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15 things you need to know about MHRA Human Factors expectations

We now have official guidance for Human Factors and Usability Engineering in a member state of the EU.

19th September 2017 saw publication of official guidance from MHRA (the UK medicines and medical devices regulator) for Human Factors and Usability Engineering for medical devices and drug-device combination products. You may recall that the agency published a draft document for consultation in mid 2016. The final document extends to 47 pages and includes many changes as a result of consultation responses.

While of detailed interest to people working within human factors, everyone else probably wants to find out “what does it mean for me?

So, here are 15 things you need to know about the MHRA guidance:
Thing 1.

MHRA’s newly released final guidance emphasises its applicability to all classes of medical devices and device-drug combination products, there’s absolutely no avoiding usability engineering.

Thing 2.

Content of the guidance appears closely aligned with FDA guidance and international standards, with some useful additional information to that discussed by FDA.

Thing 3.

MHRA provide a great tool for anyone making the case for usability activities within their organisation; the guidance spells out exactly the essential requirements in the Medical Devices Regulation (MDR) and In-Vitro Diagnostic medical devices Regulation (IVDR) that mandate usability activities, along with a helpful annex mapping the MDD and IVD to the new regulations.

These breadcrumbs will also help manufacturers who are working to prepare their devices for the end of the MDR and IVDR transition periods.

Thing 4.

Clearing the once muddy waters surrounding drug-device combination products, MHRA establishes that the Essential Requirements enshrined in the MDR and IVDR are equally applicable to the device components of drug-device combination products.

Thing 5.

The document provides a helpful compendium of regulations, standards and guidances that should be referred to for development. The information can be seen as a signpost for those just venturing in to this arena, and serves as a reminder for the seasoned manufacturer.

Thing 6.

MHRA appear to have adopted a more realistic approach to the guidance on risk analysis, pulling back from the previous stance of expecting documentation of all possible use errors to a more realistic approach of capturing “reasonably foreseeable” use errors. This sits well with FDA expectations. A gift for usability professionals battling to influence sensible and design oriented risk management, MHRA have included an expectation of a rationale for the prioritisation of risk mitigations, often overlooked by development teams.

Thing 7.

Thankfully, the finalised guidance requires the development of a user interface specification and a usability plan at an early stage in development, aiding the inclusion of usability activities within project timelines, resourcing and budgeting, rather than as a last minute “add-on”.

Thing 8.

The value of formative usability studies is enhanced by closing the loop from risk analysis informing formative study design through to feeding back into the risk analysis the results of a formative test (unforeseen use errors, occurrence levels, etc.).

Thing 9.

Rightly, there’s now heavy emphasis on the ethics dimension of formative testing and manufacturers responsibility to ensure appropriate ethical consideration is given to the design and execution of formative and summative studies.

Thing 10.

Summative testing (called validation by FDA) now explicitly includes training that may be needed, and sets the realistic expectation for inclusion of users who are unfamiliar with the particular device.

Thing 11.

The HF Summary Report, whilst a very useful document to describe the usability journey, does not achieve all FDA expectations (in particular a greater focus on risk), so manufacturers will need to determine how best to fulfil both sets of guidance, if they intend to market their device(s) in both the EU and US.

Thing 12.

Helpfully, the section on Post Market Surveillance identifies some potential data sources, that will help manufacturers get more out of these activities for both existing products and future development projects.

Thing 13.

Guidance is now given about what to do for older products, of particular relevance as their manufacturers gear up to ensuring compliance with the MDR in the near future.

Thing 14.

The whole topic of simulation, which previously gave rise to concern amongst manufacturers, has now been removed from the guidance. Instead, the reader is pointed towards information covered in ISO 62366 (parts 1 and 2).

Thing 15.

With regard to drug/device combination products, the guidance points to changes in the MDR that require an assessment of device components with the Essential Requirements (including those related to human factors / usability). Helpfully, the MHRA document also references EU guidance relating to drug-delivery devices and specific products.
 
What next?

Now that you’ve read all 15 things, you may find it helpful to talk with someone about what you’ll be doing differently for your upcoming projects, and existing products.

Pick up the phone today, or write an hello(Replace this parenthesis with the @ sign)threecircles.eu?subject=Follow%20up%20-15%20things%20you%20need%20to%20know%20about%20MHRA%20Human%20Factors%20expectations to our team right now.

Navigating the transition

The countdown clock to the application of new EU Medical Device Regulation (MDR) started its three year life in May 2017.

Understanding the changes, let alone navigating them successfully to prepare for compliance in May 2020 is no small task.

Thankfully, the UK regulatory agency (MHRA) has produced a guide to help you get to grips with what has changed and what you may need to do to get ready for a smooth transition in 2020.  After a detailed review of the MDR, we published the 15 things you need to know.

Unlike many other regulatory changes in the EU and US, there will be no “grandfathering” of existing medical devices under the MDR, so we strongly recommend starting your preparations sooner rather than later.  If you’re developing or marketing a Class 1 medical device, you should read about what’s happened with the self certification route too.

