October 15th 2019

A good night’s sleep is increasingly considered to be just as important for our health and well-being as eating healthy food and exercising regularly. Unfortunately, today’s 24/7 high-stimulus, digital world is renowned for disrupting our natural sleep patterns. The average 21st century human is now sleeping significantly less than in the past. In 2017, McKinsey reported that more than one in three Americans does not get enough sleep – roughly the same number who are obese.

What is more, our sleep quality – as well as quantity – has decreased as well.

This emerging need has created an ecosystem of manufacturers, retailers and health service providers as well as pharmaceutical companies that has formed around sleep health. The McKinsey study reported the US sleep-health industry is currently worth between $30 billion to $40 billion and has historically grown by more than 8 percent per year, with few signs of slowing down.

In addition to the traditional categories of clinics, pharmaceuticals and bedroom furniture and bedding, a new wave of sleep gadgets has emerged. Crowd funding sites are full of novel sleep devices from masks to robots. Many are connected, continuing the trend of measuring and connecting our lives. Some even aim to stimulate the brain to create therapeutic effects.

Certainly sleep is becoming better understood, but scientific knowledge is still at a relatively early stage and this equates to a general lack of understanding through the population, government and mainstream industry.

“It’s an exciting time for the emerging sleep-ware industry”, says Clare Beddoes of Cambridge Design Partnership: “Here at CDP, we believe that sleep-tech is an exciting area that is evolving rapidly, following closely on the heels of the developments in the fitness and wellness sphere, which has seen an explosion of innovation in recent years”.

“We’re already working with companies assisting them in defining opportunities to innovate and we expect many interesting and successful advances in the area of sleep technology in the near future.”

With this in mind, here are five basic questions we think you need to ask if you are planning to bring a new sleep-tech product to market. If you have the answers to these then, with any luck, you won’t be losing sleep over your product development!

1. Can you show that your customers actually need your proposed product?

It’s great to have an idea for a product that you think might be the answer to an insomniac’s prayers. But are you sure it’s what the market really wants, needs and will pay for? Our approach is to start with the user and to identify the unmet needs where solutions will be really valued. This makes sure you’re heading in the right direction before you spend a lot of time and money pursuing a new idea.

2. What is the existing competitive landscape for similar products?

We’re fascinated by the plethora of sleep devices on the market and although it is increasingly crowded, we believe that the market is in an early phase and there are most definitely spaces for products that address the needs of broad market groups. So take the time to find out what the competition is and where the spaces are for innovation for the majority of mainstream consumers.

3. Where do market unmet needs align with technical solutions that can improve sleep?

The aim must be to create the must-have sleep-tech product. Just recently, here at CDP we worked on a technology to monitor REM sleep. We discovered that not only did users want to know how much REM sleep they had every night, they wanted to know whether it was enough and, then, crucially, they wanted to know what to do if it wasn’t. Successful products need to close this loop and not leave customers stranded.

4. What is the best revenue model for your concept?

This is crucial in the digital world. Will your product work if sold for a one-off payment or would it be a better proposition as the start of a relationship with your customer? Will customers pay for every night they sleep better, or will they not notice the difference? In the AI enabled world consumers are beginning to expect customised solutions, continuous updates and evidence- based feedback.

5. Who are the most impactful sleep professionals for you to work with?

To develop and launch your product successfully, you’re going to need clinical and scientific back-up. So, do you need to work with doctors, psychologists, clinical researchers or YouTube sleep experts? Should you be turning to the peer consumer community, personal trainers or artificial intelligence? It’s all about finding the best development support route and final endorsement.

That way, your innovation journey will stand the best chance of seeing those sweet dreams of success become a reality.

September 12th 2019

Chris Houghton

Partner and head of FMCG

In packaged products, context is king

Chris Houghton leads Brand Innovation & Packaging at Cambridge Design Partnership, he has worked on an array of successful insight, design and strategic innovation projects with top consumer goods names including Arla, Carlsberg, Coca-Cola, Diageo, Nestle, PepsiCo, Procter & Gamble and Unilever.

Following his ‘Context is King’ keynote speeches at PACE in Amsterdam and AIPIA in New Jersey, he summarises five key questions brands need to answer when building an innovation pipeline.

