About the Client
A North America-based medical technology company specializing in designing and manufacturing custom implants for orthopedic surgery. The client is an industry leader, utilizing advanced technologies and patient scan data to create tailor-made implants and instrumentation for hip and knee replacement surgeries. They continuously push the boundaries of what is achievable in the field of joint replacement, setting new standards for patient care and surgical outcomes.
Business Challenge
Time spent on designing an implant based on patient-specific anatomy is way too high and prone to multiple iterations, causing high turn-around time. The instrumentation for such custom implants has to be tailor-made, causing furthermore complexity in the design process. The manual process of designing custom-specific implants is labor intensive and is not highly scalable, person dependent and prone to errors due to fatigue and lacks consistency among designers.
Requirement
About the Client
- A requirement for a high level of proficiency in clinical knowledge, 3D design, and manufacturing processes.
- Expertise in interpreting patient scan data, creating precise 3D implant designs, & manufacturing implants accurately.
Reliable and Repeatable Process
- The need for a consistent and dependable process for custom implant design & production.
- Ensuring predictability in results to guarantee successful orthopedic surgeries and patient comfort.
Improved Mobility and Comfort for Patients
- Enhance patient mobility and comfort through custom implants.
- Deliver tangible improvements in the quality of life for individuals undergoing hip and knee replacement surgeries.
Solutions
Integrated Software Modules for Scan to Manufacturing:
Implement integrated software modules to streamline the entire process from reading patient scan data to the final manufacturing of custom implants. The key modules of the software are :
Utilize advanced image processing techniques to accurately read and segment patient scan data (DICOM) and convert to 3D mesh, a crucial step in creating custom implant designs.
Automate the custom implant and instrumentation design process using any industry-standard CAD software (in this case Solidworks)enhancing efficiency and precision. Prepare the implant and instrumentation for manufacturing with 3D printing.
Develop a surgical planning tool that facilitates collaboration with the surgeons during the implant design process. Generation of surgeon reports for the final designs.
Test Methods and Validation Plans
Establish rigorous test methods and validation plans to ensure the implants and instrumentation meet the stringent standards of the safety, reliability, and effectiveness of custom implants for the patients.
Technical Documentation
Develop the technical documents required for submission to regulatory authorities for necessary approval/certification.
Benefits
Reduced Cycle Time in Implant Design
The client saw a significant reduction in the time required for custom implant and instrumentation design, leading to quicker delivery of patient-specific solutions.
Enhanced Collaboration with Surgeons
The solution implementation improved collaboration and communication with surgeons, enabling them to participate actively in the design and planning process, leading to better patient outcomes and satisfaction.