How to Budget for Biocompatibility Testing in Your Medical Device Project

Biocompatibility testing is a critical part of medical device development, ensuring that your product is safe for human use. However, for many medical device manufacturers, budgeting for biocompatibility testing can be challenging due to varying costs, regulatory requirements, and unexpected expenses. In this guide, we break down the key factors to consider when planning your biocompatibility testing budget, helping you avoid costly surprises and streamline your development process.

1. Understand Regulatory Requirements

Before estimating costs, you need a clear understanding of the regulatory requirements applicable to your device. Different markets have different standards:

• FDA (U.S.) follows ISO 10993-1 as the primary standard for biocompatibility.
• EU (MDR) also adheres to ISO 10993-1, with additional documentation and justification requirements.
• Other markets may have country-specific guidelines but often refer to ISO 10993-1.

Understanding which tests are required for your device classification and intended use is crucial to setting a realistic budget.

2. Define Your Device’s Risk Profile

Biocompatibility testing requirements depend on factors such as:

• Nature of patient contact (surface, externally communicating, implantable)
• Duration of contact (limited, prolonged, or permanent exposure)
• Materials used and their history of safe use

A well-documented material selection and justification process can help reduce the number of required tests and lower costs. Good laboratories such as NABI will help you navigate this process, ensuring that only necessary tests are performed while maintaining compliance.

3. Identify Required Tests

Based on ISO 10993-1 and regulatory expectations, common biocompatibility tests include:

• Cytotoxicity (basic screening test, often required)
• Sensitization & Irritation (evaluate allergic and irritation potential)
• Systemic Toxicity (assess acute, subchronic, or chronic toxicity risks)
• Genotoxicity (determine potential DNA damage or mutation risks)
• Implantation Studies (for implantable devices)
• Hemocompatibility (for blood-contacting devices)

A thorough biological evaluation plan (BEP) can help prioritize necessary tests and eliminate redundant ones. On many markets, a BEP is mandatory, and it must be written by individuals with the appropriate qualifications, knowledge, and experience in testing. If you choose to cooperate with a trusted laboratory, they will identify all the required tests for you, ensuring compliance while optimizing cost and efficiency.

4. Request Quotes Early

Costs can vary significantly between biocompatibility testing laboratories. Obtain detailed quotes that include:

• Individual test pricing and package discounts
• Turnaround times (faster results often come at a premium)
• Additional fees (e.g., sample preparation, reporting, consulting services)

Comparing multiple quotes can provide cost-saving opportunities while ensuring quality and compliance.

5. Account for Pre-Testing and Material Characterization

Before full biocompatibility testing, material characterization and chemical analysis may be required:

• Extractables & Leachables (E&L) testing for chemical safety assessment
• Material characterization to justify reduced testing
• Pilot studies to identify potential risks before full-scale testing

While these steps add costs, they can prevent failures that would require costly re-testing later.

6. Plan for Potential Failures and Retesting

Biocompatibility failures can occur due to unexpected material interactions or contamination. To mitigate risks:

• Allocate a buffer budget for potential re-testing
• Work closely with your testing lab to interpret results and adjust your strategy
• Use material screening early to identify issues before full biocompatibility testing

Having contingency funds can prevent delays and ensure regulatory approval timelines are met.

7. Factor in Documentation and Expert Consultation

Regulatory agencies require detailed justifications and reports. Some labs provide regulatory support, but these services may come at an additional cost. To ensure compliance and streamline approvals:

• Comprehensive documentation: Proper test reports and justifications are essential for regulatory approval.
• Expert consultation: Guidance on test selection, study design, and regulatory expectations can help avoid unnecessary tests and costs.
• Regulatory submission support: Assistance in compiling test data into structured regulatory submissions can prevent delays.

At NABI, we always grant regulatory support, helping customers to launch their products effectively by ensuring all documentation and justifications meet the necessary standards.

8. Optimize Testing Strategies to Save Costs

To make the most of your budget:

• Use historical data if materials have prior biocompatibility evidence
• Leverage chemical characterization to reduce unnecessary testing
• Combine tests where possible to save on sample costs and lab fees
• Negotiate bundled pricing with your lab for multiple tests

NABI customers do not need to worry about this, as we always provide fully optimized solutions, considering both time and cost to ensure the most efficient and effective testing strategy.

9. Consider Timeline and Cash Flow Impact

Biocompatibility testing can take weeks to months. Plan for:

• Lead times for lab scheduling and test completion
• Phased payments based on testing milestones
• Parallel testing when necessary to accelerate approvals

Effective scheduling prevents project delays and helps manage cash flow efficiently.

10. Choose the Right Testing Partner

A trusted biocompatibility testing laboratory can make a significant difference in cost efficiency and compliance success. Look for:

• Accreditation and regulatory experience (FDA, ISO 17025 certification, GLP compliance)
• Proven track record in your device category
• Clear communication and support for test planning and regulatory submissions

Additionally, be aware that some laboratories may be banned by certain competent authorities (e.g., FDA) or may have received warnings. Information about such laboratories can typically be found on the FDA’s website under their “Warning Letters” section or by checking the FDA’s inspection and enforcement database. It’s essential to verify the laboratory’s standing with the relevant regulatory bodies before proceeding.

Final Thoughts

Budgeting for biocompatibility testing requires a strategic approach to balance cost, compliance, and efficiency. By understanding regulatory requirements, defining your risk profile, selecting the right tests, and planning for contingencies, you can optimize your testing budget and streamline the approval process.

Choosing the right laboratory is crucial, and NABI stands out as the best choice. We hold all necessary accreditations and certifications, ensuring full compliance with FDA, ISO, and GLP requirements. Our cost-effective and time-efficient approach minimizes delays while maximizing budget efficiency. At NABI, we provide full support at every stage, from test selection to regulatory submission, helping you bring your medical device to market with confidence and efficiency.

If you’re looking for expert guidance in navigating biocompatibility requirements, NABI is here to help. Contact us to discuss your testing strategy and ensure your medical device project stays on track!

About the Author: Dr. Damian Matak

Dr. Damian Matak – an expert in medical device biocompatibility testing, serving as the CEO of ISO 17025-accredited and GLP-certified laboratories, including NABI – North American Biomedical Institute and EBI – European Biomedical Institute. As a member of the Polish Society of Toxicology and the I Local Ethical Committee, Dr. Matak contributes significantly to advancing safety standards in the biomedical field.