How Much Do Medical Device Clinical Trials Cost? Complete Budget Breakdown
- Beng Ee Lim
- 4 days ago
- 16 min read
Medical device clinical trials vary widely in cost depending on device risk class, study design, patient count, duration, and endpoints. Typical total budgets range from ≈$1 M to $20 M+ for studies supporting regulatory submissions – with higher budgets common for large pivotal trials. Per-participant costs for device studies often range from about $14,000 to $50,000+ per enrolled patient depending on complexity and follow-up. Many companies overspend because they assume clinical data is required when it may not be, especially for most 510(k) devices. Engaging FDA early through a Pre-Submission (Pre-Sub) meeting can clarify whether clinical is needed and save significant cost and time.
This guide shows you when clinical trials are actually required, what they cost in detail (not vague ranges), what drives costs up, and how to budget accurately before committing resources.
The First Question: Do You Actually Need Clinical Data?
Many teams assume they need a clinical trial.
In reality, most medical devices cleared through the 510(k) pathway do not require new clinical data. FDA has stated that clinical data is requested in under 10% of CDRH 510(k) submissions, with industry analyses commonly estimating ~10–15%.
Before committing to a clinical budget that can range from hundreds of thousands to multiple millions, you should first answer one question:
Will FDA actually require clinical data for my device, and if so, what kind?
The most reliable way to get that answer is through the FDA Q-Submission (Pre-Submission) program, which allows sponsors to receive written FDA feedback, and when appropriate, a meeting, before finalizing a clinical strategy.
When FDA Typically Requires New Clinical Data
No Suitable Predicate Device Exists
If your device is truly novel and no substantially equivalent predicate exists, you are likely looking at a De Novo or PMA pathway.
In these cases, clinical evidence is often required, depending on:
Risk profile
Intended use and claims
Ability of nonclinical testing to address key safety and performance questions
Examples
First-in-class AI diagnostic
New implant mechanism
Novel therapeutic energy delivery
The Predicate’s Clearance Relied on Clinical Evidence
If your chosen predicate used clinical data to address critical risks, FDA may ask whether similar evidence is needed for your device.
This is not automatic, but FDA will expect a clear justification if you believe:
Bench testing
Nonclinical testing
Literature
are sufficient to address the same questions.
You may be able to avoid new clinical data if you can demonstrate that your device is lower risk, less invasive, or that differences do not affect clinical performance.
Technological Differences Raise New Safety or Performance Questions
FDA focuses heavily on whether differences in technological characteristics introduce questions that nonclinical testing cannot fully answer.
Common triggers include:
New materials
New energy sources
New mechanisms of action
Different delivery methods
Even with the same indication, these differences can push FDA toward clinical data if real-world performance cannot be adequately demonstrated on the bench.
Novel Indication or Patient Population
Clinical data is more likely when your device:
Targets a new anatomical site
Expands to a different disease state
Introduces use in pediatric or other distinct populations
In these cases, existing literature may not adequately represent your intended use.
FDA Guidance Explicitly Indicates Clinical Validation
Some device-specific FDA guidance documents clearly outline situations where clinical validation is expected for certain claims or technologies.
Always review:
Device-specific FDA guidance
Relevant recognized standards
Clinical data recommendations tied to your product code
When You Can Often Avoid New Clinical Trials
Strong Predicate + Robust Nonclinical Evidence
You can often avoid a new trial if:
Your predicate did not require new clinical data
Your device is substantially equivalent
Bench, V&V, and risk testing adequately address safety and performance
In these cases, bench testing plus literature is often sufficient.
Well-Established Technology with Extensive Literature
For established technologies:
Published literature can support the clinical context and known risks
Literature alone rarely replaces performance testing
FDA still expects verification and validation where feasible
Literature works best as supporting evidence, not a substitute for engineering data.
Lower-Risk Modifications to an Existing Cleared Device
For certain changes to a legally marketed device, a Special 510(k) may be appropriate.
This applies when:
Changes are well-controlled
Evaluation methods are well-established
Performance testing demonstrates equivalence
The FDA Pre-Submission (Pre-Sub): Often the Highest-ROI Regulatory Step
What It Is
A structured FDA interaction used to align on regulatory and evidence expectations before committing to a clinical plan.
