry can perhaps be forgiven for not having led in the sustainability space. Healthcare requirements are a barrier, as materials must be well understood and de-risked for a specific healthcare scenario before they can be used, but this should not stunt long-term innovation.

One way that future technology could reduce surgical waste is by harnessing fluid-resistant materials, improving the efficacy and safety of personal protective equipment. Going further, incineration techniques could be completely transformed by advances in energy recovery processes: being able to create large amounts of heat or electricity to feed back to the hospitals efficiently and at a larger scale than currently performed.

An emerging technology that promises radical change in surgical training is extended reality – simulating virtual environments or even overlaying them with real environments to enhance the experience. Extended reality expands access to expert training while streamlining the associated hospital footfall and travel. Virtual reality headsets are allowing trainees to view, practice, and learn surgical procedures, reducing the hours needed to be spent in surgical theaters.

The advent of very low latency wireless technologies, including 5G, could allow us to push virtual care even further. Even when surgeons are in a different country and time zone to the patient altogether, mixed reality could allow expert surgeons to offer real-time assistance and robotically assisted surgery systems could enable entirely remote surgery. This reduces travel but more excitingly it widens the opportunity for patients to receive specialist care wherever they live.

Societal filters: rapid recovery and reduced complications

There’s a risk we limit our understanding of surgical carbon footprint to manufacturing, electricity usage, and disposal. But we must consider the trickier question: how can we reduce the burden of the patient on the healthcare system through improved outcomes and reduced complications? One study found that anti-reflux surgery on the NHS could, despite having a high initial financial and carbon cost, be more carbon-efficient than ongoing medical treatment by the 9th post-operative year (and cost-efficient by the 14th year).

One tool in the arsenal is less invasive procedures. These require more specialized training and increase procedure complexity, particularly during early adoption, but they can drastically reduce patient recovery times and pressure on hospital beds. Less invasive procedures can also reduce the number of rehabilitation trips required for physiotherapy and occupational therapy.

Innovations that reduce follow-ups should be pursued and anything that reduces post-surgical complications or provides more durable treatment is likely to drive better overall sustainability. For example, improving surgical wound closure systems could help reduce infection rates, one of the leading causes of hospital readmission following surgery (3% of patients die as a consequence). The medical device industry can also deploy digital health tools to improve medication compliance, to introduce disease prevention strategies and to stimulate rehabilitation, all of which will lead to better outcomes from surgery and minimize unnecessary procedures, in turn reducing the carbon footprint.

At the heart of innovation is the need to understand the user. Following my experiences with surgical professionals in the operating theater, it’s great to be part of an innovation team at CDP that actively pursues “green” solutions while being respectful of the vital work that surgeons do.

ISO 11608: All change for injector standards

April 1st 2021 6 min read

Steve Augustyn

Senior Consultant Mechanical Engineer

Anyone who works with injection devices will be familiar with the ISO 11608 series of standards. The standards cover requirements, test methods, and design guidance for needle-based injection systems, and they are currently nearing the end of the most comprehensive review and update since 2012.

This review of ISO 11608 aims to better align the various parts of the standard and define a new class of device coming to the market, on-body delivery systems (OBDS), which the current revision of the standards doesn’t adequately describe. CDP develops and verifies many needle-based injection systems on behalf of our clients. Our manufacturing capability also gives us insight into the challenge of moving from building a handful of devices to building thousands of products. The Final Draft International Standard will be published soon, and I’d like to share some of the proposed changes.

It’s important to note that the current status of these standard parts is “draft”. The details of these documents may well change before publication, assuming that the various international bodies approve the publication of these standards. That said, let’s get into some detail.

ISO 11608 – update history in brief

Since the publication of ISO 11608-1: Pen Injectors for Medical Use – Requirements and Test Methods in 2000, the standard has expanded to cover many aspects of needle-based injection systems (NIS). The various parts of the published standards now cover:

General Requirements (11608-1 since 2012)
Needles (11608-2)
Finished Containers (11608-3)
Electronic and Electromechanical Injectors (11608-4)
Automated Functions (11608-5)

These standards were then joined by 11608-7 (Accessibility for persons with visual impairment) in 2016, which covers design guidance for improving accessibility to NIS for visually impaired users. These parts of the standard come under the remit of ISO Technical Committee 84 (ISO TC84), a committee focused on defining the requirements and test methods to ensure safe and effective devices are made available to the widest number of people.

I’ve had the privilege of being one of the UK’s representatives to this committee since 2013, so I’ve had a front-row seat for many of these discussions. So, what changes should device manufacturers and designers anticipate?

