Shisa Kanko is a proven method of reducing human error. This valuable tool could be implemented across the NHS and pharmaceutical industry to save time, money and lives during the coronavirus pandemic and in the future.

Why do we need Shisa Kanko?

Humans are fallible, we all make misteaks. Like that one, the majority of these mistakes are of little importance, but sometimes the consequences are significant. In industry and healthcare, human error impacts finances, efficiency, deadlines, reputations and lives. We are all equally capable of seeing what we want or expect to see at times, rather than what is actually there. Any method that is proven to minimise the potential for error is worthy of our attention.

Many years ago I lived in Japan and was aware of Shisa Kanko but I hadn’t appreciated its validity at the time. I recently happened across a post written by Malcolm Finlay, a Consultant Cardiologist working with the team building the Nightingale Hospital in London. Unintended human error in this setting could have disastrous consequences. Finlay foresees an increased likelihood of communication errors among tired/stressed individuals communicating through their PPE in a high pressure environment, treating COVID-19 patients. His suggestions to overcome this are three-fold:

• Individuals should introduce themselves at the start of every encounter
• Repeat back all critical data
• Use Shisa Kanko

What is Shisa Kanko and how does it reduce human error?

Shisa Kanko (指差喚呼) is the practice of pointing and calling, and it is used to increase occupational safety. Japan and China’s railway network implemented it to reduce human error, with impressive results. The 1994 Railway Technical Research Institute study revealed an 85% reduction in mistakes when carrying out simple tasks. Consequently, Shisa Kanko was rolled out across industry in Japan.

Shisa Kanko is a behaviour based approach using auditory, kinesthetic and visual stimuli to prevent tasks being carried out with a lack of attention. Instead of functioning on ‘auto-pilot’ to carry out routine tasks, the individual performs a coordinated response requiring him/her to point at the object of the action and call out its status. The process requires focus and attention and reduces the probability of user error.

Scientific research reveals an increase in blood flow to the frontal lobe of the brain when an individual uses Shisa Kanko; the frontal lobe is an area of the brain that controls attention. Shisa Kanko sharpens focus and attention while reinforcing learning and strengthening neural pathways. Incidence of error is drastically reduced, the potential is great.

Potential Applications of Shisa Kanko

Healthcare

The potential for human error across healthcare could be reduced significantly. Examples include: application of PPE, drug dispensing and administration, patient observations, equipment choice and use, selection of syringe/device, area of patient being attended to/operated on, and post surgical removal of swabs and instruments. The list is extensive.

The use of Shisa Kanko could be applied to procedures at every level. Individuals point to the task they are going to complete and say its current status out loud, e.g. (point to figure on screen) “Oxygen sats for patient Mr X, 78%”, (point to chart) “I am recording 78% on the patient’s chart”. Full attention is on the detail of the task.

Nightingale Hospitals

As London’s Nightingale Hospital opens, with others across the country following, systems that prevent error will be vital.

Communication will be restricted by additional PPE, workers will be unfamiliar with each other and the environment, routines will be altered and the situation will be challenging and stressful. Shisa Kanko could improve communication and minimise mistakes.

Never Events

In 2019, NHS England published 435 reported Never events, an increase from 423 the year before. Never events are, ‘serious, largely preventable patient safety incidents that should not occur if healthcare providers have implemented existing national guidance or safety recommendations’.

These events are highlighted and investigated as a learning tool, and their occurrence is indicative of the need for more robust safety measures. Universally practised Shisa Kanko could have a dramatic impact.

Pharmaceutical Industry

Within the pharmaceutical industry, research suggests that as much as 40% of deviations are due to human error, that translates to a lot of time and money wasted. Laboratory techniques can be repetitive and it is too easy to perform repetitive, seemingly mundane tasks without full attention. Unexpected or seemingly accurate data may result from undetected errors earlier in the procedure.

Patient Self-Administration

Non-adherence is a known problem with certain medications, and asthma self-medications are prime candidates, as I have previously discussed. Patients experience symptoms and require medical intervention which could have been avoided through better adherence.

Initial training for patients from healthcare professionals using Shisa Kanko would help patients ‘attend’ to the IFU (information for use) and memorise steps accurately. The result is correct, longer-lasting adherence of the medication and a reduction in symptoms.

The Future

Imagine future training within any industry that includes Shisa Kanko. Not just healthcare but also construction, manufacturing, transport, mining, automotive, energy, and travel. These industries among others could benefit from the application of Shisa Kanko, training individuals to improve attention to the task and reduce human error.

A BIG THANK YOU to the NHS and All Key Workers

Originally published as a LinkedIn Pulse article entitled Shisa Kanko could reduce mistakes and save lives (May 2020)

The process for the design, development and industrialisation of medical devices, including drug delivery devices, is well understood. The whole process is broken down into discrete phases of work, which help to de-risk the programme when carried out in sequence.