Cost
FDA meeting fee: $0
Sponsor cost: internal regulatory, clinical, and engineering time, often supplemented by external support
Timeline (Typical Targets)
Written FDA feedback typically targeted around day 70
Meetings commonly scheduled around 70–75 days after receipt
Meeting duration is usually ~60 minutes
(Timelines can vary by FDA workload and division.)
What You Can Clarify in a Pre-Sub
Is clinical data required?
Feasibility vs. pivotal study expectations
Acceptable endpoints
Patient count expectations
RCT vs. single-arm acceptability
Follow-up duration
Even when a trial is required, early alignment often leads to smaller, faster, and more focused studies.
This is also where having a structured evidence workspace, like Complizen’s predicate and evidence mapping tools, helps teams clearly tie risks, tests, and claims back to FDA expectations before those questions reach a reviewer.
Bottom Line
You do not need a clinical trial simply because your device is new.
In most cases, you should align with FDA before locking your clinical protocol and budget. A well-timed Pre-Submission can prevent unnecessary trials, reduce study scope, and eliminate months or years of avoidable spend.
Types of Clinical Studies and Their Costs
If FDA confirms that clinical data is required, the next question becomes:
What type of clinical study does FDA expect for this device?
The answer has a major impact on cost, timeline, and regulatory risk.
Below are the most common clinical study types used for medical devices, with realistic cost and scope expectations.
Early Feasibility Study (EFS / Pilot Study)
Purpose:
Early feasibility studies are used to:
Demonstrate proof of concept
Collect preliminary safety and performance data
Identify design, usability, or procedural issues early
These studies are common for novel or first-in-human devices and are often conducted under an Investigational Device Exemption (IDE).
Typical Scope:
10–30 patients
Single-arm (no control group)
1–3 sites
Short follow-up (30 days to ~6 months)
Typical Cost Range:
~$300K to $1.5M (actual cost depends on IDE requirements, sites, and monitoring intensity)
Example Cost Breakdown:
(Illustrative example only, not a standard template)
Per-patient costs: ~$12K × 20 = $240K
Site startup and activation: ~$40K
CRO project management and monitoring: ~$180K
Data management and statistics: ~$90K
Regulatory and IDE support: ~$80K
IRB fees and insurance: ~$90K
Estimated total: ~$700K–$800K
Timeline:
Typically ~9–18 months, driven by:
IDE review and approval
Enrollment speed
Follow-up and closeout
When Used:
First-in-human studies
Novel device concepts
Data generation to inform pivotal study design
(PMA or select 510(k) submissions)
Purpose:
Pivotal studies generate the primary clinical evidence used to:
Support safety and effectiveness (PMA)
Support substantial equivalence when clinical data is required for a 510(k)
Typical Scope:
50–300+ patients (device- and indication-dependent)
Single-arm or randomized controlled trial (RCT)
5–20 sites
Follow-up from 6 months to 5+ years
Typical Cost Range:
~$2M to $20M+
Example Cost Breakdown:
(Illustrative example: 100-patient single-arm study, 12-month follow-up)
Per-patient costs: ~$25K–$30K each
Site startup and management (10 sites): ~$400K
CRO management and monitoring: ~$1.2M
Data management, statistics, regulatory support: ~$600K
IRB fees and insurance: ~$300K
Estimated total: ~$5M–$6M
Timeline:
Often ~2–5+ years, driven by:
Enrollment duration
Required follow-up
Data analysis and submission preparation
When Used
PMA submissions (Class III devices)
510(k)s when clinical data is required and nonclinical testing is insufficient
Novel indications or higher-risk uses
Post-Market Clinical Follow-Up (PMCF)
Purpose:
Post-market studies collect real-world clinical data after approval to:
Monitor long-term safety or performance
Fulfill regulatory conditions
Typical Scope:
50–500+ patients
Often registry-based
Multi-year follow-up
Cost Range:
~$250K to $3M+, spread over several years
When Required:
EU MDR (PMCF plans are mandatory for many devices)
FDA post-approval studies (PAS) or Section 522 studies
Conditions of approval or clearance
Purpose:
To validate diagnostic performance metrics such as:
Sensitivity
Specificity
Reproducibility
Typical Scope:
100–500+ samples
Retrospective (archived samples) or prospective collection
Multiple sites for demographic and prevalence diversity
Cost Range:
~$500K to $3M
Key Cost Drivers:
Sample procurement, especially for rare conditions
Reference method or “gold standard” testing
Reader studies and inter-reader variability assessments
Timeline:
Typically ~12–24 months
Why This Matters:
Choosing the wrong study type, or overscoping the right one, is one of the fastest ways to burn budget and delay market entry.
