User Studies

Benefit from our industry-leading human factors expertise, access to high-quality global user panels, state-of-the-art study facilities, and experienced local language moderators. Our specialized quality management system ensures regulatory compliance, reliable study material handling, data integrity, and personal data protection and privacy.

User studies

Our process

Study synopsis and stakeholder alignment

Study synopsis

and stakeholder alignment

We start by assessing and scoping all relevant aspects of the study, resolving outstanding questions, and aligning all stakeholder expectations and timelines.

1

Participant Screener and Study Protocol

Participant Screener and Study Protocol

Next we define study methodologies, procedures, and participant and user interface characteristics in line with regulatory requirements.

2

Institutional Review Board and Ethics Committee Approval

Institutional Review Board and Ethics Committee Approval

When applicable, this step will ensure that the benefits of the study outweigh potential risks to participants

3

Study Execution

Study Execution

Carrying out user studies includes global management of study participants and study sites, material handling, session moderation, and note-taking, including recording or live-streaming.

4

Analysis and Reporting

Analysis and Reporting

Results analysis and reporting cover root-cause analysis, user requirements evaluation, and reporting (including systematic impact assessment on risk analysis).

5

Risk Assessment

Risk Assessment

Finally, we support risk assessment and defining risk management activities and mitigation in compliance with regulatory requirements.

6

Formative studies

Formative studies

We conduct a variety of face-to-face and remote formative user studies, across a range of medical products and therapeutic areas, at all stages of design and development and in all major target markets.

  • Focus group studies

  • Comparative analysis studies

  • Human factors and usability expert reviews

  • Medical and clinical expert reviews

  • Formative usability studies

  • Pre-summative testing

Summative (validation) studies

Summative (validation) studies

We have significant experience performing user studies as part of design validation activities as per ISO 13485 (EU) and 21 CFR Part 820.30 (US). We are up-to-date on all applicable standards and regulations including IEC 62366-1, EU Medical Device Regulation (MDR), and US FDA guidelines.

  • Simulated use studies

  • Actual use studies

  • Comparative use studies

Your perfect study partner

Scalability

Scalability

Whether your goal is to outsource all study activities or look for the most cost-effective solution, we tailor the study set up to meet your individual needs. For example, we can support your own in-house study project or we can conduct all activities from defining the study synopsis to supporting your risk management activities.

Experience you can rely on

Experience you can rely on

Our team has completed over 30 studies across a range of medical products and therapeutic areas, at all stages of design and development and in all major target markets. To deliver best-in-class service on complex user study projects, we work together with our trusted partner KDA, a dedicated German healthcare and research specialist with over 25 years of experience.

Design and development expertise

Our industry-leading expertise in medical device design and development translates into unique benefits and unparalleled service quality for our clients because we:

  • Seamlessly integrate study results to inform your risk analysis and design decisions.

  • Identify and capture the relevant stakeholder inputs, concerns, and requirements and align and translate them into a concise, approvable study procedure.

  • Execute the study field phase with your design and development perspective in mind.

  • Analyze the study results under systematic consideration of your user requirements, use-related risk analysis, and the regulatory requirements and expectations.

  • Effectively inform and seamlessly integrate the study results into your risk analysis and design decisions.