Usability Services

We provide customized usability consultations and testing throughout the product development process. Through MedStar Health, our usability experts have direct access to healthcare domain specialists and end users in a wide array of clinical settings and use environments. From directed customer needs assessments to complex clinical simulations, we connect developers with clinical subject matter experts to optimize feedback specific for your product. Our services promote safe, marketable and effective products that will be market-ready faster.

Medical Device Usability Evaluation

We analyze usability through tailored evaluations for your unique product and development needs.

From directed customer needs assessments to complex clinical simulations, Usability Services connects developers with clinical subject matter experts to maximize feedback specific for your product.

Guidance for FDA Regulatory Submission

Is your product on track for regulatory approval?

We conduct all necessary evaluations to meet regulations such as:

  • FDA Human Factors Guidance for 510(k) Pre-Market Approval
  • ANSI/AAMI HE75 Human Factors Engineering – Design of Medical Devices
  • ISO 62366 – Application of Usability Engineering to Medical Devices
  • ISO 9241 – Ergonomics of Human System Interaction
  • Other relevant medical application standards such as MIL, W3C, etc.

Customized Approach at All Stages of Development

We can help at any stage of the product development lifecycle.

Our team performs formative and summative testing for both pre-market and post-market activities. Getting started with early-stage formative tests can save you time and money before final prototypes have been created, and we also plan and coordinate summative tests to provide the necessary documentation for regulatory approval.

Examples of our core competencies throughout the product lifecycle include:

Types of Products We Evaluate

Our usability experts have the experience and expertise to evaluate a wide range of medical devices and products.

Our capabilities include evaluation of:

  • Medical Devices in All Healthcare Domains
  • Medical Device Accessories
  • Websites and Mobile Applications
  • Health Information Technology 
  • Documentation and Training
  • Anthropometrics and Accessibility
  • Signage and Labeling
  • Instructions for Use

Testing Environments for All Needs

Partnering with Usability Services gives you access to a variety of settings and users to aid in the development of your products.

Our staff and collaborative partners have a wide range of expertise across multiple settings, including: static laboratory (heuristic/expert reviews), usability laboratory, and in-situ testing (in the actual use environment). In addition, our SiTEL Simulation center gives you access to a rich array of simulation environments including high fidelity patient-based healthcare simulators, IT prototype development, “serious game-based” simulation, and others. We also offer an unparalleled “actual use environment” laboratory within MedStar Health.


Guest column series on Med Device Online by Natalie Abts

How To Effectively Evaluate Instructional Materials and Labeling Before Development Is Complete

For more information about usability, please contact Lawrence Wolpert at [email protected].