The big cover up; designing masks for a pandemic world, and living with a new normal

May 7th 2020

Ben Strutt

Over recent weeks the news has shown daily challenges faced by mask-clad shoppers waiting in long queues for basic household goods; reports of front-line healthcare workers unable to procure personal protective equipment (PPE); and huge efforts being made by businesses to ramp up or re-task production facilities to meet new demands. Now in the UK, the government is set to reverse its original advice on the use of face masks by the general public outside the home.

A recent article by the Lancet reflected that where previous research on the use of masks in non-health-care settings had predominantly focused on the protection of the wearers, there is an alternative rationale to also protect the people around users from respiratory droplets, which in the context of a virus pandemic, places weight on different operating criteria and benefits. This is also supported by recent studies in South Korea, and Hong Kong .

My colleague Richard Owen recently wrote a blog on personal ‘bio-security’, the importance of hygiene and the limitations of some types of face masks as PPE for the general public. The benefits of masks derive from a complex interplay of technical, anatomical, and even emotional and social factors contributing to their performance, use and adoption.

While a complete understanding of how Coronavirus is transmitted is still being researched by scientists across the world, basic engineering can help us understand some of the issues and choices facing the general public. The ideal solution would be a mask that forms a two-way barrier to viruses while allowing the user to breathe normally. That way you are protected from others, and others are protected from you.

Unfortunately, there are some technical challenges. Firstly the Coronavirus is very small, in the order of 100nm in size, so they can exist in droplets that hang in the air and filters have to be quite dense, or utilise complementary technologies to form a barrier to them. Whilst it is relatively easy to make filter media that meets this technical specification, avoiding unwanted leakage between the mask and the face, that short circuits the filter, becomes the main design challenge. Because everyone has face contours that are different, and masks must fit tightly to seal, those that seal well are less comfortable to wear for long periods of time. This discomfort is exacerbated by the resistance experienced by inhaling and exhaling through the barrier membrane, leading to fatigue.

Then there is the problem of condensation inside the mask caused when the wearer’s warm humid breath condenses on the cooler mask components. This adds to discomfort caused by pressure against the areas of the face where skin is close to maxillofacial sub-structure, and by skin sensitivity to the material choice in some users.

It also stands to reason that if the mask successfully catches viruses from the environment, then over a day it will effectively concentrate them in one place. So removal and disposal of the mask requires care to avoid it becoming a direct source of infection itself.

Finally, there is a good argument that increased demand for masks from the general public will mean that supplies may be diverted away from those most at risk and in most need, healthcare workers and carers treating sick patients.

As with any medical device, design is a compromise based on the likelihood and risk of different outcomes. To completely minimise risk requires a military style NBC (nuclear-biological-chemical) suit, which is obviously not a practical solution. So the mask performance is determined by the possibility of meeting enough virus to cause disease, the likelihood of the virus getting through, or more likely around, your mask, together with the usability, availability and cost of the mask that determines if you wear it in the first place. This means different designs of mask are the best compromise in different situations, but the wearer must understand the protection they have and not stray outside the environment their set up is designed for.

There is also the question of who the mask is protecting, the wearer or the people they meet? Is the virus inside or outside the mask? Many existing mask designs have small valves to let exhaled air bypass the filter to reduce condensation and breathing effort, so these don’t provide any protection from viruses escaping.

In a population where you don’t know who is infected, then public coughs and sneezes pose a high infection risk. As Richard pointed out in his blog, particles can easily travel several meters from the person who sneezes, well beyond the social distancing 2m radius. Logic suggests that even a leaky, home-made mouth cover would absorb a percentage of the sneeze or cough, and so reduce the dose acquired by others close by. In this situation the risk to the user of concentrating their virus in the mask is irrelevant as they have the virus anyway. However, sharing masks or asking others to handle or wash them poses new opportunities for infection.

So in an environment where governments and scientists are weighing up different lock-down exit strategies, even a simple, imperfect mask appears a positive measure for those who don’t know if they have the virus but want to reduce the potential of onward infection.

In addition, there is also a psychological effect to consider. In a world where many people have been indoors for weeks, emerging for the first time back into public spaces where there may be an unseen ‘enemy’, is likely to increase levels of social anxiety.

