Business Problem

Medical product recalls for drugs and devices in the United States were traditionally managed through slow, paper-heavy processes that were prone to miscommunication and delays. These inefficiencies increased operational risk for suppliers and providers and posed serious threats to patient safety.

The challenge was not only to digitize recall workflows, but to ensure that recall information could move reliably across the ecosystem. While suppliers initiated recalls digitally, providers often received recall notices as unstructured PDFs, requiring manual data entry. This led to inconsistent records, delayed acknowledgements, and limited visibility into whether recalls reached providers before being reported to regulators.

The platform needed to support end-to-end recall execution, from supplier initiation to provider acknowledgement, while eliminating manual effort, improving data quality, and maintaining regulatory trust.

Technology Solution

IncubXperts designed and evolved a web-based medical recall management platform that combined workflow automation, secure collaboration, and AI-assisted data ingestion.

Key solution capabilities include:

• Automated Recall Workflows: Digitized recall execution enabled suppliers to target specific providers, track acknowledgements, and ensure timely completion of recall protocols.

• Role-Based Access and Self-Service Onboarding: Granular permissions for admins, suppliers, and providers improved security, while self-service registration reduced administrative overhead.

• Real-Time Dashboards and Reporting: Centralized dashboards provided visibility into recall progress, provider responses, and compliance status, supported by custom reporting tools.

• AI-Powered Provider Intake: Unstructured supplier PDFs submitted by providers are automatically converted into structured recall records using OCR and domain-specific AI extraction.

• Human-in-the-Loop Validation: A review interface allows extracted fields to be validated, corrected, or rejected before being committed, ensuring accuracy and auditability.

• De-Duplication and Data Integrity Controls: Intelligent checks prevent duplicate recall creation and maintain consistent records across the platform.

• Secure, Scalable Architecture: Cloud-native services, audit trails, and resilient infrastructure support high availability and regulatory requirements.

Together, these capabilities transformed recall management from a fragmented process into a unified, data-driven system.

Technology Stack

• Frontend: Vue.js, TypeScript

• Backend: .NET Core Web API, Node.js services

• AI & Automation: OCR and large language models orchestrated for schema-driven extraction and validation

• Cloud Infrastructure: AWS (S3, EC2, Lambda, API Gateway, DynamoDB, Amplify, Auto Scaling)