510k Consultant Pricing: Fixed Fee vs Time & Materials vs Hybrid
Understanding 510k consultant pricing models is crucial for budgeting and avoiding surprise costs. Here's a breakdown of the most common pricing structures and when each makes sense.
1. Fixed Fee Pricing
What it is: A single, all-in price for the entire project scope. You pay the same amount regardless of how many hours the consultant works.
When It Makes Sense: This model is ideal for straightforward projects with a very clear scope and predictable path. For example, a Class II device with a strong predicate, where all testing is complete and the documentation is well-organized.
- Budget Predictability: You know the exact cost upfront. There are no surprises, which makes financial planning easy.
- Focus on Results: The consultant is incentivized to work efficiently to deliver the final product, not to log more hours.
- Simple to understand and manage
- Higher Upfront Cost: Consultants build a "risk premium" into fixed fees to cover potential unforeseen issues. You might pay more than you would on an hourly basis if the project goes exceptionally smoothly.
- Inflexibility: If you need to change the scope mid-project, it can be difficult and may require a new, separate contract or a costly change order.
- Risk of "Scope Creep": This is the biggest danger. If the project's needs expand beyond the original agreement, the consultant will rightly push back or demand more money.
Real-World Scenario: A startup has a new dental imaging device very similar to one already on the market. They've completed all testing, have clear predicates, and the regulatory pathway is well-defined. A fixed fee of $45k covers the entire submission preparation, with clear milestones and deliverables. This works perfectly because the scope is unlikely to change.
Best for: Highly defined projects where the scope is crystal clear and unlikely to change. Typical range: $30k–$80k for a full 510(k) submission.
Payment structure example: 30% upon signing, 40% upon delivery of first draft, 30% upon FDA submission.
2. Hourly Rate (Time & Materials)
What it is: You pay for the hours the consultant actually works, typically at $150–$350+ per hour depending on experience level, location, and specialization.
When It Makes Sense: Use this model when the project scope is unclear, the device is novel, or you anticipate needing flexible support over a long period. It's also common for specific, short-term tasks like reviewing a document or providing strategic advice.
- Flexibility: You can easily adapt the project as you go. You only pay for the work that is actually done.
- Lower Initial Commitment: You aren't locked into a massive fee. This can be helpful for early-stage companies managing cash flow.
- Transparency (If Done Right): Detailed invoices can show you exactly where the time and effort are going.
- Budget Uncertainty: The total cost is unknown and can easily spiral out of control if not managed carefully. This is the biggest risk.
- Misaligned Incentives: This model rewards time spent, not necessarily efficiency. You need to trust that your consultant is working diligently.
- Requires careful monitoring and detailed invoice review
Real-World Scenario: A company is developing a novel software-as-a-medical-device (SaMD) product. The regulatory path is uncertain, and they aren't sure how much testing the FDA will require. They hire a consultant at $250/hour to guide their strategy. This makes sense because the scope is fluid and will evolve based on FDA feedback and research.
Best for: Early-stage strategy, gap analysis, or responding to complex FDA questions where the workload is unpredictable.
Critical tip: Always insist on a "not to exceed" (NTE) cap per month or per project without written approval. For example: "Hourly rate of $250/hour, not to exceed $15,000 per month without written approval." Also request detailed, itemized invoices breaking down work by task, date, and time spent.
3. Retainer Model
What it is: A fixed monthly fee for a set number of hours or general availability. You pay a recurring fee (usually monthly) in exchange for access to their expertise and a set amount of their time.
When It Makes Sense: Retainers are best for long-term, ongoing regulatory support rather than a single, discrete project. This is perfect for companies that need regular strategic advice, quality system management, or have multiple products in development.
- Guaranteed Access: The consultant prioritizes your needs. You're not just another project in their queue.
- Proactive Partnership: This model encourages a deeper relationship, where the consultant becomes an integrated part of your team, thinking proactively about your regulatory strategy.
- Predictable Monthly Cost: It helps with monthly budgeting.
- "Use It or Lose It": If you don't use the allotted hours, you often lose them, meaning you've paid for nothing.
- Potential for Inefficiency: If there isn't enough work to fill the retainer hours, it can be less cost-effective than a simple hourly arrangement.
- Less suitable for one-time projects
What to Negotiate: Monthly fee and included hours, overage rate for work exceeding included hours, unused hours policy (can they roll over?), scope of included activities, and termination clause (30–90 days notice).
Best for: Ongoing support after a submission, QMS maintenance, or having a regulatory expert "on call" for questions.
Typical structure: $4k–$15k/month for 20–40 hours of availability. Example: $4,000/month includes up to 20 hours, with overage at standard hourly rate.
4. Hybrid AI + Consultant Model
What it is: AI-powered software handles structured drafting and evidence mapping, while a consultant focuses on strategy and review. This reduces consultant time (and cost) on manual work.
- Significantly lower cost ($5k–$20k vs $30k–$80k)
- Faster preparation (2–4 months vs 3–6 months)
- Consultant focuses on high-value strategy work
- Structured, consistent output
- Requires comfort with AI tools
- Less traditional "hand-holding"
- May not suit very complex, novel devices
Best for: Startups, teams seeking cost-efficiency, structured workflows, and RTA prevention. The consultant reviews AI-drafted content rather than writing from scratch.
Example: Cruxi structures the submission, drafts sections, and maps evidence. A consultant then reviews, provides strategic input, and manages FDA communications. Total cost: $5k–$20k in service fees.
What Drives 510k Consultant Pricing Up?
- Device complexity: Novel tech, borderline De Novo, or unclear regulatory pathway
- Software-heavy devices: Require extensive cybersecurity documentation, IEC 62304 compliance
- Multiple device variants: Each variant may need separate documentation
- Lack of clear predicates: Requires extensive predicate research and justification
- Need for clinical data interpretation: Clinical studies add significant complexity
- Scope of work: Strategy-only vs full drafting vs ongoing FDA management
Payment Schedule Best Practices
Never agree to pay 100% upfront. A fair payment schedule aligns payments with progress:
- 30% upon contract signing (to initiate the project)
- 40% upon delivery of the first complete draft of the 510(k)
- 30% upon final submission to the FDA
This structure ensures the consultant gets paid for their work as it's completed, and you retain leverage to ensure the project reaches its final milestone.
Handling Scope Changes
No project plan is perfect. If you discover a new requirement or need to pivot, the contract must define a process for this—typically a Change Order. This is a mini-SOW for the new work that includes a description, deliverables, and cost, which must be signed by both parties before work begins.
Example clause: "Any services requested by Client that fall outside the scope of the SOW will be considered a scope change. Consultant will provide a written Change Order detailing the new work, timeline, and fees. No work on the scope change will begin until the Change Order is signed by both parties."
Need Help Choosing the Right Pricing Model?
Our comprehensive 510k Consultant Engagement Guide includes:
- Detailed pricing breakdowns by firm type
- Negotiation strategies based on your device stage
- Contract clauses to protect your budget
- Real-world pricing examples