Monthly Archives: June 2016

Why you must include Human Factors when you develop a medical technology

Put simply, it’s the law.It's the law - blue flashing light

Essential Requirements are enshrined in Europe’s Medical Devices Directive (MDD), which clearly require Human Factors to be considered. If you’re curious to read the text, click here.

As you might expect, similar requirements are described in the Active Implantable MDD (AIMDD) and for IVDs. And for self-test IVDs the requirements are even more specific, as devices must be “easy to use by the intended lay user at all stages of the procedure,” and have reduced as far as practicable the “risk of user error in the handling of the device and in the interpretation of the results.”

For the US market, guidance has been available from FDA for several years and you may recall finalised guidance being published earlier in 2016 (here’s our post about the changes in that document).

European guidance has been notable by its absence.

Until now, that is.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a draft guidance in June 2016.

MHRA draft HF guidance 2016-06The guidance applies to all classes of medical devices, and drug-device combination products that are regulated as medicines.

So whichever submission route you choose, your dossier will be looked at with this guidance in mind.  And for those companies looking to supply their newly developed medical technology to the UK’s health service, there’s more; MHRA recommend that NICE and NHS commissioners;

“… investigate and challenge whether appropriate attention has been given to design features of a medical device to ensure safe and effective use in the intended environment.”

Fortunately, the guidance compares well with that from FDA and many similar terms are used.   Just as the US moves away from talking about summative usability testing to calling it usability validation, they pass the EU moving in the other direction. However, all is not lost, it’s just a difference in terminology. The underlying requirements and expectations are very similar.

The comment period for this draft guidance closes on 5th August 2016.

 

You may be unsure what human factors activities are needed for your medical device or combination product.  Get in touch today, because it’s never too early to get started on the right path.

 

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Examples of relevant Essential Requirements

Annex 1 of the Medical Devices Directive, Essential Requirements related to Human Factors:

reducing as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety)” Essential Requirement 1, Annex 1 of the MDD

the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic featuresEssential Requirement 9.2, Annex 1 of the MDD

The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device.” Essential Requirement 10.2, Annex 1 of the MDD

Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.” Essential Requirement 13.1, Annex 1 of the MDD

Annex 1 of the In Vitro Diagnostic Medical Devices Directive, specifically relating to Self Test IVDs:

ER 7.1. Devices for self-testing must be designed and manufactured in such a way as to:

  • ensure that the device is easy to use by the intended lay user at all stages of the procedure, and
  • reduce as far as practicable the risk of user error in the handling of the device and in the interpretation of the results.

ER 7.2. Devices for self-testing must, where reasonably possible, include user control, i.e. a procedure by which the user can verify that, at the time of use, the product will perform as intended.’

How to find out what you really should be covering in your Human Factors programme

Regulators and developers from across the EU, the Middle East and Baltic countries gathered together at the Autumn 2015 Medical Device School, in London. In just 50 minutes, in addition to exposing the fundamental importance of Human Factors, I outlined the key steps they are expected to take along the development journey. Concluding with a Q and A segment, attendees commented:

crowd“For me, one of the most important sessions of the school

“I particularly liked that human factors was covered in detail”

“Excellent presentation”

For the April 2016 session of the School, the organisers asked me to include two sessions. Delegate feedback about the whole Autumn school asked for more interactive elements, so my second session would give them practical experience of several of the key steps along their usability journey. With that in mind, we would focus on something that everyone would be familiar with and allowed them to get to grips with applying concepts immediately.

As before, my first session started by explaining why Human Factors is important, before moving on to share what is involved in a good Usability programme for device development. wide eyedThought provoking images underlined steps on the journey, interwoven with stories gathered from experiences in the field. At the climax of an account of one usability study, you could feel the collective wince as I described a patient’s long term practice with Type A needles (which are supposed to be single use). To finish, participants attained an insight into how all of this fits together with other paths in development.

“Great insight into the detail involved and how I can get started”

“Brilliant and easy to talk to. Really good interactive activities”

How easy is it to make a cup of tea?A quick leg stretch and freshening of coffee mugs later, we dived straight into putting this newfound approach to work. Over the course of three group activities, the room was plunged into the world of making a cup of tea. Sounds straightforward? It was. Until, that is, they became exposed to the challenges faced by someone with impaired vision and arthritis, walking a while in their shoes. How difficult it became to perform an everyday task!

“A great way to get inside the heads of our users and understand things from their point of view”

“Workshops were very energetic and welcomed”

“Excellent, very well paced, good practical demonstrations”

meeting penThis newfound sense of place enabled them to work on defining User Needs and extending that knowledge towards risk analysis, teasing out some of the less obvious use related risks. When it came to ideas for ways to mitigate these problems, creativity and appreciation for a different view of the world resulted in some unusual solutions.

The conversation continued over lunch. Delegates were talking about how they could use what they’d just learned when they got back to the work environment.

“I’d like to steal your first workshop, because it’ll explain to our teams why and how we can think like the people we’re making it for”

“I got a better understanding of how to apply this to manage my risks”

“I know now what we should be doing, and who to call for expert help”

Now you’ve read this, how about getting in touch to find out how you can benefit from this or other training courses we have delivered, achieving similar results to these people.