ARTICLE SUMMARY:
In this edition of Consultants Corner, Marina Daineko explains why companies really need to dig into the details of a device’s materials, manufacturing processes, and, importantly, its intended use to successfully establish a risk-based biocompatibility testing plan.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
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Marina Daineko is a biocompatibility subject matter expert offering services to help medical device manufacturers meet regulatory requirements. She has previously served in compliance and biocompatibility roles in the medtech sector and holds an MSc in analytical chemistry. Her passion for materials science has led to 15 published scientific articles and the development of two innovative patents. |
The Question: How Do You Know Your Device Is Biocompatible?
A medical device is a multifaceted system. The specific materials that the device is made from are an important part of that system, but they aren’t everything. The system is also defined by the processes employed to make it, and ultimately by the clinical context in which the device is used. When it comes to assessing a device’s ability to perform its function in the human body without unacceptable risks, every one of these factors needs to be fully considered. “You need to do deep investigation and analysis,” underscores Marina Daineko, a biocompatibility expert and consultant.
Daineko says one of her favorite phrases is, “There’s no such thing as a biocompatible material.” In her view, the quote captures the core challenge and “beauty” of modern biological evaluation of medical technology—namely, that evaluating whether components of a device are safe and biocompatible depends completely on how the product is constructed and how, exactly, it is intended to be used. There is no definitive list for device firms to reference to check on the acceptability of their material or the specific tests they will need to conduct on it. “You can’t just copy and paste the information,” Daineko asserts.