We recently spent a fortnight undertaking immersive field research in China to develop a specification for a new technology-enabled personal pollution mask. The aim of this project was to avoid the health risk associated with inhalation of pollution in busy cities, where particles, designated as PM2.5 (atmospheric particulate matter less than 2.5 microns in size) can reach into your lungs and even be absorbed into the bloodstream.

We found in addition to the practical concerns about pollution filtration, inhale/exhale experience, fit, carriage, and maintenance, even in a pre-pandemic world some wearers expressed a strong feeling of responsibility to wear a mask as a social courtesy to protect those around them from anything they may be carrying, especially in enclosed spaces such as packed rush-hour buses.

We were also struck by the tension between the reassurance of efficacy for many adult users provided by an industrial aesthetic, against masks with a more informal or fashion-oriented design language, which were perceived to reduce confidence in their functional credentials. Children reversed this insight, with use compliance being directly influenced by designs with comic or novelty value!

In the UK, like in many European countries, pre-pandemic it was incongruous to don masks in public places. However, the low cost and low burden of incorporating them into city life seems a small price to pay to reduce infection rates. Indeed, it is a habit that may well survive the current pandemic and become a new social norm.

References:
[1] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30918-1/fulltext
[2] https://www.medrxiv.org/content/10.1101/2020.03.12.20034660v1

Brexit and the Implications for the Medical Device Industry

January 31st 2020

It’s been 42 months since the United Kingdom EU membership referendum took place, and with the date for ‘Brexit’ upon us it is time to reflect on upcoming changes.

What is known? At 11pm on Brexit day, Friday January 31st 2020 the UK formally leaves the EU and becomes a ‘third country’ (which means the UK will have the same status as countries like the USA and China), although EU law will continue to apply during the transition period as the UK and EU negotiate a trade deal. This transition period is planned to run until the end of December 2020. The outcome of negotiations is uncertain, it could be a deal that maintains the free flow of medical devices and diagnostics between UK and Europe, or the UK may remain a ‘third country’ and EU law ceases to apply.

So at the end of December there is a possibility that manufacturers who currently sell CE approved medical devices will fall into one of three categories; UK manufacturers selling into the UK, UK manufacturers selling into the EU, and EU manufacturers selling into the UK.

The first category is easy as UK manufacturers will have their product’s CE status transferred into UK law, so there will be no issues.

However, for UK manufacturers wishing to sell to the EU it might be more complex.

UK Manufacturers or importers may no longer be considered economic operators in the EU after the end of the transition period. So, in order to place Medical Devices on the EU market, Manufacturers would need to be based in the EU, or contract with an Authorized Representative, Person Responsible for Regulatory Compliance (PRRC) and an importer based in the EU.
Then moving forward, new CE certificates would only be issued by Notified Bodies based within the EU.
Finally, in the event of a no-deal situation in December 2020, all certificates issued by UK-based Notified Bodies would become void in the EU.

In the event of no deal in December 2020 there would also be an impact on European Manufacturers wishing to sell into the UK after the transition period.

EU manufacturers would need a ‘UK Responsible Person’ to take responsibility for their product in the UK, and register their product with the MHRA.
The UK will mirror the key elements contained within Regulation 2017/745 (MDR) and 2017/746 (In Vitro Diagnostic Device Regulation, IVDR), via the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 when each is applied, the MDR on 26th May 2020 and the IVDR on 26 May 2022.
After the transitional period, all medical devices (including active, implantable medical devices), In Vitro Diagnostic devices and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market. The timelines for this are in line with the risk classification of the device and range from 4 months for high risk devices to 12 months for low risk ones.

With the implementation status of the Medical Devices Regulation in Europe not where anyone in the Industry would wish it to be, and only nine, or potentially eight (if there is no deal in December 2020) Notified Bodies designated against the MDR currently, it is clear that the industry as a whole is struggling to cope with the extent of the regulatory change.

The good news is it looks like the MHRA will take a pragmatic approach to the ‘worst-case’ no-deal scenario at the end of December 2020, whereby the European Regulations are transposed into UK Regulation so existing products do not immediately lose approval status; this goes a long way to maintaining access to vital products on the UK market and provides a clear pathway forward.