There are many variants of the process itself, but they all essentially represent a natural and progressive flow, along the lines of specification definition, concept design, proof of principle demonstration, detailed design, pilot manufacture, verification and validation, and industrialisation.

Despite this, there is one aspect running through all these phases, which may seem menial and of limited value. and which too many design teams get wrong (or ignore) resulting in an enormous impact on cost, quality and time.

I refer to Tolerance Management which encompasses tolerance analysis, tolerance allocation, tolerance assignment, and process capability. Part of the problem is that it’s a ‘Chicken and Egg’ situation.

During detailed design, the design engineer is assigning dimensions and tolerances to components, and then carrying out detailed tolerance stack-up analyses to see if the overall variation in the parts and assemblies is sensible. (Note: statistical, never ever worst-case!)

However, at the detailed design stage, it is often too early to understand the relationship between the individual design tolerances and the eventual process capability. It is a complex relationship, which involves material selection, process selection, number of tool cavities, component geometry and structure, tool wear, etc.

It is only during the later stages of pilot manufacture and industrialisation that the design team start to understand what process capability can be achieved, and what the practical impact is of the chosen design, dimensions, and tolerances.

If there is a problem, it is often too late to resolve through design and re-tooling, and the pressure is then on the manufacturing team to achieve a reasonable process capability with unreasonable tolerances. This is typically achieved running the process at slower speeds than planned, and accepting the need for higher levels of inspection, rework and scrap. All very stressful, time consuming and expensive.

Fortunately, there is a way to tackle this problem.

Obviously, no-one can start manufacturing before the detailed design is complete – that would be messing with the fabric of space and time! – but the design team can access a wealth of experience and knowledge that is readily available. These databases can help predict the likely process capability for a given process, design, geometry and tolerance, which can then be fed into the tolerance analysis, thus informing the design suitability. My favoured knowledge-base is TolCap (www.tolcap.com), but there are others available.

Admittedly, this puts more burden on the design team, but everyone can agree it is better to resolve any problems at that earlier design stage. It means improved performance, greater reliability and reduced costs, rather than living with the consequences of non-capable processes and parts during manufacture.

This is a real solution to the problem.

Originally published as a LinkedIn Pulse article entitled Design Tolerances and Process Capability: A Chicken and Egg Story (April 2019)

Rugby is thriving at Royston RFC. Every week hundreds of men, women and children from Royston, and surrounding villages in South Cambridgeshire and North Hertfordshire, take part in training and matches at Royston Heath.

Local medical device development consultancy Cambridge Medtech Solutions recently sponsored the Mini Section during its end-of-season tour to Chichester International Mini Rugby Festival 2018.

“Here are Royston RFC, rugby is a positive experience for the children. It is great fun, and it helps to build their self-confidence, physical fitness, character, resilience and teamwork,” said Mick Clark of Royston RFC. “Our end-of-season tour for the children is a major fixture in the calendar. We are delighted that Cambridge Medtech Solutions joined as a sponsor.”

Stuart Kay, director at Cambridge Medtech Solutions said “Royston RFC is the latest organisation to benefit from CMS’s sponsorship programme, which was launched in 2016. Our funding is aimed at the overlap between community, youth and health, and we know rugby at Royston will continue to grow from strength to strength.”

Rugby is available at Royston for all ages and abilities, including adult non-contact touch rugby. Training takes place throughout the week. For more information on training or volunteering, go to www.roystonrugbyclub.co.uk

Saracens and England No. 8 Billy Vunipola joined Royston to give out the awards for the Mini and Youth age groups at their presentation and fun day on Sunday 13th May. Billy is celebrating a call up to the England squad for the upcoming tour to South Africa.

Stuart Kay, director of Cambridge Medtech Solutions, was a panel judge at last week’s ‘Health Hack’.

This event was the latest in a series of workshops organised by Medtech Accelerator in partnership with the Eastern AHSN and Health Enterprise East.

Health Hack is a two-day intensive event based on a theme. Recent themes have been Rehabilitation, Surgery and Patient Safety.

It provides a platform for NHS clinical innovators to work with industry experts to help develop their ideas for innovative solutions in medical technology, including devices, diagnostics, software and eHealth. Participants include clinical stakeholders, NHS experts, product developers, academics and business consultants. After an open call for innovations, with the potential to meet unmet clinical needs and generate commercial benefit, several individual ideas are shortlisted.

Each innovator has the opportunity to shape their idea with the support of a team of experts and to refine it ahead of presenting to a panel of judges. The winning idea is given the opportunity to present to Medtech Accelerator Investment Panel, with a chance of winning up to £125,000 of funding to develop the idea.

