• Hertfordshire Business Awards 2017 Finalist

Double Finalists in Hertfordshire Business Awards 2017

November 17, 2017

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!

  • Shigeo Shingo

Thanks to Dr Shigeo Shingo

January 26, 2017

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), SMEDMuda (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!

  • Beads of Courage

Beads of Courage

June 27, 2016

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 Judge Business School

Management of Technology Innovation (MoTI) Collaboration Project

March 24, 2016

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.

  • Regenerative medicine, whole organ, tissue engineering, decellularisation, decellularization, pre-clinical, research platform, bioreactor

Tissue Engineering x Systems Engineering

October 2, 2014

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.


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

  • Longitude Prize

£10 Million Prize Fund

June 19, 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

  • Headway

Mind Your Head – the Headway Cambridgeshire Grand Challenge

May 30, 2014

Cambridge Medtech Solutions is supporting Headway Cambridgeshire with their ambitious and exciting new ‘Mind Your Head’ campaign.

Headway Cambridgeshire, in partnership with the National Institute for Health Research (NIHR) Brain Injury Health Technology Cooperative, hopes to inspire people to come up with new ideas for products and services which would improve patients’ quality of life – or prevent brain injury in the first place.

‘Mind Your Head’ includes elements of BBC shows The Apprentice and Dragon’s Den, as teams of ‘solvers’ devise and pitch innovative solutions to the dangers and challenges of head trauma.

The facts on brain trauma:

  • Six people are admitted to Addenbrooke’s Hospital every day with traumatic brain injury;
  • Head injury is the most common cause of death and disability in people under 40;
  • More than 1.4m people are admitted to A&E in England & Wales with a brain injury every year – that’s equivalent to half the population of Wales;
  • Brain injuries can occur from various causes – including road, work, or sports accidents, assaults, falls or strokes – but the effects are long lasting; including loss of movement to issues associated with hearing, sight, speech, memory and concentration as well as emotional problems.

Karen Bevan, from Headway Cambridgeshire, said “We desperately need better ways of preventing these injuries, as well as new products and services to help people recover from and adapt to life with brain injury. We’re looking for everything from simple service-based ideas right through to game-changing, technology-based innovations, so we need everyone’s input. It is great to have Cambridge Medtech Solutions supporting the campaign, taking part and able to provide guidance to our solvers.”

If you’d like to know more about how you can support the ‘Mind Your Head’ Grand Challenge, visit www.mindyourhead.brainhtc.org

  • product requirements specification

Product Requirements Specification

January 20, 2014

Once you have established your User Needs, the Product Requirements Specification (PRS) is a technical statement of what everyone on the project team is aiming to deliver, across the whole spectrum of the project, and what the final design will be verified against.

It is much more than simply a list of product function and performance requirements, and is therefore a very detailed document.

As with most aspects of a medical device development programme, there is no single ‘one size fits all’ solution for how to manage a Product Requirements Specification, but there are some good options.

Here at Cambridge Medtech Solutions, we have a preference for using the Total Design elements by Pugh. These elements have been used very effectively on a wide range of projects over many years – although it is worth noting that in some projects, some of these elements aren’t applicable.

How does this list compare with what you consider and include in your specifications?

  • Performance
  • Environment
  • Life in Service
  • Shelf Life Storage
  • Maintenance
  • Target Product Cost
  • Competition
  • Shipping
  • Packaging
  • Quantity
  • Manufacturing
  • Size
  • Weight
  • Aesthetics, Appearance and Finish
  • Materials
  • Product Life Span
  • Standards and Specifications
  • Ergonomics, including Essential User Input
  • User
  • Quality and Reliability
  • Processes
  • Time-scales
  • Testing
  • Safety
  • Company Constraints
  • Market Constraints
  • Patents, Literature and Product Data
  • Political and Social implications
  • Legal
  • Installation
  • Documentation
  • Disposal

If you would like to know more about how to capture, understand and document your Product Requirements Specification, please contact us to discuss.

  • Requirements Specification

User Requirements Specifications

January 15, 2014

A User Requirements Specification (URS) is simply a statement of the ‘user needs’, from their point of view, with respect to the medical device being developed.

It is a critical document at the early stage of any development – the regulators will expect you to validate your device against these requirements – and its apparent simplicity belies the challenge of correctly understanding the user needs, and the massive impact they can have on the device design, development and industrialisation programme.

After all, who wants to develop a medical device that users don’t want, or cannot use safely?

Despite its importance, there is no clear agreed definition of what should be included in a User Requirements Specification. Nevertheless, there are some common elements which most experts agree on, and if you consider it in conjunction with ‘follow-on’ documentation such as the Product Requirements Specification (PRS) then it is possible to hone in on some sensible and practical headlines.

Here at Cambridge Medtech Solutions, we find the following elements and prompts to be most effective.

Intended Use

  • Starting with the devices ‘Intended Use’ (or ‘Indications of Use’), split it into a series of discrete requirements of what exactly the device is, and how the user should interact with it.

User Interface

  • State the known physical characteristics of the device, the operating logic of the user interface, and what primary (essential) tasks the user is expected to perform.
  • Consider how the device should be set up and maintained, either first time or every time it is used.

User Population

  • State all the intended device user population and their characteristics – e.g. clinical or non-clinical, operatives or non-operatives, age, infirmity, visual acuity, hearing ability, manual dexterity, inhalation capability, trained or un-trained.
  • Where appropriate, state the user populations for whom the device is not intended.
  • Consider the training and information that the various user populations will require to operate the device safely and effectively.

Environments of Use

  • State the environments in which the device is intended to be used – e.g. home, hospital, ambulance, factory and the great outdoors. Consider the difference between a clinical setting and a home setting with children, pets, etc.
  • If appropriate, state the ‘extreme’ or ‘inappropriate’ environments for which the device is not suited, or which can be expected to affect device performance.

Use-Related Hazards and Harms (optional)

  • State the use-related hazards that have either been identified during early development, or have occurred with similar devices.
  • Alternatively, start your Risk Assessment now – and capture all the hazards and harms there.


If you would like to know more about how to capture, understand and document your users’ needs in a User Requirements Specification, please contact us to discuss.

  • real-time clock, risk assessment

Real-time Risk Assessments

October 17, 2013

A risk assessment is not just an essential component of any medical device development programme – it can also be a very effective design input.

The challenge is that many tools and techniques used are time consuming, and are based on a single snap-shot of the design.

Unfortunately, this does not fit with a medical device – especially large complex systems – that is progressing through a rapid development programme, and the risk assessment team often finds itself assessing an ‘earlier’ design which is no longer relevant.

At Cambridge Medtech Solutions, we use a ‘Real-time Risk Assessment’ approach that is quick, efficient and effective.

Crucially, it enables risk control interplay between electro-mechanical and software elements, addresses the requirements of the Medical Device Directive, and is consistent with ISO 14971:2012 and IEC 62304.

If you want to know more, and to explore how this approach can help you, then please contact us.