In the EU, UK manufacturers would be eligible to apply at national level for time-limited derogation for ‘protection of health’, but this is only likely to be granted for those devices with no alternative product for use in life threatening conditions, and is likely to be subjected to additional restrictions.

Here at Cambridge Design Partnership we’ll be keeping a close eye on the details of Brexit implementation and the impact on the healthcare sector. Next month we’ll be focusing on the implications of the changes to the Medical Device Regulation as the Date of Application approaches and how to be best prepared.

To find out how CDP can help you with the details of Brexit implementation and your MDR and IVDR transitions, please get in touch.

Optimising material in design innovation

January 16th 2020

Mark Buckingham

The interplay between choice of materials and product design provides unique opportunities for innovation. The criteria for selecting materials for an application are constantly evolving. A holistic approach where materials, process and form are all part of the design provides the best route to maximise potential.

A key question repeatedly encountered in product design is ‘what materials will work in this application?’ A good starting point is to consider the purpose. How is function created by the interplay between the shape and composition of the product? Is it important what it looks like? Should it let the light in or keep it out? What about electrical properties? Does it need to insulate to protect the user from mains voltage inside, or conduct electricity to prevent build-up of charge? Should it be very strong, or break in a controlled way in extreme conditions to fail safely? If it gets very hot or wet, do we expect it to continue to function in the same way, or should it undergo a recognisable change to indicate that it is no longer safe to use?

First Impressions

In many markets, first impressions of a new product design are very important and different materials can convey distinct messages. Does it feel cold or warm, grippy or slippery, rigid or flexible? Does the surface texture give an impression of a quality product that will last? Should it be a particular colour to stand out or blend in?

Is It Safe?

We want our products to be safe, but choice of appropriate materials will depend on the application. Medical devices and products used by children or in contact with food need to be tested to the appropriate standards to check that no harmful ingredients might leach out during use. But inside a nuclear power station, the ability to continue to operate unaffected by radiation will be crucial.

Will It Last?

For many materials, properties will change with time, and this may affect the period of usability of a product. Predicting lifetime will depend on the temperature range over which articles are used. Accelerated ageing at a range of elevated temperatures can be carried out to model the expected life of products at room temperature. If use at low temperatures is envisaged, it is also important to check that materials which are flexible at room temperature do not become brittle when very cold.

For repeated or extended use, materials need to be chosen which retain their properties over time. Ease and comfort of handling may be very important, for example fit and grip, or the ability to stay clean and free of microbes. Items subject to repeated deformation may tend to change shape. For high voltage applications, the ability to retain safe insulating properties is important.

What About Costs?

We often focus on the opportunity for cost reduction by material substitution, but in many applications the cost of the materials is only a small fraction of the end price of a product. There may also be some scope to include small amounts of expensive materials in the formulation to provide additional functions. For example, ‘smart’ materials may be included to modify optical, magnetic, thermal or electrical properties.

Material substitution can often reduce overall costs by providing a route to reduction in process time or temperature. Choosing a more expensive material that can be handled in a simpler type of fabrication process is another option. Manufacturing methods are continually evolving; hence the choice of process needs to be regularly reviewed. When rapid delivery of prototypes is crucial, additive manufacturing may offer a route to fulfil this need. However, when moving to a different process for larger volume production, it is important to verify that the material will perform in the same way.

One Material or Many?

In the area of composite materials, thermoset systems have proved difficult to recycle, but the recent increased use of high temperature engineering thermoplastics in composites provides more possibilities.

Many material problems can be solved by understanding the interface between different items e.g. how implants interact with the human skeleton in the long term or careful process control of co-moulded plastic and rubber parts to ensure good adhesion between them. Often the simplest solution is to store newly manufactured parts under controlled conditions for a set time before exposing them to customer use.

Planning for the Future

The availability, price and customer acceptability of many materials continues to change, and consumers and manufacturers are increasingly looking to choose more sustainable alternatives. Be this through materials that facilitate recycling or repair, use of sustainable raw materials such as a move from oil based to plant based raw materials, or through a reduction in the energy embodied in the material manufacture, processing and recycling at the end of life.

