“Many believe that precision lies in the tools alone; the calipers, the micrometers, the shining instruments of measurement. But I tell you this: no tool, however finely crafted, may serve the realm of quality unless it is understood, trusted, and proven repeatable.

For in the shadows of uncertainty dwell the errors of man; bias, inconsistency, and haste. Without Gage Repeatability and Reproducibility (GR&R), your numbers are but illusions, your data mere whispers in the dark. You may think your process capable, your control charts steady, yet if your gage falters, all crumbles to dust.

So, heed my counsel. Test your gages as you would test your courage. Let each operator, each part, and each measure be known and trusted. Only then shall your data bear truth. For if your gage be unworthy …

…you shall not pass.”

– Gandalf in conversation with Boromir

“One does not simply specify ±0.005 on every dimension without paying for it.

That path is treacherous, lined with endless inspection time, skyrocketing machining costs, and machinists’ curses whispered into the wind.

Tight tolerances are not free. They demand precision tooling, slower feeds, more scrap, and meticulous quality control. Each extra decimal place is another coin tossed into the furnace of manufacturing cost.

Only specify tight tolerances where function demands it. Leave the rest with generous fits. Consider function, material choice, manufacturing process, part geometry. Determine what actually matters.

For in manufacturing, wisdom lies not in precision alone, but in knowing where precision is needed.”

– Lord Boromir, Captain of the White Tower, High Warden of the White Tower, Steward-prince of Gondor

What if you could predict patient deterioration before it happens?
Before they are discharged from hospital?

In today’s fast-paced clinical environments, early detection of subtle changes in a patient’s condition can mean the difference between recovery and crisis.

That’s where the Rothman Index and the NHS Early Warning Scores help.

They are both powerful, real-time patient acuity score derived from routine EMR data – vitals, lab results, and nursing assessments. It’s visual, easy to interpret, and continuously updates as new data comes in.

Why it matters:
💡 Identifies at-risk patients earlier
💡 Supports timely interventions
💡 Reduces readmissions
💡  Reduces unplanned ICU transfers
💡 Enhances discharge planning
💡 Improves patient outcomes

Hospitals using these metrics are seeing measurable improvements in care quality and operational efficiency.

It’s not just data – it’s insight. And insight saves lives.

Source: DOI:10.1186/s13037-024-00391-2

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.