Optimizing Biocompatibility Testing for Class III Implants: A Cost-Efficient Approach​

Problem Statement​

Our customer, a US-based medical device manufacturer, has revolutionized the field of biomedical device production. Leveraging their expertise in developing highly sophisticated, miniaturized Class III implants, they have mastered cutting-edge, scalable manufacturing techniques to innovate medical technology.

The customer required comprehensive biocompatibility testing for an innovative, miniature Class III implant designed to be placed on the dura mater of the spinal cord. This implant aims to assess tissue oxygenation in the spinal cord.

Solution​

• Decos delivered a strategic, cost-effective approach to selecting the most suitable biocompatibility testing facility that offered cost-effective solutions while ensuring that the reports were acceptable to regulatory bodies. After a thorough evaluation, we suggested partnering with a testing lab accredited by GLP,  ISO, and AAALAC, guaranteeing that the results would be accepted by all relevant regulatory bodies. 
• Our team worked alongside the lab to perform the required tests in compliance with ISO 10993-1 standards, tailored to the unique duration and nature of the implant.​
• We also supported the development of the Biological Evaluation Plan (BEP) and handled all discussions related to the biocompatibility testing process.​

Key Benefits

• Cost-effective: We identified a biocompatibility lab that provided high-quality, affordable testing services, delivering results accepted by major regulatory agencies.​
• Regulatory compliance: Our expertise ensured that all testing was aligned with ISO 10993-1 standards, critical for global regulatory approval.​
• Cost savings: We reduced costs further by avoiding unnecessary additional tests, by conducting an extensive literature review and toxicological risk assessment for specific components.​

The approach by Decos contributed to the successful development of the implant and provided significant benefits for the customer, including cost savings and regulatory compliance.