In an interview with Utilized Medical Trials, Brian Ongioni, chief product officer, uMotif, mentioned how the corporate actively incorporates affected person and web site suggestions all through the digital well being product lifecycle to make sure its instruments are each accessible and intuitive. By involving finish customers early within the growth course of, uMotif goals to scale back burden on sufferers and scientific websites alike, whereas additionally guaranteeing that digital endpoints are usable, significant, and able to standing as much as regulatory scrutiny. Ongioni shared insights into the corporate’s co-design methods, real-world examples from scientific trials, and his perspective on the evolving position of synthetic intelligence in enhancing patient-reported outcomes.
ACT: What position do sufferers and websites play in validating or adapting digital endpoints earlier than they’re submitted to regulators or payers?
Ongioni: That basically ties again to the Parkinson’s examine instance. We develop particular person devices—whether or not publicly out there or licensed—and maintain workshops and periods with committees which are impartial of any single examine. These teams are keen and keen to supply suggestions in order that when these digital endpoints are in the end utilized in a examine, they’re related and appropriate for submission.
In a single latest session, contributors emphasised being cautious with their information—they don’t need to share it except it can in the end be acceptable for regulatory submission. Getting this early suggestions and embedding it throughout the platform actually helps guarantee the information is helpful and submissible.
Full Interview Abstract: uMotif integrates affected person and web site suggestions all through the product growth lifecycle to make sure its digital well being instruments are accessible, intuitive, and really reflective of end-user wants. That is achieved by way of devoted affected person and web site committees that collaborate with product groups early within the software program design course of. Whether or not it includes evaluating new options or reviewing early-stage prototypes, these stakeholders present enter that’s integrated earlier than study-specific implementations, guaranteeing accessibility is embedded from the outset quite than added later.
A notable instance of this co-design method occurred throughout a Parkinson’s illness trial. Sufferers got entry to the platform earlier than the examine launched, permitting uMotif to make essential changes to accommodate their particular motor challenges. This included redesigning display navigation and repositioning measurement instruments to scale back burden and guarantee information might be reliably collected for the supposed endpoints.
Balancing affected person usability with web site workflows can also be a core focus. uMotif developed a “hub mannequin” to streamline the expertise for scientific websites, consolidating disparate methods right into a unified platform. By observing and incorporating web site enter—equivalent to understanding their day by day routines and workflow priorities—the corporate optimized performance to scale back administrative burden. This site-and-patient-first mindset extends to the validation of digital endpoints, the place uMotif organizes separate workshops for affected person and web site committees to supply suggestions on new devices, guaranteeing their relevance, usability, and potential regulatory acceptability.
Trying forward, uMotif sees synthetic intelligence and machine studying enjoying an more and more essential position in refining patient-reported outcomes. These applied sciences may help the transition from paper to digital codecs and improve scalability. Whereas there’s ongoing skepticism, AI has the potential to assist floor what issues most to sufferers by amplifying their voices all through the event lifecycle, supplied it’s applied thoughtfully and iteratively.