Bill Gates famously wrote, Content is King back in 1996. His forecast…“Content is where I expect much of the real money will be made on the Internet”…

How right he was as we’ve seen the digital revolution establish over the past decade. On demand streaming services have overtaken traditional audio and video formats with gaming next on the horizon. Coupled with new business models, the likes of Uber and Airbnb have tapped into consumer demands making brands sit up and think what should we do to take advantage of this fertile digital landscape?

Context #1. Who?

Who are you designing for? Do you understand their cultural sensitivities, their customs and established rituals? Do you know their values? Their gender or generation? Their mental and physical abilities? Are they tech-savvy – do they need to be? The better you understand specific population cohorts the better your chance of successfully meeting their expectations.

Each culture and country has its own technology trajectory and utilisation levels. The worldwide average for time spent on the internet is now 6hrs 42mins which is just above USA’s average but some way short of chart toppers the Philippines clocking in at over 10hrs per day (source Digital 2019, wearesocial.com users aged 16-64).

Some categories like beauty and cosmetics are ahead of the curve with high digital engagement. L’Oreal was one of the first brands to realise this with their Makeup Genius app which allows users to compare before/after make-up and hair effects on-screen. This pre-purchase, augmented reality tool enables fast navigation of product choices to help consumers decide what to buy – within two years L’Oreal said it had 20 million users worldwide.

For decades, beauty brands have been heavily reliant on celebrity endorsements or experts in lab coats to target and assure consumers but today that paradigm is changing. Millennials increasingly seek individuals that they can relate to, building seemingly intimate relationships with those they follow on Instagram and YouTube channels, who ultimately steer their lifestyle decisions. This mix of opinions, edited evidence, facts and ‘fake news’ can confuse many consumers, so building trust is more important than ever.

Context #2. What?

What category does your brand belong? Beverages, confectionery, personal care? The answer to this is obvious, of course and you’ll invest great effort closely tracking the activities of your competitors. But that is just the start. Innovations don’t always come from your direct competitors. Instead, brands are often blindsided from an unassuming left field competitor, arriving at speed with disruptive and transformational innovations. For instance toothpaste brands didn’t expect their category to be impacted by confectionary companies making chewing gum with teeth whitening claims.

We look at the ‘what’ in a solution agnostic way using the ‘jobs-to-be-done’ methodology. In a nutshell this approach states that when consumers become aware of a job they need to get done, they look around for a product or service that they can hire to do so.

Procter & Gamble’s Tide is a good example of a brand that have extended their portfolio to cater for changing contexts. The core range is unsurprisingly traditional powder, liquid and convenient pod packaging, but more recently Eco-Box was introduced to address e-commerce shipment and improved sustainability stats. The brand has even stretched beyond products solutions with the test market launch of Tide Cleaners. A direct to consumer, digitally enabled, subscription service that targets ‘generation rent’ to simply drop/collect dirty/clean laundry. This cleverly allows the brand to reach new consumers whilst experimenting with new business models, partnerships and logistical infrastructures in a low risk way.

Context #3. Where?

Where is your product used? At home, at work or on the go? Each location may present a different hierarchy of jobs. In fragrance, for example perfumes have clearly defined packaging conventions. Consumers expect a thick-walled glass bottle, an elegant closure with a precise dispensing atomiser. This objet d’art is entirely appropriate to adorn a home dressing table. However, if on the go, this format no longer seems so practical for a handbag.

In 2017 British parfumier Jo Malone launched Fragrance Paintbrush under the brand Jo Loves. A compact perfume gel applicator that is crucially handbag friendly. This delivers an entirely different application ritual, delicately brushing quick drying fragrance onto the skin rather than the traditional perfume spritz.

In a digital, augmented world understanding the ‘where’ is crucial to enable or enhance the experience, especially when leveraging the surrounding environment. Whilst outside the packaged goods world, I find EuroStar Odyssey an insightful and charming experience to entertain children during a long train journey. Instead of uninspiring views inside a concrete tunnel beneath the English Channel, the carriage is virtually transformed into an underwater viewing gallery with dolphins and whales swimming besides you to help families kick start their vacation.

Context #4. When?

