Use Case: Transforming Regulatory Submissions in Medical Devices

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Use Case: Transforming Regulatory Submissions in Medical Devices & Real-Time Visibility

Context

Medical device organizations manage regulatory submissions through PLM Platforms, where thousands of design, testing, and compliance documents are stored. Submission teams face mounting pressure to deliver timely, complete, and globally compliant dossiers for health authority approval.

Current Pain Points

Manual effort & inefficiency: Extracting structured data from PDFs, forms, and reports is labor-intensive.
Fragmented information: Critical data dispersed across PLM, emails, spreadsheets, and vendor systems.
Limited visibility: Dependencies between design, risk, and testing documents are hidden, slowing impact analysis.
Reactive responses: Regulatory queries often trigger high-cost, last-minute evidence-gathering "fire drills."

Opportunity

Transform the PLM platform from a passive document repository into a proactive Regulatory Intelligence Platform.

Our Solution

Data Intelligence Capabilities Applied:

AI-Enhanced Ingestion: Automated structuring of content from PLM documents (design files, lab reports, compliance forms) using AI-powered OCR and NLP.
Graph-Powered Intelligence: Map relationships between product components, risk assessments, tests, and regulatory requirements for real-time impact analysis.
Generative AI + RAG Decision Support: Augment LLMs with structured/graph data to auto-generate draft responses to regulators, citing evidence directly from PLM.

Business Value

Faster approvals: Cut submission preparation time by 30–40%.
Lower costs: Reduce manual document review and reformatting.
Improved compliance: Traceable, evidence-backed responses minimize regulatory risk.
Scalability: Supports onboarding of new business units and product lines with consistent quality.

Valuation & Example Calculation

Formula: Annual Savings = (Average FTE Hours Saved per Submission × Hourly Cost × Submissions per Year)

Example:

Average time saved: 120 hours per submission
Hourly cost: $80
Submissions per year: 100

Annual Savings = 120 × $80 × 100 = $960,000

When scaled globally, with ~20 business units, potential savings exceed $19M/year, in addition to faster approvals and reduced compliance risks.

Key Metrics (Expected Impact)

30–40% Faster response cycle times

$960K–$19M Annual labor cost savings

Higher Audit-readiness & compliance

Strategic Fit: Aligns with the vision of digital acceleration in regulatory affairs, ensuring compliant, efficient, and globally scalable medical device submissions.