Category: Analysis

Innovation in Hemodialysis event|
By Clare Beddoes and Matt Brady
July 19th 2019
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Clare Beddoes

Clare Beddoes

Senior Medical Innovation and Research Consultant

Matt Brady

Partner

Innovations in Hemodialysis

In our recent blog post ‘What’s Next In Hemodialysis’ we looked at some of the trends that are driving the industry. This month we report from the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) congress in Budapest. With more than 110 companies exhibiting to 9,500 attendees, Matt Brady, Partner and Head of Medical Therapy, and Clare Beddoes, Senior Healthcare Innovation Consultant, highlight some of the latest innovations in renal care.

Home dialysis on the up?

This is the question we asked before the conference, and from what we saw the answer seems to be a resounding “yes.”  And within the home hemodiaysis (HHD) space, we see a definite trend toward user interface enhancement.

We visited the stand of home haemodialysis (HHD) market leader NxStage, which we noted was nicely connected to its new owner Fresenius Medical Care’s booth by a smart, ‘on-brand’ blue carpet. Here we had the chance to open, load and look at all aspects of the NxStage machine that a patient would have to learn to interact with at home. Undoubtedly the world leader in HHD, the NxStage system has now been around for nearly 20 years. Whilst its user interface is clearly effective to date, we imagine NxStage will move to modernise this under its new owner, with a view to reclaiming UI leadership from less established players.

Quanta is a good example of a company launching a modernised user interface on an existing HHD setup, this update launched at ERA-EDTA last year and was again on display this year.  The clean and stylish tablet-controlled Physidia machine impressed us, with a detachable tablet-style UI which allows patients to program and control their machine from the comfort of their armchair, as opposed to having to reach up to a screen, which can be difficult or uncomfortable during a dialysis session.

As well as those companies we know are dedicated to producing machines for patients to use at home, we heard interest in HHD from other players, perhaps currently better known for their expertise in in-center dialysis. Several told us they are considering, or are currently developing, machines dedicated to HHD. In our opinion, understanding the complexity of physician, patient and healthcare system drivers, needs and barriers for HHD will be key to successful new entries into this market.

Emerging competition from China – or Canada?

As we anticipated, we again saw many interesting companies from China, several of whom still hint at an interest in entering western markets – but there was no “big reveal” at this time.  Instead, the big surprise entrant at the congress was a new company from Canada. NephroCan is a Vancouver-based company offering a range of dialysis products including membranes, blood lines, a chair and reverse osmosis machines – with the promise of an in-center dialysis machine by the end of the year. An impressive debut with a large booth – NephroCan is certainly one to watch.

Biofeedback is gaining traction

At one level biofeedback is well established in HD – for example through routine monitoring of venous blood pressure, flow and arguably clearance (Kt/V). This year we noted an uptick in interest in novel approaches to biological monitoring to help ensure successful dialysis and safeguard the patient.

The South Korean company InBody markets various formats of a non-invasive device which works using inductive measurements through the soles of the feet and the hands. This indicates not only how much fluid to remove from a dialysis patient (by determining their “dry weight”) but can also measure various nutritional status indicators, such as segmental muscle and fat mass,  and evaluate segmental fluid imbalances to identify circulation issues.  Although InBody’s biggest market focus currently is gyms (tracking athletes’ hydration status, lean muscle mass, etc) rather than dialysis clinics, the company has recently been accepted onto the NHS Supply Chain and has UK dialysis clinics in its sights.

Meantime, market leader Fresenius Medical Care was promoting active control of sodium levels as a software upgrade to their existing 6008 dialysis machine, and we heard of other firms who are exploring the use of sensors and algorithms to more tightly control fluid balance and blood pressure during dialysis.  Here at Cambridge Design Partnership, we see this as a very positive trend, given that variations in blood pressure and volume are key drivers of congestive heart failure, one of the most significant comorbidities of End Stage Renal Disease (ESRD).