When is your product used? This can have a crucial bearing on consumer engagement levels especially regarding available time and tolerance levels. For example, a parent making up baby formula has very different functional, emotional and social ‘jobs’ depending on the time of day. Sterilizing equipment, measuring and mixing powder at 3pm is very different to 12 hours later for the 3am feed in the dark whilst you’re still half asleep, was that 4 scoops or 5?

When is a crucial dimension for digital interaction too. Many successful smart packaging examples have come from high engagement categories like alcoholic beverages and beauty where consumers make extra time for interaction and brand owners see sufficient ‘value’ to deploy cost sensitive technologies and/or content.

Context #5. Why?

Why should we choose your brand? What motivates us? What jobs are we trying to achieve? ‘Why’ ties together all of the other contextual considerations and forms the heart of any value proposition and reason to believe.

Take PepsiCo’s Gatorade brand for instance with their emotive message of #WinFromWithin. They understand people are motivated to ‘win’ especially in a sporting context. This reinforces how the brand was created in 1965 by scientists to provide athletes competitive advantage through superior hydration. Fast forward 50 years and the brand found themselves losing share with an influx of competitors big and small. To reverse this trend they identified contextual consumer jobs to cater for their needs more comprehensively. This prompted the launch of G Series, primarily a ‘When’ based product range to help athletes before (Prime), during (Perform) and after (Recover) sporting efforts. This triggered their portfolio to grow beyond solely sports drinks into food to create an ecosystem of sports fuels, from chews, bars, powders, drinks etc. More recently we’ve seen the launch of the Gx Bottle, a smart hydration system that helps individuals to customise their own products, with connected sweat tracking and variable carbs and electrolyte pods, the Nike ID of the hydration world.

So ask yourself, is your brand prepared for this revolution? Do you cater for those consumers that don’t accept one-size-fits all? Whilst Content may be King in the purely virtual, service-based world, Context is King for physical, packaged offerings where content can augment and enhance the physical experience rather than be able to entirely replace it.

June 26th 2019

Adam Turner

Consultant Mechanical Engineer

How much does sleep cost?

Margaret Thatcher famously said ‘sleep is for wimps’. Sadly, that’s not good advice, but also, it seems, it is exceedingly bad for the economy. Even though we spend around a third of our lives asleep, society it seems, has been mis-sold the value of a full night’s sleep.

RAND Europe, a Cambridge based not-for-profit policy research organisation undertook a study into the impact of sleep on the world’s economies. Marco Hafner, a senior economist says: “Our study shows that the effects from a lack of sleep are massive. Sleep deprivation not only influences an individual’s health and wellbeing but has a significant impact on a nation’s economy, with lower productivity levels and higher mortality risk among workers.” RAND found that employees who sleep less than 6 hours per night report on average about a 2.4% productivity loss due to not being at work or employees being at work but working at a sub-optimal level, compared to workers sleeping between seven to nine hours per day. (RAND, 2016). Scale that up to the UK’s workforce and it equates to a cost of $50bn each year.

Evidence also shows sleep suppression is a predictor of ‘all-cause’ mortality, including fatal car accidents, cardiovascular disease, strokes and even cancer. A recent study by the Foundation for Traffic Safety reported that, compared to drivers who had slept for at least 7 hours in the past 24 hours, drivers who reported they had slept less than 4 hours had 11.5 times the crash rate.

Based on empirical evidence, the number of individuals receiving less than the recommended 8 hours of sleep is increasing. This is due to several lifestyle influences connected with a modern 24/7 society, such as psychosocial stress, unbalanced diet, lack of physical activity and phone, tablet, and computer use, among others. (Roenneberg, 2013)

So how can we address this challenge?

According to sleep scientists there are simple measures we can take, the most important thing you can do is to self-impose a rigid sleep and wake up time each day, even at weekends. It seems there is no such thing as catching up on sleep, in fact, it only serves to aggravate the problem. Having a lie-in cranks your natural body clock (circadian rhythm) forward in time so when Monday rolls around and you must wake up early, it’s like having 3 hours or so of jet lag. Not the best way to start the week!

Two things to avoid in the evenings are caffeine and alcohol. Caffeine has a half-life of about 6 hours, so a post-lunchtime coffee would be equivalent to drinking a 1/3 of a cup of coffee right before bed. Conversely, alcohol can be a powerful sedative but is also one of the most influential suppressors of REM sleep, arguably the most important stage of sleep.
Health education often does not teach the importance of sleep. Every parent knows from experience that sleep is of fundamental importance to their child’s development and can dramatically affect the child’s ability to learn new skills.

