HUMAN FACTORS & HEALTHCARE RESEARCH

Create stellar patient and HCP experiences with iterative user testing

From exploratory research to your final validation study, we help you to create safe, effective, and engaging experiences for your customers.

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Send us your details and we’ll get back to you to set up a free intro-call.

Our experience with medical devices and related products

INJECTION DEVICES

Needle safety devices
Connected devices
On-device labeling

PACKAGING, LABELING & IFU

Clinical applications
Injection devices
Infusion pumps
Oral therapies

DIGITAL ASSETS & CONNECTED DEVICES

Digital therapeutics
Website and desktop software
Clinical and patient decision support systems
Remote patient monitoring and management

PUMPS, DIAGNOSTICS & OTHER DEVICES

Surgical devices
Imaging systems
Clinical diagnostics

OUR COMMITMENT TO QUALITY

Part of our DNA

We have been applying HF/UE to medical device development longer than the FDA has been regulating it! HF/UE best practices and industry standards are part of our DNA. Our research is conducted according to the guidelines found in IEC 62366-1, TR 62366-2, FDA guidance on applying HF/UE to medical device development, AAMI HE75, and other standards wherever appropriate.

Research tools we use

Ethnography
Contextual inquiry
Concept assessments
Focus groups
Task analysis
Diary studies
Post-market surveillance
Use FMEA

Research tools we use

Ethnography
Contextual inquiry
Concept assessments
Focus groups
Task analysis
Diary studies
Post-market surveillance
Use FMEA

DESIGN & ITERATE

Get feedback early and often to fix use-related risks while it’s still easy to do so.

Rapidly test early design iterations in small sample formative usability tests to mitigate use-related risks.
Document updates to the use-related risk analysis (URRA) and progress the HFE report to reflect the evolution of your product’s design as a result of formative evaluations.
Refine and finalize definitions for intended users, use environments, and (critical) tasks.
As product design approaches production equivalence, shift focus to refinement of research protocols and simulation of use environments in preparation for human factors validation.

Research tools we use

Formative usability testing
Collaborative design workshops
Heuristic / expert evaluations
Information architecture assessments
Comparative usability testing

Research tools we use

Formative usability testing
Collaborative design workshops
Heuristic / expert evaluations
Information architecture assessments
Comparative usability testing

MEASURE & VALIDATE

Know where you stand and get the insight you need to focus future development efforts or to document the achievement of objectives.

Ensure that intended users, critical tasks, and elements of simulated use are appropriately defined.
Conduct thorough root cause analysis of all observed use errors, close calls and operational difficulties to determine if residual use-related risk is acceptable.
Validate that your product can be used safely and effectively by its intended users, in its intended use environments, for its intended uses.

Research tools we use

Human factors validation testing (aka summative usability testing)
Comparative usability testing
Benchmarking

Research tools we use

Human factors validation testing (aka summative usability testing)
Comparative usability testing
Benchmarking

MANAGEMENT & STRATEGY

It happens that organizations do not have proper medical device development processes in place (because there is rarely need for it) or the organization is large and processes vary from department to department. We support you in getting the task done.

We provide consulting and interim management to set up one-time medical device developments according to regulatory needs.
We analyze existing processes (or create them). We align them to be more efficient and at the same time fulfill all regulatory requirements.
We connect you to international partners worldwide and execute your studies where you don’t have boots on the ground.