Category: Analysis

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By Karla Sanchez, Alison Hart and Maru00eda Fernu00e1ndez-Martos Balson
April 3rd 2020
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Karla Sanchez

Karla Sanchez

Senior Consultant Biomedical Engineer

Alison Hart

Consultant Data Scientist

Maru00eda Fernu00e1ndez-Martos Balson

Biomedical Engineer

COVID-19 Modelling

Models are everywhere – anyone who has played a computer game has encountered a model, but in a pandemic, mathematical models are vital for understanding the dynamics of transmission, disease progression, healthcare needs and the overall outcome on the population.

Recent real world events have shown that critical decisions are being taken based on model data. Many people are still uncertain of how models work which can lead to them being met either with undue suspicion or absolute faith. In reality models are incredibly powerful, as you can test different courses of action quickly so an optimised response can be formulated, but their limitations need to be understood.

What is modelling?

Here we try and explain the basic principles of models, how mathematical models can help and what their limitations are.

Mathematical modelling involves making a mathematical representation of a system where the expected outcome of changing various parameters can be calculated. This means you can examine the outcomes of many scenarios using the same model. For example, the models reported on recently look at the spread of Covid-19 with different levels of social distancing and other interventions such as school closures. A model of a complex system is usually a collection of many separate models, each a breakdown of a different part of the system. For example, the first thing to consider when modelling the spread of disease is infection. You need to know certain things such as;

  • how likely is the infection to spread person to person with each contact?
  • how often do people come into contact with each other?

These values are called parameters and can be changed depending on the situation. The equations behind epidemiological models for the spread of infection are well established, but the parameters will vary between countries depending on things like the breakdown of age and population density. Crucially, epidemiological models rely on data. Sourcing these parameters is all part of modelling and assumptions have to be made.

For recent UK modelling this data came from a number of diverse sources. Census data could give a good indication of the age and distribution of households, data on social connections broken down by type (work, school, home) and age came from a BBC citizen science project. Even knowing this, data on class sizes, commute distance and company size were then needed to create a virtual population to simulate the spread of the disease.

Models can also show where collected data may be inaccurate. Recent models monitoring the situation in Spain found that the number of COVID-19 deaths reported appears to be significantly underestimated, given existing data on the expected seasonal number of deaths in a normal year and data on the total number of deaths recorded in the past few weeks (by any cause).

Simple demo of infection model.

This is a very simple model purely looking at infection.  When ‘infected’ balls come into contact with others susceptible to the disease there is a probability that the other balls will become infected. There is no death rate, everybody recovers and is then immune.  The speed of the balls represents the number of social contacts. The probability of infection, the proximity for infection, the length of the infection all need to be set.  Even in this toy model many assumptions have been made.

What changed with the recent modelling?

Having modelled infection and the population, the outcome needs to be considered. What proportion will recover and develop immunity? What proportion of people will become hospitalised? Of them, crucially, how many will need intensive care and specialist equipment like ventilators. All these parameters depend on the disease itself. Unfortunately, Covid-19 is practically unknown, researchers have had only a few months to study it. That means there has been a degree of uncertainty with the parameters fed into the models.

One widely reported model that looked at the impact on the UK population was led by Imperial College London. Having updated their models with better information from Italy on the proportion of patients requiring  intensive care beds, it found that the UK’s National Health Service would not be able to cope without further action, which led to the recent dramatic change in government policy.

In the report, the team presents a pandemic curve for different degrees of potential government intervention. The different measures that they considered the impacts of were: no intervention, household isolation, social distancing, and school closures. With no intervention, the model predicted a need for hospitalisation thirty times what the current UK healthcare system can manage. Only by combining all of the measures would the healthcare system not be overwhelmed.

This is one of the graphs from the Imperial paper [1]. The vertical axis shows the number of critical care beds needed through time in each scenario. The blue region shows the time period on the horizontal axis where various social distancing is applied. The horizontal red lines show the maximum number of NHS critical care beds available. The various lines, explained in the key, show the difference between doing nothing,  applying some social distancing and with full school and university closures. This graph shows that without all measures being taken the number of available beds would be exceeded.

What happens next? What about the large peak when the measures are withdrawn?

We need time. Time to get better testing, time to find new treatments and more ventilators. The current model suggests the current restrictions should keep the number of cases at a manageable level for the next few months.

The Imperial model makes important assumptions. Firstly, it assumes that measures put in place to control the spread of the virus are all lifted at the same time, which is neither realistic nor advisable. Secondly, it assumes that recurrences of the outbreak after the initial lift of restrictions continue for an indefinite period. In reality, this may not happen due to people acquiring immunity or the availability of a vaccine. Finally, it doesn’t account for infected cases that have gone undetected or for tools such as contact tracing, which can help break the chain of transmission.  All of this will affect the number of people who become infected once the measures are lifted.