It is also important for employers to recognise the importance of sleep and tiredness. Creating brighter workspaces, having outside eating areas and encouraging staff to take lunchtime walks all help to promote the natural melatonin hormones which regulate the sleep/wake cycles.

One such company that has embraced a positive sleep culture is Google. Google has implemented a flexible working arrangement with employees so they can match their hours to their circadian rhythm and have installed ‘sleep pods’ in their facilities to encourage naps, thereby germinating creativity and productivity, and reducing health problems and sick leave. It is also reported that the insurance giant Aetna pays a $300 a year bonus to staff that get at least seven hours of sleep per night recorded and verified using a sleep tracker such as a FitBit.

A big challenge is shift work. Many industries that have to provide essential 24/7 services need this capability and worryingly the World Health Organisation has listed night shift work as a ‘probable carcinogen’. Clearly more work is needed to develop strategies to protect those who have to work at night.

In a second blog, coming out next month we will be looking at how the emerging sleep tech industry, estimated to be worth over $30bn a year in the US, is addressing these challenges. Do they fulfil our unmet needs or are they creating more unnecessary gadgets?

April 30th 2019

Bridging the design transfer chasm

The challenges of bridging the ‘design transfer chasm’ are well known in the medical device industry. If your approach to design and innovation has not fully anticipated the intricacies of volume production in a regulated environment, then difficulties will arise when it is sent to your manufacturing partner to be made at scale.

Developing high volume medical devices is a complex challenge, there are many issues beyond the design itself to consider such as usability, component cost, part variability and suitability for high-speed assembly and inspection. Product designers creating new products from a clean sheet often rely on manufacturing engineers to rectify issues later down the line.

Unfortunately, rectification can be a tortuous process as each design change can have many unintended knock-on effects. When manufacturing delays impact the launch of a product, the direct costs and financial damage can be significant. The window of opportunity in which to sell a new product while it is still under a patent is limited, causing unforeseen harm to income potential.

Some contract manufacturers address this concern by offering a design and manufacture package, however this strategy can leave the manufacturer’s intellectual property and know-how embedded in the product. This ties in the manufacturer and restricts your ability to control supply chain profit margins in the long term by competitive second sourcing, adding risk in the future.

To address these challenges, Cambridge Design Partnership has created a product innovation model called Potential Realised. We find it offers a better solution by developing the new product within an environment where a holistic team of product development and manufacturing engineers work in parallel. The benefit of having the design and manufacturing teams working closely together is that production problems are foreseen, and issues fixed quickly, by either design or manufacturing changes.

The key step that leads to the success of this approach is a robust phase of short-run manufacturing organised by an extended design team towards the end of product development. The manufacturing team develops a comprehensive pilot manufacturing process which includes tooling and process qualification. This run provides both regulated product for clinical trials and verifies the capability of the design and manufacturing process.

The result is a detailed and tested package of manufacturing documentation alongside the completed technical file and clinical trial data. The designs are handed over with a quality control plan, standard operating procedures, jigs, and validated test methods. This means that all the intellectual property including the know-how relating to both the design and manufacturing process is transferred, enabling a competitive tender process to identify the most cost-effective volume manufacturing partner.

A key advantage of Potential Realised is revealed when conducting clinical trials. Trials normally start between design and full manufacture, so there is a danger that if design transfer requires alterations to the product, elements of the controlled clinical trial may need to be repeated. There are countless examples of pharmaceutical companies needing to repeat or extend clinical trials due to delivery device design changes during design transfer, or to take extra time to perform bridging studies to demonstrate to regulators that changes have not impacted clinical performance. Instead, with the Potential Realised approach, a short manufacturing run for clinical trials is integrated into the development process and is conducted in a manner representative of how the product will be made once it goes into volume manufacture, thus significantly reducing these risks.

In the field of medical device innovation, Potential Realised integrates short-run manufacture into product development bringing a raft of advantages, not only saving both time and money in commercialisation but bringing forward product launch and vital product revenues.

To find out more, explore Transfer to Manufacturing.

January 4th 2019

James Baker

Partner

How is digital technology maturing in healthcare?