New information about the safety of existing materials may also emerge. For example animal fur and asbestos insulation are no longer available and plastics are now often called resins. Which materials will become unpopular or unavailable next?

How Does Material Choice Integrate into the Overall Design?

The CDP team has very broad knowledge in a variety of areas of consumer, industrial and medical applications from materials for printed electronics through adhesives and hydrogels to pesticides for rodent control. We have not just a materials expertise but an expert interface with engineering and manufacturing disciplines to offer a range of product design solutions.

We have specialist experience in materials for energy generation and storage, from batteries to supercapacitors and fuel cells, enabling us to identify opportunities to generate intellectual property in both materials and applications.

In particular, the CDP skillset includes a detailed understanding of materials in healthcare applications. This is of particular importance for drug delivery devices, where this capability provides a vital insight into the possible chemical interactions between a medical device and the drug being delivered. Manufacturing processes such as sterilisation methods, coupled with formulation characteristics including viscosity, surface tension or particle size will all have an impact on the selection of materials.

In a Nutshell

When we consider materials, product form and manufacturing process separately, we can go a long way towards achieving a good design. But it is only when we look at the choice of appropriate materials as part of the overall design and manufacturing process that we can achieve so much more.

We use so many different products in our everyday lives and they all need to be made from the most appropriate materials so that they will continue to perform well for many years.

AI in healthcare, separating facts from fiction

November 27th 2019

James Baker

James Baker, partner at Cambridge Design Partnership, considers the future for AI in the real world with help from a sideways look at its portrayal on the big screen.

In the movies, we often see big tech and deep data combine to challenge humankind in new and ever more fiendish ways. Indeed, at the cinema, human interaction with Artificial Intelligence (AI) is a rich seam of storytelling, which rarely ends well, for the human!

Meanwhile, back in the real world, we are now in an era where digital data, and more importantly the insights that can be drawn from it, can be as important – and as valuable – as physical objects. At Cambridge Design Partnership (CDP), one of our specialisms is the design of medical devices, often using information and machine learning to provide utility and value beyond the physical device alone.

So, in the spirit of fun, here is what the silver screen tells us about the big questions surrounding machine learning in healthcare, and we ask how these ideas relate to the reality of what the technology can achieve today?

What price genetic data? (Gattaca)

In the 1997 film Gattaca, only genetically perfect humans are eligible for better jobs and lifestyles. We cheer on Ethan Hawke’s ‘genetically inferior’ character as he assumes the identity of a superior being in order to become an astronaut.

In today’s world, less than 20 years since Gattaca was filmed, genetic profiling and statistical prediction is gathering speed. Mapping of genomic sequences to traits is a rich area of study and just this week, Matt Hancock the UK Health secretary announced that all babies could receive a complete genome sequencing at birth. Crucially, this technology has the potential to predict an individual’s likelihood to suffer illness in the future. But should the way you are treated as a patient, or indeed a person, be determined by an assessment of your genetic makeup? Already insurers are asking for access to medical records and premiums are affected by the presence of certain diseases, so should they also be able to consider the likelihood of future illness as well?

Diagnosis – how far should you go? (Minority Report)

The film Minority Report envisages a world in which arrest and incarceration is based on a prediction of the likelihood to commit a crime before it has occurred.

Already today’s healthcare and wellness technologies create significant amounts of data about individuals. New processing methods and machine learning can analyse these multiple sources and draw conclusions.

Yet many clinicians don’t want every possible analysis to be given to them. For example, who is responsible if systems predict the probability of an illness, but the medical practitioner can’t confirm this conclusively? Does informing the patient provide any utility?

There are recent moves to define what can and can’t be done with personal data, such as the European Union’s General Data Protection Regulation (GDPR). These seek to control access to and ownership of data, but as yet, there are no similar frameworks to control the conclusions drawn from it.

What if AI overtakes human intelligence? (Ex Machina)

In the film Ex Machina a humanoid robot is created and given ‘intelligence’ built using a record of billions of human internet searches. But then (surprise!) the robot uses its knowledge of human interactions and desires to achieve its own freedom, deliberately misleading its human masters to do so.

