Ahead of this November's Extractables & Leachables Europe we spoke to Matthew Jorgensen, Chemistry and Materials Scientist at Nelson Laboratories, about his presentation on E&L chemistry for medical devices biocompatibility assessment, industry changes, future challenges and much more.
Q1. Your presentation looks at E&L chemistry for medical devices biocompatibility assessment; can you briefly explain what it will be covering?
All newly marketed medical devices require a demonstration of biocompatibility per ISO 10993. Chemical characterization followed by toxicological risk assessment can be used to address a number of potential biological risks that would otherwise require lengthy and expensive animal tests. This presentation will outline strategies for generating extractable/leachable chemistry data that is adequate to support biocompatibility of medical devices, which in some ways is different compared to strategies suitable for pharmaceuticals.
Q2. What changes have you seen in the E&L market in the last 5 years and how does that influence your current strategy?
We have seen increased acceptance and support of E&L chemistry data by the US FDA, which has in turn resulted in a dramatic increase in demand for these types of analyses by medical device manufactures throughout the United States and Europe. We have also noticed an increased level of expertise from the FDA and other regulatory bodies when it comes to chemistry. With the increase in demand by manufacturers and increase in finesse by regulatory bodies, having a scientifically sound testing strategy is more important than ever.
Q3. What is your current approach to future challenges within the market?
One of the challenges I see is balancing the requirements of manufacturers in terms of cost and turn-around-time with what is necessary to provide the best data to toxicologists assessing data to make conclusions that affect patient safety. One way we are looking at solving this problem is by using toxicologists that have strong expertise in chemistry. That way there can be a meaningful dialog between them and the chemistry labs doing the analysis. There are often strategies that streamline analysis while still providing strong data.
Q4. What are you most looking forward to at E&L Europe 2017 conference in Lyon?
Mostly the opportunity to connect with and learn from others immersed in E&L, like John Iannone. Hopefully I can help folks considering E&L find testing strategies that meet their needs while at the same time meeting the demands of toxicology.
Matthew will be presenting as part of the Biocompatibility session. Other presenters in the session include PPD, Becton Dickinson and Bristol-Myers Squibb. You can view the full programme here.
Representatives from Apple, AstraZeneca, GSK, Mylan, MHRA, Novo Nordisk, Allergan, Sonceboz, Bayer, Baxter, Solvias and many more have already confirmed their attendance, so book today to ensure you stay ahead of the competition.
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