Combination product human
factors engineering programme

Challenge

Providing human factors (HF) support for our client on a combination product development, from initial analysis to final FDA submission.

Approach

Using our initial HF analysis, we developed user-friendly instructions for use (IFU) and product labelling. We then conducted a formative study which helped optimise the IFU further, and developed the protocol for a validation study.

Outcome

Supported our client’s human factors engineering (HFE) programme to form part of a successful FDA submission.

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From initial analysis to FDA submission

We were approached by a top 20 global pharma company for HF support on a combination product development. Our team guided the client through a comprehensive programme of HFE, from initial analysis and formative testing and IFU development, to validation, reporting and successful submission to the FDA.

The foundation of our client’s HFE programme was a thorough and thoughtful analysis of the tasks, user interface, opportunities for use error and use-related risks associated with the product.

IFU and labelling development

With our HF analysis as a solid foundation, working together with our design colleagues we applied our expertise in information design to develop the text, graphics and layout for a user-friendly IFU. In conjunction with the IFU, labelling was also developed. This was completed with an understanding of the practical, commercial, manufacturing and regulatory constraints under which this labelling is developed.

Formative testing

The next step of the project was to test the usability of the system, and verify the effectiveness of the IFU in a formative study. We conducted individual in-depth interviews with 26 participants in Boston, USA.

On a combination product development, with a ‘drug’ primary mode of action, the HFE primary objective was to demonstrate that intended users would be able to safely and effectively administer doses using the delivery system provided, and that residual use-related risks were acceptable.

In response to findings of the formative study, we optimised the instructional material, linking use-related risks and difficulties observed. Changes to pictograms, wording and IFU layout were implemented to enhance the prominence of the user interaction points.

Validation and report for submission

We developed the protocol for a simulated-use validation study, applying our understanding of the available guidance from the FDA and the relevant standards: ANSI/AAMI HE75 and ISO 62366.

We conducted the study with 70 participants across three sites in the USA – Philadelphia, Chicago and Los Angeles. Our team acted as moderators at all study sessions, and used their experience to gather valuable insights to influence documentation required for submission. Any observed safety-critical errors or ‘close calls’ were discussed and investigated at the end of the session to establish root cause.

Combination product human factors engineering programme

Reporting

By examining the data we had collected from the formative and summative HF work, we were able to support our client’s HFE summary report in line with FDA draft guidance.

Team completed the HFE programme described above, from known use-error review, to final report ready for submission in 15 months.

By examining the data we had collected from the formative and summative HF work, we were able to support our client’s HFE summary report in line with FDA draft guidance.

Late changes and rapid ‘re-validation’

A few months after completing this programme of work, our client came back to us with a number of changes to the labelling of their device. Our HF team assisted them in re-validating the system, using the existing validation study protocol.

Initially we agreed a mini-validation approach, involving 16 participants recruited to represent varying parts of the intended user population. We were able to coordinate and conduct this study rapidly in New York, USA.

Shortly after we had completed this mini-validation, for programme risk management reasons, our client decided to expand the re-validation programme to a total of 60 participants. Time pressure on this was extreme, but our staff responded quickly and effectively. This final validation study was successfully completed in two cities in the USA; Atlanta and Boston.

We updated the HF report and this became part of a successful submission to the FDA.

Outcome – successful submission to the FDA

On a combination product development, with a ‘drug’ primary mode of action, the HFE primary objective was to demonstrate that intended users would be able to safely and effectively administer doses using the delivery system provided and that residual use-related risks were acceptable.

Team’s HFE programme met this objective for our client, through close collaboration and on a tight timeline. The HFE summary report was part of the successful submission to the FDA.

This client continues to choose us for human factors services.

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Combination product human factors engineering programme