Monthly Archives: January 2016

The forgotten twin?

Human Factors and Usability are “hot topics” in the medical device world (and increasingly for drug/device combination products too), yet the concept and the disciplines are not new. Designers and Developers have, at some level, been considering the user for years. But, it’s not just about “User Centred Design”.

A toe in the water with Human Factors

When I started in Device Evaluation, more years ago than I care to remember, we thought we viewed the device designs from a user perspective. I conducted Failure Mode and Effect Analyses (FMEAs) looking at all the ways users could destroy or misuse our devices. We even did a lot of user trials, though they were mostly with colleagues. My first thought, when I came across “Usability” back then, was that it’s the stuff we did when we tested the instructions with others in the development team.

Device Evaluation and Human Factors

How perspectives change. Across more than 15 years in Device Evaluation , I spent many happy months destroying devices (known as robustness testing) in a materials testing lab. Looking back, Human Factors at that time seemed the forgotten twin sister of device testing. It was the element often overlooked or dismissed in favour of purely physical testing.

Sometimes, I started testing a device in a lab, only to discover that I used it incorrectly and had to start over. At the time I put these lapses down to being forgetful, not concentrating properly or that the device was “just annoying”.

In the intervening years, I’ve studied and practised Human Factors in depth. You might be expecting me to recount the story of my turning point. Yet I had no sudden epiphany, no ray of sunlight breaking through the clouds. Rather I had a growing appreciation of the rich variation in how people think and behave.

Study has armed me with a more extensive arsenal of tools with which to understand users better. Experience has taught me that we ask a lot of people, when they get hold of these devices. Even tasks as simple as removing a device cap can be tricky. In fact cap fit is one of the hardest things to get right with many devices, particularly combination products.

The dangers of focussing on just Device Evaluation

That reminds me of a combination drug / device project I worked on a few years ago. I spent many hours performing cap fit tests, passing and failing batches based on the axial force required to pull the caps off. Part way through the tests I observed a user study where most people applied a sideways bending action to pull the cap off. The sideways bend weakened the device, causing it to fall apart shortly after. I had to question the point of all that axial testing… so much for fine tuning the cap design for the axial pull apart force!

Performing user studies, or getting “real” user thoughts, can make a world of difference to what you classify as being critical to design. Yes, the axial pull apart force was important to cap removal, but critical to creating a robust design was how the device was really used.

Why Human Factors and Device Evaluation are closely related

old twin sistersYou can perhaps see why these two disciplines are twins. Often, one of the two seems to be ignored or forgotten by development teams. Perhaps that’s a result of the twins being very different in nature, as siblings often are. On the one hand, you have a discipline that is very method and results data driven, mechanical and “hands on”. On the other hand you have a discipline that’s focussed on thoughts, actions and reactions of uncontrollable test participants.

Development teams seem to have a natural preference for one or the other, a comfortableness that fits with their collective learning style. Similar to our development as human beings, recognising the potential weakness or blind spot is the first (and biggest) step to beefing it up, to get the balance right.

What happens if you focus too much on one twin?

Consider what happens when you do as much physical lab testing as you like, but miss something obvious like how people really remove a device cap. Then, it’s back to the drawing board for the design, with all the delays, costs and lost profits that entails.

Consider what happens when you do lots of Usability testing with your device design, get great results from the final design iteration, but the device falls apart or stops working as expected when subjected to repeated use. Again it’s back to the drawing board to improve the robustness of the design, with delays, cost increases and lost opportunities for profit.

It can be hard to recognise an imbalance between the twins and address it.

You may already be thinking about getting in touch with us to check if you’re treating both siblings equally and how to achieve balance. Pick up the phone or email us today.

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:

CDRH New Year’s resolutions

The FDA has shared its New Year’s resolutions, including the guidance documents the Center for Devices and Radiological Health intends to publish in 2016.

In line with the Center’s published priorities for 2016 (more on that next time), the application of human factors and usability engineering to medical device design makes it onto the list, as well as incorporating patient preferences into device premarket approvals.

FDA 2016 Guidance priorities

The resolutions are split into

  • The A List (those draft and final guidances the FDA “fully intends to publish”), and
  • The B List (those that will be released “as resources permit”).

We are curious to see which of the comments made by industry are included in the Final Guidance documents.

You can read what others in the industry, such as Eli Lilly, Smiths Medical and GSK, are saying at the US government website www.regulations.gov. Search for the relevant guidance document (e.g. human factors FDA will find the agency’s draft guidance document on that topic).

