Tag Archives: risk management

Normal service has been resumed!

It’s finally happened! It's the law - blue flashing light

Despite following recommended security practices, we’ve been the subject of a website hack, posting some bizarre items to our blog feed over the past day or so.

Please accept our apologies for any concern recent postings may have caused.  We have removed the suspect articles.

Normal service has been resumed.  Coming later this week, celebrating our 10th birthday….

Three ways to smooth your path for device development

Medical Device Development routemap v5.0 narrow viewSpring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September.

Children learn and grow at an alarming rate, especially when you’re looking back over what seems like a very short time and realise that the baby you remember holding in your arms “yesterday” is now a teenager.

The route map too is growing up fast. It’s being used across the world, from Australia, through Asia to Europe and on to North America. Users have fed back great experiences. Uses ranging from a desktop aide mémoire, a teaching aid, through to a planning and design review tool!

There comes a time when a child learns new skills, and naturally integrates them into their daily lives and toolkit.

We’re proud to announce the launch of the route map for medical device development 5.0 today. Numerous user suggestions have been incorporated in this new version, along with two new tracks; Intellectual Property and Market Research.

The route map continues to help you in three ways, it;

  1. Describes the journey you’ll embark upon, from a device idea through to launch.
  2. Sets out the main activities for each of 9 disciplines, through four stages of product development.
  3. Identifies the points where there are major interactions between disciplines.

And here it is…

Click to open a pdf version you can download

Click to open a pdf version you can download

You may already see how this picture will be helpful, whether you’re working in medical devices, combination products, pharmaceuticals, aerospace, defence, electronics…..

Send me your thoughts on how you can use the route map, because having a straightforward, independent view is always valuable.

FDA finalises Human Factors Guidance – Part 1

We’re just over a month in to the year and the FDA’s CDRH have published a final version of their guidance “Applying Human Factors and Usability Engineering to Medical Devices”.

FDA HF guidance FINALThe document, published on 3 February, is the result of nearly 5 years of consultation with industry since releasing a draft guidance back in 2011.

Detailed examination of the published guidance is probably a topic for another time (as there’s lots to discuss). For now, I’ll make you aware that it contains some key bits of information about:

  • Human Factors Engineering process
  • Risk Management and Human Factors
  • Design Verification
  • Summative Human Factors testing
  • Human Factors Engineering Summary report
  • Changes to products already on the market

In this and subsequent posts, we’ll look at how they may impact what you’re either already doing, or plan to do.  Let’s get started with the first two topics.

Human Factors Engineering process

The expectations of your HFE process have been simplified, harmonising with ISO 62366. They’re closely aligned with how we’ve been supporting our clients’ HFE activities.

It may be that your process for HFE is either too simplistic for what’s required (e.g. just focussing on usability of the device), or sits out of alignment with the agency’s expectations. Take the time now to review what you have in place and identify where changes may be required.

ISO 62366 process flow

Usability Engineering and Risk Management in ISO 62366

Risk Management and Human Factors

As with last year’s revisions to ISO 62366, there’s now a clear emphasis on Risk Management from the User’s perspective (aligned with ISO 14971: Application of risk management to medical devices), throughout an HFE programme. The concept of a hierarchy for risk elimination or reduction measures by and large remains intact, however there are now 3 levels;

  • Inherent safety by design;
  • Protective measures in the medical device or the manufacturing process;
  • Information for safety.

As you’ll probably be aware, the agency expects risk mitigation measures to start at the top of the hierarchy.

Users and Use Related Hazards are placed front and centre, with the importance of identifying and categorising (for subsequent risk control activities) the Critical Tasks in using your device (or combination product) underlined through extensive discussion in the guidance document. Indeed, this part of the published guidance includes techniques like Task Analysis, Heuristic Analysis and Expert Review as your initial basis for risk identification.

Risk Management activities now play a bigger part in the analysis and reporting of your HF Validation Study. Reporting that must include an examination of residual risks, and an overall Usability risk-benefit analysis conclusion for the developed product.

Perhaps now is a good time to have an independent review of your Risk Management plan, activities and documentation to ensure they are ready to meet the agency’s newly published requirements for Use Related risks.

When is the guidance effective?

You will have some time to assimilate the requirements…

A whole 8 weeks, as they go live on 3 April 2016.

How will these changes will affect your product development?

What impact they will have upon your Human Factors Engineering programme?

Get in touch today to discuss how you can best navigate the changes and emerge with a Human Factors programme that is “just right”.

Closing the gap between EU and US Human Factors requirements

Medical device manufacturers can have a tough time gaining approval of new devices in the US, due to the increased scrutiny of the usability aspects of device design. To some the EU has been seen as a little more “relaxed” when it comes to testing and documenting device usability; the usability engineering process for medical devices is implied and not demanded as part of regulatory submission.

But now, the playing field is levelling out.  The standard for Usability/Human Factors ( IEC 62366) was recently updated to IEC 62366-1: 2015.  May seem like a subtle difference, yet the content change is significant if you’re developing either a combination product or medical device.

IEC 62366 was closely tied with the Risk Management standard, ISO 14971: 2007 and crammed full of examples of processes and documentation. Until this year, 62366 only required that a Usability Engineering File was created and that usability studies were carried out to verify and validate the safety of the medical device design. Now, however, the usability engineering file must contain results of both formative and summative testing,  Summative testing is used to verify and validate the medical device design (IEC 62366-1:2015 subclause 5.9).

There is also now an expectation that summative testing will find use errors that must be analysed, to identify the root cause and determine whether their severity warrants further risk control measures.

Ambiguity over setting study acceptance criteria has been removed at a stroke. Gone are the days when the Human Factors standard used to imply that, for example, a 90% success rate in correctly using the device was acceptable. The focus has now clearly shifted to examining what happened to the 10% who failed to use the device correctly and the consequences for user safety.

All these changes to study design and acceptance criteria requirements will bring EU activities closer to the FDA requirements.

As Europe tightens the usability requirements of medical devices, the only remaining difference between the FDA and the EU is; at what point will the regulators ask to see your Usability Engineering process; pre or post regulatory dossier submission?

If you need help and support or would like a quick chat about your usability engineering programme, get in touch to learn how we can help you improve the usability of your product.