To date, clinical innovators have come from NHS bodies and trusts throughout the East of England region, including:

• Queen Elizabeth Hospital King’s Lynn,
• Norfolk and Norwich University Hospitals,
• Cambridge University Hospital,
• Southend University Hospital,
• Royal Papworth Hospital,
• Colchester Hospital University,
• North West Anglia, and
• Basildon and Thurrock Hospitals.

“I’m passionate about developing new medical devices which can improve patient outcomes and help healthcare providers” commented Stuart.

“The Health Hacks are fantastic ways to foster the next generation of innovation, and all the ideas presented have the potential to make a real difference to patients, the NHS and businesses.”

For more information about the Medtech Health Hack workshops or the Medtech Accelerator Awards please visit www.medtechaccelerator.co.uk

Cambridge Medtech Solutions has been shortlisted as finalists in both the ‘Commercial Business in the Community’ and ‘Social Enterprise Award’ categories in the prestigious Hertfordshire Business Awards.

Hosted in conjunction with KPMG, the awards are given to outstanding businesses which are visionaries and leaders in their specific field; celebrating excellence, quality and innovation.

As experts in medical device development, CMS have been recognised for our free Zephyr Guide app for asthmatic and COPD patients with ‘press and breathe’ inhalers. The team working on the project put in a lot of hard yet creative work, and have delivered an app of exceptional quality. It has been warmly welcomed by patients, carers, doctors, nurses and pharmacists.

Well done team Zephyr!

As a young engineer, I started my career in production engineering, and was introduced to the works of Shigeo Shingo.

I was soon hooked by his books on the Toyota Production System, Just-in-Time Manufacturing (JIT), Poka-Yoke (mistake proofing), SMED, Muda (waste) and much more.

Through his books, I read about the improvements developed and introduced at Toyota by Taiichi Ohno (considered the father of the Toyota Production System); and I was inspired to work in Japan and learn more.

Many years later, these ‘lean‘ lessons have stuck with me, and are foundation bedrock for the way I approach the design, development and industrialisation of medical devices.

I heartily recommend the Shigeo Shingo books to any engineer and designer, of all disciplines!

The Beads of Courage programme is designed to provide an additional treatment and offers support for children and teenagers undergoing serious illness and treatments. The initial reaction to the Beads is “aren’t they pretty” but it is not until you see it in action and talk to children and care givers that you can see the impact that they have.

This programme supports over 20,000 children in the US, UK, Japan and New Zealand and has been evaluated over the past 8 years. Major benefits of the programme are that it helps to decrease illness-related distress, increases the use of positive coping strategies, helps children find meaning in illness and restores a sense of self in children coping with serious illness.

The Beads of Courage programme also provides something tangible that a child can use to tell family and care-givers about their experience during treatment. The beads also help explain to teachers and friends what has happened to them whilst they have been away from school. Parents of younger children enrolled in the programme can use the beads in the future to explain to their child what they have been through.

The beads help the children to take ownership of their journey and to make sense of the experience they are going through in a very visible and tangible way. The beads gives them a tool to explain it to themselves and others, adults, medical professionals, brothers, sisters, friends and says to everybody “this is my story, this is what I’m doing – its not nice but I’m strong and I will get through it”.

Cambridge Medtech Solutions recently supported the “Dancing with Butterflies” performance by the Lisa Rusay Dance School, at the Mumford Theatre in Cambridge. It raised money for the Beads of Courage Programme at Addenbrooke’s Hospital.

Cambridge Medtech Solutions has recently collaborated with the MoTI Project, involving team members from the Judge Business School and the Institute of Biotechnology, University of Cambridge.

Cambridge Medtech Solutions has developed a medical device app for smartphones and tablets, and worked with the team to carry out an extensive assessment of the market landscape and to explore potential commercialisation strategies.

Stuart Kay, Director at CMS said, “The MoTI team have produced an insightful and effective analysis of the situation, and a straightforward and rationale approach to the user, market and regulatory needs. The group’s work clearly represents added value to the project.”

The Judge Business School is consistently ranked as one of the top global business schools, and is particularly strong in entrepreneurship and innovation management.

The Institute of Biotechnology is an internationally renowned centre of excellence. It is a unique entrepreneurial organisation within the University of Cambridge, targeting its research at the interfaces of the biological, chemical and physical sciences.

Excellent! You’ve made good progress with the whole organ perfusion / tissue engineering protocols, and now you are ready to proceed with the development of a more advanced bioreactor. Whether is it for on-going clinical research or it is the final system, you need to start the conversation with the systems engineers, who will add a different perspective as you all work towards a robust and capable outcome.

