Advantages of Choosing End-to-End System Design and Execution with a Single Vendor
Industry: Medical Devices – ENT Debrider System Development
Technology Focus: Surgical Tools, Motion Solutions, Embedded Electronics
Introduction
In the fast-evolving medical device industry, the design and development of highly specialized surgical tools are critical for improving patient outcomes and enhancing surgical precision. One such device is the ENT Debrider System, designed to assist in the removal of tissue during ear, nose, and throat surgeries. The client approached Fontierz to design and develop a customized ENT Debrider System, with specific requirements for performance, ergonomics, and system functionality.
This case study highlights the challenges encountered during the project, the innovative solutions developed by Fontierz, and how the end product met the rigorous standards of the medical industry.
Client Requirements
The client had a detailed set of requirements for the ENT Debrider System, which included specific parameters for speed, functionality, and design. The key specifications for the system were as follows:
1. Speed Requirements:
The hand tool was required to have a maximum speed of 12,000 rpm, with an initial speed of 1,000 rpm, adjustable in increments or decrements of 500 rpm.
2. Blade Design:
A blade with zero and forty-degree angles, with the ability to integrate irrigation. The blade design was to follow the design of a predicate system, though the development and manufacturing of the blade itself were not part of Fontierz’s scope.
3. Oscillation Mode:
The system required a fixed oscillation mode with a range of 1,000 rpm to 5,000 rpm, adjustable in 500 rpm steps.
4. Console Design:
A console with a TFT display and touch screen keypads for easy control and interaction. The controls for the user interface were to follow Fontierz’s standards.
5. Irrigation Pump:
An inbuilt irrigation pump was required to ensure effective flushing during surgical procedures.
6. Foot Switch:
A wired foot switch was needed, with an IP67 rating for protection, ergonomically designed based on a predicate system.
7. Handpiece Design:
The hand tool should be ergonomic, lightweight, and capable of integrating suction, with a tolerance of +/- 15% compared to the predicate device.
8. Diagnostics:
Power-on self-diagnostics and mode selection for oscillation and linear drive were also necessary for safe and reliable operation.
Challenges Faced
While the client’s requirements were clear, the project presented several challenges that needed to be addressed to ensure the successful development of the ENT Debrider System:
1. Integration of Multiple Features
The design had to incorporate various components, such as the motor control, irrigation system, oscillation mode, and user interface, into a compact and ergonomic hand tool. Integrating these diverse features while ensuring high performance and reliability required careful planning and coordination across multiple engineering teams.
2. Ergonomics and Usability
Surgical tools must not only meet functional requirements but also provide surgeons with ease of use and comfort. The handpiece had to be lightweight, balanced, and easy to handle, while also accommodating the necessary components, including suction and irrigation systems.
3. Precise Speed Control
One of the critical features of the system was the precise control of speed, especially in the range of 1,000 rpm to 12,000 rpm. Developing a reliable system that could accurately adjust speed in increments of 500 rpm without compromising performance was a technical challenge.
4. Compliance with Standards
The system needed to meet medical device standards and ensure compatibility with existing devices in the operating room. This required rigorous testing and validation to meet regulatory requirements.
5. Foot Switch Design
The foot switch was an integral part of the system’s operation. It had to be designed to withstand harsh conditions in the operating room, while providing reliable performance. The IP67 protection rating and ergonomic design parameters based on a predicate system presented an additional challenge.
Fontierz’s Solutions
Fontierz tackled these challenges by leveraging its deep expertise in medical device development, system integration, and product design. The following solutions were implemented to ensure the success of the project:
1. Comprehensive System Design
Fontierz took a holistic approach to the ENT Debrider System’s design, integrating all components—motor control, oscillation systems, irrigation pump, and user interface—into a seamless unit. This ensured compatibility and prevented issues that might have arisen if different teams worked on each component separately.
2. Advanced Motion Solutions
Fontierz employed advanced motion control technologies to ensure smooth and precise speed adjustments for the hand tool. A high-performance motor was selected to meet the required speed range of 1,000 rpm to 12,000 rpm, with fine-grained control increments and decrements of 500 rpm. This solution allowed for accurate tissue removal without compromising on safety or performance.
3. Ergonomic Handpiece Design
The handpiece was designed with ergonomics in mind, focusing on user comfort and usability during extended surgeries. The final design was lightweight and easy to maneuver, with the addition of suction and irrigation systems integrated into the hand tool for enhanced functionality during procedures.
4. Foot Switch Development
The foot switch was designed to meet the IP67 protection rating, ensuring durability and reliability even in challenging surgical environments. The ergonomic design, based on the client’s requirements, ensured that surgeons could easily control the system without straining during operations.
5. UI/UX Development
Fontierz developed the console interface, featuring a TFT display and touchscreen keypads, based on Fontierz’s UI/UX standards. The user-friendly interface ensured that surgeons could quickly adjust settings, monitor the system, and operate the ENT Debrider System efficiently during surgery.
6. Compliance and Testing
Fontierz performed rigorous testing of the ENT Debrider System to ensure it met all necessary regulatory standards and could be safely used in medical environments. The system went through extensive power-on self-diagnostics and performance validation to guarantee reliability during surgery.
Outcome
The ENT Debrider System developed by Fontierz successfully met all the client’s requirements, overcoming the technical challenges faced during the design and development process. The final product was:
1. Reliable:
The system’s motor control and speed settings worked seamlessly, with precise adjustments for optimal performance.
2. Ergonomically Designed:
The handpiece was comfortable for surgeons to use, with the added functionality of an integrated suction and irrigation system.
3. User-Friendly:
The TFT touchscreen display and intuitive interface made it easy for surgical teams to operate the system with minimal training.
4. Durable and Compliant:
The foot switch met the IP67 rating, and the entire system passed the required compliance tests for use in the medical field.
5. Timely Delivery:
Fontierz’s integrated approach allowed for a streamlined development process, ensuring that the ENT Debrider System was delivered on time and met all quality and performance standards.
Conclusion
Fontierz’s end-to-end product design and development approach provided the client with a high-quality, reliable ENT Debrider System that met all functional, ergonomic, and regulatory requirements. By managing the entire development process, Fontierz ensured seamless integration of all system components, minimized risks, and delivered a product that exceeded expectations. This case study demonstrates the benefits of partnering with a single vendor for the design and development of complex medical devices, ensuring quality, efficiency, and reliability throughout the product lifecycle.
