With the increasing complexity of dual-classified medical devices, how do you see the field of extractables and leachables evolving in the next 5-10 years?

In my view, the future is already here. The real challenge now is applying risk-based approaches to ensure we fully understand what is being administered to patients. The analytical methods are available, but the role of raw material and component suppliers is crucial in this process. Why is that? While the ultimate responsibility always lies with the Market Authorization Holder—the manufacturer of the medical device or pharmaceutical product—the authorities are increasingly focused on understanding the complete extractables profile. This scrutiny begins with the material choices at the base level and extends all the way to the component level.

Take, for instance, a system made up of multiple components: a film, a stopper, or a port system. The extractables profile of each of these components is integrated into the broader risk analysis. This analysis informs decisions on whether simulation or stability studies are needed to confirm the presence of leachables, ultimately validating or refining the initial risk assessments.

Being able to clearly communicate this “story” to regulatory authorities becomes significantly easier when robust data is available right from the start. If the raw materials and components come with comprehensive extractables data—especially at Analytical Evaluation Threshold (AET) levels—manufacturers can form a clearer picture and make more informed decisions throughout the development process. In this way, suppliers play a critical role by providing foundational data that feeds directly into pharmaceutical risk assessments. The more detailed and accessible these data sets are, the smoother the process becomes for manufacturers. This collaboration not only reduces unnecessary studies but also ensures that the final products meet safety and regulatory standards efficiently

 Your presentation focuses on infusion bags as an example of dual-classified devices. Can you give us a brief insight into why this particular area is so challenging from an E&L perspective?

Infusion bags? Well, let’s just say they are an analytical nightmare in large-volume parenteral products! The combination of diverse materials, like rubber stoppers and polypropylene films, certainly keeps things interesting. But the real challenge? That comes from the ultra-low AET thresholds that push the boundaries of analytical testing. And when you add the drug matrix into the mix, things can get really tricky.

Now, I could go on about how simulation studies or biological testing—particularly in vitro methods—could offer some clever alternatives, but I don’t want to spoil too much! After all, that’s what my presentation is all about. So, let’s just say, this is where the fun really begins, and I hope you'll stick around for the full story!

 This conference brings together experts from various aspects of the medical device and pharmaceutical industries. What are you most looking forward to learning or discussing with your peers during the event?

 I’m particularly excited about the toxicological aspects and the upcoming Master Class during the event. One of the most critical challenges in bridging MedTech, Pharma, and Biotech lies in establishing clear zones and target limits for compound quantification and evaluation, especially when the AET (Analytical Evaluation Threshold) is exceeded.

Currently, there is no universal harmonization on how these limits are set, and this remains a key focus for creating robust toxicological assessments. Understanding how we can quantify and evaluate compounds that surpass AET values is essential for ensuring patient safety and regulatory compliance. I'm eager to explore how we, as an industry, can work together to address this gap, harmonize practices, and develop clearer standards that guide these evaluations across sectors.

This aspect is pivotal in creating the cross-industry bridges that connect the regulatory and scientific landscapes of MedTech, Pharma, and Biotech, and I look forward to contributing to this Master Class and related discussions.

 As the Principal Consultant at Avisulting LLC, how do you leverage your extensive experience from companies like B. Braun, Johnson & Johnson, and Ferring Pharmaceuticals to address the complex E&L challenges faced by your clients?

As the Principal Consultant at Avisulting LLC, my extensive experience from companies like B. Braun, Johnson & Johnson, and Ferring Pharmaceuticals allows me to bring a multi-industry approach to solving complex E&L challenges for our clients. At Avisulting, we work closely with toxicologists, regulatory experts, and R&D teams to ensure that regulatory compliance is achieved while offering practical solutions that meet the demands of both the pharmaceutical/biotechnology and medical device industries.

One standout example from my time at Johnson & Johnson involved an implantable infusion pump, a combination product for long-term drug delivery. Even in the early 2000s, the FDA emphasized the importance of E&L studies in combination with traditional biocompatibility tests, such as in vitro and in vivo assessments, to meet regulatory requirements. This experience highlighted the critical need for chemical characterization in identifying hazards, particularly for combination products, and the difficulty in aligning ISO standards with pharmaceutical requirements at the time. Back then, the lack of alternatives often meant resorting to animal testing to satisfy both regulatory frameworks.

Today, thanks to advancements in chemical characterization, we can significantly reduce the need for in vivo tests, especially when compared to older practices such as those outlined in USP <88> for some packaging materials. In addition to in vitro testing—widely used as an alternative for irritation and sensitization—chemical characterization in the field of E&L plays a fundamental role in reducing in vivo tests and, by extension, minimizing animal testing, which is a critical ethical consideration.

At Avisulting, we are also proud of our role in supporting the early adoption of guidelines such as USP <1663> and <1664>, which established industry consensus on E&L testing. This evolution continues with the latest guidance like USP <665>, and we remain at the forefront of helping clients navigate this dynamic landscape. By leveraging chemical characterization for medical device, we contribute not only to regulatory efficiency but also to ethical practices by reducing the reliance on animal studies.

 This conference covers a wide range of topics in E&L management. How do you think events like this contribute to advancing the field, particularly in addressing the challenges of dual-classified medical devices?

Conferences like this one don’t just foster collaboration; they also bring together experts who are actively involved in voluntary commissions or directly engaged in regulatory submission processes. It’s an invaluable opportunity to connect with professionals who help shape evolving standards like ISO, USP, and ICH, and to see how these changes are influencing the future of E&L testing.

At Avisulting, we recognize how crucial it is to stay aligned with the regulatory frameworks that span both the medical device and pharmaceutical/biotech sectors. Engaging in these discussions allows us not only to contribute to science-driven guidelines but also to anticipate the changes that will streamline compliance and ensure patient safety. Conferences like this provide the perfect platform to dive deeper into how we can align risk management approaches (such as ISO 10993-17 for devices and ICH Q3D for pharmaceuticals) and address the growing complexity of dual-classified products.

I would also like to take a moment to thank Smither for breathing life into events like this over the years. Their dedication has made it possible for our industry to come together, exchange knowledge, and shape the future of E&L testing