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Navigating fertility treatments can be a physically and emotionally demanding experience for women. As the sole child bearers, women are more directly impacted by procedures like in vitro fertilization (IVF), which require a significant toll on their bodies even before pregnancy begins. The initial stages often involve 2-4 weeks of fertility hormone treatments, frequently administered through multiple self-injections. Recognizing the stress associated with this process, RQM+ is dedicated to helping bring innovative solutions to market that can ease this burden.
One example of RQM+'s impact in this area involves work on a novel injection device intended to make the self-injection process simpler and less painful for women undergoing fertility treatments. The goal of this project was to gain valuable regulatory insight from the FDA regarding the potential testing requirements for this innovative device and to narrow down the available regulatory pathways. A key challenge identified was the fact that this product was a “combination product,” integrating a device (the injector) and a drug (the fertility drug), which comes with unique regulatory considerations.
While the FDA has improved communications regarding combination product expectations, clarity on necessary evidence for novel products is still needed. To help overcome these challenges, RQM+ played a crucial role. Initially, RQM+ educated the client on the FDA’s current and typical regulatory expectations for drug delivery devices through a comprehensive regulatory strategy. Subsequently, RQM+ assisted in developing a meeting package to present to the Agency and facilitated a face-to-face meeting with the FDA to obtain critical feedback on the available regulatory pathways.
In a follow-up interaction, RQM+ submitted a meeting package and secured written feedback from the Agency concerning preclinical and clinical expectations. This critical feedback obtained by RQM+ was vital for the client’s product development process, helping to accelerate market access for a treatment designed to ease the strain of an already overwhelming process for women.
By facilitating this engagement with the FDA, RQM+ helped to ensure that this less painful and streamlined technology could potentially reach women sooner, alleviating some of the physical stress associated with necessary injections in fertility treatments and the psychological stress of tracking multiple treatments.
Stay tuned later this week for part two of this series, "Addressing Unmet Needs in Women's Health: Devices for Mental Health Support," where we'll delve deeper into the critical unmet needs in women's mental health and explore how innovative medical devices and combination products can offer much-needed support. Discover how RQM+ leverages its collective expertise to navigate the complexities of product development and regulatory processes, accelerating the path to market for solutions that can make a real difference in women's lives. Don't miss out on this insightful discussion!
In case you missed this month's RQM+ Live! panel discussion, access the webinar on demand to hear industry leaders and regulatory experts share real-world strategies MedTech companies can use to navigate these barriers and bring life-changing innovations to market.
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