The recent Digital Health World Congress 2018, which was held in London at the end of November, covered aspects of medical and mobile technology. It certainly presented an interesting and diverse line-up of speakers and exhibitors.

A key learning we took from the event is that digital health (the intersection of digital technology and healthcare) is maturing. In recent years, digital health has experienced a strong ‘hype cycle’ but, as the event illustrated, we are beginning to see real-world roll outs that address true user needs and have measurable business success.

Keynote speaker, Adrian Byrne, CIO at University Hospital Southampton NHS Foundation Trust, presented a fascinating maturity model of patient information systems delivered by Healthcare Information and Management Systems Society (HIMSS). He explained that the adoption of electronic medical records is a key building block that serves as a foundation for new digital services and associated technical innovations that can improve healthcare. But the creation of systems for electronic medical records is only the start of the journey – to succeed it needs the willingness of end users to adopt it and continued championing to maintain momentum.

A key takeaway from the event was that where deployments have succeeded, they provide quantifiable gains for patients and other stakeholders. An example that Adrian described is a simple patient ID barcode solution, which enables the patient to be scanned prior to any medication being given to them. Already it has prevented over 300 patients from being given the wrong dose.

Another real-world example, which is being rolled out in Kent, is a simple App called WaitFree. It recommends which A&E facility the patient should attend in order to help minimise waiting time. Using the information of current waiting times at each A&E facility in conjunction with an estimation of the user’s travel time to each facility, it recommends which facility they should attend in order to be seen quickest – which may not necessarily be the closest one! This has a clear benefit for the patient but also benefits the healthcare system as load on the system is distributed more evenly, maximising utilisation of scarce resource.

A major theme from the event was leveraging smartphones to provide new diagnostics. For example, healthy.io is turning a smartphone into a regulatory-approved urinalysis device. Its first product, dip.io, uses the phone’s camera to assess various urine test results. This means that a subset of the 42 million tests conducted each year in hospital can now potentially be moved into the home, increasing convenience to the patient but also reducing costs on healthcare incurred through hospital visits.

An example of the convergence of medical and consumer diagnostics is Nimasensor, a connected gluten and peanut sensor device. Whilst gluten and peanut allergies are increasingly recognised and catered for, the creator identified the significant challenge to sufferers who would commonly be ill after meals out even if they had been careful to select food without allergens. The Nimasensor enables users to conduct an on-the-go analysis of foodstuff, thereby enabling restaurant visits with more confidence that illness or even fatal consequences will not occur.

All of this is reflective of a trend that is increasingly seeing consumers take ownership of their own wellbeing and healthcare. It’s moving away from the traditional model of sick care provided at a surgery or hospital. With this traditional model users have no real means of determining how sick they actually are before accessing services and creating an ever-increasing demand with health services stretched to the limit. However, companies like Doctorlink are trying to simplify user access by triaging and facilitating efficient access only when required. This enables practitioners and providers to be utilised more efficiently.

Whilst at the event there were many examples of services being built into Apps to help HCP’s during their day-to-day jobs. There was also a healthy mix of companies embarking on a product and service deployment. For example, Qardio is providing a wide range of health wearables like blood pressure monitors, and Tytocare has developed a camera-based toolkit for home diagnosis that feeds data straight to the clinician.

Augmented Reality/Virtual Reality (AR/VR) was also demonstrated at the event. Proximie is conducting some very compelling remote surgery assistance where the experts no longer need to travel the globe to assist in theatre. Instead, they can be virtually ‘there’ via the latest webcams, and so enhancing the level of support they can provide to a wider audience.

Equally compelling was Oxford VR who demonstrated dramatic behavioral improvements with people fearful of heights. With the use of VR tools they are quickly able to quash people’s fears and within a few hours empower them to tackle heights, escalators etc.

Overall, at Digital Health World Congress 2018 we saw many passionate and insightful enterprises pitching into the healthcare market, sometimes with a boost of funding, and then growing organically to deliver increasing levels of benefit around a specific need. Whilst this is exciting there exists the inevitable potential for fragmented and competing services, which is already one of the biggest problems in healthcare.

Here, at CDP, we start by examining a new healthcare challenge from all angles. This enables us to focus innovation on a sound foundation rather than taking new technology and looking for a home for it. This involves researching and thinking around users and how their needs can be best addressed, as well as the business imperative to create a profit. So when we finally deploy technology it efficiently addresses both user and business needs, with the foundation for scale built in.

