Bold Human Factors

Medical device human factors research

We believe that institutionalizing best practices in user-centered design and human factors engineering leads to better health outcomes for all. Applying human factors best practices to product development is much more than a validation study. Yes, we have the expertise to plan, manage, and execute your human factors validation study… but creating safer and more efficient, effective, and engaging experiences for your customers starts much earlier than that and so do we. The foundation for safe and effective use begins with exploratory research and spans the entire development process.

Part of our DNA

Our experience with medical devices and related products

Injection devices

Form factor considerations
Clinical and home use
Needle safety devices
Connected devices
On-device labeling

Packaging, labeling, & IFU

Clinical applications
Connected devices
Injection devices
Infusion pumps
Oral therapies

Digital assets & connected devices

Digital therapeutics
Patient support applications
Websites and desktop software
Clinical decision support systems
Remote patient monitoring and management

Pumps, diagnostics, & other devices

Infusion pumps
Surgical devices
Clinical diagnostics
Robotic surgery systems
Patient & caregiver diagnostics

Explore

Understand the challenges faced by patients, caregivers, and healthcare providers when interacting with similar products already on the market.

Observe intended users of your product in their natural use environments to inform definitions of critical tasks and to better understand early on what use-related challenges and risks your product should account for.
Analyze behavioral observations and qualitative use-related feedback, as well as existing post-market surveillance data to get a comprehensive understanding of barriers to safe and effective use.
Inform the development of a robust human factors plan that will minimize the amount of time and effort required to validate safe and effective use, and ground early strategic design decisions in data.

What we do

Ethnography
Contextual inquiry
Time & motion studies
Concept assessments
Focus groups
Task analyses
Diary studies
Post-market surveillance

Design & refine

Get feedback early and often to course correct while it’s still easy to do so.

Rapidly test early design iterations in small sample formative usability tests to ensure the experience afforded is the experience intended, and to mitigate use-related risk.
Document updates to the 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.

What we do

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

Measure

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

Rely on the outputs from your preliminary analyses to prepare for human factors validation and 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 or if additional risk mitigation is necessary.
Validate that your product can be used safely and effectively by its intended users, in its intended use environments, for its intended uses.

What we do

Summative usability testing
Human factors validation testing
Comparative usability testing
Benchmarking
Remote or in-lab testing
Post-market surveillance

Our commitment to quality

We take the quality and integrity of our research seriously, and invest heavily in the development of expert human factors practitioners

Industry standards and best practices
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.
Quality Management System

We are ISO 9001:2015 certified from the certifying body of NSF-ISR. Read more about our certification.

Internal and external training
All of our human factors practitioners go through a robust internal training program prior to their first project, benefit from our apprenticeship model, and have plentiful external training opportunities.

We are ISO 9001:2015 certified!

Achieving certification is a demanding process that includes a rigorous audit to demonstrate our conformance to quality assurance and information security standards, as well as, controlled processes that ensure excellence in the training and development of our researchers, participant recruitment, vendor management, and development and execution of research protocols. This globally-recognized certification represents our commitment to quality and, ultimately, you!

Enough about us, let's talk about you!

We’d love to have an opportunity to bid on your project.
Responsiveness is important to us so we promise to get back to you immediately!

+1.630.272.5994
hello@boldinsight.com

 

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