Q & A with Matt Conlon: Sterilization Industry Trends and Opportunities
Matt Conlon, V.P. and General Manager of REVOX® Sterilization Solutions, discusses the latest advancements and opportunities in the medical technology and sterilization industries.
What is the leading trend you have seen in the past year in the medical device market?
MATT CONLON: There is an obvious trend toward biologics and combination devices. Biologics and more complex delivery devices are sensitive to the high temperatures associated with traditional sterilization processes. The REVOX sterilization process can play a key role in helping medical device makers take advantage of this trend because its VPA process is conducted at room temperature (21°C), allowing full sterilization of drug-delivery devices without affecting the biologics or medications they contain.
What industry changes have you noticed in the past year with the materials used in the construction of devices, injection processes, safety, and improved patient outcomes?
MC: Overall, devices are becoming more sophisticated and combination devices are a good example of that. The trend is always toward greater ease of use for the patient and greater efficiency in the manufacturing process, so this requires the integration of diverse material components that need to survive the sterilization processes. High-temperature sterilization methods often necessitate separation of components and assembly either post-manufacturing or even at the point of surgery. With more than 100 materials now tested and confirmed for compatibility, and the ability to control VPA penetration with the REVOX VPA process, most products can be fully assembled before sterilization.
Likewise, we are seeing a tremendous increase in the need for room temperature sterilization of advanced combination devices and prefilled syringes. We’ve seen commercialization plans compromised simply because higher temperatures associated with traditional sterilization methods tend to impact the medication(s) within prefilled syringes.
Some restraints on the growth of the global medical device market include strict regulatory requirements, cost pressures, and the need for continued innovation to drive competitive advantage. How is REVOX Sterilization working to overcome these challenges?
MC: All of these challenges are exemplified by the obvious preference and potential advantages, from various standpoints, to have a combined, single device for medication delivery. If vial syringe packaging were “good enough,” manufacturers wouldn’t be challenging that status quo with the costs and risks associated with prefilled syringes. The sterilization method used on prefilled syringes can be the difference between success and failure. Elevated temperatures in the sterilization process may affect the medication itself. And surface sterilization with lower temperature methods is often more challenging than the term implies. With the goal being sterilization of every component of the device without touching the drug, the method needs to have the capability of penetrating mated surfaces, such as the threads on a plunger-to-stem assembly, while providing variable controls to limit the penetration to just short of reaching the drug itself. This is where REVOX sterilization excels. From a cost standpoint, depending on the standing infrastructure of a manufacturer, contracted sterilization is the standard sterilization process. REVOX sterilization enables on site, in-line sterilization that can significantly reduce per-unit costs.
Are pharmaceutical clients noticing the same trends that REVOX Sterilization has seen?
MC: One of our clients expressed a desire to launch their product as a pre-filled syringe. However, by the time they found us, their project timeline pressures were intense. We showed them the REVOX feasibility for sterilizing prefilled syringes, but the project timelines were such that they were concerned that incorporating a novel sterilization method could cause potential delays for their product launch. For now, they are continuing to use vial syringes for their product, but they decided to keep the option open to later convert to pre-filled syringes that could be easily sterilized using the REVOX VPA method.
Another client of ours has seen the proverbial writing on the wall in terms of the ever-tightening EO residual standards. As the residual limits are lowered, there is a need for additional EO post-processing aeration time, and as a result, manufacturers’ WIP (work in process) production time and volumes increase. We’ve continued to work with this client to demonstrate the efficacy and economic benefits of transitioning from EO to in-house VPA sterilization.