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Conducting Biocompatibility Testing for a Medical Device: Part II
Interview with Jeff Geesin, Research Director & Medical Device Consultant
About Jeff Geesin
Jeff Geesin is a biochemist with extensive experience in corporate research and technical expertise in extracellular matrix biology, wound repair and regeneration, tissue engineering/regenerative medicine, and preclinical models of disease for testing therapeutic approaches. He managed project and career development activities for up to 30 technical staff with budget responsibilities up to $15 million, and projects to clinical stage for device and drugs in numerous therapeutic areas including orthopedics, dermal wound repair, women's health and urology, neurology, dermatology, and cardiovascular. Jeff currently works as an independent consultant, providing preclinical strategy development, biology/mechanism of action writing and strategy for planning for regulatory submissions, due diligence of products or technologies, and patent portfolio assessments and strategies. For more information, visit www.geesinconsulting.com or http://www.linkedin.com/in/jeffreycgeesin.
How would you help a device client who is looking to establish pre-clinical plans, including biocompatibility testing?
I help my clients in a few key areas: I can help them to look at and or develop their strategy, identify needs in the marketplace, and ascertain where technologies would be of best use. I occasionally get involved in assisting with research proposals to help obtain funding, as well as working to identify the required testing and supplier(s) best suited to perform efficacy and safety studies. I can also assist with writing for FDA submissions related to mechanisms of action and biology components. I can also be of help in developing intellectual property strategies to protect investment.
What are your thoughts on technical strategies for meeting FDA requirements?
It's important to develop a pre-clinical plan to address at risk issues and potential adverse effects to apply to your clinical plan. I have encountered situations in which a device material hasn't been characterized in depth before the biocompatibility studies are carried out. The FDA requires complete characterization, and if they don't see sufficient data to support this they would require the device maker to re-do its animal studies. I have encountered some device makers who haven't looked at cytotoxicity (for example, assessing problems related to local necrosis) prior to performing animal studies; I recommend running a cytotoxicity study first, to save the wasted time of having to run additional animal studies. I have also seen cases where the implant isn't properly fixed in the implanted animal which makes assessing tissue interaction difficult. Sometimes, samples are not properly trimmed or oriented when imbedded when they are sent for Pathological analysis which makes taking proper measurements difficult. It is also important to ensure sterility before the implantation study, as this can cause confounded tissue responses. When the selection has been narrowed down to a few device prototypes, it would be wise to go ahead and initiate the study as soon as possible, including the most promising candidates. The FDA is asking for human safety trials for almost everything and it's important to be aggressive with your timelines where possible. Streamlining the manufacturing process of your device from the beginning is crucial; if changes are needed after you've initiated your safety studies, you will be required to re-do your studies and you'll be required to re-run your studies with implants produced with your final manufacturing process.
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