A competing model by Oxford University followed the publication of Imperial’s model. This model stated that under-detection of cases could be high, indicating that a significant part of the UK population could have already contracted the virus. This caused a big media response, however, given the data available it seems an unexpected conclusion to draw, as epidemiologist Adam Kucharski pointed out.

The Imperial model has since been refined and other competing models have been published, but the consensus remains.

It’s important to remember that the model is only based on what we know now. Models are continuously updated. Research teams are now focusing on measuring the impact and preparedness of healthcare systems by predicting the number of hospital beds, ventilators and testing kits needed based on what the models are telling us. They are also looking at the big question of the length of time needed before lifting restrictions and how to prevent a second wave of the outbreak, and models will help us to understand this better.

So in a few months the situation will have changed, the model will be updated with more information and the curve may look very different. Data should start to emerge to confirm level of immunity gained from recovering from the disease. More hospitals are currently being built and there is a national effort to produce more ventilators. Doctors have already identified the response that causes some patients to develop severe symptoms while most have a mild version, which may make it possible to screen people to detect who is most vulnerable or identify better treatments.

Given the rate of learning in the last 3 months the picture may be very different when more accurate assumptions  are fed into the models.

Once a vaccine has been developed, we may  require modelling for rolling it out to best effect, as well as monitoring changes in the virus. This will feed into the ongoing body of research for this pandemic and will help us prepare for future pandemics.

While models are not always accurate, they help build a consensus of understanding that informs policy and helps save lives. Taking the right measures at the right time is key in the fight against Covid-19 and through modelling we can make the best-informed decisions possible from the data available.

References

[1] https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/Imperial-College-COVID19-NPI-modelling-16-03-2020.pdf
[2] https://www.gov.uk/government/groups/scientific-advisory-group-for-emergencies-sage-coronavirus-covid-19-response 

Surgical robotics
March 25th 2020
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Where’s the value in surgical robotics?

The first robot-assisted surgical procedure was performed in 1985. In the 35 years since, the field of surgical robotics has exploded, with both surgeons and patients demanding access to the technology. This boom has brought with it plenty of vocal advocates, and just as many critics, debating the risks and rewards of robotic technology over traditional open and laparoscopic techniques.

The main criticism of robot-assisted surgery comes down to the fact that, despite the lofty initial and recurring costs associated with robotic equipment, patient outcomes of robotic-assisted procedures seem to be no better than conventional laparoscopic procedures. Some may see this as evidence that investing in surgical robotics is nonsensical, but it is worth considering the future potential of the technologies. For while the tools and techniques used in conventional laparoscopy may see slow incremental improvements over coming decades, each new generation of surgical robots will likely continue to bring radical step-change improvements in procedural precision, patient safety and surgeon control and comfort.

Current benefits of robot-assisted surgery

The current generation of surgical robots offer a few significant advantages over traditional laparoscopy.

  • Ergonomics & surgeon comfort: the ergonomics of laparoscopy are not ideal and can take a toll on a surgeon’s body. During robot-assisted procedures, the surgeon sits at a workstation and controls his surgical tools using ergonomic master controllers. If the surgeon needs to take a break at any point in time, they can let go of the controllers, and the robotic instruments will maintain their current positions.
  • Precision: a robotic system translates the inputs from the surgeon’s controllers to output motion of the surgical instruments. This allows for motion scaling (for example, 3mm of movement by the surgeon results in only 1mm of movement of the surgical tool), providing unprecedented surgical precision.
  • Stability: while providing some haptic feedback to the surgeon is desirable, a robotic system can handle all the stresses and loads associated with a procedure without translating them all back to the surgeon’s hands. Along with surgeon comfort, this allows for improved stability.
  • Better visibility: the steerable robotic endoscopes provide a high-definition 3D visibility of the surgical site, allowing the surgeon to better see what they are doing, compared to 2D endoscopes used in laparoscopy.

More hands: while we humans are tragically limited to typically having only two hands, robots are not subject to such limitations. The da Vinci Xi, for example, has four robotic arms. The surgeon toggles back and forth between controlling different combinations of these arms using foot petals.
Fast learning curve: learning how to safely and effectively perform robot-assisted procedures tends to be faster than training to perform laparoscopic procedures.

Current limitations of robot-assisted surgery

Advocates of surgical robotic technologies tend to focus on the various benefits without mentioning some noteworthy risks and challenges:

  • Setup time: nurses and surgical assistants often complain about the long time it takes to prepare a robotic system for a procedure, including wipe-downs, draping and loading of surgical tools.
  • Lack of haptic feedback: current robotic systems provide very limited feedback of applied forces to the surgeon. Instead the surgeon is required to use the visual feedback from the 3D endoscope to judge what amount of force he is applying to patient tissue. Some studies suggest that surgeons apply significantly higher forces and stresses to tissue using robotic systems than using laparoscopic tools, potentially resulting in more damage to the tissue.
  • High cost: a daVinci Xi system costs about $2M USD. Each da Vinci surgery may cost $3,000 USD more to the patient / insurance company than a traditional laparoscopic operation.

