MD&M West takes place annually in Anaheim. The event brings together premier MedTech engineers, and thinkers. In this special “hot tech” section, we highlight exciting research, people, and technology shaping the industry’s future. We caught up with Jennifer Riter, Senior Director, Business and Technical Operations for West.

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Q&A With Jennifer Riter, West Pharmaceutical, Inc.

Q: What are a few common examples of essential performance requirements (EPRs) in wearable Medtech?

When developers think about EPRs for drug-device combination products, they should do so based on an outcomes risk assessment for that particular combination product.

For example, for on-body systems, some common EPRs would be total volume delivered, injection time, and actuation force. Developers also have to consider the adhesion of the injector onto the body and may need to look at peel force.  Another consideration would be if there’s a cap included in the on-body system, they may need to define the force required to remove that cap.

Occlusion detection is another common EPR. If the assembly of a drug-device combination could cause an occlusion in the needle of the injector, that raises the risk of the patient not getting the proper dose of the drug. So, developers of wearable medtech may need to understand occlusion detection testing as part of their requirements.

Q: What top regulation considerations should Medtech engineers be aware of?

This is a rapidly evolving area. As medical device manufacturers are thinking into the future, they need to increase their understanding of combination products and what needs to be done to bring those products to market. During a February 2022 webinar West held on demystifying EPRs for combination products, one-third of attendees cited the development of an appropriate testing strategy as their top concern when it comes to meeting the needs of regulators.

Regulatory agencies such as the FDA are putting out guidance documents to help manufacturers understand premarket pathways for combination products. In Europe, the medical device regulations (MDRs) were recently updated to include combinations of devices and medicines. It’s important for device manufacturers to understand those MDRs.

We’re expecting the FDA will publish a guidance document on EPRs this summer. This document should provide clarity on what the agency expects from manufacturers when they submit EPRs for combination products. As more drug manufacturers look to bring these combination products to market, that clarity will be essential.

Q: What quality controls should OEMs put in place to minimize risks associated with EPRs?

Device manufacturers routinely perform design Failure Mode and Effects Analyses (dFMEAs), and from that risk assessment, they should be able to determine the critical quality attributes (CQAs) of their particular device.  Based on this, the drug manufacturer will be able to define their CQAs and EPRs for the combination product.

Once they have their critical quality attributes associated with the combination product, they will determine which of those are essential to performance. From there, having a control strategy in place for the combination product, based on their risk assessment is critical.

All of this should be happening in phase 1 of development. Many companies get hung up when they are not developing the drug in parallel with the device. Pulling the drug development scientists and the device engineers together earlier in development is critical to the success of bringing a combination product to market.