Previous Year's Device

The project team in the 23-24 project cycle developed a watertight design using latex device with a flower-shaped adhesive  with a liquid indicator to alert user of loss of watertight seal. For more information regarding the device designed in the previous cycle, please see the team website from last academic year. 

Developments

• Switched material from latex to silicon to make the device more accessible, as latex is a common allergen. 

• Developed molds in Fusion360 used to manufacture device prototypes. 

  • Ensures that all device models have standard measurements and can be reproducible for ease of manufacturing. 

• Changed the device shape from circular to petal shaped to make the device applicable to different breast sizes. 

• Introduced curvature into the device to prevent compression of the nipple. 

• Developed a clinical trial to test the efficacy of the device. 

Experience and Skills Gained

• Developed skills regarding CAD design and prototype modeling. 

• Utilize principles of regulatory affairs to develop a medically safe device prototype using materials approved for use in other FDA approved devices (Diamora adhesive, medical grade silicone). 

• Ethical considerations were assessed in the selection of materials. 

  • A silicone device is biocompatible and can be reused, therefore reducing waste and the effect of the product on the environment. 

• Developed an understanding of how to assess manufacturability and feasibility of production through material selection, as silicone is an material commonly used in medical devices while still being relatively inexpensive. 

• Developed an understanding of clinical trial phases and regulations. 

• Utilized FDA and IRB resources and manuals to construct the relevant clinical trial phases. 

Page done by: Rylee Hickey