Machine learning using huge amounts of information is an approach we see increasingly used in real life. In the field of diagnostics, AI is already showing great promise in diagnosing conditions such as Alzheimer’s and in facilitating cancer diagnoses. AI predictions are compared with a gold standard diagnostic to determine the most significant automated metrics to detect the condition.

This approach is already being used in cancer screening, enabling earlier detection through far more extensive analysis than is possible manually.

But what if AI doesn’t react like we expect? (2001)

An all time classic, 2001 cleverly hides a story of unintended consequences within a ground breaking and spectacular space opera. The HAL character appears to have a sinister agenda and behaves malevolently, attempting to kill off the human crew – but ultimately is understood to have been driven by conflicting orders.

In the real world, AI can deliver responses that are not what we expect. Large data sets may still contain insufficient information, erroneous or poor-quality data, which by chance may create patterns that have no meaning.

A good example of where AI can deliver unanticipated (and unwanted) behaviour is the late, unlamented Microsoft Tay chatbot. Its premise was that, by listening to and learning from posts on Twitter, it could generate useful tweets and help manage commercial Twitter accounts. But within hours of its release in 2016, Tay began posting inflammatory and offensive tweets and had to be taken down.

So, before we make AI systems independent, how can we be sure how they will behave and who takes responsibility for their actions?

Sometimes, AI can really help us (Wall-E)

The 2008 story of a good-natured planetary janitor-bot left to clean up our human mess shows how AI can really benefit humankind, turning its hand to automating work that would otherwise be onerous and low value. See also, C-3PO and R2-D2 in the Star Wars movies. It’s surely no coincidence that the two loveable droids are the only characters to appear in every single film in the Star Wars franchise.

Back in 1950, computing pioneer Alan Turing predicted that by the year 2000 computers would be able to trick us into believing they were human 30% of the time. He was not far wrong, in 2014 a chatbot called Eugene Goostman convinced 33% of judges that “he” was a 13-year-old from Ukraine, thus officially passing the Turing Test. We see these kinds of natural language interaction technologies being used increasingly in consumer goods, but also finding utility in medical applications such as triage with patients seeking care. This enables faster access and a better “customer experience” whilst also allowing healthcare practitioners to focus on provision.

In conclusion, at CDP our focus is on how to realise value for our clients, and machine learning is one of the tools we can bring to bear. With the ongoing bombardment of new technologies, it is important to understand when it can provide effective solution, and when more traditional methods will provide the best results. It’s no longer a question of what can we do with AI?

We need to ask: What should we do?

Preparing for the new IVD regulations

October 25th 2019

Sarah Follett

Management System Lead

It may seem like there is plenty of time before the new IVD (in vitro diagnostics) regulation (IVDR) [EU 2017/746] comes into effect. The deadline for transfer is 2 years later than that for medical devices [EU 2017/745], so May 2022 might seem distant. However, given the changes that are required, clued-in manufacturers should be working now to be ready.

For those with products currently certified by a notified body (NB), there is additional breathing space. The key here is to get the current certificate renewed and extended by the current NB, which can give 5 years transition, meaning product can still be put on the market until 2024 and stay in use until 2025.

However, for the vast majority, their product was self-certified against the IVD directive [98/79/EC], which means come the 26 May 2022 deadline, the CE mark required for sale in Europe will be null and void. So, what do you need to do, as a manufacturer with a self-certified IVD on the EU market?

Where to start?

Firstly, do not panic! Easier said than done, but there is a wealth of information out there, if you know where to look or who to ask.

Step one, rationally review the Intended Purpose of your product. Have you really nailed it down in terms of what type of test it is, what is measured and how it is measured, patient population, intended user, use setting, purpose of the test? This will dictate much of what happens next and determining where your gaps lie. Without a proper Intended Purpose statement, you may not classify your product accurately, and within some classifications there are groups of products that have their own specific requirement above the standard ones. For example, near-patient testing (Point of Care) and Companion Diagnostics both have specific requirements in addition to those for other devices of the same classification.