Bespoke patient care

The sheer number of companies offering dialysis products such as bloodlines and membranes was staggering. How does a company differentiate its products in such a crowded marketplace? One solution could be by promoting the use of bespoke prescriptions, according to an interesting presentation we listened to by a leading nephrologist, citing an eminent Japanese physician who holds a stock of 25 different membranes. This gives him greater flexibility to tailor prescriptions to the individual patient, taking into account comorbidities, nutritional status, stage of disease etc. and to monitor and change this over time. Many delegates that we spoke to agreed that bespoke prescribing of this nature should become more commonplace.

This is, indeed, an exciting time for the renal care industry. In such a crowded space it will be increasingly important for all players (large or small, new or established) to understand where the opportunities for innovation and improved patient care exist.  CDP’s innovation research & human factors team, biomedical engineers, industrial designers, software & electronics team, and manufacturing engineers, all share a passion to develop products to improve patient lives. We have the experience and innovation skills to create new products in this life-saving sector, and we are ideally placed to continue to play our part in driving innovation in renal care.

How much does sleep cost|
By Adam Turner
June 26th 2019
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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?

A future for food||
By Paul Scott, Charles Griffith and Isaac Black
June 25th 2019
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Paul Scott

Mechanical Engineer

Charles Griffith

YINI Student Engineer

Isaac Black

YINI Student Engineer

A future for food; the need for innovation in agriculture

Currently agriculture is facing challenges from many directions. Modern hyper-intensive farming (demanding the highest crop yield from monocultured crops with less regard for long-term fertility or ecosystem metrics) is interrelated with the great environmental threats; destabilising climate change, biodiversity, oceanic dead zones and poor global soil health. In turn these issues are impacting agriculture.

Often it is trends in our society that influence business strategy and investment. CDP has an in-house team dedicated to tracking them and based on the mega-trends we see today, we think that agriculture is heading for a revolution.

CDP’s Year in Industry Students Charles Griffith and Isaac Blanc, give us a Gen Z view of the future.

The Big Picture

Agriculture has undergone three great revolutions. The first was ten thousand years ago, which saw humans first begin to cultivate seed crops and domesticate animals. The second was three centuries ago during the Industrial Revolution, which saw human and animal muscle power replaced by machinery. The third came about in the last half of the 20th century, which saw the start of modern intensive food production, and has supported an ongoing boom in the human population. This revolution was characterised by increased agrichemical use and highly specialised and lately GMO crops.

Perhaps today we are starting to see signs of a new agricultural revolution, with the emergence of a new technology called Controlled Environment Agriculture (CEA). As the name suggests, this involves producing crops for food or pharmaceutical products, using technology to control many or all growth parameters. Whilst typically referring to controlled indoor environments for plants, it also extends to animal agriculture. Here, factors like animal autonomy, reproduction and hormonal balance, as well as environmental conditions, may be controlled to maximise feed conversion ratios. Taking control of traditionally “natural” factors in this way is allowing CEA to offer significant gains in productivity, reliability and quality of produce. Currently, commercial CEA is chiefly producing leafy greens, while more complex crops like nuts, coffee or avocados are trickier and require the technology and market to mature further.

However, we can see four mega-trends that we think together will stimulate the innovation needed to create a fourth revolution in agriculture.

Health and Wellness

Consumers are increasingly becoming aware of how the food they eat can further their health and wellbeing. As an example, we’ve all heard that leafy greens are good for us (they are rich in many micronutrients) and so it’s resulted in an increased demand for them. However, leafy greens are highly perishable and, due to the logistical challenges in supplying these foods year-round with traditional farming methods, their prices are high for what is essentially just a leaf.

It makes sense that in its early days, most current commercial CEA crops are leafy produce as no pollination is required, the plants have a small form factor and offer fast ROI as their lifecycle is short. Consumers concerned with chemicals and pollutants in their food can seek solace in the bio-secure origins of controlled agriculture produce. Additionally, leafy greens from vertical farming or controlled greenhouse operations (like BrightFarms, which was born in New York) can boast higher mineral profiles compared to outdoor crops.

Premiumisation and Traceability

Mega-trends of ‘premiumisation’ and ‘traceability’ are also catered for by CEA. In terms of premiumisation, with affluent consumers becoming ever more interested in the quality and production of their food, some CEA warehouse operations market their produce as being more local, grown with minimal or no insecticides, herbicides or fungicides, and offering superior quality compared to outdoor plants, both in perceived freshness but also nutritionally.

In terms of traceability, there has been an increasing desire amongst consumers to buy locally, which has emerged from several factors including supporting the local economy, eating fresher food and reducing carbon emissions and pollution caused by transport. However, with an increasing proportion of the global population now living in urban areas the question is: how can you buy locally grown food when you live in a huge city?

CEA start-ups have a unique opportunity to capitalise on this dilemma, as the technology is ideal for urban agriculture. For instance, Gotham Greens, which run three high-tech greenhouses in NYC and one in Chicago, boast that their produce is “hyper-local” and even grow a type of rocket they call ‘Chicago Crisp’. Business seems strong for companies like this; BrightFarms have grown about 10x in crop capacity between 2015 and 2019.

Sustainability

Perhaps the trend with the widest impact is sustainability. The Earth has finite resources and it’s critical that we use these in a more efficient and circular manner. Taking water as an example, the global freshwater supply is under increasing strain and water prices are rising. Outdoor agriculture can consume an enormous amount of water whereas when using techniques like hydroponics, aeroponics, deep water culture or the nutrient film technique (NFT), CEA warehouse projects are able to make saving upwards of 90% when compared to similar crops grown outdoors.

There is also a huge strain on arable land. Industrial agriculture has led to degradation of much topsoil while deforestation and heavy tilling have rendered land unabsorbant and vulnerable to extreme weather (of course, more likely with progressing climate change). Heavy agrichemical use can decimate the soil microorganisms that play a crucial role in decomposing and upcycling nutrients (therefore more fertilisers are needed for the same growth, and the cycle continues). The reduction in agricultural capacity contrasts with the growing human population, not to mention the need to rewild and reforest in order to capture carbon and foster the recovery of our biodiversity.

Clearly, innovation is needed here and while single-story controlled agriculture can significantly boost productivity and reduce land use, there is another somewhat more hyped branch of CEA – ‘Vertical Farming’. This practice of producing food in vertically stacked layers increases the yield per square metre. However, the construction cost is high, and so is better suited to urban environments where the land use savings will counteract this. Artificial lighting, most often provided by LED lights, consumes power which may not come entirely from renewable energy sources. There is a great need for increased efficiency in vertical farming, in both building and running the systems.

Changing the demand side

Of course, while we all want to eat more greens, we can’t discuss food sustainability without mentioning the impact of animal agriculture. The most comprehensive study on agriculture to date, found meat and dairy provides 18% of global calories and 37% of protein, yet requires 83% of currently used farmland and produces 60% of agricultural greenhouse gas emissions, when all production factors are included. The UN has urged, for the sake of sustainable resource management, for humans to shift away from meat and dairy. The impact of animal agriculture is not bound to land either; for example, the fishing industry is responsible for a significant amount of plastic found in the ‘great pacific garbage patch’. Meanwhile, other studies have shown that such a shift would be better for public health too.

This has all led to our final mega-trend: the rise of flexi’s, veggies and vegans. Changing what we eat has the most potential of all to reduce the environmental impact of our food. Consumers would benefit from help to do so, one way to do this would be the introduction of environmental labelling on food. We have labelled household appliances in this way for years, and they have improved so much in response that we have had to create new energy efficiency categories. The top right image in this article’s illustration is an example of such a label, inspired by a proposal from Joseph Poore at the University of Oxford. Additionally, rapid advances in alternative meats mean this transition is looking increasingly attractive to those consumers who don’t want to change their diet.

Conclusion

Innovation in agriculture is not only being driven from evolving consumer preference, but also from the needs of our planet. We are living in an age of widespread intensive agriculture, for all its achievements, it has also brought about environmental challenges. Without wide reaching, transformational innovation to change our food system, there may not be enough capacity in the future to feed us all.

Fortunately, innovation is emerging, for example advances in CEA are facilitating new food systems that offer benefits on many fronts from increased freshness, locality and nutritional profiles to reduced environmental impact. However, many challenges remain to increase efficacy, reduce costs and upscale. Solving these will require inspirational engineering, new digital approaches, robotics, AI as well as biology and commercial innovation.

As young engineers at the start of our career, we are looking forward to addressing these challenges!

It’s all about the UX
June 18th 2019
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It’s all about the UX

There is no doubt that User Experience (UX) is a hot topic throughout today’s design world. But how is the personal approach to product development affecting the field of healthcare? Lucy Sheldon, people-centered designer, and Andres Barrera, user experience designer, went along to the first ever User Centred Design (UXD) Healthcare conference to find out…

Lucy and Andres write: Here at Cambridge Design Partnership, one of our specialisms is designing healthcare devices, from asthma inhalers to blood sugar monitors, that are used by patients rather than health professionals. In such situations, the experience of the user/patient is key to the success of the product. Do they like using the design or will they give up on it?
Because of this, we were intrigued by a new conference devoted entirely to User Experience (UX) within the world of healthcare.  So we headed off to the User Centred Design (UXD) Healthcare conference in London this spring to find out more and report back:

Who was there?

Attendees ranged from new start-ups to digital health specialists employed by global pharmaceutical companies. This was a chance for us to check out what’s happening right across the board in healthcare UXD.

What was the focus?

Many of the presentations were about the ways in which digital technologies can deliver a cost-effective and successful preventative healthcare model. Loud and clear came the message: a people-centered healthcare approach requires great UX at its heart. Healthcare solutions that the patient uses in their own home have to be problem-free and a joy to use. Otherwise compliance becomes a real problem.

Which innovations stood out?

We liked the look of the myCOPD app, an app which offers patient education for people with Chronic Obstructive Pulmonary Disease. This app delivers advice from world experts and is, in effect, a complete online pulmonary rehabilitation class. Another interesting project is the Babylon Health start-up, which offers online GP consultations. This company is already working with the NHS, allowing patients the option of signing up with Babylon Health rather than a traditional GP surgery.

Why is UX so much at the forefront of healthcare these days?

The rising incidence of long-term health conditions such as diabetes, heart disease and asthma is driving investment with a shift in emphasis. Now the focus is on helping patients to cope with their chronic illness, in terms of both reducing symptoms and improving outcomes. There is also much more investment in preventing lifestyle-related illnesses occurring in the first place.

What is the aim of UX in healthcare today?

Several of the speakers referenced the term healthspan (quality of life), which is now considered alongside lifespan as a measure of healthcare success. The question is no longer just: how long will you live? What matters is now how long you will live in good health.

What else is new?

Presentations which outlined how augmented reality in digital tech could be used in healthcare. Gaming-based digital tech allows users to overcome phobias in virtual reality. One idea we heard being discussed was a digital game in which the user overcomes their fear of heights by travelling up escalators, going onto balconies, etc. This is proving genuinely effective in helping people overcome debilitating phobias.

Did AI feature?

Absolutely. We were struck by a presentation which outlined the ways in which Artificial Intelligence (AI) – or perhaps more specifically machine learning – frees up healthcare professionals to do their high-level work more effectively. Algorithms can analyse patient data such as heart-rate, flagging up noteworthy results and saving hours of human time poring over charts to spot anomalies.

The appetite for digital therapeutic treatments is certainly growing and, for conditions such as depression there are, we discovered, several therapies that the patient uses themselves that have already been clinically validated. This impressed us a lot.

Did you come back to Cambridge Design Partnership feeling inspired?

Definitely. Here at CDP we work on a wide range of healthcare projects that have UX at their heart and we know just how crucial it is. For example, we designed the First Response Monitor as a way of helping first responders such as paramedics triage patients. The monitor helps assess which patients need help soonest via nose clips which record oxygen levels and display results using AI on a smartphone dashboard. In such a high-pressure situation as. Say, a serious road accident, kit needs to be reliable and simple to use. Our UX design, both for the physical product (the nose clip) and the digital tech (the smartphone dashboard) was key to its success.

How can CDP offer the best UXD to its clients?

We offer global companies the opportunity to create healthcare products – be they digital or physical – that not only fulfil the brief but truly delight the user. Our Potential Realised product design process, which links research, design, technology, engineering and manufacturing into a single integrated process allows us to meet and exceed customer expectations for UX.

Finally, how is the future looking for UXD in healthcare?

There is an exponential growth of health-tech start-ups right now and design in healthcare is evolving towards a more holistic and democratic approach. Patients no longer simply expect a prescription or a pill to solve their problems. Instead, they are taking ownership of their treatment and their health, often using digital technology. Where this is supported by machine learning, we are convinced that UX has the potential significantly to enhance healthcare delivery.

manufacturing – we bridge the chasm
April 30th 2019
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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.

IMG_20190321_225751_resized_20190322_120409429 (002)
March 22nd 2019
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Employer of the year – CDP scoops Employer of the Year award in the 2019 Cambridge News Business Excellence Awards

Simply the best

CDP scoops the ‘Employer of the Year’ award in the 2019 Cambridge News Business Excellence Awards

It’s official: Cambridge Design Partnership is indeed a truly great place to work.

CDP won the prestigious Employer of the Year award for 2019 at a reception at King’s College in Cambridge this month [March 2019].
“We’re absolutely delighted to win this award,” says founding partner, Mike Cane. “We have always wanted to be an inspiring and supportive place to work. This just shows we are getting it right.”

In the past year, CDP, which employs over 130 people at its Cambridge HQ and in the US, has become an employee-owned company. It’s a move which Mike believes helped to impress the judges. “We decided to become employee owned to give all staff the opportunity to share in the organisation’s future and help them focus on creating great innovation. Our aim as a key employer in Cambridge is to foster the skills and careers of our engineers, scientists and designers and help them to excel.

Mike adds: “As an employee-owned company, the well-being of our clients and staff is at the centre of our business approach. The fact that we all work for each other collaboratively, supports our multi-disciplinary team based approach to innovation.”

Employees are able to contribute to business-related decisions through an elected employee committee. Mike adds: “As innovators, we recognise that our people are the real value in our organisation and the key to our future growth.”

The company encourages and rewards staff with a wide range of measures. These include significant training and career development programs, team-building social events such as curry nights, local community engagement and regular staff activities like daily lunch-time walks and spot prizes for success. “Above all, there is a real culture of staff helping and supporting each other to serve our clients to the best of our ability, which contributes to making CDP a fun and creative place to work,” says Mike Cane.

February 27th 2019
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CDP to open new office on the US East Coast

Cambridge Design Partnership (CDP) is opening a new base on America’s East Coast, aimed at meeting the needs of its US customers. Focusing on CDP’s strengths in product and technology innovation, particularly in healthcare, the new facility will open this month (February 2019) in North Carolina.

‘We are very much looking forward to opening this new technically-led base on the East Coast,’ says Jez Clements, partner at CDP. ‘A large and growing proportion of our work is helping US companies innovate and this will enhance the services we offer.’

The new base is sited within a state-of-the-art innovation centre in Raleigh, North Carolina, an area known as the ‘Research Triangle’, thanks to its three universities and the cities of Raleigh (the state capital), Chapel Hill and Durham. ‘There has been a research park here since the 1950s and there is a strong pool of local talent to help us expand here in the future,’ says Jez.

‘Our specialisms in innovation, technology, product design and manufacturing engineering span right across the consumer, healthcare and digital sectors, for which there is a high demand in the US. Our experience includes developing everything from safety-critical professional medical devices, connected and digital solutions, toys, consumer electronics and branded fast-moving consumer goods (FMCG). We are increasingly aware that our growing US business needs its own facility nearby.’

CDP’s new base will be led by Aki Laakso, an experienced mechanical engineer by background, who worked at CDP in the UK for many years before moving to the US in 2016. Also heading up the new facility is Hans Pflaumer, a mechanical engineer with specific experience in medical robotics and drug delivery systems.

‘Our East Coast US customers have expressed a desire for us to have an office within their time zone, and North Carolina is also convenient for Boston and New York,’ explains Jez. ‘This facility will also widen our recruitment reach to the very best international talent.’

The new facility is another step on the journey CDP is making to move closer to its international customers. Founded over 22 years ago in Cambridge, UK, CDP has clients all over the world and, while healthcare innovation remains it’s largest sector, projects range from cookware to complex digital systems.

‘Specialising in healthcare, consumer, and digital innovation, our solutions start at the point a business decides upon the need for innovation and finishes with the launch of a breakthrough new product that is customer-focused and commercially effective,’ explains Jez. ‘Our product development and prototype manufacturing quality systems are certified to ISO 13485/9001, the internationally-agreed standard for medical devices.’

‘We’re delighted both to be opening a base on the East Coast and also to welcome Aki Laakso back to CDP. We look forward to many fruitful projects being developed at our new US base,’ says Jez. ‘Increasingly, we are working globally and it may well be that we establish further bases, particularly in the Far East. These are very exciting times for CDP.’

By Louise Place
January 18th 2019
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Louise Place

TitleHead Of Regulatory Affairs and Senior Quality Assurance Consultant

Is medical device regulation failing to ensure patient safety?

For the last decade I have been part of the medical devices industry, most recently as part of a design consultancy firm specialising in medical device innovation. In the last few years our world has been shaken with reports of the failure of medical device implants and the insinuation of industry wide misconduct.  The headline statistics are certainly shocking, in the investigation recently published by the ICIJ, their research suggests that in 2017 nearly 300,000 patients were harmed by medical devices in the US alone. Clearly something is wrong.

However, personally I have never come across anyone in the industry who wishes to cause harm to a patient, in fact it’s completely the opposite. Where I work, it is our company’s primary policy to improve lives through innovation and the stories that have hit the headlines do not to make it clear that most people in the industry are diligently working towards making sure all new devices are safe.

I spend my life around medical devices. These include items as varied as a surgeon’s scalpel, an insulin injection pen or a portable oxygen delivery system. They also include implantable meshes and spinal support systems and complex hospital equipment designed to keep extremely sick people alive.

Each device I work with is the product of many years of design and testing before it is allowed near a patient. During that time, it undergoes substantial testing to ensure that it works according to the design intent, for the conditions it is expected to experience and the intended life both on the shelf and in use. Biocompatibility testing is carried out to ensure that anyone encountering contact with materials does not suffer an adverse reaction and a robust risk management process, including medical professional opinion, underpins all this to attempt to account for foreseeable harms from the use of the product. At every stage in this development process the concern is for the patient and one of the most common questions asked is whether you would be happy for a close relative to use the final product.

If a device does reach a human being for clinical evaluation, and not all do, the use in that person is strictly controlled. The safety profile, as far as possible, needs to be determined and the risks of the use of the device, as well as the benefits, need to be established and controlled as far as possible. In the United Kingdom, this assessment is carried out by the Medicines Healthcare Regulatory Authority (MHRA) and it takes several months for agreement, during which this information is assessed. It is also usual for an independent Research Ethics Committee to confirm the well-being of trial participants and agree to the trial. Once agreement is obtained recruitment may begin and appropriate volunteers may start a trial once they have signed an informed consent form which details the potential risks and benefits of the study. All trial participants may withdraw from a trial at any time without needing to give a reason.

Prior to a device being launched on the open market in Europe and depending on risk classification (the lowest risk devices can be launched after the creation of appropriate technical document with limited oversight), the summary of all the development documentation detailed above, and more is assessed by a Notified Body. These organisations, whilst not part of governmental structure, are designated by their national competent authority (e.g. MHRA) as having passed a strict assessment which confirms that they have the relevant in-house knowledge to question and approve a device for use. Post market surveillance also takes place to ensure that as more information becomes available through use, appropriate changes are made to the design and even withdrawal of product if it is deemed necessary because of a safety risk.

Europe is currently poised to welcome an update to the Directives and Regulations governing the development and assessment of Medical Devices to the market. This is the culmination of nearly a decade of discussions from the European Commission downwards to ensure the safe development of medical devices. The new Medical Device Regulations (MDR) place stricter requirements on the in-patient testing of devices, the post market follow-up (especially with regard to implantable devices) and the re-classification of some devices into higher risk categories. All medical devices, both yet to be conceived and those on the market already, must meet these regulations as manufacturers will no longer be permitted to rely on historical approval.

