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

Our experience with medical devices and related products

  • syringe Injection devices
  • Needle safety devices
  • Connected devices
  • On-device labeling
  • packaging Packaging, labeling & IFU
  • Clinical applications
  • Injection devices
  • Infusion pumps
  • Oral therapies
  • devices Digital assets & connected devices
  • Digital therapeutics
  • Website and desktop software
  • Clinical and patient decision support systems
  • Remote patient monitoring and management
  • smart 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.
We don’t just adhere to best practices; we work with other industry thought leaders to define them through our corporate memberships with AAMI and other organizations.

OUR TOOLS AND SERVICES

Applying human factors best practices to product development is much more than executing a validation study

Creating safer, more effective and engaging experiences for your customers starts much earlier. The foundation for great products begins with exploratory research and spans the entire development process.

EXPLORE & UNDERSTAND

Understand the challenges faced by patients, caregivers, and healthcare professionals when interacting with similar products already on the market.
  • We observe intended users of your product in their natural-use environments. This helps inform definitions of critical tasks, as well as, provide a better understanding early on for which use-related challenges and risks your product should account.
  • We analyze behavioral data, qualitative feedback, and existing post-market surveillance data to get a comprehensive understanding of barriers to safe and effective use.
  • We inform the development of a robust human factors plan that will minimize the amount of time and effort required to validate your product.

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

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

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.

Research tools we use

  • Stakeholder workshops & interviews
  • UX infrastructure
  • UX coordination & management
  • Knowledge transfer
  • Process description
  • Compliance with regulations

GET IN TOUCH

Meet Wolfgang and Matthias, our lead Human Factors experts

Let’s discuss how we can support you in improving your customers‘ experience.

Wolfgang Waxenberger

Experience Creator and leading human factors expert at UINTENT HAMBURG

Matthias Gasser

Experience Creator and leading human factors expert at UINTENT BASEL

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