The future

Many of the criticisms above are valid and must be taken seriously. Effectiveness and safety of robotic technologies must continue to be proven, and limitations should be assessed and accounted for. However, these should be seen as criticisms of current robotic systems on the market today, not as criticisms of robotic surgery in general. If anything, these criticisms hint at where surgical robotics is headed next. While Intuitive Surgical continue to innovate, the field of players is also getting wider, with companies like Johnson & Johnson, Medtronic and Stryker investing billions into research and development. Future generations of robotic systems will bring a range of short-term and long-term improvements and will redefine what is possible in surgery.

Increased haptic feedback is expected to be a key feature in some future systems. This will allow the surgeon to truly feel the motions and gestures they are executing with the robotic instruments.

The cost of robotic systems and tools is expected to decrease as the volume of robotic systems and tools sold continues to grow and with increased competition, as new companies bring their robotic systems to market in the coming years.

There may be potential benefits in surgeons being able to carry out procedures remotely. Already today, the surgeon workstation does not necessarily have to be in the same room as the patient. Taking this to the next level, future systems may allow an expert cardiovascular surgeon to perform specialist surgeries all around the world from the comfort of his own office.

The Big Question

All of these features still depend on a human being (the surgeon) having control of every movement of the robot. The big question is: at what point will we be comfortable giving up some of this control to a robot? Crossing this line will increase the productivity of the scarcest of resources, highly trained surgeons, and start to significantly improve the cost-benefit equation for these systems.

Leveraging image recognition and artificial intelligence, it is fathomable that, in the quite near future, we could have a robotic system capable of making decisions and performing certain tasks independently. Especially with repetitive tasks like suturing, a robot could be trained to become increasingly efficient and effective.

However, as we’ve seen with self-driving cars, we humans have very little tolerance for injury and death caused by robotic systems. Despite worryingly high death tolls caused by inebriated and distracted drivers, it is not enough for new technology to reduce injury and death. Even a single death caused by a self-driving car convinces some that the technology is not ready. This may be the same psychological and regulatory hurdle that surgical robotics must overcome to realise its potential.

Connect with CDP

For more on how to accelerate innovation in surgical robotics, from device design to clinical value, contact Cambridge Design Partnership.

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Engineering sensory experiences|Ben Strutt|Martha
By Ben Strutt
March 24th 2020
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Ben Strutt

Ben Strutt

Partner

Engineering sensory experiences

Humans are multi-sensory organisms! We navigate the world around us through five senses all working in parallel, deriving not only practical information about our surroundings, but also emotional and social meaning.  In milliseconds we unconsciously make decisions that keep us alive, shape our day, define our preferences and ultimately drive our choices.

As we are exposed to new sensory experiences, we develop deep seated cognitive constructs that in turn further influence our decision-making – perhaps the illusive sixth sense!

Our perceptions of flavour and fragrance in our food and drink is one of the most hard-wired responses.  Initially designed to help the human species survive and reproduce by finding things safe to consume, after the more recent industrialisation of food it has become an opportunity to engineer the parameters that influence preference, liking and consumption.

Today an entire industry has grown up around flavours and fragrances; sensory sciences came of age as a discipline to help objectively understand, parameterise, and engineer the specific attributes that impact on our choices. Sensory Panels, expert groups of individuals, carefully trained to objectively parameterise different formulations are core to the development of new product specifications; from defining our favourite toothpaste mouth tingle, to building corporate confidence in the transition to a sugar substitute in a $bn snack brand (our team have worked on both!), it is likely that a sensory expert will have been involved along the way!

But is this, in many ways standardised approach, limiting us? Are opportunities being missed to leverage this scientific rigour and usefully blend it with subjective consumer perception? How should sensory science engage with global trends, omni-channel product experiences, the circular economy, declining brand loyalty and steady growth of e-commerce?

At CDP we are working in a number of ways (two of which we’ve outlined below) to make product specifications more commercially effective, and more sensorially affective, and we had the chance to display some of our work at the Pangborn Sensory Science Symposium last year.

1. Look beyond flavour, fragrance and mouth-feel!

Online grocery shopping is growing rapidly, and yet the physical pack interaction experience has always been central to in-store decision-making.  While traditional sensory sciences often bias us towards flavour and fragrance, the old proverb reminds us that the first bite is with the eye, and CDP’s team believe that other senses can be leveraged through intelligent packaging design to amplify under-utilised sensory cues.  Our Front End Innovation team have developed a methodology to effectively translate formulation attributes into packaging parameters to help reinforce the anticipation of consumption at the first moment of truth. We have worked closely with the makers of some of the most famous mayonnaise and spreads brands in the world to, for example, elicit, create and reinforce positive haptic cues in the jar lid, giving confidence in the seal and re-seal experience, and to premiumize the acoustic signature of the thin-walled pack-lid on repeat opening. Even the maker of dry, powdered soups and bouillons was able to leverage packaging parameters that positioned the product closer to more desirable attributes of naturalness and freshness. Our team includes scientists and engineers, which means we can provide a rigorous quantitative technical specification for that enhanced, consumer-validated pack experience!

