Category Archives: Strategy

Considerations for Usability studies for medical devices with complex user groups

Medical devices, and combination products, are typically targeted at therapeutic areas with large patient populations, so recruitment is fairly straightforward. Usability studies recruit participants from groups of representative users, commonly from;

  • Healthy, able bodied adults,
  • People with Type II Diabetes,
  • People with Rheumatoid Arthritis,
  • Non-specialist Healthcare Professionals.

Key aspects of the study design must be tailored to the representative users and adequate to deliver a sound piece of development;

  • Participant informed consent,
  • Study design ethics,
  • Participant data protection and anonymisation,
  • IRB or Ethics committee review, where required.

And of course, design the study to provide the maximum feasible insight into the device design, Use Errors, and risk mitigations, gathering data that can be directly related to design inputs and envisaged design outputs, all whilst ensuring the cognitive burden upon participants is appropriate.

Developing a medical device for a challenging user group

There are additional challenges when you’re developing a medical device for an unusual or complex group of users.  The picture is further complicated when you’re developing a medical device that is intended for use by several, disparate, user groups.

Specific additional requirements arise for study design, when the user groups include;

  • Minors (i.e. people under the legal age of majority), either as a discrete and separate user group or as a sub-group,
  • Vulnerable adults,
  • Disease groups with extremely low incidence, or
  • Specific specialisms of healthcare.

When you’re considering designing a Usability study for a device for these user groups, consider how you’ll address;

  • Recruitment of the participant and their parent/guardian,
  • Identifying a study centre (or centres) located where there is a sufficiently large pool to recruit from. Achieving adequate participant numbers often results in conducting your study across multiple centres,
  • Working with a recruitment partner that can adapt to the unique challenges these groups present,
  • Consent and involvement of someone with parental responsibility in the study,
  • Design of study documentation to ensure both the carer and participant are able to give informed consent based upon information that is understandable to them,
  • Identifying study facilities that are suitable for the particular needs of your participants (e.g. venue and study room access).

For low incidence disease groups, evaluate the number of participants you’d want for a study against the numbers of people, in the chosen country, who are likely to fit the anticipated inclusion criteria.  This will guide your thinking about how many people are needed/can participate in your Usability study, forming part of your rationale for the study design.  You may even decide to hold the study in another country than originally envisaged, to get sufficient participants involved.

Evaluating external support

Often, development teams look for external support to Usability study design, execution or reporting.  If your project is in that situation, it would be sensible to include some or all of the considerations we’ve mentioned, in your discussions with potential suppliers, particularly for complex study requirements.

Answers to these questions will help you select the optimum support package to ensure you get the most out of the study.

Benefit from our experience

We have undertaken a number of studies that involved challenging user groups like those described above, both in the UK and North America.

As a result, we have developed strong relationships with expert recruiters and study facilities across the UK, East Coast USA, Midwest USA, Canada. These organisations understand the specific requirements and constraints, to support successful formative and validation studies for our clients.

Perhaps your development project involves an unusual or challenging user group demographic? Get in touch today for support in delivering a Usability programme and studies that meet your requirements from the start.

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.

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.

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 (hello(Replace this parenthesis with the @ sign)threecircles.eu) with your contact details.