Category Archives: training

Human Factors Engineering 101

We’re pleased to be presenting again at the Medical Device School in London, UK, later in November.  Matthew once again joins a panel of industry peers to provide delegates to the School with both an introduction to the world of Human Factors Engineering for Medical Devices and the opportunity for a practical application of HFE principles.

If you haven’t yet had an opportunity to find out what it’s like to work with us, here’s a taster from two previous sessions:

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, Matthew 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 Matthew to include two sessions. Delegate feedback about the whole Autumn school asked for more interactive elements, so our 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, our 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 Matthew 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”

You can achieve similar results.  Get in touch to find out how you can benefit from this or other training courses we have delivered.

 

 

Getting to grips with managing a medical technology project

With increasing pressures on healthcare businesses to get to market quicker, with lower development costs, managing your projects effectively has never been more important.

However, regulatory expectations folots of signpostsr medical technology development are continuously evolving.

There’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 project management 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.

Perhaps you want to understand the crucial steps that need to be taken to ensure successful project completion? Then clear your diary for Tuesday 27th September 2016. We have collaborated with Medilink South West in delivering a one day seminar to outline the common pitfalls and how to avoid them, as well as providing implementable strategies to apply to existing and new projects.

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

img_20150917_123707740-croppedThe day is will cover topics like:

  • Why projects fail
  • Why project management makes business sense
  • Project leadership and project management
  • Navigating the complexities of medical device development
  • Key strands of medical technology development:
    • Defining your project
    • Development
    • Industrialisation
    • Product Launch
  • Working with project management methodologies

“Very good, in depth project management tools”

extremely useful, very interesting and well structured.  My interest was held all day which given that it was an all day session is extremely difficult to do.”

At the end of our time together, you will have

  • Gained a thorough understanding of the latest principles of project management
  • Learned how to plan effectively, identifying and mitigating significant risks to your product’s development
  • Created a toolkit for adopting and implementing practical steps and measures at each stage of the process

“Workshops were very energetic and welcomed”

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

Get started with resolving your project issues by clicking here to book your seat right now.

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.

Have you taken these steps to make your medical device safe?

Pressures to get to market quicker haven’t eased up any over the past year. Everyone’s looking for an advantage to press home. Developing medical devices that really meet users’ needs will give you that competitive advantage.98000

And, given how many people die in hospitals each year due to human error (98,000 in the US and nearly 12,000 in England alone), there is an ethical imperative to get it right.

Against this backdrop, the Medical Device School is held in London twice a year, attracting regulators and development organisations from across the EU, and further afield.

Medical device human factors

Following a very successful maiden seminar at the school last November, I recently had the pleasure of returning to present and lead sessions covering the theory and regulatory expectations of Human Factors and, very importantly, its practical application.

Across several “full-on” hours, delegates to the School 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.

Experiencing User Needs first hand – human factors in action

Exercise photoAs you may have come to expect from us, students experienced three full immersion workshops during our all-too brief time together. These workshops are an integral feature of our training events. Delegates experienced first hand some of the key steps in satisfying Human Factors requirements, from identifying User Needs through to identifying and evaluating use related risks!

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

The conversation over lunch was full of enthusiasm and eagerness to implement what they’d learned.

Pick up the phone or email us right now about your training needs, because it is never too early.