Tag Archives: training

Back by popular demand – one day seminar on Human Factors and Medical Devices

Developing medical devices that really meet users’ needs will give you a distinct competitive advantage. Following a robust development process that is focused upon the users shortens your time to market, reduces development costs and maximises the uptake of your product.
IMG_20150910_133403063_HDRRecently, we were invited to deliver, once again, our course “Incorporating Human Factors in your MedTech Design Process”. We previously had the pleasure of delivering the course with the support of Medilink, as part of their professional development programme. Our most recent event was tailored to meet the the needs of a product design client and held in-house for their complete design team.

“That was the best training we have ever had”

Throughout an intensive, action packed day, attendees learned how to deliver a more effective process for product development, incorporating ISO 62366:2015 alongside US and EU regulatory requirements. Delegates took away a tool-kit that enabled them to understand their product’s target user group(s), identify and mitigate risks effectively, make data based decisions and improve their products by incorporating robust market advantage features into design.

IMG_20150910_143517074_HDRFull immersion workshops are an integral feature of our seminars and this one was no exception, as you can see from these photos. Delegates experienced first hand some of the key steps in satisfying Human Factors requirements, from identifying User Needs right through to designing and executing a brief formative study!

“A great insight into the detail which is involved with the designing of a medical device”

Delegates left the event full of enthusiasm and keen to implement what they’d learned.

All of our professional development sessions can be run in-house and tailored to fit your specific needs. Examples of our recent sessions include medical device development, design controls and risk management.

Is herding cats easier than Design Controls?

With increasing pressures on healthcare businesses to get to market quicker and pressure to lower development costs, managing your design controls activities effectively has never been more important. However, regulatory expectations for medical technology development are continuously evolving. IMG_20150917_121626071There’s a natural tension between these two aims that is further complicated by the interactions and interdependencies of the major strands of product development. Following a process that is focused on doing the right things, at the right times, ensures the balance is maintained, shortens your time to market and reduces development costs.

This may all sound difficult to balance, managing to cope with these strands going off in sometimes wildly different directions.  If you’ve ever even thought about herding cats, you’ll appreciate the challenges involved.  However, in the latest of our programme of professional development training courses, in collaboration with Medilink West Midlands, we had the pleasure of focusing on how to manage control these strands,.Getting to grips with Design Controls

“Excellent, interactive aspect of the course was a brilliant idea”



Our goal was to provide attendees with an understanding of the crucial steps that need to be taken to ensure successful project completion. We outlined common pitfalls and how to avoid them as well as providing strategies to apply to existing and new projects.
Typical of the training events we deliver, the day was intensive and action packed, no time for delegates to switch off!

“Excellent, very well paced, good practical sessions”

Talking issues through
As usual, there were several full immersion workshops, interspersed with “classroom” sessions, as you can see from these photos. Delegates experienced first hand the key stages of defining and managing a project though to completion.

Delegates left the event full of enthusiasm and keen to implement what they’d learned.

“I wish we’d looked at this course 18 months ago”

They left better equipped for their next (or current) device project and perhaps more capable at herding cats too.

All of our professional development sessions can be run in-house and tailored to fit your specific needs. Some of our recent sessions include project management, medical device development, design controls, Human Factors and risk management.

93% of asthma patients can’t use their inhalers!

How often do you see people on tv use an asthma inhaler, only to exhale or start talking straight away? Instruction leaflets typically ask the user to hold their breath for at least 5 seconds before breathing out, yet I can count on the fingers of one hand, how many times I’ve seen this portrayed accurately.

If media portrayal is so inaccurate, it’s no surprise that most asthma patients don’t really know how to use their devices. Recent research found that only 7% of them use inhalers correctly, getting the full benefit of their prescribed medication.

It matters, because repeated under dosing results in poor management of the condition, often leading to people being put on stronger inhalers than they actually need. Dr Samantha Walker, director of research and policy at Asthma UK, said in a recent BBC interview, “This is also hugely wasteful – asthma-prescribing is one of the most expensive areas of cost for the NHS, costing almost £1bn annually.”

Tyical instruction leafletMuch reliance is placed upon the patient reading, and keeping hold of, their instruction leaflet. But, we know that 60 percent of users won’t ever look at that leaflet, let alone refer to it later on. Training, particularly during an annual visit to the asthma clinic, is often relied upon to “fix” poor technique. How effective can a 5 minute session be for unlearning habits that have been reinforced over many months?

Guidance from FDA includes a hierarchy of ways to mitigate device risks. At the top sits design changes, designing out use errors or reducing their occurrence, training and then instruction leaflets sit at the bottom.

Poor inhaler technique can, at least in part, be mitigated through the design changes incorporated into breath actuated inhalers and capsule inhalers. So perhaps the changes being called for recently by UK healthcare charities should extend to use of appropriate alternative devices, to improve disease management and reduce long-term costs to the health service.

It’s not just asthma patients that struggle. Studies in the US show that just 16% of people prescribed adrenalin auto-injectors used them properly. People often didn’t hold the injector in place for at least 10 seconds or didn’t push down forcefully enough to allow the adrenalin in. Auvi-Q is a great example of a device that seeks to address these problems. It talks the user through each step, even counting up to 10 for them whilst they’re injecting.

Aiming for the stars


The most interesting and memorable presentations tell stories, infused with the speaker’s passion and real-life experiences.  Check out Al Gore’s TED presentation to see what I’m talking about.Al Gore at TED

So, when Medilink invited me to present a “master class” in human factors for medical devices, it was my opportunity to step up to the plate.

The timing was fantastic!

For the past 3 years I’d been learning about NLP and putting it into practice.  As part of my training, I needed to deliver a presentation that demonstrated all I’d learned as a Master Practitioner.  The topic was up to me, an ideal opportunity to create something out of the ordinary that I could also use for the master class.

I wove together three stories about how people interact with everyday objects and their usability. I added some images to fit with the stories, steering clear of “death by powerpoint”.  Along the way we talked about the main steps in getting human factors right and why it’s so important to a good medical device.

And the results….

  • I passed the Master Practitioner course with flying colours…
  • Feedback from the Medilink course attendees last November was entirely “very good” or “excellent”.

In fact, I’ve been invited back for a repeat of the master class later this year.  Perhaps you’d like to come along. It’s on 25th September, in Birmingham, here’s more information.