Originally launched in late 2024, Fivos’ Device Evaluation Portal (DEP) has undergone a significant evolution over the past year, with advanced development focused intensely on increasing visibility for device manufacturers in the vascular and neurovascular spaces. As a central hub that turns clinical registry data into a strategic information asset, the DEP directly answers today’s toughest post-market challenges, specifically the critical information gap that develops once a medical device “leaves the box”.
To learn more about the portal’s latest enhancements and its power to deliver high-fidelity insights as global regulatory compliance requirements shift, we recently sat down for a Q&A session with Fivos VP, Head of Product Will Israel.
About Will:
Will joined Fivos in the spring of 2026, bringing decades of product management experience, renewed energy, and a clear strategic direction to our data services team. He has been instrumental in accelerating the DEP roadmap by consistently diving deeper into the “why” of the solution, ensuring every stage of development serves a meaningful purpose for our partners. Will’s extensive background spans the clinical, provider, payer, and member ecosystems. This comprehensive industry depth enables him to help healthcare organizations solve their most complex business problems through targeted product strategy, advanced analytics, automation, and artificial intelligence.
Q: What primary problem does the Device Evaluation Portal solve for device manufacturers?
A: Traditional device tracking leaves a void between factory distribution and the actual patient journey. While device manufacturers have a clear understanding of how they anticipate their device will be used, actual clinical usage information is lacking. The DEP reflects a device’s practical application, providing scaled, real-world evidence (RWE) on actual usage and one-year performance metrics.
Q: What drove Fivos to build this portal now?
A: We prioritize keeping a pulse on the evolving regulatory landscape to anticipate how changing guidelines will impact our industry partners. For us, the tightening demands of global compliance frameworks underscored a critical need for device manufacturers to access high-fidelity, real-world data—particularly for complex requirements like FDA label expansions and European Union Medical Device Regulation (EU MDR) Post-Market Clinical Follow-Up (PMCF) reporting. Given our deep data expertise, we felt uniquely positioned to deliver a better solution.
Our goal with the DEP is to centralize robust registry networks into a unified, on-demand interface that bridges the historical informational gaps device manufacturers have faced. By utilizing the portal, manufacturers gain immediate, actionable insights into not just how their devices perform mechanically, but how they truly impact patients’ lives over the long term.
Q: How does DEP architecture work?
A: The DEP utilizes layered intelligence, with a two-tiered approach for subscriptions. The baseline snapshot provides macro-level tracking: clinical registry case volumes, basic patient demographics, and overall follow-up durations over multi-year intervals. For deeper clinical context, users can track how patient characteristics (age, sex, smoking status, comorbidities like diabetes) interact with specific device performance parameters. The second tier houses the most vital evidence, bringing forward rigorous in-hospital technical success markers, procedure complications, 1-year survival/durability metrics, and Kaplan-Meier (KM) curves.
Q: A key feature of the portal is “Blinded Peer Benchmarking.” What does that mean for a manufacturer’s competitive standing?
A: The DEP enables users to stack their device’s specific outcomes directly against aggregate blinded peer data. Commercial teams can then use this data to identify regional or clinical variance and address underperformance issues before they evolve into regulatory liabilities. We have found this information is particularly useful for the quality teams to use as a leading indicator to help them plan for deeper dives into the underlying variables driving the trends.
Q: Beyond strictly checking the box for regulatory compliance, how can teams leverage this portal commercially?
A: Again, our clients have expressed that they have found this solution really useful in helping see further ahead before problems become pronounced. Or seeing potential value callouts as those leading indicators to help plan for campaigns around success. Another pathway is leveraging the DEP as a discovery tool to determine if the device is being used off label. Registry data with a deep focus on procedural workflows has some of the best data available for being able to see when this happens. In those cases, we can assist in more custom analysis to see the relationships with the underlying data.
Accelerate innovation through data-driven proof. Schedule a demo of the device evaluation portal or reach out to our industry sales team to learn more about our comprehensive real-world data services for device manufacturers.