Monthly Archives: February 2016

FDA finalises Human Factors Guidance – Part 2

In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to Medical Devices”.

FDA HF guidance FINALIn part 1, we looked at both the Human Factors Engineering process and Risk Management and Human Factors, two of the key topics covered by the Center:

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

Lets look at how the topic of Design Verification may impact what you’re either already doing, or plan to do.

Design Verification

Design Verification has vanished from a Human Factors perspective – probably a relief for device development teams who were scratching their heads about what was needed in addition to Design Verification as described in ISO 13485 and 21 CFR §820.30 Design Controls.

So now, we can focus on Design Verification being all about confirming that the design outputs (i.e. the device design and associated specifications for performance and attributes) meet the design inputs (what you wanted the device to be able to do). It’s about physical evaluation and testing of devices to confirm, for example, that the force required to turn a dial meets your specification limit. To confirm that the robustness and mechanics of your design function as intended.

Now that might sound straightforward, just get some sample devices from (pre-)production and test them, right?

Design Verification tests shouldn’t be “tick box” tests. Sadly, that’s often what is done by way physical testingof Design Verification, however this misses the fundamental point of verifying the design – to confirm that the device performs as required, throughout the range of your specifications. Design Verification demonstrates that devices manufactured/assembled with components from all across your specified ranges actually do work together, and more than that, they work as intended. Verification shows that your “design envelope” works in practice. It also gives you reasonable confidence that, when your manufacturing and assembly processes vary (within your specification) which they will do, the end product is safe to place on the market. And in the long run, that should mean less surprises.
Certainly, the scale of Design Verification can vary hugely, depending upon the number of components, their manufacturing process variability and so on. But it doesn’t need to be a big deal.

You need to be able to rely on the results of Design Verification

Taking care to plan, design and execute DV is a great step on your journey to getting your product on the market. Consider how you will know you can rely upon the data that are generated and analysed.

We’re often asked whether test equipment need to be qualified and test methods validated? You could take the approach of using development equipment and test methods that are not yet optimised. How will you be able to show, to your board and investors, that DV is truly representative of production data?

The long and the short of it is;

  • Qualify your test equipment before using it for DV,
  • Optimise and then validate the test methods you plan to use during DV.

Take both steps and you’ll have a high degree of confidence that the results you get are translatable to production and routine inspection situations. And there’s the added bonus that you would have needed to do the work anyway during industrialisation and launch preparation.

Spare yourself the nightmare of discovering at that late stage that there was a critical issue with the way you planned to release batches of product onto the market.

When is the guidance effective?

You will have some time to assimilate the requirements…

A whole 6 weeks, as they go live on 3 April 2016.

How will the 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 Design Verification programme that is “just right” – you know, “fit for purpose”.

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”.

A flurry of activity from FDA

fda draft guidances list 2016-02-05It’s been a busy week for the US Food and Drug Administration’s CDRH.  In the space of a couple of days, the Center has published one final and two draft guidances related to Human Factors.

Just over a month into 2016 and the Center has already achieved 3 of its stated priorities for the year, with the release of these documents;

  • Applying Human Factors and Usability Engineering to Medical Devices (Final Guidance),
  • List of Highest Priority Devices for Human Factors Review (Draft Guidance),
  • Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (Draft Guidance).

We’re hard at work in the office analysing the content of these documents, so we can give you a summary of the changes and requirements for your teams developing medical devices or combination products.  We’ll be publishing a summary of the key pieces of information next week.

You may want to know how these guidances impact your planned or ongoing development activities.  Send me an email to schedule a time to talk further.