ISO 11608-1 – Needle-based Injection Systems

In this revision of the 11608 family, TC84 has worked to align the various parts, ensuring every potential NIS is addressed in the collection of parts, that they integrate well, and topics aren’t duplicated. ISO 11608-1 is the ‘parent’ part – the fundamental section of the standard that establishes the requirements and test methods for all NIS devices covered by the whole standard.

The revision to part one includes the introduction of OBDS (more fully described in ISO 11608-6) and several new concepts. These concepts include primary function, the functions of the device that allow it to be used safely and effectively. Functional stability, which expands testing regimens to simulate whole-life testing for reusable devices, is also introduced in this revision. In addition, the design specification for the NIS must consider the impact and requirements of the medicinal product, and the guidance on risk-based design approaches has been expanded.

There are also several smaller modifications to ISO 11608, including moving all requirements for electronics and EMC testing to ISO 11608-4, the addition of a choking hazard warning for small components, and the associated test fixture. A section has also been added to the document giving guidance on design verification with reference to ISO 13485.

ISO 11608-2 – Double-ended Pen Needles

The changes to ISO 11608-2 (Double-Ended Pen Needles) are more subtle. The determination of flow rate has been expanded to include suggested flow ranges and the sample sizes have been brought in line with the requirements in ISO 11608-1. The testing requirements to confirm compatibility between a needle and a specific NIS have been revised to include dose delivery and needle hub removal force. In addition, the samples required for functional compatibility have been reduced and guidance has been added regarding the requirements for the inner needle shield.

ISO 11608-3 – Containers and Integrated Fluid Paths

The scope of ISO11608-3 has now been expanded beyond defining cartridge geometry and performance to cover NIS Containers and Integrated Fluid Paths. Again, this change has been prompted by the development of OBDS. The requirement for resealing the cartridge has been reduced from 1.5x the intended use to a minimum of 1.0x the intended life. At the same time, the particle size for coring characterization has increased from 50um to 150um or larger. General requirements for soft cannulas and fluid line connections have also been added – another feature of the standard that can be traced back to introducing the OBDS class of device. Cartridge geometry definition has also been moved to an informative annex, meaning it’s no longer mandatory.

ISO 11608-4 – Needle-based Injection Systems Containing Electronics

I’ve had no direct visibility of the updates to ISO 11608-4. However, colleagues from the dedicated work group have summarized the two high-level changes as:

an expansion of the scope to include all electronics on a NIS (not just those concerned with the delivery of the drug product)
medicinal product delivery while connected to mains power (for recharging the battery) will be permitted

The challenge for part 4 has been to reference the parts of IEC 60601 which are appropriate for NIS. Part 4 references IEC 60601 explicitly, adopting the general requirements, means of patient protection, and power input requirements from the relevant components of the standard. The minimum ingress protection has been increased from IP22 to IP52, allowable temperatures for skin contact are defined, failure obvious to the user after free fall preconditioning is permitted, and the use of NIS in oxygen-rich environments has been defined.

ISO 11608-5 – Automated Functions

The revised text for ISO 11608-5 now explicitly directs the reader to ISO 11608-1 for general requirements and focuses on automated needle insertion and dose delivery. Requirements for fenestrated needles (needles with holes in the side) have been defined and the implications of non-perpendicular needle and cannula insertion are explored. The dose accuracy test has been modified for needles with automated insertion, and defining and measuring automated dose delivery time is now a requirement.

ISO 11608-6 – On-body Delivery Systems

This review includes the introduction of ISO 11608-6 defining the requirements for OBDS. This part of the standard initially expanded quickly as new terms and definitions were added but many of the new concepts have been adopted into the following component documents: 11608-1 (General Requirements), 11608-3 (Container and Integrated Fluid Paths), and 11608-5 (Automated Functions).

The crucial difference between an OBDS and an infusion pump is that the OBDS’s performance is defined by dose accuracy for a fixed volume; an infusion pump is defined by the rate at which the medicinal product is delivered. OBDS are also distinct from other NIS types in that they are attached to the body, whereas traditional NIS are held by the user for the duration of the delivery. The requirements and design guidance reflect this difference in use and the concept of a delivery profile (as a characterization tool, not a performance requirement) has been included to help device builders better understand their products.

This summary only scratches the surface of the comprehensive review of ISO 11608, and on the current timeline, these changes will not be published until late 2022, but if your development program extends beyond that date, I hope you found this summary helpful. The draft standards can be purchased from the ISO web store if you’d like to better understand the scope of the changes and the implications for your device development and verification program. If you’re a device developer and struggling with device performance, CDP has expert teams to help overcome these problems.