2. Involve the consumer!

Involve them precisely because they are not trained panellists; involve them in Sprints, and co-creation and in-home sensory research, as well as more traditional central location or lab testing! It can be extremely illuminating to involve consumers in exploratory formative research, rather than just for validation of what a sensory panel have advised or specified. Involving them early on can lead to serendipitous moments where new connections are made – leading to new value propositions, and opportunities for brand extension. It can also lead to surprising revelations that highlight some limitations of objective sensory science methods, when a consumer responds to small, almost imperceptible changes to a pack design in an unexpected way.

In many industries, the manufacturing and regulatory lead times and consumer loyalties associated with changing formulations can be far more restrictive than changing pack design; our work has demonstrated time and again that we can influence consumer perception of key formulation attributes such as efficacy, healthiness, freshness, and strength, even prior to first use, by making changes solely to the packaging look, feel, and sound.

New products and experiences are coming onstream all the time, and for some of these a sensory panel base line or ‘normal’ specification does not yet exist; we have recently been working on an entirely new category of product which demanded a new sensory protocol to be created, and which at the heart of it considered how the device and formulation had to work in harmony to create the consumption experience. We were excited to pioneer a collaboration between our team and affective methodologies, with those of a more traditional flavours and fragrance partner, and the result is an optimised, category transforming product-formulation experience.

As a sensory industry, we need to re-imagine the relationship between the formulation and the devices or packaging containing and dispensing it; it is a closer and more mutually symbiotic relationship than past practice gives credit to. Through this insight we have more opportunity than ever before to positively engineer a multi-sensorial consumer experience that truly delights.

The 2016 National Health Interview Survey
By Graham Myatt
March 18th 2020
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Graham Myatt

Senior Healthcare Consultant and North America Business Development Lead

Combining treatments to better manage pain

The 2016 National Health Interview Survey of 17,000 Americans reports that 1 in 5 people suffer chronic pain1. Significant effort and money are being invested by companies ranging from large Pharma to small Tech start-ups to address this “pain epidemic” as evidenced in the clinicaltrials.gov database showing over 2,500 “pain” trials which are actively recruiting. Some of the more interesting studies are looking at the benefits of combining pharmacological and non-pharmacological approaches to pain management, reflecting a growing recognition within the medical community that a multi-modal approach can often offer a range of significant patient benefits.

While the body of clinical evidence supporting a multimodal approach grows, we have to recognise that many people who suffer from pain already mix-and-match different therapies to meet their individual needs. Moreover, they are talking about their experiences and treatments, sharing advice and influencing each other through the many on-line blogs and forums dedicated to chronic pain. After spending a few hours surfing through these resources it’s clear that a large proportion of sufferers still have unmet pain needs and they are unafraid to try different, often non-pharmacologic, solutions in addition to their medications. These non-pharmacological treatments are varied and can include Transcutaneous Electrical Nerve Stimulation (TENS), Movement Therapy, Massage Therapy, Virtual Reality Assisted Distraction, Mindfulness and Suggestion Techniques, Cognitive Behavioural Therapy, and Acupuncture.

In fact, the most powerful insight is that people don’t expect there to be a single product or treatment which will address everyone’s pain (though that would be nice). Instead, they are looking for a range of options that are tailored for their specific needs which include social and emotional elements, not just functional pain reduction. For example, time, money, ease of use, on-demand access, drug-free, stigma-free, and building pain treatment into their health and wellness routines are all important elements that pain sufferers are looking to address.

This leads to an interesting question we should ask ourselves… “how can the medical community and companies help each pain sufferer along their treatment journey to identify the right combination of pain treatments that meet their specific set of needs – and adjust depending on changes in their circumstances?”

The answer probably lies at the intersection of current Consumer and Healthcare trends. People are wanting to take more responsibility and control of their Health and Wellness status and are prepared to use technology to achieve this goal.

The scientists at Cambridge Design Partnership have deep consumer experience in this sector as well as proven technical capabilities to:

  • monitor people and their behaviours with wearable technology and instrumented devices,
  • capture and analyse this data to create useful insights,
  • use machine learning to draw out further insights and make recommendations and
  • implement complementary techniques like Biofeedback, to reinforce therapies.

This toolkit enables us to create new and exciting products and services to better help pain sufferers optimise their individual treatment regimens – what to use and when to use it. Remember, pain sufferers are already experimenting to find the best multimodal regime for themselves – we can help them take the next step.

For more information about our capabilities in Consumer Healthcare, please contact Graham Myatt at hello@cambridge-design.com

1. James Dahlhamer et al, “Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults
United States, 2016”, Weekly / September 14, 2018 / 7(36);1001–1006.