This is why teams increasingly map:
Device risk
Predicate strategy
Clinical expectations
Testing plans
in a single evidence workspace before engaging FDA, exactly the gap tools like Complizen are designed to address.
What Actually Drives Clinical Trial Costs: The Real Numbers
Clinical trial budgets don’t explode randomly.
In almost every medical device study, the same five variables account for the majority of cost overruns. Understanding these drivers lets you model realistic budgets and, more importantly, control them.
Cost Driver #1: Per-Patient Costs
Per-patient costs are almost always the largest single line item in a device clinical trial.
Multiply your per-patient cost by your patient count, and you’ve already accounted for a large portion of the total budget.
What Per-Patient Cost Includes:
Patient recruitment and screening
Study procedures (imaging, labs, device use or implantation)
Follow-up visits and assessments
Investigator fees
Site overhead
Patient compensation (when applicable)
Typical Per-Patient Cost Ranges
(Industry-observed U.S. ranges, not FDA standards)
Device Type | Typical Follow-Up | Cost per Patient |
External diagnostic (non-invasive) | None | $5K–$10K |
Non-invasive therapeutic | 30–90 days | $8K–$15K |
Minimally invasive device | 6–12 months | $20K–$35K |
Implant (orthopedic, general surgery) | 12–24 months | $25K–$50K |
Cardiovascular implant | 2–5 years | $50K–$100K |
Neurostimulator / complex cardiac | 5+ years | $75K–$150K+ |
Why Per-Patient Costs Vary So Widely
Procedure complexity
Office visit or simple device use: ~$5K–$10K
Outpatient procedure with sedation: ~$15K–$25K
Inpatient surgical implantation: ~$30K–$60K+
Imaging requirements
No imaging: baseline
X-ray: +$2K–$5K per patient
CT or MRI: +$5K–$15K (multiple timepoints)
Specialized imaging (angiography, echo): +$10K–$30K+
Follow-up duration
30-day follow-up: baseline
6-month follow-up: often ~1.5× baseline
12-month follow-up: often ~2× baseline
Multi-year follow-up: can triple or quadruple total cost
Example: Per-Patient Cost Calculation
(Illustrative example only)
Device: Minimally invasive surgical tool
Study: 60 patients, single-arm, 12-month follow-up
Per-patient estimate:
Screening and enrollment: $2K
Baseline visit and imaging: $3K
Procedure and hospitalization: $12K
Follow-up visits (5 × $2K): $10K
Investigator fees: $4K
Total per patient: ~$31K
Patient-related cost: ~$1.86M
Cost Driver #2: Number of Sites
More sites can speed enrollment, but they also increase fixed overhead.
The Trade-Off:
Few sites (1–3): lower startup cost, slower enrollment
Many sites (10–20): faster enrollment, higher upfront spend
Typical Site Startup Costs (Per Site):
IRB submission and approval
Contract negotiation
Investigator training
Site initiation visit
Equipment shipping and setup
Typical range: tens of thousands per site
Example: Site Strategy Trade-Off
Option A:
2 sites
18-month enrollment
Startup cost: ~$50K
Option B:
10 sites
6-month enrollment
Startup cost: ~$250K
Difference:
~$200K higher startup
~12–14 months faster enrollment
Which is better depends on:
Time-to-market value
Confidence in site performance
Cost of extended trial duration
Industry heuristic: expect 30–40% of sites to under-enroll despite startup investment.
Cost Driver #3: Study Duration (Enrollment + Follow-Up)
Time is one of the most underestimated cost drivers.