I’d like to thank my colleagues from ISO for their assistance in drafting this summary. In particular, Robert Nesbitt, Director of Portfolio Strategy at Abbvie and project leader for the ISO 11608-1 review, and Bibi Nellemose and Lars Brogaard from Danish Standards, whose tireless efforts as TC84’s secretariat keep the whole process running smoothly.

Connect with CDP

For more on how to navigate ISO 11608 changes and develop injection devices that meet evolving standards, contact Cambridge Design Partnership.

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Making it last: Why testing is vital to product sustainability

March 25th 2021 6 min read

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.

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.

What next for events in the world of COVID-19?

February 11th 2021 6 min read

Ana Romero

The impact of the pandemic has dramatically shaken up the world of conferences and events. Ana Romero, Digital Marketer and Events Coordinator at Cambridge Design Partnership, looks back over a tumultuous year and asks, “what next”?

Here we are, almost exactly a year ago. This is Pharmapack, in Paris. The two-day event was attended by 5,500 delegates and more than 400 exhibitors, and just look at the optimism on our faces! We don’t know it yet, but this is the last physical event we’ll attend before the pandemic descends, forcing us into our spare rooms and at the mercy of Teams, Zoom, and an emerging world of digital-only events.

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CDP team at Pharmapack in Paris, February 2020. Left to right; Jon Powell, Senior Consultant, Ana Romero, Digital Marketer and Events Coordinator, Martha Hodgson, Market and Design Insights Research Consultant, and Uri Baruch, Partner and Head of Drug Delivery

Welcome to chaos

A month later, in March 2020, the events world was in chaos and turmoil. I was busy contacting the organizers of each event we were planning to attend, checking their websites for updates, following the news and, arranging refunds for cancelled conferences.

Many conference organizers simply announced that they would be cancelling their 2020 offering and would be back in 2021. But others tried to offer a virtual experience. The idea of going online came as a relief to us here at CDP – as we were just as keen as before to share our expertise, to network with our peers, and meet tomorrow’s clients.

However, the transition to digital has been challenging, especially for event organizers dramatically adapting their business model and event delivery in a matter of weeks.

Forget the plan; it’s time to adapt.

So what have we learned? The most immediate learning for us at CDP has been that a good virtual conference is made by enabling the sort of interactions which make a physical conference so valuable. Can you get talking with someone who is visiting the event, develop them into a contact and then, hopefully, a client?

The first virtual conference we attended didn’t work at all. We couldn’t network with other companies, to reach the people we wanted or to strike up any sort of rapport with other attendees. A low bar had been set.

However, in only a few months, I’ve seen many improvements in the different platforms used and some real successes so far. Several virtual conferences we’ve attended during the pandemic have offered far better ways to connect and market to delegates. For example, some platforms allowed us to see and filter the delegate list (by name, role, and company name) and to request a one-to-one meeting with that person. In addition, the ability to watch presentations on demand made it easier to book a video conference during a session slot and later go and watch what we missed, something that wouldn’t have been possible in a real-life event.

Virtual conferences have crystallized how important it is to have your material in a digital and interactive format. We’ve learned to have just enough collateral in the digital booth to initiate a conversation. In a virtual exhibition, it’s easier to visit a virtual booth and fill your virtual goodie bag with all of the marketing collateral with just a click. This also has the risk of someone (including competitors) downloading your collateral and leaving the booth without saying a word. While this wouldn’t normally happen in a physical event it’s not hugely problematic: our materials can be seen by anyone.

One downside is that international events may not be particularly international: if an event is taking place on UK time and you want people from around the globe to virtually attend, you’ll find it’s tricky to enable conversations between members that are located in the US or Asia, due to the time differences. We’ve noticed this effect in the events we’ve taken part in.

We don’t expect face-to-face events to return properly in 2021. While many events companies are talking a confident game that plans for face-to-face before the year is out, most are adding other options to their virtual offerings. Think here of webinars, roundtables, and other additions that tend to suggest the new world is becoming “baked in”.

The post-COVID future

With all this virtual activity and conferencing ability we might ask, will the world ever go back to face-to-face conferences?

My feeling is that the leap to digital is a permanent one, but that physical conferences are far from finished. There are some significant downsides to virtual interaction that cannot easily be overcome. The first is the nature of the experience itself. If you travel to a conference and attend for two or three days, you are committed. You have spent time and money to get there, and as a result, you give it all your attention and energy, which makes the whole process more immersive. By contrast, a digital conference that you attend from your office or your home will struggle to capture your focus in the same way. You are so much more likely to be reading emails, on the phone, or being interrupted by your kids.

