Challenge icon

The Challenge

Developed a complex novel software as a medical device (SaMD) that provided clinical decision support to aid patient care in a rare disease. The clinical care workflows and communication between HCPs was complex and thus to design user friendly software these intricate workflows which required user insights and user experience considerations early and throughout the development process.

Surgeon using Software as a Medical Device (SAMD) to look at skeleton
Unique Challenges:

To optimize the software for utility and ease of use, we designed a user experience and usability engineering design and testing program for this novel SaMD from the earliest stages of development through to final product design, testing, and drafting of the De Novo FDA submission.

The software was complex, not only because it used Machine Learning to train the system to automatically measure the organ volume from MRIs, but a proprietary algorithm to predict likely disease progression was also deployed. This required the development of unique design inputs, planning, and testing, and to establish thorough validation methods for the software algorithms in cooperation with the FDA.

The users (Radiologists and Specialists) had communication challenges in supporting patient care which necessitated evaluation of design requirements in the context of current workflows. Further, system outputs needed to be both patient friendly and provide key data to support payor reimbursement. Design and Development considerations also included:

  • Compliance (e.g., 21 CFR 820, ISO 13485, IEC 62304, IEC 62366, ISO 14971, etc.)
  • Usability
  • Privacy
  • Security
  • Multi-region scalability
Solution icon

What We Did

Early Product Development:
  • Defined use environments, user roles, and requirements for new software concept
  • Researched and defined workflow for the new software within a multi-provider system including assessment of pain points in communication between the Radiologist and HCP Specialists to optimize communication between providers
  • Developed user requirements for the software solution
Human Factors:
    • Conducted usability risk evaluations to identify use errors
    • Utilized industry standard System Usability Scale (SUS) to determine ease-of-use and user satisfaction with the software
    • Conducted studies with a total of 79 participants (i.e., 37 nephrologists, 28 radiologist and 14 nephrologist/radiologist support staff)
    • Recommended and applied iterative improvements to the design to reduce potential use errors
  • Identified additional user group and mapped out system workflow with between user to incorporate into the Human Factors Program
  • Delineated contextual help content within the software
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Results Delivered

  • Achieved a high SUS score, demonstrating above average perceived usability comparable to the average usability score for the top 10 apps across iPhone, Android, and Tablets
  • Provided iterative Formative Evaluation reports to inform strategic decisions during development
  • Provided Human Factors Engineering (HFE) Summary Report and all supporting documentation for submission
Key outcomes icon

Key Outcomes

  • Demonstrated the impact of iterative improvements in the design and usability of the software
  • Assisted client with a Human Factors Program to support their successful De Novo application submission