1. Research & Strategy I began by conducting thorough research on the Enso device, its clinical applications, and the regulatory landscape for FDA-cleared medical devices. I reviewed existing product documentation, clinical studies, and competitor approaches to pain relief education. Using this foundation, I developed a content strategy and curriculum outline addressing key user needs: understanding how the device works, proper usage, safety information, expected outcomes, and how it fits into broader pain management approaches.
2. Framework Development Given the regulatory constraints of medical device content, I created a comprehensive tenets document establishing strict voice, tone, and messaging guardrails. This framework defined how we would communicate device benefits and limitations while maintaining FDA compliance. I outlined what claims we could and couldn't make, how to present clinical evidence, and how to balance educational value with regulatory requirements. I circulated this document with internal stakeholders across product, clinical, legal, and regulatory teams to ensure alignment before content production began.
3. Content Development I authored evidence-based content drawing from clinical literature, device specifications, and FDA-cleared labeling. Each piece required meticulous attention to claim substantiation — every statement about device efficacy, safety, or usage needed to be supported by approved clinical data or regulatory documentation. I crafted content that translated complex medical device functionality into accessible language while maintaining the precision required for regulatory compliance.
4. Multi-Stakeholder Review Process This project required navigating a complex, multi-layered approval process. First, I submitted content to my editor for structural and clarity review. After incorporating editorial feedback, I moved content through clinical review to verify medical accuracy and appropriate scope of practice. Next came the critical legal review, where attorneys evaluated every claim for regulatory compliance and liability concerns. Simultaneously, regulatory affairs reviewed content against FDA requirements and approved device labeling to ensure consistency. I managed this intricate process by tracking feedback from each stakeholder group, reconciling conflicting input, and iterating content until all parties approved.
5. Final Approval & Publication Once content cleared all review stages, I prepared materials for publication. I selected appropriate visuals that met regulatory standards (avoiding overpromising or misleading imagery), formatted content in Contentful, and coordinated with the localization team through Smartling to ensure translated versions maintained regulatory compliance. After final sign-off from regulatory and legal teams, I published the education and product content to the app, making critical device information accessible to users while maintaining full FDA compliance.