This exercise shouldn’t be conducted by your Regulatory department in isolation. There may be market and business considerations to be made; Is there really a market for the Intended Purpose that you can support? Will there be an adequate return on the additional investment that may be required?

New requirements

An obvious difference is the change from the Essential Requirements Checklist (ERC) to the larger General Safety and Performance Requirements (GSPR). This is another good place to start, because completing all the relevant references to the Technical File within the GSPR will immediately point you towards where there are disparities, or the evidence is insufficient.

The key gaps in current Performance Evaluation data are likely. Previously not required, the IVDR now calls for things like Trueness, Precision, positive and negative predictive values (PPV/NPV) and specimen handling and controls. For some, this will require new calculations to be made using existing data, while other manufacturers will find they just don’t have what they need to meet these new requirements. For older products, was the clinical trial run with a comparison against something still considered state of the art? For self-certified manufacturers, it is important to be aware that it is going to be much harder to provide justification for not carrying out clinical performance studies. There is no grandfathering for the new regulations; all products are considered new and must stand up on today’s merits.

Risk and risk management has a far bigger presence in the IVDR than it had in the IVDD. This is one area that current self-certified manufacturers, in particular, should turn their attention. Have all possible indirect harm situations been considered and included? Are all residual risks in the IFU? And all manufacturers will need to consider the latest version of ISO 14971 when it is published at the end of the year.

The Post Market surveillance requirements and activities have been significantly beefed up from the IVDD. It requires more than logging customer complaints within internal systems, instead involving active and systematic data gathering, together with a Periodic Safety Update Report (PSUR) for Class C and D devices and Post Market Performance Follow-up. Processes will need to be in place that capture new requirements to log information in EUDAMED, to review scientific literature for new off-label use scenarios (as just one example), and ensure risk is considered and updated throughout the product lifecycle.

Out of your hands

The elephants in the room, which are totally out of manufacturer’s control, are EUDAMED being ready for use, and NBs being certified against the IVDR. EUDAMED is required for use with the MDR, so expectations are it should be ready in time for the IVDR. Of greater concern are the NBs. Currently, just 2 notified bodies have received this certification (DEKRA, Germany and BSI, UK). Others are known to be in the pipeline (approximately 10 more), but until they are announced there is big uncertainty. Add to that, the scope of the certifications, which also won’t be known in advance, so some manufacturers may still need to change their NB, even if they are certified to the IVDR, because they cannot support their product range.

There is a lot to do to be able to sell your IVD after 26th May 2022. However, with the right planning and support, all the documentation can be put into place. It remains to been seen if the notified bodies will be able to keep up with demand, but at least manufacturers can be prepared when they get to the top of that queue!

Connect with CDP

For more on how to navigate the new IVDR requirements and prepare your IVD products for EU market compliance, contact Cambridge Design Partnership.

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Developing guidance for regulatory submissions

September 12th 2019

Helen Simons

RAPS (Regulatory Affairs Professionals Society) publish a set of excellent “Fundamentals” books, each covering a different regulatory context: US, EU, Canadian and International (which covers other markets). These books detail the key aspects of the regulations for pharmaceuticals, medical devices and IVDs (In vitro diagnostics) with considerations about how they should be followed and implemented. These are essential for healthcare companies looking to make submissions outside of the jurisdictions they are familiar with.

These books need to be regularly updated as regulations evolve to ensure they are current, and I have been chosen as a subject matter expert for the US fundamentals book that looks at the requirements of the FDA (Food & Drug Administration). I have recently updated the chapter “supply chain and traceability”, along with a second author, Jyoti Chauhan.

This chapter was initially introduced in the last edition (10th) and so was relatively new to the book. Upon reading, I was most surprised that it did not cover any elements of supply chain or traceability for medical devices, only focusing on pharmaceutical requirements, specifically the Drug Quality and Security Act. I felt the chapter was lacking in detail on medical devices because traceability is a key topic at the moment with the introduction of UDIs (Unique device identifiers) in the last few years, so this was a big gap to be missing.