COVID-19 quarantine - How we are keeping our innovation projects moving
By Jez Clements and Mike Cane
March 13th 2020
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Jez Clements

Partner

Mike Cane

Partner

COVID-19 quarantine – How we are keeping our innovation projects moving

Mitigating infection means more and more people are working away from the office. At Cambridge Design Partnership we have geared up to work remotely, both internally with our project teams and externally with our customers. In this special blog, Jez shares some of the communication approaches we are using.

Here at Cambridge Design Partnership, we have a wealth of experience in remote working and conferencing. Our move to create the best possible virtual comms was initially sparked by our clients all over the world, with whom we seek to work closely in a collaborative and creative atmosphere from our HQ in Cambridge, UK and our East Coast engineering hub in Raleigh, North Carolina in the US.

We were mindful of the findings of Professor Albert Mehrabian, who back in the 1970s first mooted the concept of non-verbal communication. He found that in a test where people were asked to convey their feelings, 7% of communication was conveyed by the speaker’s words, 38% by their tone of voice and 55% by their body language.

In a vibrant meeting atmosphere like a brainstorm or creative discussion we naturally prefer the face to face experience, we find we talk a lot with our hands, technical props or mocks ups. So the trusty teleconference is lacking. Low cost video conferencing has been around for a while, but we have found that with a careful choice of hardware, software and etiquette, it’s a game changing tool.

The basics

We need teams to feel as though multiple locations have merged together, with everyone feeling relaxed and engaged so that they can fully contribute to the discussion. It’s crucial that everyone can see and hear each another, as well as look at what’s being presented or created, such as sketches, models, prototypes, videos and other simulations.

Choose the right platform

We use the Zoom videoconference platform; it integrates with Office and is easy to use. We simply email a link to join a meeting and with one click, the participant is in. Having said that we can easily add a password if needed.

But the software is only part of the equation, the camera and audio on many laptops leave much to be desired, and there are lots of relatively low cost add-ons that make all the difference.

Get plenty of cameras

You need high-definition video so participants can clearly see each other’s facial expressions and body language. This is surprisingly important – remember Professor Mehrabian’s findings! We use the Logitech range of high definition video conferencing cameras. We use ‘Connect’ for personal use and ‘Meet Up’ in larger conference rooms, they plug into your laptop and are transformational. They can be placed in your room to give a feeling of space, so the camera is not looking up your nose like many laptops do and the images are much more lifelike and expressive.

For groups you need enough cameras and screens for all team members to see and be seen. This makes everyone feel connected, rather than just having one camera focused on a whiteboard or a ‘talking head’. We link these cameras and screens into the meeting using the Zoom platform.

Clear audio

Having clear audio is essential, especially in larger rooms when people move about. Meet up offers great audio, but those who have to use laptops on their own need headsets or a Jabra table-top speaker/microphone, they are omni-directional and work really well with groups in larger rooms. It’s so important not to have to strain to make out what is being said, it makes the meeting much more relaxed and natural.

The role of the smart phone

Another key tool is the humble smartphone. This provides the flexibility for individual members to communicate very quickly. For instance, if there is a sketch or prototype someone wants to show, they can grab their smartphone, activate the Zoom app (use the joining code) and immediately share their camera. Of course, people can also join the meeting just with a smartphone.

Preparation is key

We always set up our meeting rooms in advance. No matter how good your kit is, there is often a technology ‘moment’ that needs resolution. You don’t want to lose that creative vibe as your team waits for IT issues. Also, don’t forget the conventional best practices for meetings apply as normal. Make sure you have a facilitator who issues briefing documents well ahead of the meeting and takes charge of the session with a clear plan.

Reap the benefits

With many virtual meetings and brainstorming sessions now under our belt, we’ve found that the remote working technology can actually enhance the communication experience. For instance, instead of all huddling around the same whiteboard or drawing, our use of smartphone cameras means that a drawing or virtual model can immediately be shared with everyone, regardless of their location. We have also found that a virtual meeting is usually much easier and quicker to organize, with more chance of all key players being able to attend and less time wasted while we wait for everyone to be available. It’s also hugely helpful that sessions can be easily recorded. This can be useful in unpicking exactly what was said and decided during a session.

Also, it’s remarkable to see how we are able to screen-share in our virtual meetings and work on complex Computer Aided Design (CAD), zooming in and highlighting areas, with the whole meeting able to follow and contribute.

In conclusion…

Now that we are used to virtual meetings, here at CDP we feel comfortable and confident with the technologies involved. It’s remarkable how people who are hundreds or even thousands of miles apart can work together really effectively, if the technology infrastructure is set up correctly.

The current outbreak of corona virus is worrying on every level, to which there are not many easy answers. However, there is a lot that we can do to ensure our economic activity is not hit too hard by the situation. We are happy to advise our clients how to make our virtual communication as effective as possible, and keep our innovation projects moving.

