In the realm of women’s health, while significant advancements have been made, there remain critical unmet needs. One area of particular concern is mental health, a topic that unfortunately still carries a stigma. Women often bear a significant mental load related to family and child-rearing, in addition to their professional lives and personal needs. While pharmaceutical options are frequently the primary avenue for treatment, there’s a growing recognition of the potential for innovative medical devices and combination products to offer additional support for women’s mental well-being. The RQM+ team has worked on devices intended to reduce anxiety and depression, improve insomnia symptoms, and devices to assist and alleviate stress for new mothers in caring for their little ones.
Whether it’s a pharmaceutical product, a medical device, or a novel mental health treatment that doesn’t fit well in either of those buckets, products must go through rigorous evaluation to demonstrate they are safe and effective. The path to reach that end goal isn’t always obvious, and sometimes, when not done appropriately, can slow down or even prevent health products from reaching patients. Approaching product development and product improvements strategically and early in development, optimizing the development process, obtaining important feedback from Health Authorities, and managing quality and clinical expectations throughout the product lifecycle can accelerate that process, and that is where we at RQM+ shine! RQM+ has invaluable collective knowledge that our consultants can tap into when working on a project, which essentially means that every client we work with gets the benefit of every other expert in RQM+!
It’s important to keep in mind that every medical device must undergo a rigorous process to get on the market. A recent experience sitting in an ICU with a loved one made me contemplate the incredible impact that we make on patients and their families. That ICU room was literally full, floor to ceiling, wall to wall, with medical equipment that was helping keep my loved one alive. I couldn’t help but consider how many people and how much effort it takes to bring each device from an idea in someone’s head, into development, through the regulatory process, and finally to the hospital and connected to someone’s loved one. It wouldn’t be an exaggeration to say that it takes anywhere from 50 people to several hundred people for each device. Each of us that works in the MedTech space are one of the many individuals that enhances the lives of patients and their families every day.
RQM+’s Commitment to Women’s Health and Innovation
As a company that was founded by women, RQM+ supports the full lifecycle of medical devices and combination products for women and for all patients alike. RQM+’s experience in developing comprehensive regulatory strategies, preparing meeting packages for regulatory agencies, and facilitating crucial dialogues can be invaluable for companies seeking to introduce innovative mental health devices for women. By leveraging our collective knowledge and expertise, RQM+ helps clients navigate these uncertainties, potentially accelerating the path to m