Attending the MDIC 2026 conference highlighted how critical a proactive medical device data strategy is becoming for manufacturers looking to navigate current compliance hurdles. The discussions across the sessions and workshops made it obvious that traditional approaches to study design and evidence collection are creating new operational challenges that teams must address to meet agency expectations.
By sitting in on this year’s panels, collaborative workshops, and regulatory briefings, we captured five core operational takeaways that are actively reshaping medical device study methodologies.
5 Essential Insights from MDIC 2026
- The “Big Shift” in Data Strategy
There is a notable paradigm shift in how manufacturers approach studies. The current focus centers on reviewing available data to support post-market analysis or post-approval studies first, then developing protocols based on that data. This reverses the traditional method of drafting a protocol before identifying the supporting data.
- The Challenge of RWE vs. RCT Standards
A significant pain point discussed is the FDA’s increasing expectation for PMA and PAS data to mirror the structure of Randomized Controlled Trials (RCTs). Many industry professionals view this as an unattainable standard, as Real-World Data (RWD) is gathered through clinical practice where practitioner priorities necessarily differ from controlled study parameters.
- Navigating Label Expansions
During a workshop on label expansion, it was concluded that a single, standard database rarely satisfies every requirement on its own. While in some circumstances a single source simplifies the process, having another source may offer synergy. One example is linking our PVI registry dataset to CMS claims data through our partnership with the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), enabling access to longitudinal outcomes extending beyond one year.
- The Fivos Advantage: Patient Experience and Outcomes
A recurring theme throughout the conference was the growing emphasis from both the FDA and CMS on outcomes, real-world evidence, and patient-centered data. Fivos is uniquely positioned to support these evolving needs by providing high-quality real-world data for regulatory and clinical initiatives, and by capturing meaningful longitudinal clinical outcomes across large registry populations. Industry representatives also expressed strong interest in our ability to derive additional variables, integrate dynamic content, and tailor analyses to support evolving evidence generation strategies.
- Reliability and Compliance
Finally, it was clear that our data is considered highly reliable due to our auditable documentation, established SOPs, and CAPA resolution processes.
Managing the Evolving Data Landscape
The operational realities discussed at MDIC 2026 illustrate that the gap between clinical practice and regulatory expectations is widening. Navigating this environment successfully requires manufacturers to reverse the traditional protocol method and leverage a combination of calculated variables and dynamic content to satisfy CMS requirements. Ultimately, success relies on partnering with data platforms that prioritize auditable documentation and established SOPs to ensure compliance at every stage.
Contributors: Suzanne McDonald, Senior Clinical Research Specialist II and Erick Lines, Vice President, Industry Sales