I am not claiming my world is perfect and the statistics show this. But carefully implemented medical device regulation maintains and promotes high standards of safety and efficacy. I’m proud to say that here at Cambridge Design Partnership the focus is always on the welfare of the patient. I wouldn’t have it any other way.

A toast to manufacturing
By Caroline Zakrzewski
January 14th 2019
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Caroline Zakrzewski

Consultant Drug Delivery Devices Scientist

A toast to manufacturing

We are all manufacturers. Without appreciating it we manufacture products ourselves every day. Think back to breakfast this morning – did you make toast?

Most mornings my son has toast for breakfast. The process of making his toast mimics the work I do every day at CDP in the development and commercialisation of manufacturing processes for medical and drug delivery devices, and which my colleagues undertake for consumer products. At all levels – medical, commercial, domestic – the principles are the same, it’s the depth to which each stage is undertaken that differs and knowing how deep to go.

Creating breakfast starts by selecting the bread, the critical raw material of the toast making process. It’s important to have bread available – a rather simple stock management exercise that fails more often than I’m prepared to admit. The nicest bread comes from a local shop and this shop sits at the top of our approved suppliers list, although we often dual source from other local shops. An additional consideration is the type of bread (the raw material specification). White is preferred over brown, fresh preferred over sliced. This specification also helps to determine whether the bread is likely to go stale or mouldy before it’s used. Shelf life and storage conditions play a huge part in this, as they do for many consumable goods and drug combination products.

The manufacturing equipment we use for conversion of bread into toast is a toaster. An open grill or fire would do the job but are more prone to process variation resulting in a burnt or underdone offering. I consider these options to be more akin to manual, proof of concept processes and the more advanced, semi-automated toaster frees up the operator to do other tasks, like packing a school bag or making a cup of tea. Getting a new toaster is fraught with uncertainty! Once out of the box it’s plugged in to check that it works (installation qualification) and then a series of trials is embarked upon to find the right setting for a perfectly done slice of toast (operational qualification). It then remains on this setting for a while to prove that it works consistently several mornings in a row (performance qualification). The toaster is now “validated”, and everything is fine until the settings are changed because someone wants a teacake and you need to try and remember your previous settings (change control). Luckily, we can reduce the stress and uncertainty of new process equipment by thinking about and documenting these risks and challenges up front and developing specifications and designs that fulfil your needs – you’ll have had specifications for your toaster too, even if this was only an undocumented request that it matches the kettle.

After emerging from the toaster, the toast undergoes a visual inspection (quality control) to confirm that it’s suitable (within specification). If it’s burnt it becomes a reject and goes in the bin, if it’s underdone then rework is appropriate as it can go back in the toaster although more attention is required for this phase.

The final stage is toppings; usually butter and honey, and presentation. This is the area which has historically generated the most complaints and it mirrors the drug delivery market where most complaints are generated due to labelling and packaging errors.

As we sit eating our breakfast I can reflect on the current low level of complaints and how it’s taken us years to develop an effective morning routine. The same is true at CDP where years of experience enable me to help clients navigate through the development of complex manufacturing processes and their accompanying regulations.

My top tip for not getting burnt would be to talk to all the key stakeholders and understand the following;

  1. The final product – what needs to be produced and in what quantity; the difference between making toast for two and making toast in a busy café.
  2. The scope of the manufacturing process – it is just toast, or will you also need it for bagels, crumpets and teacakes?
  3. The expectations of the consumer/patient and the regulatory environment – do you need the toast to be gluten free? or made in a certifiably hygienic environment?

And remember, in the end we are all manufacturers – even if the scale and complexity of our products are worlds apart.

By Mike Cane
January 9th 2019
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Mike Cane

Partner

Is ‘Design Thinking’ how successful innovators think?

So where does Design Thinking come from? Design is a creative problem solving skill that has evolved over centuries. It was the Modernist movement that in the early 20th century helped set the scene for today’s practical and aesthetic design solutions that can be manufactured at low cost. The ideas behind Design Thinking started life in creativity research in the 50’s and 60’s and more recently crystallised at Stanford University before being popularised for the wider business community by David Kelly, founder of IDEO.

