To improve on the device we currently have, we plan to enhance the adhesive performance in order to ensure a stronger and longer-lasting skin attachment under different conditions. It is important that the device withstands movement and sweat while staying watertight. There also needs to be more exploring of alternative biocompatible material that are softer and more flexible to increase the comfort of the device for longer term wear if needed. Additionally, future designs will need to consider reusability and sustainable packaging to reduce any environmental impact the device might cause. Finally, it will be important to test the device across a more diverse range of skin tones and types to improve the device's inclusivity and effectiveness.
Patenting is currently in Progress. We have worked on revising the previous version of the patent to include the most recent iterations of the device. We are working with the UCSD patenting office to ensure everything is properly filed. For any questions regarding our patent, reach out to the UCSD Patenting office.
Before initiating any clinical trials for the device, the device must undergo rigorous preclinical testing to confirm it's safety. Preclinical testing will need to focus on confirming the safe usage of the device on human skin without introducing any bad side effects. This includes ISO 10993 Biocompatibility Testing, and specifically focusing on standards for category II external contact devices. These tests include evaluations for skin irritation, sensitization, cytotoxicity, and acute systemic toxicity. By performing these tests, we aim to ensure that the device does not produce any harmful biological reactions and therefore ensure that it is safe for extended wear. The results from these preclinical testing methods will help us collect data to include in our submission to the FDA and IRB to get clinical trial initiation approval.
Clinical testing is a major step in validating the safety and effectiveness of the device in a real-world setting. We plan to submit a comprehensive clinical trial protocol to both the FDA and IRB, including an application for IDE, Investigational Device Exemption. The goal of this study will be to assess whether the device can successfully reduce ductal inflammation and prevent the entry of fluids through the nipple for high-risk individuals. The clinical trial will be designed to include diverse participants, while excluding those who are breastfeeding or have nipple piercings or known adhesive allergies. Outcome measures of the clinical trial will include user comfort, irritation levels, wear time, and overall effectiveness in fluid prevention.
Bringing the device to market and making it easily available to users is one of the biggest goals for this project. To bring the device to market, we need to prepare for the full FDA regulatory process. Based on its intended use and level of risk, the device will likely fall under Class II classification. This will require completion of the De Novo classification process, followed by a Premarket Notification 510(k) to demonstrate substantial equivalence to legally marketed devices. We would also need to develop a commercialization roadmap that includes scaling up production, quality control testing, and identifying potential industry partners to help carry out the testing and clinical trials of the device. Once FDA clearance is obtained, we will be positioned to launch the device for broader clinical and consumer use, with the goal of offering an accessible, preventive solution for those at risk of breast cancer.
Page done by: Rand Ato