The Challenge
Catheterization is a critical medical procedure, but existing devices for female patients often fall short in terms of comfort, usability, and efficiency. FemEase was created to address several key issues:
- Patient Comfort: Traditional catheterization devices can be uncomfortable, leading to pain and anxiety for patients.
- Usability: Devices designed for female catheterization often lack intuitive design, making the process cumbersome
for both healthcare professionals and patients. - One-Handed Opera: Many devices required both hands for operation, creating complications in clinical settings.
- Child-Friendli: There was a need for a design that was less intimidating and more approachable for younger
patients.
Our goal was to design FemEase to address these issues while meeting rigorous regulatory and safety standards.
The Development Process
1. Initial Design and Prototyping
The first iteration of FemEase focused on creating a functional catheterization device that could streamline the
procedure for healthcare professionals. We began with a prototype designed for functionality, but feedback from early
testing revealed several areas for improvement:
• Comfort: The initial design needed enhancements to reduce discomfort during insertion and improve the overall user
experience for patients.
• Usability: Although functional, the first prototype required both hands to operate, limiting flexibility for healthcare
professionals
2. Redesign for One-Hand Operation
To address usability concerns, the design was revisited with a focus on simplicity and efficiency. Our engineers reworked the mechanism to allow for one-handed operation , giving healthcare providers more control and flexibility during the catheterization process. This was a key breakthrough, as it allowed for greater ease of use, especially in busy clinical environments.
3. Enhancing Patient Comfort and Safety
With patient comfort as a top priority, we redesigned the catheterization aid with softer materials and a more ergonomic shape. These improvements reduced discomfort and made the device more approachable for patients, particularly for younger patients who may feel anxious about the procedure. The device was made out of a plastic polymer that offered the equivalent strength of a metallic material, but greater comfort as the plastic will not have the same thermal or cold feel as a metal utensil would.
The device was optimized to provide the best field of view for the insertion of the catheter, thereby reducing the probability of mis insertion of the device, with subsequent complications.
Lastly, the geometry of the device was adapted to eliminate the possibility of damaging or injuring delicate tissue during the procedure. On the one hand, the device needed to easily engage tissue for insertion, but on the other hand it needed to avoid subjecting the tissue to shearing or stretching which could easily lead to injury.
4. Iterative Prototyping
Several rounds of prototyping were conducted to refine both the design and functionality. Each iteration was tested by healthcare professionals and patients to ensure the device met real-world needs. Feedback was incorporated into every new version of the product to enhance usability, patient comfort, and overall safety.
The Solution: FemEase
After several rounds of testing and design refinement, catheterization device. Its key features include:
- One-Handed Operation: Allows for easier handling by healthcare providers, making the process quicker and more efficient.
- Ergonomic Design: The shape of the device was carefully crafted to ensure insertion, reducing anxiety and discomfort for patients. patient comfort and safety during insertion, reducing anxiety and discomfort for patients.
- Scalable for Manufacturing: The final design was optimized for scalability, ensuring that the product can be manufactured efficiently while maintaining quality and regulatory compliance.
Results and Impact
FemEase is now ready for full-scale manufacturing and market entry. The innovative design addresses the key challenges of female catheterization by providing:
- Improved Patient Comfort: patients. The use of softer materials and ergonomic design significantly reduces discomfort for Reduced instances of complications (ex UTIs, lacerations)
- Enhanced Usability for Healthcare Providers: The one-handed operation feature simplifies the process for healthcare providers, improving efficiency in clinical settings.
- Ready for Market: FemEase meets all necessary regulatory standards and has been developed with scalability in mind, allowing for rapid production and distribution.
Key Takeaways
- Collaboration and Feedback-Driven Development: Continuous feedback from healthcare professionals and patients was key to refining the design of FemEase. Each iteration brought us closer to the final solution, ensuring the product meets real-world needs.
- Prototyping for Success: Multiple rounds of prototyping allowed us to identify issues early and refine the product through design and material adjustments. This iterative approach helped ensure that the final product was safe, comfortable, and ready for the market.
- Innovation with Purpose: FemEase is an example of how thoughtful, user-focused design can lead to meaningful innovation in medical devices, improving both patient experience and clinical outcomes
Conclusion
FemEase represents a significant step forward in female catheterization devices, providing a solution that addresses both patient comfort and healthcare provider usability. Through innovative design, rigorous testing, and a commitment to meeting real-world needs, Go Vertical ICM successfully developed a product that is now ready for manufacturing and market entry.