HUMAN FACTORS AND USABILITY

Auxergo can offer you a range of bespoke services covering the entire development process. We can support you through all of your device's development, part of your device's development or just carrying out the final validation. For our full range of services read on below.

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Market Innovation

We are frequently asked by early-stage projects to see if there is a market need for their concepts. We can carry out a literature review and a market study to assess the market need for your device, presented in a final report. It is vital for companies to understand the current market and have insight into potential opportunities in future markets. In addition, they may be useful to send to potential investors or for grant applications.

User Research

User research is often performed in the conceptual phase and prototype-release phase. In the healthcare design and development process, user research forms a source of reliable data to base device requirements upon and can indicate the business return of the device once released. Truly understanding the user is pivotal in designing any medical device or system.

 

Auxergo collects and analyses user data such as user abilities, capabilities, limitations, and preferences, and how these vary across the population in use scenarios. There are many types of user research which Auxergo can perform. The most commonly requested are:

  • ethnographic research

  • one-to-one or focus group interviews

  • observations in user environment

  • diary studies

  • conditions research

  • heuristic evaluation

  • contextual enquiry

  • research into global clinical practices

  • user-based requirements research

 

These can be done individually or in combination, and are presented in a final report.  

 

We are happy to support you in the recruitment process, finding participants such as healthcare professionals and patients for the testing of your device or system (see PARTICIPATE).

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Human Factors and Usability Studies

Auxergo is a specialist in human factors and usability engineering. This scientifically looks at the role of users in a medical device or system and how they would be expected to use it. Its core objective is to provide evidence of use safety by researching and evaluating how safe, effective and efficient the device or system is to use. We offer the service of fully providing a report and evidence of the safe and effective use of a medical device using a usability engineering methodology compliant to the relevant standards and regulations. We are able to perform all aspects required for regulatory compliance, from user research through to formative studies and summative studies (for validation).

 

Most of our human factors and usability services and testing centre around:

  • human factors consultancy and advice

  • human factors and usability plan development

  • usability studies and testing

  • risk analysis/testing

  • prototype testing (including device and system)

  • user behaviour change analysis/testing

  • use environment testing (including the clinical, community and home environments)

  • human factors reporting

  • use safety testing

  • predicting use errors

  • interface errors testing (including medical device interface and device instruction interface)

  • instruction for use (IFU) testing

 

For IFU design and testing, we use supporting technology like eye tracking to gauge concentration.

 

Formative Studies

A formative study is the iterative evaluation of a device or system with an intended user to enable safe and effective use during the design and development process. The output at this stage is to verify that the design of the medical device or system is safe, effective, learnable and satisfying to use, as well as meets the design inputs and User Interface Specification requirements. Involving human factors and usability studies in an early stage can help you with design insight to differentiate your medical devices from competing products. We employ many techniques like cognitive walkthrough to collect feedback on early design concepts.

 

We tailor our approach to your design complexity, stage of development and overall budget. We can critique your device to identify design strengths and opportunities for improvement, which can usually be done quickly and at low cost yet produce valuable findings. We also can conduct a formative usability test of your device or a specific aspect of the design identified in the risk assessment. A formative test might be a more formal activity involving detailed test planning and reporting.

 

We provide services in:

  • formative study protocols

  • an expert review or heuristic analysis

  • user research

  • usability testing

  • risk management

  • a formative study reporting

  • design recommendations (see CO-DESIGN)

  • development of participant screener and recruitment of study participants (see PARTICIPATE)

  • arranging study logistics in a range of facilities and locations to fit your budget and requirements

  • supporting technology such as biosensors, eye-tracking, digital diary, and tachistoscopic metering (if needed)

 

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Summative (Validation) Studies

A validation study, or summative evaluation, is the final use evaluation of a medical device or system with intended users. The output is to validate that the design of the medical device or system is safe, effective, learnable and satisfying to use, as well as meets the users' requirements.

 

We can carry out your validation studies and prepare your human factors validation report for the FDA and CE marking regulations, thereby helping to release your products into the markets successfully.

We can provide the following support:

  • protocol design and discussion guide

  • user research

  • identification of critical tasks for a validation testing

  • risk management

  • usability testing

  • analysis findings

  • final report for the FDA and CE writing

  • recruit target participants

  • arranging study logistics in a range of facilities and locations

Post-market Stage Evaluation

We can conduct Voice of the Customer (VoC) and device assessments, including design reviews and usability tests, of marketed devices. Such reviews may serve the following purposes:

  • provide benchmark performance data that forms the foundation for developing a next-generation device or a competing product.

  • provide user interaction-oriented performance data upon which to base a marketing claim.

  • gain insight into reported interaction issues that might have led to device complaints, returns, and other types of failures.