As a designer at the start of my career in the ‘80s I was struck by the radically different approaches to design taken by the engineering and industrial design professions. You could say engineering design was based on the scientific method (collect data, analysis and conjecture, hypothesis, experiment and review) with plenty of mathematical analysis and optimisation based on first principles. In contrast, industrial design placed personal creativity, taste and empathy with consumers as the most important skills, validated by stories of the design heroes of the past with their seminal work displayed in museums and galleries.

In business, academic research has shown companies tend to adopt one of three generic models of innovation; technology lead, market lead and ‘fast following’. It’s a generalisation, but you can see how those from the engineering design camp might resonate with the technology lead strategy, believing that innovation flows from a technology breakthrough. Those from the industrial design camp naturally align with a market lead approach, looking to new trends and needs in society to create opportunities. Finally, those who are most interested in the short-term bottom line may adopt the ‘fast follower’ model as the most pragmatic strategy.

If you look at the hot innovation sectors today, take Digital as an example, success depends on integrating both the technology and market lead strategies. Creating completely new business models by better meeting customers’ needs using the most effective technology. This needs a truly holistic innovation approach and exemplars are simply today’s most valuable companies, so this logic is undeniable.

So is Design Thinking a joined up approach that integrates traditional engineering and industrial design processes? It is certainly associated with the well-known Venn diagram linking what customers want with what is technically possible and commercially viable.

But is it the way that successful innovators think today? OK, this is an unfair challenge. Design Thinking is a simplified model that resonates with a wide audience and succeeds in encouraging some important behaviours. It makes the customer the primary reference point for innovation, something that is surprisingly easy to forget when technology becomes too exciting or daunting. It encourages questioning assumptions and the group working that is often absent in siloed organisations, essential when agile disrupters are snapping at your company’s heels. It also champions creativity that is a skill often driven out of companies in their search for operational efficiency. It finally encourages a learning approach using experimental iteration and minimum viable products, to improve ideas based on customer feedback, avoiding the confirmation bias that can sometimes fool teams into inadvertently launching a product that won’t succeed in the market.

However, on the other side of the coin I believe Design Thinking can introduce fatal flaws for the unwary innovator and this is why we have created our own proprietary approach to innovation at Cambridge Design Partnership, called Potential Realised. Like Design Thinking, our approach is people centric, creative and based on learning, but it’s a more demanding, professional framework that requires an expert delivery team with a broad range of specialist skills, particularly because it is compatible with the ISO13485 and FDA standards for medical device development.

There are three major differences between Design Thinking and Potential Realised. While keeping the consumer at the heart of the program, Potential Realised fully integrates the key role that technology plays in innovation and the specialist capabilities needed. There is a focus on the fundamental principles of the scientific method, placing learning and evidence center stage. This is essential to deliver technically complex products efficiently and to minimise the cognitive biases that can adversely influence outcomes. A good example is the emphasis Potential Realised places on gathering objective evidence at the front end of innovation when it can be difficult to obtain, rather relying on ‘empathy’ with the target market. Evidence is vital at this stage because the right decisions have a profound effect on the final commercial outcomes and project costs. Built into Potential Realised are the stages needed to obtain these vital facts.

It also recognises that iteration, while an efficient approach when costs are low at the front end, becomes an expensive mistake as investment rises and as the innovation gets closer to market. When implementation costs are in seven or eight figures your process has to include a high level of integrity.

Finally, Potential Realised is firmly based on the holistic nature of innovation, recognising a successful product launch is only as good as its weakest link and making sure all the design, technical, and business activities have their place and integrate together throughout the project to avoid pitfalls and most importantly, to allow the innovation process to be optimised financially.

While Design Thinking is certainly a part of how successful innovator thinks, Potential Realised’s scope is much bigger; it is scalable to even the largest projects and it actively optimises the return on your investment in innovation. It achieves this with building blocks that uncover the best possible commercial opportunity and create an efficient technical implementation and manufacturing capability.

If you would like to learn more about how Potential Realised can do this for your business, please get in touch.