Website-Graphics_mobile-hero_brexit-regulations-952×500
January 31st 2020
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Brexit and the Implications for the Medical Device Industry

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.

Coronavirus outbreak
By Richard Owen
January 27th 2020
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Richard Owen

Senior Consultant Bio-scientist

Coronavirus outbreak; what can we learn about personal bio-security

We have all heard about the serious outbreak of the Coronavirus in and around Wuhan in China. It would appear that a virus strain has mutated and gained the ability to move from its animal host (possibly bats or snakes) to infect humans. It’s potential to spread is clear and cases of infection are rapidly increasing. This story is accompanied in the media with pictures of people wearing face masks as protection. So we asked, how effective are surgical masks or is there a better personal “bio-security” approach?

To answer this, you have to consider how respiratory viruses (such as Corona, Influenza, Rhinovirus and Adenovirus) are spread. There are two main mechanisms for a virus to spread from an infected person to their unwilling victim. The first is pretty direct and involves release of airborne virus-containing droplets from the upper respiratory tract, most likely during a cough or a sneeze. A cough travels at about 50 mph and can expel almost 3,000 droplets, whereas a sneeze can double that speed and expel an astounding 100,000 droplets1. Droplets that are less than 5µm in diameter hang around in the air for extended periods and when breathed in cause infection. The number of viruses needed to infect is surprisingly low. The previous SARS (Severe Acute Respiratory Syndrome) virus was found to be able to cause infection in a mouse when they were dosed with less than 10 viruses2. The larger drops will rapidly fall out of the air and land on surfaces around the infected person. These are unlikely to be breathed in unless people are in very close proximity, such as together in a crowded train.

The second route of transmission is via the droplets that end up infecting surfaces such as tables, chairs, door handles etc with viruses. which are transferred to people’s hands when touched. It makes sense that when the number of infected people is relatively small compared to the general population, in public places where hundreds touch the same things each day, you are much more likely to come into contact with a virus the infected person left behind than meet them face to face. Once a virus-containing droplet is on your hand it is highly likely to end up in your mouth, nose or eye. Try not touching your face for 30 minutes and see how difficult it is!

So if those are the transmission routes, how effective are simple fabric-based surgical masks? Well they won’t stop you inhaling the small air-borne droplets which will go straight through the mask. But they may stop many of the larger airborne particles that you may be exposed to on a train, so they have some benefit to the uninfected wearer if you are unlucky enough to meet an infected person. But then your mask is infected itself, and needs to be disposed of carefully.  But to completely stop the small particles, you would need a properly fitting mask more akin to a gas respirator which would significantly impede your breathing, and may startle your fellow travellers!

The key benefit of the surgical mask is the other way around, they significantly decrease the number of larger droplets released by infected people, acting as a sort of “splatter guard” and hence decrease the number of droplets on surfaces. This is well recognised in many Asian countries where it is seen as highly anti-social to have a cold and not wear one.

Masks are much more effective when paired with regular hand washing or use of alcohol-based hand sanitisers, which kill viruses and significantly decrease the chance of transferring live virus to your face. In a recent study, the University of Michigan found that use of simple face masks alongside hand sanitisers decreased flu infections by an impressive 50% to 75% compared to no control measures. There was no statistically significant decrease in infections with the face mask alone3.

A decrease of this size in transmission rates for such a simple, easily available, cheap and low burden method is very much worth having. At the start of an outbreak that has the potential to change from an epidemic (local) to a pandemic (worldwide) it is critical to decrease the rate of spread to allow government-based control measures (quarantine, hospital treatment and vaccination etc.) time to catch up.

To a large extent, the sanitiser or washing your hands regularly, is your main weapon against infection, and the mask is mainly to stop you infecting your friends should you unfortunately meet up with the virus.

References

[1]  American Lung Association
[2]  J Virol 90 (1), 57-67
[3]  Facemasks, Hand Hygiene, and Influenza among Young Adults: A Randomized Intervention Trial

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December 12th 2019
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CDP opens new building at their Cambridge HQ

Cambridge Design Partnership recycles ten old shipping containers to create a new upcycled office building.

As you’d expect from a business specialising in innovation, when it came to extending their company HQ at rapid pace, they came up with a rather clever plan.

CDP have just opened a remarkable new building at their Cambridge HQ, created from ten shipping containers and a tensile fabric atrium. The innovative design provides a new canteen and refreshment area, as well as six meeting rooms and six video conference booths.

“The challenge was how to create a temporary building that would provide the spaces the business needed. Our current offices are built around a large courtyard car park, so we thought that it would provide an ideal location for a new structure,” says Mike Cane partner at CDP.

“We wanted a new working space that would be both inspirational and have a life after we finished with it. Basing the design on recycled shipping containers provided fast construction and several options for reuse”.

