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 were complex, and thus to design user friendly software, these intricate workflows required user insights and user experience considerations early and throughout the development process.
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:
