The medical device industry is experiencing rapid transformation. While fields like big data, AI, and telehealth garner attention, the heart of healthcare innovation lies in the design and development of groundbreaking medical devices. At Kickr Design, we specialize in turning innovative ideas into life-saving medical devices, guiding businesses through the complex journey from concept to FDA approval.
Understanding Medical Device Development
Creating a medical device requires rigorous testing, precise processes, and detailed documentation. Our team of biomedical engineers is dedicated to helping clients navigate these challenges, ensuring that each device meets the highest standards and complies with all FDA requirements.
Here are a few examples of how we have helped clients develop innovative medical devices:
Smart Syringe: This device improves dosing accuracy, saving time and reducing errors. We developed its internal electronics, user interface, and housing, then prototyped it for user testing.
CDC HIV Testing Device: We’ve worked with the CDC to develop a low-cost, portable HIV testing device. It simplifies the testing process with a single button press and provides feedback on test success. The device uses custom electronics and firmware, making it user-friendly and efficient.
LIT Medical Device: Designed for lung isolation and single lung ventilation, this device reduces user error and saves lives. Through extensive prototyping and user feedback, we optimized the design for manufacturing under strict FDA regulations.
Quick Tourniquet Innovation: This device addresses the challenge of quickly and effectively applying a tourniquet. It reduces application time and pain, providing a life-saving solution for military personnel. The prototype includes a snap-on feature and a custom pneumatic mechanism for uniform pressure application.
From Ideation to Implementation
Our team of engineers and designers brings a full suite of services to the table:
- Concept Development and Design: We work collaboratively to refine your vision, ensuring usability and functionality are at the core.
- Engineering Expertise: Our biomedical engineers ensure your device meets rigorous safety and performance standards.
- Prototyping and Testing: We create functional prototypes to validate your design and gather valuable user feedback.
- Regulatory Support: We guide you through the FDA approval process, ensuring your device meets all requirements.
- Manufacturing Solutions: We can help identify and connect you with manufacturers to bring your device to market.
Let’s Bring Your Medical Device Vision to Life
The future of medical device innovation is bright, with many opportunities to improve patient outcomes and care delivery.
Contact us today for a free consultation and estimate. Our team of engineers and designers is here to help you navigate the complexities of medical device development and achieve your vision for the future of healthcare.