Medical Image Viewer Guided 510(k)

Summary

Rology is an established teleradiology firm who had developed a custom medical image viewer and was seeking 510(k) clearance. Their engineering team didn’t have any regulatory experience. Innolitics developed a strategy that balanced business goals, regulatory costs, and software considerations. We then guided their team, using our Medtech OS platform, through the 510(k) process. We assisted with writing the necessary software documentation, including cybersecurity to successfully complete the submission (K231385) under the LLZ “Medical image management and processing system” product code.

The Problem

• The central challenge: accelerate the FDA clearance process for this revolutionary platform, essential for expanding into regulated markets.
• The overarching aim was to swiftly and efficiently traverse the regulatory challenges, ensuring their platform's trailblazing features remained intact, to offer affordable, top-tier teleradiology services to a wider demographic.
• Rology's team, packed with expert software and AI/ML engineers, crafted a transformative teleradiology platform, but faced hurdles with complex medical-device development regulations and FDA guidelines, including standards such as IEC 62304, ISO 14971, ISO 13485, and AAMI TIR57.
• This process needed to be streamlined without distracting their talented engineering team from further advancements.
• Historically, the industry focus was on obtaining FDA clearances for traditional PACS systems and DICOM viewers, often associated with high costs, making them less feasible for many healthcare providers.
• Rology's innovative platform combined the essentials of these traditional systems but enhanced with cutting-edge features for a 2-sided and on-demand teleradiology platform, like their dynamic matching system that optimized radiologist selection based on subspecialty and availability.

The Outcome

Rology secured FDA 510(k) clearance (K231385), for its Teleradiology Platform as a Class II Medical image management and processing system (radiological). This establishes Rology teleradiology platform as the world’s premier FDA-cleared on-demand and 2-sided teleradiology solution, according to Rology’s analysis.

The Solution

• In their pursuit of regulatory clearance, Rology considered various alternatives. While they contemplated unraveling the regulatory web internally, they recognized the immense value of specialized knowledge in this field.
• Additionally, they evaluated multiple regulatory consulting firms, but the decision ultimately swung in favor of Innolitics. Why? The unmatched expertise and track record of Innolitics in radiology, combined with their comprehensive understanding of regulatory landscapes, made them the perfect partner for Rology.
• Innolitics didn't just offer regulatory guidance; they provided strategic support. Working in tandem, both teams transformed potential obstacles into stepping stones, streamlining the FDA clearance process.
• A pivotal tool in this journey was Medtech OS. Designed by the engineers of Innolitics with over a decade's experience in medical device market integration, Medtech OS is more than just an eQMS. This state-of-the-art, fully customizable operating system, founded on Notion, served as the linchpin in Rology's swift move towards market readiness. Its structured framework, combined with its adaptability, ensured that Rology's pathway to the market was both efficient and compliant.
• The collaboration between Rology and Innolitics was initiated with a strategic session, where we zeroed in on a regulatory strategy. The aim was to harmoniously integrate AI's capabilities with Rology’s business objectives, most notably the swift market penetration. This process was rooted in a deep understanding of Rology's business vision and the essential claims they intended to put forth about their platform.
• Armed with a strategy, Innolitics provided expert guidance to Rology, assisting in pinpointing potential discrepancies in their software and subsequently framing the design documentation, strictly adhering to our established development protocols.
• Ensuring the highest standards, the platform underwent rigorous verification, validation, and clinical testing to ascertain safety, cybersecurity, and efficiency.

• Our joint efforts encompassed:
  • Crafting comprehensive System and Software Architectural Diagrams for Rology's platform.
  • Systematically breaking down the system in line with the IEC 62304 Software Items criteria.
  • Steering Rology through the intricate landscape of the ISO 14971 Risk Management framework.
  • Facilitating the drafting of detailed requirements and design specifications.
  • Assisting in the formulation of the user manual and other labeling essentials.
  • Offering guidance on OTS Software documentation creation.
  • Navigating the intricacies of Cybersecurity Management, inclusive of threat modeling and the assembly of an SBOM.
• One of the key assets provided by Innolitics was the “Medtech OS”. This is a robust compilation of templates specifically curated for SaMD startups. Paired with this was a user-friendly traceability and documentation software, ensuring a streamlined process.
• Our collective effort culminated in the compilation and submission of the 510(k) to the FDA.
• The journey saw us expertly navigating a Request for Additional Information from the FDA, ensuring that Rology's platform met every stringent requirement set forth.

Rology's partnership with Innolitics exemplified the transformative power of collaboration. By leveraging Innolitics' extensive regulatory expertise and the capabilities of Medtech OS, Rology was able to swiftly navigate the regulatory landscape, obtaining FDA clearance with finesse.

This milestone not only attests to the value of combining visionary ambition with specialized expertise but also fortifies Rology's position as a frontrunner in teleradiology innovation.

The experience underscores the importance of strategic alliances in the medtech sector, reinforcing the belief that, together, organizations can scale greater heights, overcome complex challenges, and create lasting impact in global healthcare.

About Rology

• Rology is a leading provider of teleradiology services in the Middle East and Africa region, with an established presence across Africa and the Middle East, serving over 150 hospitals, and (as of 2023) completing over 600,000 reports.
• The company's engineering and AI team had successfully developed an AI-assisted teleradiology platform, designed to revolutionize the way radiology services are delivered.
• Rology’s zero-setup and zero-footprint platform boasts comprehensive modules, including an Automatic Image Acquisition Tool (Rology Connect), Automatic Workflow Management System, DICOM Viewer, Reporting Tool, and Peer Review Tool.