In the past six years, CDP has expanded from a team of 30 to 150 engineers, scientists and designers. Even with the establishment of a second engineering facility in Raleigh, North Carolina, CDP’s forward planning anticipated the need for more space at their Cambridge office.

“We had already added a new building to our site in 2014, but our continued growth meant we were becoming short of space again,” explains Mike. “Planning limitations meant we could not add a third building here, so in the medium term a move to a new larger site was inevitable. But we needed to bridge the gap. So as designers ourselves, we were inspired by other shipping container buildings we saw and decided to design our own interpretation. 20ft containers lend themselves to small, self-contained meeting and video conference booths, and their structural integrity means they need minimal foundations, so the building can be easily removed and the original car park reinstated for the next tenants. Tensile fabric roofs are translucent and make great, light and airy spaces for informal meetings and eating lunch.”

CDP was founded 20 years ago and now works globally on a wide range of technology and product design projects, focusing on the Healthcare and Consumer sectors. The company is employee-owned and won the Employer of the Year award in the 2019 Cambridge News Business Excellence Awards. CDP also recently attained a prestigious Red Dot award, deeming it to be the third best design studio in the whole of Europe and the Americas.

The shipping containers came over to the UK from China with cargo in them and have been re-purposed by Ipswich based company Adaptainer, with insulated linings, windows, electricity and IT infrastructure. The structural fabric atrium was supplied by Streetspace, with the high tech fabric manufactured in New Zealand.

“The building was constructed in just 3 months and is designed to last 3 years on our site. It’s bolted steel construction allows it to be dismantled, loaded onto trucks and moved to a new site, providing it with a second life.” says Mike. “But for now this building has helped us to stay in Toft longer, and allows us to continue to offer great service to our clients in a pleasant, relaxed atmosphere for our team.”

AI in healthcare
By James Baker
November 27th 2019
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James Baker

Partner

AI in healthcare, separating facts from fiction

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?

2020: Decade of the drones|
By Adam Turner
November 22nd 2019
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Adam Turner

Consultant Mechanical Engineer

2020: Decade of the drones

Unmanned aerial vehicles (UAVs) or drones are increasingly part of our everyday lives. Here, Adam Turner, Consultant Mechanical Engineer and drone expert at Cambridge Design Partnership, considers the future potential of this remarkable technology.

Here at CDP, we love innovation and disruptive technologies. It’s what we do. So, needless to say, I find myself hugely intrigued by the uses offered by drone technology. Where will drones go from here?

The drive to design an unmanned aircraft initially came from the military, for airborne missions that were too risky for humans. In recent times, however, drones have found peaceful uses in everything from wedding photography to rounding up sheep. As designers, here at CDP we’re pretty sure this is just the beginning.

Automated so they are easy to control, powered by (potentially) clean electricity with battery and motor technology progressing quickly, and with the opportunity to include artificial intelligence to allow fully autonomous operation, the scope for drones is enormous. Here are some applications we are excited about.

Drone taxis. There are plenty of big names like Boeing, and start-ups like Volocopter, working in this sector. For example, global taxi firm Uber is also creating a small, vertically launched drone like aircraft to offer transport within and between cities. For how long will there be a pilot on board? With the benefit of an app, you could order a drone to take you to work or out for dinner. Drone taxis potentially avoid city congestion and the noise and disruption of conventional helicopters. It’s simply a case of up, up and away…

Drone agriculture. Already, farmers use drones to check crops and livestock. In the future, I’m sure crops spraying drones, such as John Deer’s recent development will enter use.  Food productivity will surely rise, drones programmed to take a series of photos using different light spectrums will enable a farmer to track crop growth and spot any issues, leading to better yields and less agri-chemical usage.

Drone environmentalism. Already, an initiative by British firm Biocarbon Engineering to fight deforestation in mangrove forests using drones is proving much more efficient than human labour. The drone surveys and tests the soil, then drops pods containing tree seeds and vital nutrients. Beyond this, the environmental potential of drone technology is enormous. From preventing poaching of rare animals, tracking populations to tracking glacial ice, a drone can play a crucial role.

Drone cranes. The construction industry has already trialled drones to lift bricks and roof tiles into place on a building site.  Going further, drones that can lift hundreds of kgs are in development. If drones become ever larger, which we at CDP anticipate, could they then one day replace cranes as the go-to method of lifting building materials?

Drone inspection. Inspecting high rise buildings, industrial plant and infrastructure like electricity pylons and bridges, is already a cost-effective drone application. Be it using cameras or more specialist sensors.  We expect this to develop further as drone automation, and AI to detect faults, makes this even more attractive.

