Research / Human Factors


Design begins and ends with the users

HS Design’s User Research and Human Factors (HF) expertise supports our team with the goal of developing safe, usable products with the end user in mind. We believe user research requires close collaboration with our clients because understanding a client’s core competencies and manufacturing preferences is essential in order to accelerate the development process and reduce time to market.

Application of Human Factors. Our focused innovation process relies heavily on user research and human factors evaluations to verify that user needs are satisfied, and safe, intuitive products are developed. Our expertise and understanding of the intended users, uses and use environments allows our staff to ensure design concepts take these elements into consideration.

The HSD Research and Human Factors team operates under the FDA’s HF Guidance, IEC 62366 Application of Usability Engineering to Medical Devices and AAMI/ANSI HE75 Human Factors Principles for Medical Device Design and examines a product’s potential use-related risks through heuristic evaluations, use-related risk analysis (URRA), formative and summative (HF Validation) studies, and other comprehensive methods.

We conduct Formative Studies throughout the development process to identify potential issues with the design and to support decision making throughout the project. We run Summative (HF Validation) Testing on devices ready for market with the intended users and use environments.


Uncovering User Needs. HSD helps the client identify and recognize all of a product’s potential users along with their everyday behaviors — from the service tech that will repair the product, the scrub tech that will set up the product, and to the surgeons who may change their usual behavior to mitigate a challenge with the product. During the initial research phase, we explore user needs and product requirements through proven research methods including contextual inquiry, case observations, video ethnography, user interviews, and internal expert reviews. Our goal is to uncover use challenges during the development phase. Effectively predicting and mitigating risks enables the final product to become the leader in its market.

Clinical Connections. Our experience and network of affiliated healthcare professionals obtains valuable research data through case simulations, pre-clinical testing, and clinical studies.

Our capabilities in User Research and Human Factors include:

  • Contextual Inquiry
  • Design Strategy and Value Proposition Analysis
  • Task Analysis, Use Related Risk Analysis (URRA)
  • Usability testing/ Formative and Validation Studies
  • Consent and Assent Forms
  • Heuristic Evaluations
  • User Needs Documents
  • Study Planning/ Protocol and Recruiting
  • Competitive and Analogous Analysis
  • Human Factors Evaluation and Ergonomics
  • Strategic Design in Medical Device and Instrumentation



Phase 0

  • Project Scope
  • Secondary Research
  • Study Planning
  • Generation of Analysis Tools

Data Collection

Phase 1

  • Site Visits and Observations
  • Human Factors Evaluations
  • Usability Studies

Data Analysis

Phase 2

  • User Behaviors
  • Use Errors and Risks
  • Data Management

Insight Translation

Phase 3

  • Key Insights
  • Product Requirements
  • Visualize Findings
  • Value Proposition

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HS Design, Inc. Headquarters
906 Mt. Kemble Ave
Morristown, NJ 07960

5900 Keyes St, Ste 102
Frederick CO 80504