How to Combine 510k Consultants with AI Tools Like Cruxi
You don't have to choose between a 510k consultant and AI-powered software. The best approach combines both: AI handles structured drafting and evidence mapping, while consultants focus on strategy and FDA interactions. Here's how to make it work.
The Hybrid Model: Best of Both Worlds
The hybrid approach leverages AI for efficiency and consultants for expertise:
AI Tools Handle:
- Structured drafting of submission sections
- Evidence mapping and organization
- Consistency checks and formatting
- RTA prevention (completeness checks)
- Content reuse across submissions
Consultants Focus On:
- Regulatory strategy and classification
- Predicate selection and justification
- FDA communications and negotiations
- High-level review and quality assurance
- Complex problem-solving
Cost Savings: 60-80% Reduction
Traditional consultant-only model: $30k–$80k+ for full-service 510(k) preparation
Hybrid AI + consultant model: $5k–$20k in service fees
Why the savings? Consultants spend less time on manual drafting and more time on high-value strategy. AI tools handle the repetitive, structured work that would otherwise take consultants 30-50 hours.
Example: A consultant typically charges $250/hour. If AI saves 40 hours of drafting time, that's $10,000 in savings—while maintaining or improving quality through structured workflows.
Faster Preparation: 2-4 Months vs 3-6 Months
Structured workflows accelerate preparation:
- AI drafts sections in parallel while consultants review and provide strategic input
- Consistent formatting reduces back-and-forth revisions
- Evidence mapping ensures nothing is missed
- RTA prevention catches issues before submission
Traditional model: Consultant writes from scratch, client reviews, multiple revision cycles. Hybrid model: AI structures content, consultant reviews and enhances, faster iteration.
How It Works in Practice
Step 1: AI Structures the Submission
You enter your device information into the AI platform (e.g., Cruxi). The system:
- Identifies device classification and regulation number
- Suggests and scores potential predicate devices
- Maps evidence requirements across all eSTAR sections
- Drafts submission sections with traceable source citations
- Generates a complete evidence checklist
Step 2: Consultant Reviews and Enhances
Your consultant receives a well-organized, structured draft. They:
- Review the classification and predicate selection
- Enhance the regulatory strategy
- Refine the substantial equivalence comparison
- Ensure all FDA guidance is properly addressed
- Prepare for FDA communications
Step 3: Collaborative Refinement
You and your consultant work together to:
- Review and refine the AI-drafted content
- Add device-specific details and technical depth
- Ensure consistency across all sections
- Finalize the submission package
When the Hybrid Model Works Best
- Startups and small teams: Need cost efficiency without sacrificing quality
- Standard Class II devices: Clear regulatory pathways benefit from structured workflows
- Teams with some internal RA capacity: Can handle basic review, need consultant for strategy
- Multiple submissions: Content reuse across devices saves significant time
- RTA prevention focus: Structured workflows catch common mistakes
When You Might Need Full Consultant Service
The hybrid model may not be ideal for:
- Novel or borderline De Novo devices: Require extensive regulatory strategy
- Very complex software (SaMD): Need deep cybersecurity and IEC 62304 expertise
- High-risk devices: Require extensive clinical strategy
- Teams with zero internal RA capacity: Need more hand-holding
Even in these cases, AI tools can still help with drafting and organization—the consultant just spends more time on strategy.
How to Engage a Consultant for Hybrid Work
When scoping a consultant for hybrid work, be clear about:
- What AI will handle: Structured drafting, evidence mapping, initial content generation
- What consultant will handle: Strategy, review, FDA communications, quality assurance
- Deliverables: Consultant provides review comments, strategic input, and FDA management—not full drafting
- Pricing: Should reflect reduced scope (review vs. drafting)
Example SOW clause: "Consultant will review AI-drafted 510(k) sections, provide strategic enhancements, manage FDA communications, and ensure regulatory compliance. Consultant is not responsible for initial drafting, which will be handled by the client using AI-powered tools."
Real-World Example
Traditional approach: A startup hires a consultant for $60k to draft a full 510(k). Takes 5 months. Consultant spends 200 hours on drafting and 50 hours on strategy.
Hybrid approach: Same startup uses Cruxi to structure and draft the submission ($5k), then hires a consultant for review and strategy ($15k). Takes 3 months. Consultant spends 20 hours on review and 40 hours on strategy—more time on high-value work.
Result: $40k savings, 2 months faster, higher quality through structured workflows.
Ready to Try the Hybrid Approach?
Our comprehensive 510k Consultant Engagement Guide includes:
- How to scope consultant work for hybrid projects
- Sample SOW clauses for AI+consultant engagements
- Pricing strategies for hybrid models
- Tips for finding consultants open to hybrid work