Amongst the Final topics that made it onto the A List are:

  • General wellness products
  • Medical device accessories
  • Incorporating patient preferences into medical device premarket approvals, humanitarian device exemptions, and de novo classifications
  • Applying human factors and usability engineering to optimize medical device design
  • Post-market surveillance studies under section 522 of the Food, Drug, and Cosmetic Act
  • Medical device reporting for manufacturers

Draft guidance topics that reached the A list included:

  • Medical device decision support software
  • Use of symbols in labelling
  • Software modifications
  • Companion diagnostics co-development
  • Use of real-world observational patient data to support decision making for medical devices
  • Public notification of emerging post-market medical device signals

The B List also has some guidance topics which are keenly anticipated, however these will only be progressed if resources and time permit during 2016:

  • Blood glucose monitoring test systems for prescription point-of-care use (Final)
  • Self-monitoring blood glucose meters for over-the-counter use (Final)
  • Medical device interoperability (Draft)
  • Patient access to information (Draft)
  • Defining the UDI (Draft)

It doesn’t stop there, as there’s been a wealth of Guidance published by the agency over the past few decades. The FDA has asked for feedback on many Guidances published more than 10 years ago, to see if they should be revised or even removed.
Of note are:

  • Do It By Design (the FDA’s 1996 introduction to Human Factors in Medical Devices)
  • Post-market Surveillance under Section 522 of the FD&C Act (a 2006 Final Guidance)

Read the FDA proposal here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm

Top 5 posts of 2015

During 2015 we dipped our toe in the water, posting thoughts and tips both on our website and LinkedIn Pulse. At the close of the year, the results are in and one thing the top posts have in common is the sharing of difficulties and practical ways to overcome them.

You may be thinking that you’d like to re-read some or all posts, or that you missed them first time round. Simply click the post title to read the first few paragraphs.  Then, if you’d like to read the whole post, click on the link at the bottom.

And the winners, ranked by the number of readers, are…

#5: Zen and the art of Design Controls


There are days when I think “is it me?” Especially when it comes to appreciating Quality Systems. I confess I do like logic and I even get a buzz when I see a logical progression in project deliverables, moving from A to B to C and so on. It’s wonderful, having links and traceability.

I must make it clear I have never been part of a Quality Department. I have been involved in medical device development for many years and lived through, what I now think of as the unenlightened times (although immensely fun), when we defined our own ways of working, prior to the introduction of Design Controls and ISO 13485; having standards and guidance is now quite comforting for me. This probably explains why I find it distressing when I come across people who do their level best to ignore or get round the logical order laid out in Design Controls.

I struggle to grasp why it is faster to go from A to C and then back to B and then try to jump to D. Worse yet are those who think they can start at C and miss out… (click to read more)

#4: The Designer Friendly Usability Specification


Getting your head around ISO 62366:2008 can, at the least, be tricky, perhaps even frustrating. The standard mentions many documents and requirements for a medical device Human Factors programme.

Take the Usability Specification as an example. It’s meant to provide testable requirements for usability verification and for usability of the primary operating functions. On top of these, it is also expected to include criteria for determining the adequacy of risk controls that have achieved by the usability engineering process.

With me so far?

Once you’ve deciphered these requirements for your Usability Specification, you’re next asked to;

  • Add in inputs from a range of other documents (Application Specification, The Primary Operating Functions, Hazards and Hazardous Situations relating to Usability),
  • Include any foreseeable use errors associated with … (click to read more)

#3: If you don't have time to do it right …


“…when will you have time to do it over?”

Most of us will agree that there is an ever increasing pressure to deliver immediate results from our projects. As organisations in many sectors tighten their belts, there is an expectation of doing more with less, in shorter time. But, in the rush to get on with doing, are we throwing out the baby along with the bath water? Are project time-lines and costs actually increasing as a result of skipping over or rushing through the scoping or planning activities?

There are many pressures on projects within the modern organisation. Some of these are cultural, such as the belief that “productivity = doing something”.
Can we kick back against this pressure, to identify or check that we are “doing the right something”? (click to read more)

#2: Is your product development missing these key activities?


With the much anticipated and long overdue update to ISO 13485 moving out to the end of the year and probably into 2016, it looks like medical device companies can breathe easy for a little while longer, before beginning the revamp of their Quality Management System.

Is it time to relax though?

Before you relax too much, consider that people often miss out chunks of the current version of the standard, or focus on its content; forgetting about hot topics that are not currently well defined. Their absence in development projects gives me a headache on a regular basis. Headaches that are cured when we resolve things like;

  • Traceability from the initial requirements through to what has been validated and is (hopefully) about to be manufactured for the market. Often traceability is done … (click to read more)

#1: Correct these 9 deficiencies to avoid becoming regulatory inspection road-kill


It’s not unusual to be thinking about how regulators will see your product development and where they may find holes.

The closer you get to submission of your newly developed device or combination product, the larger this probably looms in your mind.

It can be useful to see what the recurring issues uncovered during inspections are, but you could easily spend days sifting through inspection trend information available online, without understanding what it actually means for you and what should you be doing now to avoid being part of the deficiencies statistics for 2015.

Top observations found during inspections of both pharmaceutical and medical device manufacturers are reported each year by the US regulatory agency… (click to read more)

What were your top reads of 2015?

Drop us a line to share your favourites.