Every additional month of trial duration adds ongoing overhead.
Typical Monthly Overhead (Mid-Complexity Device Trial):
CRO project management
Monitoring visits
Data management
Regulatory support
Typical range: ~$50K–$130K per month
Timeline Impact Example
Fast enrollment:
6-month enrollment + 6-month follow-up = 12 months
Overhead: ~$1.0M
Slow enrollment:
18-month enrollment + 6-month follow-up = 24 months
Overhead: ~$2.0M
What Slows Enrollment:
Overly restrictive inclusion/exclusion criteria
Rare disease populations
Competing trials
Seasonal procedure patterns
External disruptions
How to Estimate Realistic Enrollment:
Ask sites for actual patient volume, not theoretical
Assume 30–50% screen failure
Assume 50–70% consent rate
Build a ~30% timeline buffer
Cost Driver #4: Study Design (RCT vs. Single-Arm)
Study design choices can dramatically impact cost.
Single-Arm Studies
All patients receive the investigational device
Compared to historical controls or performance goals
Often lower cost and faster enrollment
Randomized Controlled Trials (RCTs)
Treatment vs control (standard care or sham)
Higher complexity and longer enrollment
Often 1.5–2× the cost of comparable single-arm studies
FDA may require randomization when:
Endpoints are subjective (pain, quality of life)
Superiority claims are made
Placebo effects are a concern
FDA may accept single-arm designs when:
Endpoints are objective
Historical controls are well-established
A control arm would be unethical
Pre-Submission alignment on study design can save millions by avoiding unnecessary randomization.
Cost Driver #5: Endpoint Complexity
Endpoints directly influence:
Study size
Blinding requirements
Operational complexity
Lower-Cost Endpoints:
Device technical success
Imaging measurements
Mortality
Diagnostic accuracy
Higher-Cost Endpoints:
Quality-of-life scores
Pain assessments
Functional evaluations
Composite endpoints
Cost Impact of Complex Endpoints:
Blinding and sham controls: +30–50%
Core lab adjudication: +$3K–$10K per patient
Endpoint committees: +$100K–$300K total
Why This Matters
Clinical trial cost overruns are rarely caused by a single mistake.
They come from unexamined assumptions about enrollment, endpoints, follow-up, and study design.
This is exactly why teams that map risk, predicates, endpoints, and evidence expectations early, often using tools like Complizen’s evidence and strategy workspace, avoid the most expensive surprises.
Hidden Clinical Trial Costs People Forget to Budget
Most teams focus on per-patient costs and headline trial budgets.
What catches them off-guard are the supporting and operational costs that quietly add six or seven figures to a study.
Below are the most commonly overlooked items.
1. IDE Submission Preparation
If your study requires an Investigational Device Exemption (IDE), preparation itself is a significant cost.
Typical Cost Range:
~$75K–$200K+ for IDE preparation
(does not include major preclinical testing)
What This Includes:
Regulatory consultant support: ~$50K–$150K
Internal documentation and coordination: ~200–400 hours
Supporting bench or animal testing (if needed): $50K–$300K+
Timeline:
IDE preparation: ~3–6 months
FDA review: 30-day review clock
FDA may approve, approve with conditions, or place the IDE on clinical hold
The review clock can stop if deficiencies are identified
Key takeaway: IDE prep is rarely “just paperwork.”
2. Institutional Review Board (IRB) Fees
IRB costs scale with number of sites, duration, and amendments.
Typical Cost (Commercial IRBs): ~$5K–$20K per site
Common Fee Components:
Initial review: ~$3K–$10K
Continuing review (annual): ~$1K–$3K
Amendments: ~$1K–$3K each
Example: 10-Site Study, 2 Years
Initial reviews: ~$80K
Continuing reviews: ~$40K
Amendments (2 assumed): ~$40K
Total IRB fees: ~$160K
(Academic IRBs may cost less but often add time risk.)
3. Clinical Trial Insurance
Clinical trial insurance is mandatory for many studies and varies widely.
