Newest EAB member Daniel McLain says that industry can't skip steps in proving biocompatibility for medical devices.
Daniel McLain served on MD&DI's board from 1995–2002. After a long break, he has returned, bringing with him expanded expertise on medical device topics, including toxicology, risk assessment, device development, and regulatory strategy. MD&DI is proud to once again welcome McLain to the Editorial Advisory Board.
McLain is the cofounder and president of Walker Downey & Associates Inc. (Madison, WI.) He has more than 25 years of experience with medical devices and regulatory functions that support them. As the current convener of ISO 10993, Biological Evaluation of Medical Devices—Part 11: Systemic Toxicity Evaluation, he is considered an international expert in his field.
McLain says that he hopes to influence how medical device manufacturers submit biocompatibility testing. “I don't think people in this industry would want to raise even the slightest perception of ignorance or deception, but they may not fully understand the biocompatibility environment. They need to know about options, whether these be explained through a consultant, asking a CRO, or following the ISO process as it is ultimately intended.”
McLain warns that “ISO is not a cookbook. When in doubt, [device manufacturers] may be best served by working with a third party that will make sure the right test is done the right way.” MD&DI's role, says McLain, is to “explore the gray area between ISO standards [on biocompatibility] and what the device manufacturer ultimately commits to submitting to FDA.”