September 20th 2018

Alan Cucknell

Front End Innovation Leader

Clare Beddoes

Senior Medical Innovation and Research Consultant

How to get serious about sleep – for you, your customers and your bottom line

Recently we have been investigating how sleep trends are impacting consumers and how companies can develop new solutions to help us all to sleep better.

There is growing scientific evidence, media coverage and public awareness of the impact of sleep on our health. Not just how you feel today, but for your long-term health and productivity. Reduced quality or duration of sleep, even in those without a “chronic” sleep complaint such as insomnia or sleep apnoea, has been linked to increased risk of many medical conditions such as hypertension, diabetes, depression, obesity, cancer¹, damage to the immune system, reduced tolerance to pain and reduced ability to cope with stress. In fact the US Centers for Disease Control and Prevention has described insufficient sleep as a ‘public health epidemic’².

But this is much much bigger than just a lifestyle or healthcare concern, this ‘epidemic’ of poor sleep has far-reaching economic consequences³. A recent study by the Rand Corporation put the cost of poor sleep to the U.S. economy at $411 billion/yr. So as Professor Matthew Walker (author of ‘Why we sleep’) argues, there seem to be pretty compelling reasons for all of us to “reclaim the right to a full night’s sleep”.

So, what are the implications of this sleep issue for your customers, and for your business?

As this interest in sleep grows, we are seeing a change in behaviours and spend. For some it is a return to “old tech” e.g. paper books for reading, less TV before bed, alarm clocks separate to smartphones. We may see a return to “old routines” such as earlier or healthier meal times, which in turn changes grocery shopping habits. It may even encourage adoption of “low tech” spaces (e.g. keeping phones and computers out of the bedroom), or “sleep spaces” such as Casper’s “Dreamery”. But while there are 100’s of products claiming to improve one’s sleep experience – from mattresses, pillows, sleep trackers, lights, apps and nasal strips, through to medical products to treat serious conditions … there remains considerable need for products that can translate the growing scientific evidence into tangible and effective sleep solutions. We see significant opportunities for new entrants that can address these needs in a way that doesn’t pitch “tomorrow’s health” against “today’s fun” and that can help consumers to build positive habits and relationships with their own sleep.

And let’s not forget the cost of poor sleep to companies and economies, should we also be reassessing the way we work? Is it really good to provide that free coffee and caffeinated soft drink? Are our travel schedules and policies appropriate given our improving understanding of sleep. Are there ways that employers (and those organisations that serve companies and workers) can address this? Should we leave it to employees, or as employers, should we be “nudging” people, given the huge benefits to our businesses and society of better sleep? We’d love to know what do you think.

At CDP we’re passionate about improving lives through innovation, we provide solutions to everyday life affecting issues like sleep and its effect on health, happiness, creativity and productivity. You can read more about one example of our recent work to improve sleep outcomes with ICON Health & Fitness here.

If you are interested in improving how people sleep, or how a fresh perspective on opportunities in sleep can help you and your company – please do get in touch.

1 https://www.aaas.org/news/sleep-deprivation-described-serious-public-health-problem
2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5627640/
3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5627640/

April 18th 2018

Breathing new life into clinical outcomes

The rise of connected devices and the variety of information they can generate is set to drive an increase in patient adherence to therapies. Our trials have shown that remote and hidden sensing of actual user behaviour can uncover unexpected and significant opportunities to improve the patient experience.

So how can connected technology help in the development stages of a new product, especially in a clinical environment? A recent study – Non-adherence: a direct influence on clinical trial duration and cost – by Moe Alsumidaie highlights the significant costs of non-adherence during pharmaceutical development. The study reported a 40% increase in patient enrolment to allow for non-adherence – adding an estimated $12m to the cost of a Phase 3 study.

We are also starting to see many medical device approvals in the connected space. MobileHealth reported 51 approvals in 2017 alone – the focus being on app-based patient management of disease, especially in the cardiac and diabetes sectors. There were only two respiratory-based systems reported – namely the connected spirometer GoSpiro and a new inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, dubbed the SmartTouch.

