Driving Innovation and Compliance: Design Changes for Enhanced Medical Device Performance and Cost Efficiency.
Challenge
- The client faced technical challenges while Implementing design changes in a medical device compatibility issue, system integration, regulatory compliance, and maintaining performance while making modifications.
- They required design changes to improve the performance of the medical device, to comply with new regulatory standards or guidelines, to reduce manufacturing costs, and to address feedback from users or stakeholders.
Our Solutions
- Reviewed existing design for understanding design architecture and associated limitations.
- Created 3D designs for varying thickness of the parts.
- Reviewed the designs to achieve the standards and regulations, such as the International Electrotechnical Commission (IEC) 60601 standard for medical electrical equipment.
- Delivered 3D models, 2D manufacturing drawings.
Results
- Our 3D models and drawings helped the production team to create prototypes, tooling, and molds, as well as to perform quality control inspections and testing.
- Overall, the design changes and associated deliverables improved the quality, safety, and performance of the medical device, as well as increase its marketability and customer satisfaction.
Client
Industrial Equipment Manufacturer in US
Industry
Machinery Manufacturer
