We support medtech and pharma teams across different stages of product development, from early exploration and use-related risk identification through validation and regulatory submission in the US and EU
We would love to support your next project
Most engagements are led by a single consultant, providing clear ownership and direct communication.
Where project scope or complexity warrants it, additional input can be incorporated to maintain continuity and ensure the work remains aligned with your needs.
Our services can be delivered as focused, standalone activities or integrated into wider development programmes
The areas below reflect the human factors support we most often provide.
Early development & definition
Establishing clarity around users, environments, scope, and early human factors priorities.
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Human actors strategy & planning → +
We define the scope and structure of human factors activities appropriate to your product and development stage. This may include clarifying users, environments, and critical tasks, and outlining a proportionate plan aligned with risk and regulatory expectations.
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User & context of use research → +
We conduct research to develop a clear understanding of intended users, use environments, and use scenarios. This ensures design decisions are grounded in evidence rather than assumptions.
Risk analysis & design evaluation
Identifying and managing use-related risks while refining the design through structured evaluation.
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Known use problem search → +
We review comparable products, incident databases, and available evidence to identify known use problems and recurring failure patterns, informing early risk considerations.
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Expert & Analytical Reviews → +
We carry out structured expert evaluations of your design to identify potential usability and safety concerns efficiently, applying human factors principles and domain knowledge.
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Use-related risk assessment → +
We analyse tasks, interactions, and use scenarios to identify potential use errors and their consequences, supporting structured risk management within your development process.
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Formative usability studies → +
Formative studies are conducted throughout development to explore and refine evolving designs. We plan, moderate, and report studies appropriate to your stage, whether remote, in-person, or on-site.
Validation & regulatory support
Generating robust evidence to demonstrate safe and effective use and support regulatory review.
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Summative usability studies → +
Summative studies are performed with a commercially representative device to demonstrate safe and effective use. We provide full support from planning and recruitment through moderation, analysis, reporting, and logistical coordination.
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Human factors & usability Documentation → +
We develop clear, defensible documentation aligned with regulatory expectations, including plans, analyses, study reports, and submission-ready summaries.
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Development of instructional Materials → +
We support the development and evaluation of instructional materials as part of the overall user interface, ensuring clarity and alignment with user behaviour.
Post-market support
Supporting continued safe and effective use as products evolve beyond initial launch.
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Complaint & incident review → +
We review field complaints and incident reports from a human factors perspective to identify potential patterns of use error or user interface concerns. This supports structured evaluation of whether additional risk assessment, design refinement, or usability evaluation may be required.
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Change impact & labelling Assessment → +
When design modifications, software updates, or labelling changes occur, we assess potential impact on critical tasks and use-related risk. This includes evaluating updates to instructions for use and user-facing materials to determine whether additional human factors activities or documentation updates are necessary.
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Post-market data review & Advisory Support → +
We support structured review of post-market surveillance data, trend analysis, and real-world feedback to identify emerging usability concerns. Where appropriate, we advise on proportionate human factors actions to maintain continued safe and effective use.
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Legacy product human factors gap Assessment → +
For existing or legacy products, we assess alignment with current human factors expectations and regulatory guidance. This may include reviewing documentation, risk analyses, and historical usability evidence to identify gaps and recommend proportionate remediation strategies.