Typical Cost Range (U.S.) ~$50K–$500K+
What Drives Cost
Device risk class
Invasiveness (implants cost more)
Patient count
Sponsor track record
Example Premiums
Low-risk diagnostic (50 patients): ~$50K–$100K
Moderate-risk therapeutic (100 patients): ~$150K–$250K
High-risk implant (200 patients): ~$300K–$600K
4. Data Management Systems
Clinical data infrastructure is often underestimated.
Typical Cost ~$50K–$200K for traditional CRO-managed EDC systems
Includes
EDC licensing
Database build and validation
User training
Data queries and cleaning
Ongoing Costs ~$5K–$15K per month during active trial conduct
5. Statistical Analysis and Reporting
Statistics and reporting are rarely optional and often underbudgeted.
Typical Cost Range ~$50K–$200K+
Includes
Statistical Analysis Plan (SAP): ~$20K–$50K
Interim analyses (if applicable): ~$15K–$40K
Final analysis: ~$30K–$100K
Clinical Study Report (CSR): ~$40K–$100K
6. Monitoring Visits
Monitoring is one of the largest hidden cost multipliers.
Typical Cost ~$5K–$15K per site per visit (depending on travel, SDV intensity, and visit length)
Visit Types
Site initiation visit
Routine monitoring (every 4–8 weeks during enrollment)
Close-out visit
Example: 10 Sites, 18-Month Trial
Initiation: ~$80K
Routine monitoring (8 visits): ~$800K
Close-out: ~$80K
Total monitoring cost: ~$1M
Risk-based monitoring can reduce this, but many device trials still rely heavily on on-site SDV.
7. Protocol Amendments
Most trials require at least one amendment.
Typical Cost~$30K–$100K per amendment
What Drives the Cost
IRB reapproval at all sites
Site retraining
Protocol and consent updates
Regulatory submissions
Common Triggers
FDA feedback
Enrollment challenges
Safety signals
Endpoint clarification
8. Site Dropout Costs
Sites fail more often than sponsors expect.
Industry Heuristic ~20–30% of sites underperform or drop out
Cost to Replace a Site ~$25K–$50K per site
Common Reasons
PI turnover
Competing priorities
Poor enrollment
Regulatory issues
Budget Strategy
Plan to activate ~20–30% more sites than the minimum needed.
How to Minimize Clinical Trial Costs
Strategy 1: Get Pre-Sub Agreement on Smallest Acceptable Study
FDA defaults to conservatism. If you don't ask, they may require larger studies than necessary.
Pre-Sub negotiation points:
"Can we use single-arm instead of RCT?"
"Is 50 patients adequate or do you need 100?"
"Can we use 6-month followup instead of 12?"
"Are historical controls acceptable?"
Each of these can cut costs 30-50%.
Strategy 2: Single-Arm vs. RCT
When FDA accepts single-arm:
Objective endpoints (imaging, diagnostic accuracy)
Well-established performance goals or historical controls
Device clearly superior to no treatment (control arm unethical)
Savings: 40-50% cost reduction vs. RCT for same number of treatment patients
Strategy 3: Optimize Site Count
Sweet spot: 5-10 sites for most studies
Too few sites (<3): Enrollment too slow, timeline extends, overhead kills you
Too many sites (>15): Startup costs high, many non-performing sites
Strategy: Start with 5-8 sites, add more if enrollment lagging (staged activation)
Strategy 4: Shorter Followup (If Clinically Justified)
If your primary endpoint can be assessed at 6 months, don't follow patients for 12 months just to be safe.
Get FDA agreement on shortest clinically meaningful followup.
Savings: Every 6 months of followup = $500K-$1M+ in overhead
Strategy 5: Objective Endpoints (Avoid Blinding)
Blinding adds 30-50% to costs (sham procedures, blinded evaluators, complexity)
If endpoint can be objective:
Imaging measurements (lesion size, bone healing)
Device performance (technical success)
Mortality, major adverse events
Then blinding unnecessary. Use single-arm with objective assessment.
Strategy 6: Leverage Existing Evidence
Before enrolling first patient:
Conduct comprehensive literature review
Identify published studies on similar devices
Present to FDA: "This published study on similar device shows X. Do you need us to replicate?"