The very fact that it is so effortless to attend a digital conference can make it a less valued experience. If you “bump into” a delegate virtually, by messaging them through the conference’s contact system, it is far easier for them to ignore you. However, if you meet them at a real-life event, your chances of striking up a fruitful conversation are far stronger. Perhaps this is a good thing, forcing us to be on top of our game, offering nothing but compelling content and conversations. Although the process of tracking down attendees at a virtual conference is now quite slick, there’s nothing quite like meeting someone face-to-face and all of the non-verbal communication that goes into those meetings. It’s much harder to entertain clients and to build up goodwill online.

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Ben Strutt, Partner and Head of Design and Front-end Innovation, speaking with Max Angelov from the CDP offices in Cambridge ahead of presenting at last year’s virtual Global Innovation Forum, November 2020.

A crucial part of why we here at CDP value the opportunities offered by real-life conferences is that they give us the chance to develop and share our thought leadership. The events themselves are part of our learning, and giving presentations or taking part in discussions help to raise our profile in our key markets. The fact that a virtual conference presentation will often remain online for several months extends our reach significantly. We can also access information which shows who has been watching and, where it’s relevant and data protection allows, we can reach out to them afterwards to continue the conversation. This is a definite advantage of virtual events.

But when it comes to displaying our physical work, we want to show off what we create and allow booth visitors to interact with a connected inhaler, an innovative food packaging concept or any other product development. It’s hard to replicate the tactile experience of a real-life display of products that can be picked up and examined and where a visitor can ask questions of the development team.

All of this suggests that we’re headed for a future of hybrid physical and digital events. There will be real-life events, but some digital tools, such as one-to-one video meetings, digital roundtables, and others currently being explored will stay. Physical and remote attendees will be offered far more connectivity and interaction with other attendees than ever before.

In the meantime, as we press through the pandemic and emerge on the other side, it’s crucial to be creative and make use of the technology that allows us to connect virtually. It’s fair to say that virtual events are not yet providing the full benefits of a real-life gathering. But we are where we are and it’s in all our interests to work with digital alternatives so that we can keep doing business, one way or another. Whether it’s physical or digital, I’ll see you there.

Blockchain in real-world applications. It’s not just about cryptocurrency.

December 18th 2020 5 min read

James Baker

Blockchain technology has been commonly used and popularised by Bitcoin. However, the original concept was simply to create a chain of data blocks that were robust of themselves, containing data within themselves to prove the integrity of the collected information. First seen in the 1990s, it is thought to be the earliest use of what became the blockchain concept to secure lists of information, using a combination of cryptographic algorithms and networks of data hashes. In this blog, James Baker from CDP explores other blockchain applications beyond Bitcoin.

How blockchain works

In a blockchain, each block contains an item of information – for example a certificate, an amount of money or a record of an event – and the identity of what or who this data relates to. The data in the block is encrypted. A hash is also calculated for each block, where a hash is a summary number of fixed length that can be reliably calculated from the block contents, but cannot be backwards calculated to determine those contents. The hash can be examined to determine if the contents have been changed, without knowing what the contents are. Each block also contains the hash from the previous block. This is what forms the blockchain, allowing it to be extended with new entries whilst maintaining its integrity. Each new block contains a hash of the previous iteration of the chain, providing a history of what came before. Often, it is called the ‘public ledger’ of records and provides a verifiable list of events within the chain of information. The sequence of hashes easily shows if any block within the chain is changed or tampered with.

In 2008, blockchain technology hit the limelight, driven by a virtual currency built as an application using the technology. It became known as Bitcoin, but there are now many different virtual currencies available. The architect behind this is known as Satoshi Nakamoto. It’s not clear if this is a real person, a pseudonym, or a collaborative group.

Blockchain is designed to be open, public and distributed, so is ideal to address the challenge of digital trust. The information and process is available and can be authenticated without reference to other sources. It is open to inspection by all, meaning that trust in blockchain is not trust in a single entity or organisation. This is the foundation that enables blockchain to add value in numerous applications, providing an economical and verifiable tool for identity, authentication, records, or duplication which would have been challenging to deploy with traditional approaches. The ultimate promise is to change how business is conducted, guaranteeing digital trust while cutting out many incumbents in the value chain.