My first task was to pull together all the existing guidance on the topic of UDIs which the FDA have published as well as the key aspects of the CFR (code of Federal Regulations) in relation to supply chain and traceability. It was interesting to compare them at the same time as different pieces of information are emphasised in different guidance, so I wanted to summarise these in a cohesive overview.

Adapting to the formal writing style of these publications was a practical challenge, but I hope my description and analysis will help other regulatory professionals navigate the tricky waters involved in submitting their products to the FDA for approval.

If you want to know more about these subjects or how CDP can help you with your quality and regulatory activities, then please do get in touch with us at hello@cambridge-design.com.

CDP create a remarkable ‘smart pill’ for Mars Petcare

August 13th 2019

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Innovations in Hemodialysis

July 19th 2019

Clare Beddoes

Head of Drug Delivery

Matt Brady

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.

What’s next for Hemodialysis?

June 14th 2019

Matt Brady

Jess Carroll

Consultant Mechanical Engineer

The 56th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) conference takes place this year on June 13-16 in Budapest. With this in mind, Matt Brady, Partner & Head of Medical Therapy at Cambridge Design Partnership and Jess Carroll, Mechanical Engineer from Cambridge Design Partnership consider the future of renal disease patient care.

Home dialysis on the up?

There have been some business moves recently in the renal care sector that may well signal that home dialysis is set to become more common. In February this year, NxStage, one of the world’s leading manufacturers of home hemodialysis (HHD) machines, was bought by German renal care giant Fresenius Medical Care in a $2 billion deal.

Back in the 1970s, 40% of dialysis in the US took place in patient homes but this lost popularity in the 80s and 90s in favour of patients travelling to purpose-built medical centers. Disadvantages of home hemodialysis (HHD) included the fact that bulky devices and their associated consumables took up a lot of space in homes and patients struggled with device maintenance. However, recent developments have led to smaller machines with streamlined consumables, and which are easier to clean and disinfect.

Fresenius Medical Care is the world’s largest provider of dialysis products and services and, as such, is well placed to drive the market. Its takeover of NxStage is, we believe, a move which could spark an industry-wide migration to home dialysis.

The provision of home dialysis requires support staff to check up on patients regularly and to deliver both training and the co-ordinated delivery of consumables to the patient. However, this may not be such a barrier to change: existing dialysis centers could easily be outfitted to host training events and support staff normally employed to monitor patients in center could instead offer home visits. Dialysis centers are already well dispersed in communities and well placed to support home dialysis. They could also benefit commercially from an ability to grow their patient base without requiring more seats.

What benefit would this bring to patients?

Home dialysis has many advantages for patients compared to the more usual In-Center Hemodialysis (ICHD). Treatment out of the home is notoriously time-intensive – patients typically have three sessions per week, each lasting around four hours, plus there is the travel time to and from the dialysis center. Home dialysis, by contrast, has significant lifestyle benefits. It allows the patient to have a flexible treatment schedule with no need to travel, allowing them to stay in employment/education and generally have far less disruption in their daily lives.

Additionally, research indicates that shorter, more frequent dialysis may offer medical benefits, too. It reduces post-dialysis recovery time, improves overall sense of wellbeing, improves blood pressure and reduces the amount of medication the patient needs to take. Alternatively users may choose to maintain the 3x per week schedule but conduct overnight sessions, benefitting from a slower, gentler treatment as well as the obvious lifestyle benefits. In both cases users can avoid the dreaded “dialysis weekend” inherent in the schedules of most dialysis centers.

However, it’s not just patients that look set to drive the demand for home dialysis. Payers are also leaning towards it, due to its potential for cost reductions and cost incentives. As long ago as 2011, the USA Centers for Medicare and Medicaid Services (CMS) had already adopted a new payment system for their Medicare renal disease programme which favours home dialysis. This gave dialysis providers more financial incentive to offer home dialysis services and already seems to have had an effect in the US and may also have contributed to growth in home dialysis utilisation generally.

The statistics are certainly beginning to bear this out. In 2008, 93.5% of US dialysis patients received their treatment in centers but by 2016 that figure had dropped to 89%. It is also worth noting that the overall numbers of US patients receiving dialysis has risen from 108,945 in 2008 to 121,209 in 2016, which gives a sense of the rising demand for this treatment.

