How Can Systems Optimization Improve Medical Device Portfolio Management?

Navigating biological safety risk management and evolving regulatory expectations throughout the product lifecycle

A large life sciences manufacturer needed to review and confirm all the biocompatibility data for their extensive catalog of medical devices after the Food and Drug Administration identified a documentation deficiency in their quality management system. Exponent was retained to examine the company's large library of manufacturing process and product documentation and assess potential impacts to biocompatibility that could result from manufacturer consolidation or redistribution.

This analysis involved reviewing existing manufacturing processes and manufacturing contact materials to assist in creating a biocompatibility testing strategy and evaluating areas that demonstrated substantial equivalence where existing data (or data to be acquired through the testing plan) could be used to demonstrate biological safety. This risk-based approach was performed according to ISO 10993-1:2018.

THE CHALLENGE

Reasonably assuring the safety and effectiveness of medical devices requires understanding the interactions between devices and the body. As a result, evaluating biocompatibility is important during the design verification phase as well as throughout the device lifecycle. Exponent needed to identify any gaps in the existing data and determine an optimal testing strategy to support appropriate mitigation of risks for the entire catalog of devices. While this could be accomplished by scouring thousands of pages of test reports, how could this rudimentary approach be improved?

EXPONENT'S MULTIDISCIPLINARY SOLUTION

Exponent's team of multidisciplinary experts created a robust, searchable database using information from manufacturing processes, material specification sheets, biocompatibility test results, and more. Data science experts organized the data, and health sciences experts evaluated the data and proposed a viable strategic plan based on FDA guidance documents and medical device industry standards.

EXPONENT'S IMPACT

By creating a biological safety database and performing subsequent product safety evaluations, we were able to demonstrate the biocompatibility and safety of a significant portion of our client's medical devices and identify a reliable testing strategy for the remainder of their devices.

What Can We Help You Solve?

Exponent's multidisciplinary teams of biomedical, health science, and data science experts have decades of experience testing and refining medical device technology and conducting sophisticated medical device evaluations for a vast array of clients and applications.

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