At CDP, we see a wide variety of applications where we believe blockchain can help add value, for example:

Traceability throughout supply chains

This challenge exists in numerous markets. In food supply, connecting and verifying foodstuffs as they move between producers, suppliers, manufacturers, retailers, and consumers is the gold standard for traceability. We want to know where all the ingredients in our dinner come from, how they got here, and how old they are. The same challenge exists in all supply chains. Where did these components come from, and are they legitimate? Blockchain is providing traceability and transparency for everything from automotive spares to computer parts, from pharmaceuticals to diamonds. It’s a digital certificate for each item, with an unalterable record of events associated with each item.

Healthcare

Blockchain can support a wide range of healthcare applications, including management of clinical trial data, storage of insurance information and the handling of sensor data in remote monitoring applications. One particularly promising application is in medical records, where blockchain has the potential to allow patients to truly own and control access to their medical records, enabling instant updates and improving access to services as and when required. Modern delivery systems are increasingly becoming connected, so one day they could also update your medical record directly and in real time. When patients truly own and have immediate access to a detailed record of their health and related actions, they can take better control of their conditions and treatments. Blockchain is a building block for digital healthcare and can contribute to the goal of proactive wellness rather than reactive healthcare.

Contracts

Blockchain provides a great tool for authenticating contracts. Can we use it to get rid of lawyers? Maybe not. Once again, it is a digital certificate and a record of interactions between individuals or entities. So called Smart Contracts can be used to ensure that an agreement between parties will deliver what is agreed if the terms are met, as the contractual terms are written, or scripted, in software, which simply executes. We expect blockchain to be used in everything from employment contracts to rental agreements and beyond. One application we haven’t seen yet, for another type of contract, is blockchain marriage certificates. A scary thought: Digital weddings. Drunken Vegas weddings worldwide by app…

Trading

Blockchain can open up numerous trading markets, providing the means to eliminate some of the services traditionally offered by banking institutions. For example, blockchain can streamline ‘Know Your Customer’ verification and speed up trade settlements. But it’s not just about money – Blockchain can underpin the trading of any commodity. A poster child for this is renewable energy trading, seeking to take control away from the energy companies and allow direct trading between micro-producers, such as homeowners. We’ve described blockchain as a ‘public ledger’, and trading, which depends on robust recording of transaction agreements, is an ideal blockchain application.

Circular economy

There is considerable focus on the concepts of recycling, re-use, and the circular economy, as the world struggles to balance consumption with sustainability, and the need to reduce carbon emissions. Blockchain can provide a means to identify and authenticate products and parts through a digital identity and record of actions, and therefore can be a fundamental building block for circularity of use, both for direct re-use of products and for recycling of parts rather than just materials. Think here of reusable phone chargers and packaging. By proving a product’s origins in a transparent ledger we can begin to build the consumer trust that will be vital to behaviour change. With trust and provenance established, circular purchases and behaviours can be rewarded. Going further, blockchain can be used to ‘tokenise’ natural resources, such as trees, fish stocks or oil reserves, giving them a digital identity that can be properly valued and traded.

The time is now

It’s clear then that blockchain is moving out from under Bitcoin, becoming another tool in the innovation arsenal. If there is an aspect of your business that could benefit from traceability, authentication, logging of events, or public verification of information, then blockchain could be one of the technologies we deploy to ensure efficient operations in tomorrow’s global marketplace.

CDP on inhalation trends and what we learned at DDL2020

December 17th 2020 2 min read

We’re living in an ever more virtual world. The rate of adoption and adaptation of technologies enabling remote connections and interactions has surpassed even the most optimistic predictions. An example of this is the annual Drug Delivery to the Lungs (DDL) conference, hosted by The Aerosol Society, that a group of CDP colleagues attended last week. Usually held in Edinburgh, this year it was a virtual event. With the content available as a live stream and on demand and virtual booths providing instant access to downloadable material, this approach facilitated a wider reach and more flexibility for attendees seeking to learn about advances in the industry.

The first day highlighted the move to more sustainable lifecycles of products and how this must be balanced with effective drug delivery. With 630 million pressurised metered-dose inhalers (pMDIs) being produced each year and low rates of recycling, even small changes could have a big impact; whether by moving towards biobased polyolefin materials, inclusion of foaming agents to reduce the mass of plastic, or changes to another dosage form. This mirrors the trends that CDP has seen from our clients and the complex nature of plastic sustainability, discussed here by our colleague Dan. It was great to see the different approaches and how we are tackling this as an industry, making many small improvements that can add up to a significant change.

