Proactive Planning: Combining Biocompatibility with Other Preclinical Testing Needs

Biocompatibility testing is a vital part of preclinical evaluation, but it’s just one piece of the larger puzzle. Manufacturers often face the challenge of aligning multiple testing streams — biocompatibility, electrical safety, performance verification, mechanical integrity, sterilization validation, and more — while meeting tight timelines and regulatory expectations. A fragmented or reactive approach can lead to duplication of effort, missed synergies, and delays. Proactive planning allows manufacturers to optimize resources and timelines while ensuring comprehensive risk management.

1. Strategic Integration in Preclinical Planning

Combining biocompatibility with other preclinical testing needs starts with thoughtful project planning. The key is to adopt a systems approach — one that looks at the device, its intended use, materials, and regulatory requirements holistically. Begin by:

• Mapping all regulatory requirements early: Include ISO 10993, IEC 60601, ISO 11135/11137, and others depending on the device type. This gives you a full picture of what tests will be needed and when.
• Identifying overlapping endpoints: Some tests or studies can serve multiple purposes. For example, sterilization validation samples may also be used for extractables/leachables testing if appropriately planned.
• Creating a unified testing roadmap: Develop a master preclinical testing timeline that includes all requirements — biological, functional, mechanical, electrical, and chemical. This ensures tests are sequenced efficiently and samples are used appropriately.
• Engaging testing labs early: Communicate the full scope of testing needs to the lab. Coordinated scheduling and technical consultation from the start can help you avoid rework, sample waste, and conflicting results.

2. Where Biocompatibility Intersects with Other Preclinical Studies

Biocompatibility testing often overlaps with other types of evaluations, and understanding these intersections can help streamline efforts:

• Sterilization and biocompatibility: Sterilization methods (e.g., ethylene oxide, gamma radiation) can alter material chemistry. Biocompatibility testing should be conducted on the final, sterilized product to reflect clinical use. Coordinate sterilization validation and biocompatibility testing timelines to avoid repeated runs.
• Material characterization and shelf-life studies: Extractables/leachables testing often aligns with packaging validation and shelf-life stability programs. Plan to collect shared data where possible, reducing redundant studies.
• Performance and mechanical testing: Failures in mechanical tests can impact biological safety by generating particulates or exposing inner materials. Make sure mechanical validation is completed before initiating biocompatibility testing to avoid invalidating results.

3. Key Benefits of a Coordinated Testing Strategy

When biocompatibility is combined with other preclinical testing needs as part of a single, cohesive plan, manufacturers can realize significant advantages:

• Time efficiency: Reduces total development time by avoiding scheduling conflicts and minimizing retesting due to poor planning.
• Cost optimization: Shared samples and integrated protocols reduce lab time and resource use.
• Regulatory alignment: Demonstrates a comprehensive, risk-based approach to safety and performance evaluation. Regulators appreciate cohesive, well-documented testing strategies.
• Improved data traceability: A unified plan leads to better documentation control and consistency, which is critical for both Notified Bodies and FDA reviewers.

4. Tips for Effective Coordination

• Build a multi-disciplinary project team: Include representatives from R&D, RA/QA, clinical affairs, and lab partners to ensure all testing needs are considered in planning.
• Use project management tools to track dependencies: Visual Gantt charts, timelines, and risk matrices help track testing dependencies and deadlines.
• Document your integration rationale: Maintain written justifications for combined studies, shared samples, and test sequencing decisions — this will support smoother regulatory review.
• Expect iteration: Initial plans may need refinement as material or design changes occur. Keep your lab partner informed to avoid misaligned testing or invalidated results.

5. Common Pitfalls and How to Avoid Them

• Siloed teams or disconnected vendors: When teams or testing vendors don’t communicate, it leads to redundant or conflicting studies. Solution: Centralize project management and encourage regular cross-functional meetings.
• Insufficient material documentation: Without full disclosure of material composition and processing agents, it’s impossible to design effective toxicological evaluations. Solution: Work closely with suppliers to obtain Certificates of Analysis and chemical composition data early.
• Underestimating sample needs: Some tests require multiple device units or specific configurations. Solution: Plan for sample production early, and coordinate logistics for sterilization and transport.

Final Thoughts

A proactive, integrated approach to preclinical testing — including biocompatibility — enables manufacturers to reduce risk, streamline development, and enhance regulatory readiness. By viewing biocompatibility not in isolation but as part of a larger safety and performance framework, companies can plan smarter, move faster, and avoid costly missteps. Partnering with a testing lab experienced in multi-disciplinary coordination further strengthens your path to market success.

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 EBI – European Biomedical Institute and NABI – North American 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.