User Research


Great products come from intelligent observation and sensitive user research. Inspired Usability will take you beyond market research (which is often cursory) to a deep understanding of the issues, motivation and needs of your users.  This awareness of users’ complex world, both practical and emotional, will allow you to take your project to the next level.

User research does not have to be expensive.  It works alongside your valuable existing networks.  It builds on the understanding you already have of your users and your products.  Our range of quantitative and qualitative methods will inform your design from concept to design freeze.

A few examples of our methods include:

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contextual
icon1Observation of users in their environment to understand what they really not and not just what they say they do can uncover latent design opportunities.  If you want to understand more about the context of use, workflows and mental models we can carry out fieldwork worldwide to provide you with a rich understanding of your users, stakeholders and environment.
diary
icon2Many drug delivering devices involve interaction over a period of time which may change depending on a number of external factors. Understanding how these devices co-exist into people’s lives can give you rich design insights to improve the design decisions you make. Diary studies, whether paper based or digital, are a great way to understand people with long term conditions use their medical devices.
disease
icon3If you want to know more about a specific condition Inspired Usability can carry out desk-based research using a range of sources such as social media and patient forums/charities. We can also carry out interviews with key opinion leaders in person or via social media.
focus
icon4Focus groups or one-to-one interviews are another way to help you understand your users. We can run sessions in-home or a research centre to help you uncover more about the people you are designing your products for.

codesign
icon5End users may not be able to design their own products but they offer crucial feedback on what does and does not work for them. We have experience facilitating design and feedback, and have found this process provides inspirational. We facilitate workshops and co-design sessions with your team and end users to provide new concepts and design solutions for your next generation of medical devices and combination products.

Formative Studies


Formative studies inform the design of a medical device or combination product.  They are the backbone of the usability engineering process. Inspired Usability will work with you to fit formative studies seamlessly into your design process.

As an independent research organisation we can help you along the regulatory pathway, providing human factors evidence to the regulators. Careful study design can provide you with design insight to differentiate your medical product or device from competing products. We tailor our approach to your design complexity, stage of development and overall budget. Whether you are testing low fidelity prototypes early in the design process, or want to test a specific aspect of the design identified in the risk assessment, or want a full simulated use study with high fidelity prototypes, we can design the study accordingly.

We provide services in:

  • Usability testing plan and approach for the full design cycle
  • Linking usability studies into risk management
  • Formative study protocols, discussion guide and data-collection templates
  • Arranging study logistics in a range a facilities and locations to fit budget and requirements. These include hospital simulation centres, marketing viewing facilities and private hire venues
  • Development of participant screener and recruitment of study participants
  • Moderation and observation of the study
  • Analysis reporting and design recommendations
inhomeicon7Whether you want to run a study in a specialist market research facility, onsite or in the home we will work with you to decide the best approach.

Study venues include:

  • Market research facilities with one-way glass for live viewing
  • Private venue hire with Skype link-up for smaller budgets
  • Hospital simulation centres for medical device testing
  • In-home testing for early understanding of how devices fit into people’s lives

We have contracts around the UK and worldwide

data
icon6All studies have a protocol and pre-defined data collection template. We are always striving to bring new insight into our research.

Example tools include:

  • Biosensors to indicate stress levels
  • Eyetracking to understand concentration (especially good for IFU design)
  • Bespoke diary studies with cultural probes
  • Digital diary studies for smart phone literate populations

Regulatory Support


Human Factors is now a regulatory requirement. However fantastic your medical device or combination product, it will not get to market without appropriate evidence of your Human Factors work. All our work is compliant and mindful of the relevant standards and guidelines such as:

  • AAMI/ANSI HE-75:2009 Human Factors Engineering – Design of Medical Devices
  • IEC/BS EN 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices
  • IEC/BS EN 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
  • UCM259760 ‘Applying Human Factors and Usability Engineering to Medical Devices’, FDA Guidance issued February 3rd 2016
  • Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products, MHRA Draft Guidance issued June 2016

We conduct all our research according to the relevant ethical guidelines such as the MRS and BHBIA and when appropriate seek ethical approval.

We help you evidence your Human Factors work and support your regulatory submissions either as discrete tasks or full project support. Example support includes:

  • Task Analysis to understand all the discrete steps a user will interact with a device
  • Usability Risk Assessments to assess how a user’s perception, cognition and action is affected at each discrete task to identify foreseeable mis-use scenarios.
  • Identification of critical tasks for validation testing
  • Support creating usability engineering file for regulatory submission
  • Carrying out research on identification of known use issues

Validation Studies


If you are planning on getting approval by the FDA, your Human Factors validation study must be conducted in the USA with the target user population (a minimum of 15 participants per distinct user group). We can provide the following support:

  • Identification of critical tasks for validation testing
  • Protocol design, discussion guide, pass/fail/near miss criteria
  • Working with external agencies to recruit target population
  • Moderation and observation of the study
  • Analysis and report writing
  • We are fully qualified to work in the USA