The second day went deep into specific formulations for targeted therapies. It’s always great to hear so many passionate scientists talk about their work and the benefit that it can have for patients. The biggest insight for us is how a deep and seemingly narrow investigation into a specific area can provide inspiration for unrelated therapies; the pharmacodynamic challenges of formulating an inhaled form of a parenterally administered product, engineering of particle sizes through spray drying, and the visualisation of drug particle distribution. Working across different sectors, this is the approach taken by CDP’s science team in projects such as determining the factors influencing vapour droplet size and technology scouting for novel delivery therapies. We were particularly excited to hear how advances in X-ray microscopy (XRM) are enabling the visualisation of active pharmaceutical ingredient distribution in pharmaceutical blends, giving real-life validation to predictive models of distribution and behaviour.

During the final day, the focus shifted to advances in delivery devices and challenges to the limits of their operation. Despite being widely used for over 60 years, studies show that over 70% of MDI users do not use the device as intended – so clearly there’s room for improvement. Whether the resolution is an adaption of the current MDI devices or switching to dry powder inhalers (DPIs) remains to be seen. With a step change in technology adoption this year, there is certainly a place for digital and connected solutions but as the final discussion group highlighted, in order to provide value from the digital advances the underlying technology needs to be robust.

CDP’s multidisciplinary, cross functional teams are here to help with your project needs. For more information, contact drug.delivery@cambridge-design.com

Women in innovation: Design & Research

December 16th 2020 9 min read

In this first interview of Women in Innovation series, we talked to four of our leaders working in the design and research field. Thanks to Nicki, Martha, Millie and Clodagh for sharing their stories.

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Nicki Sutton | Senior Innovation Consultant

My primary role is generating insights for innovation and design through immersive and exploratory research. That insight or opportunity specification forms the basis for early-stage concept generation and it’s always important for the researchers to be in the room when that happens. It means they represent the users, customers or wider stakeholders and ensure that their needs are being translated correctly into design and design attributes.

Does being a female researcher give you different perspectives from a male researcher in the same position?

Honestly, and speaking just personally, I don’t think so. I believe any good researcher should be able to cross divides such as gender, age, culture, etc., to empathize with the challenges that individual groups can face. Of course, some subject matters are quite gender based, where one gender may have a very different experience from the other, or not have the experience all! For example, at CDP, we’ve worked on condoms, sex toys, body hair removal and femcare, however we’ve always had mixed gender teams on those projects. Perhaps the women were a little further up the experience curve on some of the insight, but I don’t think the guys were held back!

Have any female mentors supported you through your career?

Not really. My university courses and the companies I’ve worked for during most of my career have been mainly male dominated environments. Since joining CDP I’ve been among the most senior women employee-owners and so there has not really been much scope for female mentorship. However, I do get inspired by the work of other women in the company – in the ‘front end innovation’ team and the wider organization. I see some of the younger women – researchers, strategists, designers, engineers – and I’m in awe of their sheer talent and confidence! I definitely think that our education system, at both school/college and university level, better prepares you for life in the commercial world compared to when I was passing through it!

Do you have any design heroes that you look up to?

As someone who sits at the insight end of design, I couldn’t possibly answer this question without mentioning Clay Christensen; the founding father of disruptive innovation and Jobs to be Done (JTBD). Indirectly, he has been as influential on my career as anyone. JTBD has been at the center of my work for the last 13 years. It’s now a mainstream innovation perspective, but it was still in its relative infancy when I was introduced to it. Focusing on the jobs that people want to get done in their lives as the input to design and innovation seems very obvious now, but when jobs thinking arrived, we lived in a very product-centric research world. Companies believed that users and consumers were too difficult to understand – saying one thing and doing another – so they just didn’t bother with research or research was ‘market research’ into products already launched. Today we live in a different world of design and innovation. One in which jobs, not products, are the driving force of progress.

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Martha Hodgson | Market & Design Insights Research Consultant

My passion is design research: gaining an in-depth understanding of the stakeholder, whether that’s the end user, the commercial sponsor or the key decision maker who sits within a supply chain. Uncovering and understanding unmet needs are at the heart of creating meaningful and effective innovation.

Does being a female designer give you different perspectives from a male designer in the same position?

Being a female can help in understanding some specific contexts -for example, femcare– but I believe what makes a good design researcher is your ability to semi-detach yourself personally and empathize with the context and end-user audience that you are designing for.

Do you think being female has any relevance to how you approach your work?

I think I approach design differently to any other women or men because of the unique journey I have taken to get to where I am today. My approach at work is shaped by my empathy and my understanding of others. I also believe that starting my career as a designer has shaped the innovator I am today and enables me to help improve lives through innovation. It provided me with a way of looking at the world, asking the right questions, interpreting what I see and hear, and making new connections that have led to uncovering new opportunities. It is the combination of characteristics, values, skills and capabilities that is each of our differentiators.