In the UK, the National Institute for Health and Care Excellence (NICE) already recommends that patients are given a choice over the setting and type of dialysis. In terms of cost, NxStage has reported to NICE that the average price per treatment for their System One home dialysis device is just 60% of the current NHS tariff price for home dialysis, a strong financial incentive to make the switch.

Back in 2009-2010, a study assessed that chronic kidney disease care per patient receiving dialysis can be crudely estimated at £27,000 per annum. In that same year, dialysis cost the NHS just over half a billion pounds a year (£504,680,228) with transport of the patient to and from dialysis centers costing just over £49.5 million.

As of Dec 2013, just over 27,000 UK patients were receiving dialysis, with 5% (1,113) being treated at home. The overall number of people on home hemodialysis has increased by 3% since then, with 1,256 patients receiving home treatment in 2016.

Although home dialysis is clearly an attractive alternative, there are many perceived barriers that may discourage patients from choosing it. Many cite fear of losing the in-center back-up from staff and a reluctance to self-cannulate (introduce a thin tube into their veins). Other factors include wanting to separate home life from medical life and not wishing to burden family/friends with having to assist with treatment.

However, it is likely that these barriers can be overcome with innovative new devices and systems, adequate education, including motivational training to empower the patient, as well as supportive medical staff. Another barrier which may be more difficult to overcome, though, is a lack of suitable accommodation for home dialysis, especially given today’s trend for smaller new homes and expensive house prices. One recent study of patients from a predialysis clinic in London found that only 29% of homes assessed were suitable for peritoneal dialysis and only one home was suitable for home hemodialysis.

As well as NxStage, there are several more manufacturers of home hemodialysis equipment well worth keeping an eye on. These include Quanta Dialysis Technologies (UK) which makes the table-top SC+; Outset Medical (USA) with its mobile Tablo machine and French company Physidia’s S3 monitor. Baxter, another large US manufacturer of traditional dialysis machines, again participated in Outset Medical’s $132 million investment round in August of last year, another sign that well-established players in renal care are feeling the pull of home dialysis.

Emerging competition from China?

Chinese companies Wego, Biolight and Bain Medical were in all attendance at last year’s ERA-EDTA international conference. So far, these companies have focused on the Asian dialysis market. Will their need for continued growth, alongside the much-discussed slowdown in the Chinese economy, drive a strategy of expansion into established markets?
Like Fresenius (and to a lesser extent B.Braun), Wego both produces dialysis machines and operates dialysis centers. Wego could use its experience and resources to open dialysis centers in Europe or the US in direct competition to Fresenius. Biolight produces traditional dialysis machines and related consumables. It is likely to be able to offer lower costs than European or American companies and may be attractive to payers.

Bain, by contrast, solely manufactures blood purification consumables but we noted that it displayed a functional pump at last year’s conference so is clearly growing its business. Bain already has well-established relationships with many renal care companies outside of China, and thus may be in a position to expand into machines, certainly in China first but given their impressive expansion to date we shouldn’t bet against more global ambitions in time.

So far, Wego and Biolight haven’t made any visible moves towards home dialysis so companies like Fresenius have the advantage in this field, at least for now. As home dialysis becomes more popular with patients, we predict that promoting home dialysis could be an effective commercial response by established Western and Japanese players to new competitors entering the renal care market.

It is very likely that the race to dominate the home dialysis market may drive innovation, reducing running costs and increasing patient benefits as well. All in all, this is an interesting time for the renal care industry and one which, we anticipate, will lead to better treatments for patients.

What’s next for Hemodialysis?

June 14th 2019

Home dialysis on the up?

What benefit would this bring to patients?

Emerging competition from China?

Like Fresenius (and to a lesser extent B.Braun), Wego both produces dialysis machines and operates dialysis centers. Wego could use its experience and resources to open dialysis centers in Europe or the US in direct competition to Fresenius. Biolight produces traditional dialysis machines and related consumables. It is likely to be able to offer lower costs than European or American companies and may be attractive to payers.

Matt Brady

Partner & Head of Medical Therapy
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Jess Carroll

Mechanical Engineering Consultant
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