Drone shipping. Containers revolutionised the shipping industry in the 1960’s. Will drones be the next big thing in the transportation world? While they will always be significantly less energy efficient compared to ships and trucks, giant drones could deliver high value imports quickly from ports to distribution hubs, especially in areas where other transport infrastructure does not exist. Then at a micro level, drones might bring our packages to the door and solve that tricky ‘last mile’ delivery conundrum for companies like Amazon and UPS, who are developing systems at present. As well as the multi-rotor quadcopter, we are already seeing hybrid fixed-wing drones with longer flight-times and higher energy efficiency. Some are solar-powered, to partially re-charge as they fly, or powered from renewable fuels like hydrogen.

Drone fireworks. Human beings love a light show in times of celebration, whether it’s Guy Fawkes night in the UK or an awe-inspiring Olympic opening ceremony. For an eco-friendly, reusable alternative to fireworks, hundreds (or even thousands) of light-emitting drones can perform truly astonishing displays. US tech firm Intel has already put on some truly stunning drone displays at the Superbowl and at the Winter Olympics.

Drone rescue. On a more serious note, drones can literally save lives. In search-and-rescue situations, we already see crews using drones to spot survivors. Taking this even further, a drone could drop life jackets and rafts to people at sea, or food and medicine to inaccessible disaster sites. Rescue crews in Alabama used heat-seeking drones to search for survivors after a tornado in March 2019. Ambulance drones could deliver, say, defibrillators or EpiPen’s in cases where every second counts towards a patient’s survival.  Researchers are also looking at creating swarms of micro, autonomous drones whose group behaviour is designed to automatically search inaccessible spaces like burning buildings.

Drone crime. Anyone who has seen footage of drones delivering drugs into prisons knows that this technology has its dark side. Already, there have been reports of drones surveying neighbourhoods before a burglary. In terms of terrorism, disruption and smuggling goods or even people, drone tech presents the justice system with a serious headache. Just consider the disruption to Gatwick Airport in the UK by drones in December 2018 – the runway was closed for 30 hours, 1,000 flights were cancelled and 140,000 passengers stranded.

More recently, environmental protest group Extinction Rebellion tried to use drones to close Heathrow Airport but were foiled by signal-jamming technology. Terrorist or rogue state attacks using drones as weapons is another threat. I foresee that anti-drone technology will be an important field in the coming years and that the regulation of drones will become ever more important. In the UK, the Civil Aviation Authority have brought in compulsory drone registration for drones over 250g in weight. Will drones, like cars today, have number plates, insurance and MOT tests in the future?

Drone police.  As an antidote to drone crime, law enforcement use drone surveillance in place of expensive helicopters, where their ability to search large areas quickly can be vital to ensure public safety and to catch criminals.

Drone shopping. Need a loaf of bread? New shoes? A Venti Double-Iced Toffee Almond Nut Latte with extra cream? We may one day soon team up our internet shopping habit with sending our own personal drone to fetch our purchases from the retailer. Your supermarket shopping could be dropped off on your doorstep or in a code-secured locker outside your house. Forget a drive-in Macdonald’s, could there be a drone-in Macdonald’s?

Drone communications. Bringing comms networks to regions which lack the infrastructure for internet and cellular services could well be a next step for drone technology. The Zephyr programme from Airbus is already exploring this possibility, with a solar-powered high-altitude pseudo satellite (HAPS). Zephyr, a fixed-wing drone, can stay in flight in the stratosphere without refuelling for months at a time. Among its many possible applications is the capacity to bring connectivity to the remote communities worldwide. Let’s not forget that 4 billion people on the planet are still without the internet.

Drone sports. Already drone-racing leagues are springing up. Competitors wear headsets, so they feel as though they are sitting on the nose of a drone. It’s exhilarating stuff when the drone is flying at 80mph through tight, LED lit, 3D courses. The footage can be streamed too, in HD, making this a spectator sport. In another development, drone fans have been meeting up for air battles, adding paintball guns, lasers and even a flame thrower to their drones. Even in the most traditional sports drones are proving to be disruptive. In fishing for example, a drone is used to position the bait in locations previously impossible to access from dry land. What’s next? The sky really is the limit.

Drone exploration. A popular activity is to use HD camera equipped drones to expand your experience when exploring the great outdoors.  They provide a new perspective on famous landmarks, some amazing selfies and allow the user to go to places and explore where it is otherwise impossible.

Drone photography. It has become difficult to find a TV program with an outdoor theme that does not include a drone shot to set the scene or provide fantastic images of landscapes or wildlife.  Fast paced action and sci-fi scenes are filmed by drones to allow the viewer to get close to the action.  Drone photography categories in photographic competitions are testament to the opportunities this technology provides for seeing the world in new and creative ways.

Conclusion. It’s easy to fear that drones could shape a dystopian future.  This blog has steered away from drone applications that include weapons. The shocking, dramatized viral video created in 2017 by the Future of Life Institute made this point strongly, and generated a debate about the risks of combining drone technology with AI.  But here at CDP, we are optimistic and see drones as a powerful potential force for good. It is up to humanity to ensure that this is used wisely, and that is a question we all need to consider in the coming years. How things will turn out, of course, only time will tell.