Have any female mentors supported you through your career?

Yes, I’ve had incredible women mentors, and at the same time, I’ve also had excellent men mentors. I consider myself very lucky to have different role models throughout my life and career, and there have always been strong female leaders in the places where I have worked.

Do you have any design heroes that you look up to?

No ‘heroes’ as such! I admire many examples of achievement in many forms where someone has been driven by passion, gumption, determination and a lot of hard work! I follow a group called The Female Lead on LinkedIn, which I find very inspirational – it showcases and celebrates female success, and the many forms it can take.

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Millie Ashton | Industrial Designer

Ever since I was a small child I’ve had a passion for design – I’ve spent many hours designing Lego houses, ceramic animals and 3D printed plant pots to name a few examples. Being able to turn a nebulous idea into a tangible 3D object never fails to excite me, and the fact that I’ve been able to pursue a career in it makes me feel extremely lucky. I’m grateful that my role provides me with the opportunity to help people and bring joy to them through my designs. There’s great satisfaction in creating solutions that have the potential to improve people’s everyday lives.

Does being a female designer give you different perspectives from a male designer in the same position?

I’d like to think that there aren’t many disparities between men and women in our perspectives or design approach. However, it’s difficult to deny that being a woman means you naturally have a perspective that just over half the world’s population doesn’t have – this is invaluable and allows me to use that empathy to tackle problem solving. We take pride in creating design that is centered around user insight, which is key to producing a successful solution for all gender identities. As a woman, I can come up with ideas and new ways of thinking that my male counterparts may not have, and challenge society’s norm of designing for the average adult male.

Do you think being female has any relevance to how you approach your work?

Yes, at CDP I always try to bring a fresh mindset and perspective to problems. As one of the youngest designers in the design team, I enjoy challenging and questioning design norms, as well as keeping a finger on the latest product trends. As the only female member of the Industrial Design team, I try to bring female insight into the products we design and ensure we’ve considered how other genders might use the product differently. I also feel it’s essential to design for future generations, considering how a product’s life cycle will impact the planet in years to come.

Have any female mentors supported you through your career?

Throughout my education and career, many of my peers and lecturers have been male. I didn’t have a female mentor at university, but I wish there had been more female role models to look up to. It has been refreshing at CDP to witness more women joining the company and being promoted into senior positions and hopefully female mentorship in design is something that will continue to be improved upon in time, as more women take up roles in the design industry.

What would you want to say to the design industry or anyone thinking of working in design?

My biggest tip would be this: don’t be afraid of failure or rejection. What you may think is a stupid or crazy idea might turn out to be ingenious. If you love designing things, don’t let self-doubt get in your way – passion often leads to success, and saying yes to new opportunities is vital when starting out. Never stop learning or assume you know everything, and ensure you get as much design related work experience or internships as you can, to figure out your niche.

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Clodagh Hogan | Human Factors and Usability Engineer

My background is in pharmaceutical chemistry, but I moved into the medical device design world so that I could bring my hands-on design skills and scientific background to people-centered design. I’ve always loved being able to turn an idea into a physical object and working in design allows you to be creative every day.

Does being a female designer give you different perspectives from a male designer in the same position?

No. How I approach a design challenge is based on my mindset, creativity, experience and style of problem solving. I work with multiple designers and we all have different perspectives and different skillsets, but this is down to the fact we are different people, not that we are different genders. If men were asked to list the benefits of being a man in design, it wouldn’t be something that I’d want to read and I’d take it as a negative dig towards women. I believe in equality, which means we must recognize that different people have different skills and that gender doesn’t really play a role in it at all.

Based on your experience, what are the top challenges you have faced as a woman working in innovation?

The biggest challenge I face as a woman in innovation is this assumption that I face challenges because I am a woman. I am lucky to be at an early stage in my career while things are actively changing, and it will only get better as time goes on, but change cannot happen overnight. In the near future, I hope that questions like this are no longer asked because we will be living in a world where people no longer assume that women face challenges just because they are women.

Do you have any design heroes that you look up to?

I don’t have any one specific design hero, but there are many graphic designers, illustrators, typographers, UX designers and product designers that I spend a lot of my spare time following and getting both motivation and inspiration from.

What would you say to the design industry and future woman and men that would like to work in design?

I would say that if you are interested in design, then pursue it and don’t let whether you are male or female get in your way. If you are a woman starting out, you will see that there is an imbalance. More women are taking up careers and education in design and STEM now, but it will take time for there to be balance. Know that you are starting your career during an exciting shift and that you are part of this important movement.