 

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Risk Management

Risk management is a key part of any human factors program. We can conduct specific risk management activities to assist you with the design and development of your device or system. These include:

  • risk management planning

  • task analysis

  • use-related risk identification and analysis

  • known problems analysis

  • hazard analysis

  • adverse event analysis

  • categorising critical tasks based on the severity of potential harm, using task analysis with human error identification methods

  • Principal Component Analysis (PCA)

  • risk mitigation

  • Partnership for Systems Approaches to Safety and Security (PSASS) including Fault Tree Analysis (FTA) and Failure Mode and Effects Analysis (FMEA)

  • risk benefits analysis

  • surveillance

 

What is more, for use-related risk, we identify hazard-related use scenarios based on the potential severity of harm. We report these scenarios in a summative evaluation study. We also perform a use-related risk assessment, identifying hazards and hazardous situations; as well as the sequence of events leading to hazardous situations.

 

We review the FDA's MAUDE and MedSun databases for evidence of use-related issues with devices similar to yours, conducting use error analysis. This is along with reviewing your human factors validation protocol or study results.

 

Importantly, we also conduct human factors validation testing for you, providing a written report suitable for submission to the FDA or EU.

 

Instructions for Use (IFU)

A clear and effective Instructions for Use (IFU) is critical to producing safe use and risk control.

 

We support you to design and develop your IFU by analysing the readability (along with labelling and packaging) to test if users are able to understand and comprehend important and safety-critical information. We can use supporting technology like eye tracking to gauge concentration.


The design and testing of IFU depends on the development stage and your requirements, but usually, IFU development occurs in concert with the use-related risk management process.

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Human Factors Regulation Support

Auxergo has an expert understanding of regulatory requirements and current expectations related to human factors and usability engineering. This is along with a wealth of experience in regulatory interactions with Health Authorities and Notified bodies. We can help you to understand the human factors and usability obligations across regulatory jurisdictions, and all our work is compliant and mindful of the relevant standards and guidelines, such as:

  • AAMI/ANSI HE-75:2009

  • FDA 2016 human factors and medical device guidelines

  • IEC/BS EN 62366-1

  • IEC/BS EN 62366-2

  • UCM259760-FDA Guidance issued February 2016

  • ISO 13485

  • ISO 14971

  • EU 2017/745

  • EU 2017/746

  • CFDA 2018

 

We help you prepare and evidence your human factors work for submission to regulatory bodies, including writing human factors and usability engineering summary reports in accordance with the FDA and IEC guidances, either as discrete tasks or with full project support.

 

We are also happy to support your quality control by checking your protocol documentation, human factors documentation (including for all formative and validation studies), and a gap analysis of your current quality management system to identify the ideal level of documentation. Example support includes:

  • user research

  • task analysis

  • risk management

  • identification of critical tasks for validation testing

  • interface design including instructions, labellings, and packagings

  • support creating usability engineering file for regulatory submission

  • carrying out research on the identification of known use issues

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Quality Management System

Quality Management is about improving your products and services. Your quality system should cover both internal work processes, such as administration and management, as well operational issues and externally outsourced work processes, products and services. We can build an intelligent quality management system to help you give clear, effective and usable processes and procedures that comply with medical device regulations.

All documents and procedures relating to your Quality Management System (QMS) should make your intentions and working practices clear and applicable to the people that use them; they must also have a logical flow and be a true reflection of how people operate.

We can provide you with bespoke guidance and support:

  • we review your quality system documentation (such as protocol and human factors documentation, including for all formative and validation studies) to identify gaps between your current work and the human factors requirements of the FDA’s Quality System Regulation (QSR) and the EU’s Medical Device Regulation (MDR)

  • based on our findings, we generate recommendations for embedding human factors engineering into your product life-cycle

  • we then develop your QMS or provide you with a Quality Plan

  • afterwards, we can provide continuous Quality Improvement reviews and solutions

We integrate quality and regulatory requirements into your design and development process, ensuring that you manage risk effectively, reduce development process costs, and shorten the time to finish development.

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Software Usability

We offer customised services for software usability testing. As well as software as part of a medical device, there is now Software as a medical device (SaMD) where there is no specific hardware. This is defined by International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”. Usability of all software should be considered during the design and development process, as well as at the end of development (i.e., validation) to comply with regulations. This is especially true for SaMD in the case of clinical evaluation and use-related risk assessment and control. Human factors processes for SaMD should be applied with the same rigour as for medical devices in general.

We provide:

  • usability testing for Apps, Websites and other Digital Platforms

  • GUI design support (see CO-DESIGN)

  • eye tracking

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Cambridge, UK | Shanghai, China

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