These solutions are enabling remarkable new capabilities for patients – and also for payers as we move towards outcomes-based healthcare. But are there steps that can be taken earlier in medical device development that can disrupt the whole process for the benefit of everyone?

What if we took a little bit of time to insert technology into products in either the clinical stage of drug development or early device design phases to understand how patients interact with the device and dosing regime? Two of the main methods to understand what has happened in a clinical investigation is to get patients to fill in a diary during their study and, on return, count the number of doses taken from the inhaler or capsule pack. Not quite 21st century.

Maybe, in the near future, clinical plans will include more advanced technology to enable a more accurate understanding of the efficacy of a new drug in development – was that poor resultant FEV1 clinical endpoint really due to the drug or was it because the patient simply forgot to prime the device and inhaled nothing but fresh air? Being able to unpick the actual usage data, so that these distinctions can be accurately made, could potentially help all stakeholders to better understand what the patient actually did and hence clarify where the subsequent opportunity to improve patient outcome actually lies – be it drug, device or training/education. In essence, it’s about using technology to guide design and development so that the appropriate solution is selected.

Here at CDP we wanted to go further and challenge ourselves to capture some very specific usage data for inhalation, whilst avoiding the Hawthorne effect and without changing the external form factor, thereby minimising any influence on user behaviour. It is common knowledge that all inhalers have associated use errors, so we took a commercially available one that has documented use errors and inserted miniature sensors that would enable both real-time indication and post-usage remote assessment of those use errors – namely priming action, orientation of use and inhalation/exhalation profile. We enabled the data to be time stamped and communicated to an appropriate output, in this case on-screen graphical readouts.

Behind this is the need to understand the volume of specific use data that gets logged and learn how to translate and classify the events represented as peaks and troughs on a graph. At CDP we have a wealth of experience of doing this across several sectors including sports and packaging systems.

If you’re looking for a breath of fresh air in your next respiratory drug delivery development, get in touch via hello@cambridge-design.co.uk or visit us at the RDD 2018 event in Arizona, 22-26 April on exhibit table 6.

March 5th 2018

Matt Brady

Partner

Accelerating innovation in healthcare

Our healthcare clients do amazing work on complex designs with strict oversight and regulations – which are necessary to ensure medical products are safe and efficacious. But when we collaborate, our combined teams can greatly accelerate programmes, prompting the common question: “What are we doing to move so fast together?”

Having worked on hundreds of projects, we have seen some patterns that consistently help an innovation team move quickly. There are three common elements that support rapid progress:

Good project management processes and culture
A focus on resolving the programme unknowns through early prototyping and testing
Supportive quality management structures

Let’s look at each in of them in more detail.

Good project management processes and culture

Managers of fast and effective teams tend to ensure that there are four key building blocks:

Feasible goals – ambitious goals are great but there should be a believable pathway and support that adapts to evidence to help reach the most important goals
Trusted workstream leaders and decision makers – so informed decisions can be made rapidly, communicated effectively and not revisited unnecessarily
Unanimous purpose – goals that are unambiguous, worthy and supported by key sponsors, whether driven by commercial pressures, new user and clinical insights or regulatory change
A healthy tolerance for uncertainty – this enables ambition, empowers the team to identify and manage development risks as early as possible, and means that the team (and sponsors) are not easily discouraged by the slippery patches (unexpected learnings) that many fast projects hit.

Prototype early, often and at an appropriate fidelity

Creating and testing prototypes as early as possible drives learning and produces evidence and confidence for development decisions at every stage. By prototype, I mean any tangible embodiment of an idea from which we can gather realistic feedback. Getting creative prototypes (sketches, models, storyboards, interfaces, etc.) in front of users reveals insights and unforeseen variables, gets everyone on the same page about complex ideas and clarifies key assumptions. Doing this early, often and at appropriate fidelity to answer the questions at hand (starting with low fidelity and building from there) is critical to exploring the solution space fully, informing analysis and sidestepping cycles of deliberation. By focusing on key uncertainties, iterations of prototypes will avoid delays and the cost overruns often caused by ‘sweeping these difficulties under the carpet’.

