Tag Archives: medical device development

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.

 

 

Medical Device Development – How to get the best possible return on your investment

Bringing a medical device to market requires significant investment of time, money and resources.

In our experience, the precise amounts of all three needed to successfully complete development, industrialisation and launch varies, depending on the nature, complexity and risk associated with the product.

It is not unusual for a low to moderate risk device to take 3-4 years to reach the market, supported by development investment of up to around $30million. As the device risk and/or complexity increases, so does the investment; by comparison, a complex, high risk device may take upwards of 6 years and $90 million to bring to market. There are no guarantees, of course, that the device will ever make it to the market or, if it does, that it will be commercially successful but for those that are, the rewards can be significant.

So the medical device development process can often be a perfect storm —high risks, high costs, lengthy development timelines that can eat into the revenue generation window, and potentially relatively modest returns—has created a difficult environment for medical device innovation. If you’re in this challenging environment, you’ll want to focus on strong management of process to mitigate risks and minimise time and investment, whilst ensuring your development roadmap doesn’t cut any corners.

In our experience, gained from over 25 years in device development, you stand the best chance of success if you focus on three critical factors;

  • Mitigating Risks
  • Controlling spend
  • Optimising project timescales

Mitigating Risks

To mitigate risks, first there has to be an understanding of the potential risks in the development process and secondly a plan to minimise their impact and mitigate them as far as is practical and cost effective.

Controlling Spend

Controlling spending is not just about spending wisely and getting best value, but also about making informed investment decisions (based on sound data and experience) to reduce risk by investing proactively in key areas. Sometimes, money spent in the right areas early on in the development process can save significant sums later on – the cost of quality effect.

Optimising project timescales

Optimising project timelines involves identifying key decision points and ensuring you have the data you need to make robust decisions when and where they’re needed, preventing unnecessary work or racing down a flawed development path. Creating the least impact on project timescales steps back from the fallacy of planning a “best case” project timeline, which almost inevitably falls apart at the first hurdle and ends up costing far more than budgeted and taking years longer to deliver (if at all). Instead, it looks in detail at the individual project elements and avoids the temptation of cutting corners to create a more robust, realistic, affordable and achievable plan for development through to launch and beyond.

That’s a lot to consider, no matter what development stage you’re at.

How to ensure medical device development goes smoothly

To ensure things go as smoothly as possible, when we’re brought into a project to deliver a specific piece of work we offer clients the option of a scoping day, assessing collaboration prerequisites and risk factors in a pre-collaboration checklist.

This builds the foundation for a successful working relationship, with no surprises, and enables us to help you avoid the pitfalls that can stop, stall or even derail a project completely.

Business Bridge tender success for Three Circles!

We are delighted to have won a tender to supply regulatory guidance, CE marking and support services to companies developing medical technologies, via the Keele University and University Hospitals of North Midlands NHS Trust (UHNM) Business Bridge programme.

Healthcare market access support for Staffordshire businesses

The Business Bridge programme supports businesses based in Staffordshire, UK, currently working within or hoping to access healthcare markets. The partnership between Keele University and UHNM provides fully funded innovation vouchers to the value of £7,000 to eligible companies.

The vouchers can be exchanged for access to an expert panel of specialist advisors within the healthcare and medical markets and/or specialist support such as; support for market access, product design, prototyping and testing and CE marking and other regulatory advice.

Matthew Theobald, New Product Director at Three Circles commented: “We are delighted to have won this tender and to have the opportunity to support businesses in the West Midlands looking to develop innovative products for the healthcare market.”

Click here to visit the Keele University Business Bridge web page.

 

 

Medical device development; look what you could have won…

Would you like our eternal gratitude… and a small scale model of a speed boat? (yes, really…)

Our inspection lifeboat

Three Circles, the leading medical device development consultancy, have commissioned bespoke research into the industry’s perceptions of best practice, areas of risk, and the causes and impact of delays in the development process for medical devices.

 

 

If you are currently:

  • a director or head of department with responsibility for device development within your organisation (i.e. you manage the team, control the budget and are responsible for the strategic overview and project delivery),
  • A project leader with responsibility for device development projects within your organisation (i.e. you manage the team, manage the budget and are responsible for project delivery),

then we want you to participate in our research.

The research will be conducted by an independent third party who will ensure your participation remains confidential with the results anonymised. The findings will be used to validate our route map for the development process and will be shared with participants.

Along with a copy of the research findings, you will receive our eternal gratitude and a small scale model of a speed boat and we will make a donation to the RNLI for everyone who takes part.

To register your interest in participating, please email me directly (*protected email*) with your contact details.