Often FDA accepts published literature + your bench data instead of new clinical.
Strategy 7: International Trials (Use with Caution)
Europe, Canada, Australia have lower per-patient costs:
Per-patient: $5K-$15K (vs. $15K-$40K US)
Regulatory burden often lighter for early studies
But:
FDA may scrutinize non-US data more heavily
Need to demonstrate data generalizable to US population
Language/cultural barriers
Travel costs for monitoring
When it makes sense:
Early feasibility (gather preliminary data cheaply)
FDA has indicated they'll accept non-US data (confirm in Pre-Sub)
You have international operations/partners
When to avoid:
Pivotal trial for US approval (FDA prefers US data)
Device very specific to US healthcare setting
No international infrastructure
What Kills Clinical Trial Budgets
Failure #1: Slow Enrollment
Scenario: Projected 3 patients/month, actual 1 patient/month
Impact: 24-month enrollment instead of 8 months = 16 extra months of overhead = $1.3M unplanned
Prevention:
Realistic enrollment estimates (ask sites for ACTUAL patient volume)
Relaxed inclusion criteria (don't over-restrict)
Patient recruitment campaigns
Enrollment bonuses for high-performing sites
Failure #2: Protocol Amendment Mid-Study
Scenario: FDA feedback requires endpoint change at month 8
Impact:
All sites need IRB reapproval: $80K
Site retraining: $40K
Some already-enrolled patients don't meet new criteria: data lost
Timeline extension: 3-4 months
Prevention:
Lock protocol with FDA via Pre-Sub before starting
Build endpoints carefully with statistical input
Pilot test procedures before full launch
Failure #3: Sites Drop Out
Scenario: 2 of 8 sites drop out (PI leaves, can't enroll)
Impact:
Lost startup investment: $50K
Need replacement sites: $50K additional
Timeline delay: 3-4 months
Prevention:
Vet sites carefully (PI commitment, patient volume)
Activate backup sites preemptively
Site engagement (regular communication, PI calls)
Failure #4: Designing Trial Before Confirming FDA Requirements
Scenario: Design 100-patient RCT, start enrollment. Month 6: FDA says "we would have accepted 50-patient single-arm."
Impact: $2M+ overspend, 12-18 months wasted
Prevention: PRE-SUB MEETING BEFORE TRIAL DESIGN. Cannot emphasize enough.
Failure #5: Underestimating Data Cleaning
Scenario: Assume 2 months for data analysis. Reality: 8 months due to data quality issues, query resolution delays
Impact: $200K-$400K additional statistician/data management costs
Prevention:
Invest in good EDC system with built-in edit checks
Real-time data review during study (don't wait until end)
Train sites on accurate data entry
Critical Takeaways
Always align with FDA before committing to a clinical trial. Pre-Subs often prevent unnecessary or overscoped studies.
Per-patient costs vary widely, from low-thousands for simple diagnostics to six figures for long-term implants.
Time is the silent budget killer. Slow enrollment can add seven figures in overhead.
Study design matters. RCTs often cost significantly more than single-arm studies.
Site count is a trade-off. More sites can speed enrollment but increase startup and dropout risk.
Hidden operational costs add up fast. IRBs, insurance, monitoring, data systems, statistics, amendments.
Feasibility before pivotal saves money. Small early studies prevent large downstream failures.
Enrollment assumptions must be realistic. Apply screen-failure and consent rates, not marketing estimates.
Objective endpoints are cheaper and faster than subjective endpoints.
Clinical trials are often avoidable. Many devices clear FDA with strong predicates, bench testing, and literature, but only if this is confirmed early with FDA.
The Fastest Path to Market
No more guesswork. Move from research to a defendable FDA strategy, faster. Backed by FDA sources. Teams report 12 hours saved weekly.
FDA Product Code Finder, find your code in minutes.
510(k) Predicate Intelligence, see likely predicates with 510(k) links.
Risk and Recalls, scan MAUDE and recall patterns.
FDA Tests and Standards, map required tests from your code.
Regulatory Strategy Workspace, pull it into a defendable plan.
👉 Start free at complizen.ai
Frequently Asked Questions
Can I use real-world data (RWD) instead of a prospective clinical trial?