Supportive quality management system

It’s important to design quality management structures that support the first two elements – as well as helping to assure the quality of your deliverables and supporting the building of your design history file for regulatory compliance. For example, can teams support the manufacture of short-run prototypes for testing in a clinical environment? Can the creation of ‘design inputs’ evolve with evidence from prototype testing? Are there protocols for non-clinical user studies that do not have significant risks? Does properly referenced documentation enable you to adopt evidence-based changes without massive documentation rework? Processes that insist on a ‘right first time’ project structure will typically restrict speed and slow the pace of learning without improving specifications in the end.

These three elements will come more naturally to some – but we believe that any organisation can adapt these insights gradually into their own innovation approach. Give it a try!

December 14th 2017

Louise Place

TitleHead Of Regulatory Affairs and Senior Quality Assurance Consultant

Brexit’s potential impact on medicine regulation in the UK and EU

Currently, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for just under a third of applications and updates for European medicinal product marketing authorisations – but on 29 March 2019 the UK will no longer be part of the European Union (EU).

I was struck by the enormity of the challenges ahead when I attended a recent meeting staged by The Organisation for Professionals in Regulatory Affairs (TOPRA). The title of the meeting was: ‘Preparing for the future: a conversation with the heads of medicines agencies’.

Change is nothing new in medical regulation – over the last year or so we have already familiarised ourselves with changes relating to European device submissions. For example, changes to the Medical Devices and In Vitro Diagnostic Directives (evolving into the Medical Devices Regulation and In Vitro Diagnostic Regulations respectively) as well as the pending Clinical Trials Regulation and update to the Falsified Medicines Directive. We’ve also adapted to changes to the Quality Management System standard for Medical Devices (ISO 13485) and are keeping a close eye on those being discussed for the Risk Management standard (ISO 14971).

However, this will pale into insignificance compared with the changes resulting from the UK’s decision to withdraw from the EU. Currently, on the departure date of 29 March 2019, the UK will become a ‘third country’ and the European Medicines Agency (EMA) is preparing for the worst-case scenario. There are two key aspects:

1. Continuing to market in Europe – companies that wish to continue to supply the EU, and currently hold marketing authorisations from the MHRA in the UK, would need to transition to a new European agency. Additionally, those based in the UK would need to appoint an authorised representative within an EU country, as non-EU-based companies are already required to do. I was surprised to hear that this may affect 6,000 medicinal products – no small task.

2. A new process for the UK – things won’t get easier, either, for those wanting to market in the UK. Currently, little is known about what the requirements for marketing in a post-Brexit UK might be – but there is likely to be some impact. My personal view is that, in the short term at least, the requirements won’t be too different from those in the EU. But what this will look like in the medium to long term, as viewpoints diverge, is currently anyone’s guess.

When, post Brexit, the UK’s MHRA can no longer authorise medicines for the EU market, there will be a significant additional workload for the remaining 27 member states. Add to this the recent announcement of the EMA’s relocation from London to Amsterdam – with the associated challenge of staff retention and recruitment – as well as the prospective implementation of a new process for the UK, and suddenly the 16 months remaining to Brexit don’t seem like very long at all!

January 10th 2017

IMPLEMENTING MEDICAL DEVICE CYBERSECURITY James Baker is guest columnist on Med Device Online

Connectivity is ubiquitous – it’s moved beyond an overhyped buzzword and become part of life. Offering ever-advancing levels of access, control, and convenience, widespread connectivity also increases the risk of unauthorised interference in our everyday lives.

In what many experts believe was a world first, manufacturer Johnson & Johnson recently issued a warning to patients on a cyber-vulnerability in one of its medical devices. The company announced that an insulin pump it supplies had a potential connectivity vulnerability. The wireless communication link the device used contained a potential exploit that could have been used by an unauthorised third party to alter the insulin dosage delivered to the patient.

It’s not hard to imagine the devastating impact to both consumers and the company if the reported vulnerability had been exploited. However, risks such as security will not prevent evolution of connected devices – demand for ever-increasing levels of convenience and access are driving the continued evolution and adoption of these products and services.

Cyber-security considerations shouldn’t be viewed as stumbling blocks for the connected device concept. Rather, it’s another of the many product requirements which, if considered and specified correctly at the design stage, can be implemented robustly. Above all, cybersecurity can be validated as part of a wider-reaching regulated device development process. It can’t be considered an isolated element to be bolted on, since it inherently helps to define the system architecture of what is developed.

Read full article.

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