Human Factors

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At BlueRidge Life Sciences (BRLS), we help organizations design healthcare products and medical technologies that are safe, usable, and effective for the people who rely on them.

We bring more than three decades of leadership in human factors for healthcare, with expertise spanning engineering, cognitive psychology, industrial design, and anthropology. We support clients across the full development lifecycle, from early user research and concept development through usability testing and use-related risk analysis, backed by six state-of-the-art labs and offices in Philadelphia, Chicago, and Munich.

What sets BRLS apart is how we bring scientific rigor, regulatory insight, and a deep understanding of real users together in every engagement. We know the FDA and global regulatory landscape, we right-size our work to fit your needs, and above all we believe in good science and lasting partnerships that move healthcare forward.

CORE AREAS OF HUMAN FACTORS EXPERTISE

  • The most successful solutions are born from user needs. We observe, interview, and conduct workshops with actual users, so that you can gain a more accurate understanding of your users, their environments, and key tasks.

    Examples:

    • Field Research & Contextual Inquiry

    • Design Thinking Workshops

    • Acceptability Studies

  • Whether you are in the concept phase or looking to inform design specifications, focused research with our customized data capture tools can strengthen any project.

    Examples:

    • Eye Tracking

    • Human Capability Studies (e.g., Force Studies)

  • Both our in-house designers and engineers are human factors experts. We utilize their experience to consider all aspects of the user interface to bolster and transform our clients' ideas into realistic solutions.

    Examples:

    • Labeling Development (e.g., IFUs)

    • Packaging Development

    • GUI Development

  • We use our vast experience of past healthcare products, along with market-available data, to analyze your product, no matter what phase it's in. We ensure you are in the best position possible to take the next steps.

    Examples:

    • Expert Reviews

    • Threshold Analysis

    • Competitive Benchmarking

  • Usability testing evaluates the usability of products and instructional materials. We do this by observing users simulate use of the product, and will never ask anyone to actually take or inject medication. This testing is not a clinical trial.

    Examples:

    • Formative Studies

    • Summative/HF Validation Studies

    • Comparative Use Studies

    • Recruiting

    • Moderation

  • An accurate assessment of use-related risk builds the foundation of every regulatory submission. It is important that risk documentation is built on healthcare industry experience and product knowledge to ensure risks are correctly mitigated and the safety of users is assured. We can help with that!

    Examples:

    • Use-Related Risk Analysis (URRA)

    • Perception, Cognition, Action (PCA) Analysis

    • Regulatory Support

USABILITY STARTS HERE

We are Human Factors Experts.

We conduct quality research to guide the user-centered design of your healthcare products and improve usability, safety, and appeal.

We Answer Questions You Didn’t Know You Had

Our research-driven approach provides the answers you need. From initial user needs through the evaluation process to regulatory submission, we're committed to helping you every step of the way.

We Are Not Traditional Consultants

Our team of human factors researchers collaborates with you, providing guidance through every project phase. Together, we uncover valuable insights that optimize the usability and safety of your products.

We Work Hard to Make
An Impact

Our cross-functional team is driven by their passion for understanding "the human factor". We dig deeper, ask the right questions, and translate findings into meaningful change that improves how your products perform.

Together We Can Improve The Future of Healthcare

We believe in deep rooted partnerships; we're your trusted guide every step of the way. We understand the importance of your time and budget constraints, within the bounds of good science.

Our Research Goes Where Your Users Are

Across 215 cities and counting, we've conducted field research and usability studies in the real-world settings where your products are actually used. We meet people in their homes, clinics, and workplaces to capture insights no lab can.

OUR LABS

Our six state-of-the-art usability labs in Philadelphia and Chicago feature customizable, interactive HD video setups, live streaming capabilities, and dedicated viewing rooms for seamless collaboration.

We use our labs for:

  • Usability testing sessions

  • Focus groups

  • Market research studies

  • In-depth interviews

  • Concept evaluation and feedback

  • Remote and hybrid research sessions

  • And more!

Ready to Improve the Usability and Safety of Your Product?

Contact us today to learn how BlueRidge Life Sciences can help you integrate human factors into your healthcare products.

Schedule a consultation