And with the ever decreasing pool of Notified Bodies available to work with for the higher risk devices, you’ll probably need some guidance and help before you reach out to one of the few remaining bodies to assess your product against the MDR and (re)certify your CE marking.

We’re always here to provide reassurance, guidance and a helping hand, to ensure you don’t do too much, or too little. We ensure you only do what you need to.

Get in touch today, make the most of the time you have left on that clock.

Additional Resources:

Read more on this topic with these related posts:

Human Factors high on FDA Priorities for 2016

So, the FDA’s Center for Devices and Radiological Health (CDRH) have included Human Factors in their 10 priorities for 2016 and Regulatory Science. There have been many blog posts published summarising the 10 priorities, as they “serve to accelerate improving the safety, effectiveness, performance and quality of medical devices”.

But why the emphasis?

Why Human Factors matters

Hopefully, as you’re reading this, you’ll already be aware of why98000 Human Factors is integral to safe products. As a refresher, here’s why;

  • 80% of medical device errors are due to human error.
  • Every year, around 98,000 people die in hospitals in US, 11,859 in England, due to medical errors, many of which are due to Use Errors.

“Many device recalls and adverse event reports reflect underlying human factors engineering problems including usability issues and preventable design problems” (FDA CDRH)

Yet we spend a lot of time during development working to reduce the 20% of errors that are due to device performance, testing our devices to ensure the build quality is robust and that the performance is acceptable.

What about working to reduce the 80%?

CDRH priorities include Human Factors

Well, CDRH included Human Factors in their priorities because it helps;

  • Facilitate medical device innovation and bring new technology to market,
  • Enhance or expedite the availability of medical devices while maintaining their safety and effectiveness,
  • Facilitate rapid identification of problems.

What does all this mean for those medical devices or combination products already in development?

A great emphasis will continue to be placed upon adequate and robust Human Factors programmes during development. Programmes that clearly identify who the product is being build for and their needs, demonstrate the integration of Human Factors throughout design development and culminate in evidence that the product is safe and effective in use (i.e. a robust summative usability study).

It is perhaps not surprising that the focus for 2016 includes HF, as there’s been much dialogue between industry and regulators in recent years on this topic, including the wider implications of devices being used outside the clinical setting (see our post on that topic from January 2015).

Merging of EU and US Human Factors requirements

The playing field between EU and US requirements is being levelled (our September 2015 post discusses this in detail). For the EU, developers now need to provide the same Human Factors programme evidence as for the US. So, consequently, the focus on Human Factors will be higher in the EU too.

You may well be thinking that, if you’re developing a product for several markets, it makes sense to develop to meet US Human Factors requirements, as that will satisfy 99% of the needs of the EU and other major world markets.

What does this mean for your product?

You may be thinking about how you could best ensure your development programme meets the requirements for Human Factors.

Pick up the phone (+44 1270 61 86 93) or click on the “Get in touch” tab to the right of your screen to explore how we can help you ensure your product is “right first time”.

Further reading about Human Factors

Perhaps reading this article has left you wanting to find out more about the world of Human Factors (also known as Usability).  There are two things you can do:

1. If you’re new to HF or would appreciate a refresher, you will be interested in reading our book “How Humans Factor (in medical device design)”.  Email us to request your free e-copy.

2. Have a read of other recent posts on the topic of Human Factors:

MHRA developing human factors guidance for medical devices

UK regulatory authority the Medicines and Health products Regulatory Agency (MHRA) has started to develop guidance on human factors for medical devices. We are curious to see how the guidance will fit with the FDA’s Guidance documents, published over the past few years.

The Agency has confirmed that the planned guidance will cover several topics;

  • Pre-market regulatory framework (including end users),
  • Post-market surveillance regulatory framework,
  • Standards,
  • Simulation / Usablity.

When draft guidance is published, we’ll be updating you on the content and implications for both medical devices and combination products.  Read on to understand more about what led to the announcement.

Origins of the MHRA Human Factors guidance

Development of the guidance is being managed by a task group set up by MHRA, with the involvement of notified bodies, academia, NICE, trade bodies and professional associations. The task group held its second meeting recently. At the meeting, Dr Brian Edwards of the Clinical Human Factors Group emphasised the need to consider the requirements of combination products, saying:

“It’s important to work together in particular areas where we have overlapping interests such as drug/ device combinations.”

Understanding Human Factors in medical device design

The task group was born out of a wider meeting held on 27th February 2015. The February meeting involved a wide cross-section of interested parties and considered how we can build better understandings of human factors into the design, regulation and use of medical devices, to promote patient safety.

The keynote presentation at this important event was delivered by Dr Ann Blandford, who we’ve had the pleasure of discussing human factors challenges with on several occasions over the past couple of years. Here’s what Dr Blandford had to say about the importance of human factors, at that event:


A patient perspective of the value of involving end users in device development was eloquently described by Fiona Loud of the British Kidney Patient Association:

Next steps for MHRA guidance on Human Factors

The task group will have a further two meetings to develop the draft guidance.

MHRA plan to follow up on the work already done, by sharing the draft guidance with a wider group in the Spring of 2016.

You might choose to check back here, or subscribe to our blog, to be among the first to hear about the content of the draft guidance when it is shared.