Pathway from Source to Recipient

From the start, the systems engineer will want to map out the detail of the use case flow chart, which will answer the questions “What and Why and When, and How and Where and Who?”

This might contain multiple starts, intersections and endpoints – for example, a biologically-derived scaffold recellularised with the recipients own stem cells, using a growth medium – and there are typically more questions than answers when first discussed.

To enable this, we recommend the preparation of the outline Target Product Profile (TPP) at an early stage in the clinical research / development programme, which considers the therapy, the efficacy, how the therapy is to be deployed and used, who makes the decision to use the therapy (and based on what evidence), and what the ideal claims would be.

The TPP embodies the notion of beginning with the goal in mind, and establishing it often results in a clear understanding of the regulatory pathway, and the standards and classifications that need to be met.

Mapping out the pathway will also help the whole team (clinical, engineering, commercial) to visualise and develop a common understanding of what they expect and want, to challenge assumptions, and to identify operational constraints (tissue and fluid availability, technology availability, cost, size, weight, staffing levels, physiological limits of the therapy, and operational limits of the system).

In time, this will enable the preparation of the User Requirements Specification and the Product Requirements Specification.

Risk Management

Risk assessments are not just an essential component of any system or therapy development programme – they can also be a very effective design input, and can help with the organisation of the pathway.

The challenge is that many of the standard tools and techniques used are time consuming, and are based on a single snap-shot of the design. Unfortunately, this does not fit well with complex systems such as tissue engineering bioreactors that are progressing through a rapid development programme.

We favour the use of a ‘real-time’ risk assessment approach that is quick, efficient and effective. Crucially, it should also enable risk control interplay between electro-mechanical and software elements, and is consistent with the relevant directives and standards such as ISO 14971:2012 and IEC 62304.

Advanced Testing

Testing is an area of systems engineering that is too often compromised due to the lack of samples, systems or time. It can also be compromised by only testing up to the design limits, rather than the likely operational stresses of everyday use which can combine in unexpected ways to cause a system to fail.

Multiple environment over-stress testing (MEOST) is a complex but powerful technique for testing combined interactions of all stresses, where the primary objective is to find the failure modes so they can be addressed. It can also be used to compare the robustness of two systems or design iterations.

Experience shows that this approach is quicker and cheaper than traditional testing, less prototypes / systems are required, less tests are carried out, but more failure modes are identified. This approach is not just limited to systems engineering and reliability engineering – it can also be used to evaluate the robustness of some therapies as well.

Cost

Reducing healthcare costs, whilst providing optimum levels of patient care, has consistently been a priority for healthcare leaders for the past few years, and is expected to continue.

Whilst the health economics of the different regenerative medicine / tissue engineering approaches are yet to be fully understood, it is recognised that costs need to be aligned with mainstream healthcare reimbursement systems.

Therefore, until the models can be validated, you should be pragmatic and look at every opportunity to reduce the costs per therapy. In our experience, the biggest savings can be achieved by avoiding expensive consumables (fluids, functional components and sensors), simplifying the design of the disposable set, avoiding the need for active thermal control during transport, and minimising the staffing resource required (peak and FTE).

These are some of the key considerations for any tissue engineering bioreactor system – for perfusion or persufflation; biologically-derived or synthetic scaffolds; decellularised (decellularized) or recellularised (recellularized); whole organs or ATMP; hypothermic, normothermic or hyperthermic – and you should start considering them as early in the development process as possible.

Overall, it is easier to consider these matters at the start, and to mitigate against issues that can be challenging, costly and time-consuming to resolve later in the development programme.

First printed in regen, September 2014

Many of us enjoy a challenge – whether it is solving a puzzle, learning a musical instrument, or a bit of trouble shooting. We develop medical devices!

The Longitude Prize 2014 is a new science and technology challenge with a £10 million prize fund for an innovation that will solve one of the major problems of our time, and we can help to decide what the challenge should focus on.

The six challenge themes to choose from are:

• Dementia – to help people with dementia live independently for longer
• Paralysis – to help restore movement to those with paralysis
• Antibiotics – to help prevent the rise of resistance to antibiotics
• Water – to help ensure everyone can have access to safe and clean water
• Food – to help ensure everyone has nutritious, sustainable food
• Flight – to help us to be able to fly without damaging the environment

It is 300 years since the Longitude Act of 1714, which offered a prize of £20,000 to anyone who could devise a method to accurately determine a ship’s position at sea. It was won by John Harrison with his H4 marine chronometer – it is a fascinating story, and is a great example of robust and capable engineering.

The winning idea will probably be the result of international collaboration – and we expect this challenge to be the ‘seed’ for many other exciting new ideas and technologies which will change the world for the better.

To help write this next chapter, vote for the challenge you would like to become the subject of the Longitude Prize 2014 at www.longitudeprize.org