• 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.

  • Instructions for use

Deos Slepnilg Rlaley Mteatr? (Does Spelling Really Matter?)

October 17, 2013

Bivelee it or not, rcesrhaeers hvae dirvoseced taht the oredr of ltteers in a wrod deson’t rlaley mteatr. The olny iprmoatnt tihng is taht the frsit and lsat ltteer are in the rghit pclae. Eevn if the rset are tolatly julebmd up you can sitll raed it. Tihs is bcuseae the huamn barin deos not raed ecah lteter invuddilialy, but inesatd renisgoecs the wrod as a wlohe.

It is interesting that in order for these jumbled words to be easily read, the first and last letters must be fixed.  Ti si irycludsioul ffctildui ot adre a netcseen ni wchih eht isrtf nda tsla etlters era ont fdxei.  (It is ridiculously difficult to read a sentence in which the first and last letters are not fixed.)  This may be due to the fact that your brain is able to recognize more than one specific word that is similar to the jumble of words.

For example, consider ‘ngdrea’ – in the context of flowers and soil then the word would be ‘garden’, but in the context of safety and caution then the word would be ‘danger’. However, ‘grdean’ obviously reads ‘garden’, and ‘dnegar’ obviously reads ‘danger’.

The cognitive ability of the brain, and users tendency to understand (misunderstand?) in line with their expectations, must be carefully considered when developing the interactions with a medical device, and the instructions for use. How will your users perceive or interpret the intended interaction? In how many different ways? What did they understand or (maybe more importantly) misunderstand? Is it safe for them to use the device?

Food for thought? Bon Appétit.

  • Regener8-2013

Regener8 Annual Conference 2013: Translating Regenerative Therapies to a Global Market

October 16, 2013

On 10th October 2013, delegates gathered at the Royal Armouries in Leeds, UK, for the Regener8 Annual Conference 2013.

Delegates heard from internationally-respected RegenMed experts who shared insight and best practice in the latest regenerative medicine research and discussed the challenges and opportunities in progressing regenerative therapies into the clinic. Keynote speakers were:

There were also presentations about commercialising regenerative therapies from the perspectives of different sized companies, followed by a panel discussion involving:

There was a lot of discussion about the commercial challenges, including reimbursement approval, and evidently a lot more work needs to be done to significantly reduce the high cost of goods for the majority of products in the RegenMed pipeline.  This includes the ‘lower cost’ therapies.

It is essential that product and process engineers / developers need to be involved from an earlier stage to contribute to the therapy development, including the Target Product Profile (TPP) and how it will be delivered.

Before the industry achieves critical mass, we would suggest that it is in all our interests to engage in pre-competitive collaboration in the development of a range of delivery devices and enabling technologies. This will reduce costs, and allow focus on the core therapies.

Development of these devices and systems will require experienced clinical, scientific and engineering skill sets, along with inputs from regulatory, risk management, human factors and manufacturing, amongst others.

 

Suggested further reading, or email us to request a copy:

  • IMechE

IMechE honours Cambridge Medtech Solutions Director with Prestige Award

October 11, 2013

The Institution of Mechanical Engineers (IMechE) has selected Stuart Kay linkedin_logo to receive the James Clayton Prize 2012.

The Prize is awarded to members of the Institution who have made major contributions to modern engineering science, and Stuart has been recognised for his contributions to medical device engineering over recent years.

Notable medical devices and safety-critical systems that Stuart has worked on, or led the development of, include:

  • OrganOx metra, a normothermic liver perfusion system
  • Arthroscopic surgical toolset for Chondromimetic, an acellular regenerative scaffold from Orthomimetics (now TiGenix)
  • Aptar Pharma Prohaler, a multi-unit dose disposable dry powder inhaler platform
  • Closed-loop Class III research system for a US-based CRO

Stuart and other prestigious award recipients were honoured at the IMechE Vision Awards Ceremony at One Birdcage Walk, London in September 2013.

 

The OrganOx metra® is the first and only fully automated normothermic liver perfusion device for improved organ preservation. It has been designed with every step of the organ retrieval, transport and transplant process in mind.

OrganOx metra

The OrganOx metra® is pictured with Prof. Peter Friend and Prof. Constantin Coussios, and has won the following product innovation awards:

  • Healthcare Technologies – IET Innovation Awards 2013
  • Intelligent Systems – IET Innovation Awards 2013
  • Emerging Technology Design – IET Innovation Awards 2013
  • International Award for Innovation – Altran Foundation 2013
  • Cambridge Medtech Solutions medical device

New medical device development company launched today.

September 25, 2013

A new independent medical device and enabling technology development consultancy has launched today.

Cambridge Medtech Solutions is built on the experience of working for some of the best medical device and pharmaceutical companies in the world, and is dedicated to the rapid market introduction of robust and capable products that are safe and easy to use.

Our clients operate in the high value markets of drug delivery, critical care, regenerative medicine and life science where outstanding technical leadership, product development engineering and risk management are essential.

We draw on an extensive skill base in engineering, product design and the sciences to offer a wide range of services across the entire innovation, development and industrialisation life-cycle. Our expertise and experience means that we are often at the forefront of translating science into commercially successful products.