We hope to use these ideas and perspectives to inspire other women and girls to pursue a career in design and innovation. Our women designers add enormous value to our projects and team, and we believe it’s essential to celebrate this diversity. In our next blog we’ll share more stories of Women in Innovation, here at CDP.

Six strategies that accelerated innovation in 2020

December 3rd 2020 4 min read

In so many ways, 2020 has not been the easiest of years in which to do business. But nonetheless, design technology company Cambridge Design Partnership is taking on more staff, opening new offices and gaining blue chip clients. Here, founding partner Mike Cane reveals six strategies the firm is employing to accelerate their innovation programs in this most challenging of times.

1. Finding ways to work faster

Although the COVID-19 pandemic has thrown up many unforeseen challenges, it has also provided a pressing need to hone our innovation approach this year, writes Cambridge Design Partnership founding partner Mike Cane. Our specialist knowledge of medical tech and diagnostics has seen us taking on large-scale, fast track projects to help tackle the pandemic, both in diagnostics and treatment for the disease. We are also delighted to have undertaken a significant amount of pro-bono work during the crisis, working on everything from PPE to ventilators, to help support the NHS and defeat the virus. All of these projects had urgent timescales not normally associated with complex healthcare programs, which has meant we have had to organise ourselves differently.

This huge demand to accelerate development timescales, without compromising performance and safety, has led us to refine our procedures and approaches to allow us to deliver these projects on time.

2. Market knowledge

We plan to celebrate CDP’s 25th anniversary in 2021 by hiring our 250th employee owner. This consistent organic growth has been the result of our focus on three key industry markets where innovation is particularly important to our clients’ success. This has driven us to develop in-depth knowledge and expertise in our customers’ industries, which creates a more fertile environment in which to develop the very best possible products for them.

3. A holistic approach

Here at CDP we purposely take a holistic approach to our work, with the aim of providing an end-to-end service from a clean sheet to product launch and post-market support. While our clients often come to us when they are already at some point along the new product development journey, this perspective allows us to be aware of how the task at hand contributes to the overall success of their venture. This allows us to plan projects more effectively and to add value beyond our immediate role.

Some clients do come to us for the very first strategic discussions and market research. We can then take their ideas through design and testing right up to launch and manufacture. This seamless approach enables them to avoid the pitfalls that result from changing teams at key stages in the development process.

4. Building expertise

Over the years, we have built up a wide range of technical expertise and as a result we increasingly have teams with in-depth technical specialists, such as medical robotics engineers. As the scale of our business grows, we can offer our colleagues exciting opportunities to work at the cutting edge of technology with some of the world’s largest companies. At the core of what we do is science and engineering, so we are always keen to hear from mechanical engineers, electronic engineers and software engineers, particularly those with experience of working in the regulated medical sector. We also have opportunities for people with manufacturing expertise, as we now offer our clients short-run manufacture in our own labs, as well as the know-how to take new products right up to the point of market launch and transfer to high-volume manufacture.

5. Combining local with remote

Today, our largest geographic market is the US, with assignments carried out by both our team in Raleigh, North Carolina and also at our HQ in Cambridge. Making sure we have team members close by our clients helps make sure we work closely in partnership. Also, given the shortage of engineering talent in the UK, especially in software engineering, it’s useful to be able to recruit from two pools of talent. All this means that our American operation is more important to us than ever and, as a result, we’ve recently invested in a new and larger R&D facility in Raleigh.

6. Facilities, people and performance

As well as our new office in the US, we are also investing in a state-of-the-art new facility in the UK that will be ready next year. This will significantly expand and upgrade our laboratories and workshops, as well as providing specialist facilities such as state of the art market research infrastructure, multi-technology 3D printing, optics, power electronics and manufacturing process development labs.

Among the many reasons for CDP’s consistent innovation performance is, I believe, our strong Employee Ownership culture and our innovation focused management team. We are now coming up to three years into full employee ownership, meaning that every staff member, or Employee Owners as we call them, has a real voice and stake in CDP’s approach and success. Our senior management team is 12 partners, each working in a different sector of the business, all focused on optimising our innovation projects. Even as we have grown, we have maintained our belief in a flat hierarchy, with Employee Owners fully empowered to create great new products

In conclusion…

Here at CDP, by far the most important thing we do is to put the success of our clients’ innovation projects at the centre of our business development planning. This means as well as developing new products, we are also developing our organisation, facilities and processes to provide the best possible support to our customers throughout the whole innovation process, helping them to launch the most competitive new products. As 2020 draws to a close, we’re optimistically looking to the future.