Sometimes, but with limits.
FDA is increasingly open to real-world data (registries, claims data, EHRs), but expectations are strict. RWD must:
Come from reliable, well-controlled sources
Represent the intended patient population
Address the same clinical questions as a prospective study
In practice, RWD is most often used to supplement clinical data or support post-market evidence, rather than fully replace a pivotal trial. Always discuss RWD use with FDA through a Pre-Submission.
What if my clinical trial fails? Can the data be salvaged?
It depends on why the trial failed.
If the primary endpoint was missed but safety was acceptable and trends were informative, FDA may allow the data to inform a redesigned or follow-on study.
If the failure involved major protocol deviations, data integrity issues, or poor monitoring, the data may be unusable.
Before abandoning any data, discuss next steps with FDA. Failed trials are not automatically wasted, but quality and prespecification matter.
How do I know how many patients I need?
Sample size is determined by statistical power calculations, based on:
Expected effect size
Variability of the endpoint
Desired power, typically 80–90%
Significance level, usually 0.05
Engage a statistician before finalizing the protocol.
Undersized studies fail to answer the question.
Oversized studies waste money enrolling unnecessary patients.
FDA often references similar cleared or approved devices when evaluating sample size adequacy.
Can I combine feasibility and pivotal studies into one trial?
Usually not advisable.
Feasibility studies frequently uncover design, usability, or procedural issues. If those issues appear mid-trial, protocol changes can invalidate earlier data.
Preferred approach:
Run a small feasibility study (20–30 patients), incorporate learnings, then proceed to a pivotal study.
Exception: For very well-understood technologies, FDA may accept an adaptive or staged design, but this must be pre-specified and agreed with FDA.
What’s the difference between 510(k) clinical data and PMA clinical data?
PMA (Class III): Clinical studies typically larger, longer, and designed to demonstrate reasonable assurance of safety and effectiveness.
510(k): When clinical data is required, studies are often smaller and focused on demonstrating substantial equivalence to a predicate.
Typical cost ranges (very device-dependent):
PMA clinical programs: often multi-million dollars
510(k) clinical studies: often hundreds of thousands to a few million
Do Class I devices need clinical trials?
Almost never.
Class I devices are low risk, and most are exempt from 510(k) submission entirely. Clinical data is rarely required unless the device introduces novel claims or atypical risk.
Can I run a clinical trial at my own site?
Technically yes, but expect heavy scrutiny.
FDA closely evaluates sponsor-run trials due to bias concerns. If you do this:
Use independent monitoring
Consider independent statistical analysis
Blind assessments where possible
Unless you are an academic medical center with strong clinical research infrastructure, independent sites are usually safer.
What if I can’t afford a clinical trial?
Options to explore:
Confirm via Pre-Sub whether clinical data is truly required
Strengthen predicate and nonclinical evidence for 510(k)
Run a small feasibility study to support fundraising
Partner with a larger company
Consider international approvals, understanding FDA may still require additional data
How do clinical trials in Europe compare to the U.S.?
For many low- to moderate-risk devices, per-patient costs in Europe are often lower. However:
EU MDR significantly increased clinical evidence requirements
FDA may not fully accept EU-only data for U.S. approval
EU data can be valuable, but alignment with FDA expectations is critical.
Can I reuse one clinical trial for multiple regulatory submissions?
Yes, if designed strategically.
The same clinical data can often support:
FDA (510(k) or PMA)
EU MDR
Canada
Australia
You may need region-specific supplements, but one well-designed study can save millions.
What’s the role of a CRO versus doing it myself?
A CRO manages execution: sites, monitoring, data, logistics.
Typical CRO overhead: often 20–40%, varies by model
For first-time or complex trials, CROs usually reduce risk
Very small, single-site studies may be feasible in-house with experience
When do I need an independent Data Safety Monitoring Board (DSMB)?
DSMBs are commonly expected for:
High-risk devices
Long-duration trials
Trials with mortality or serious safety endpoints
Costs typically range $50K–$200K+.
FDA often expects DSMBs for Class III PMA studies and some high-risk Class II trials.