Semester 2Â 2021
Key Stakeholders
Dr. Tom Ward & Other Surgeons
Responsible for providing resources & communicating requirements, expectations & feedback to the project team. As the client, surgeons are the intended end-users of the clamp with a goal to implement it in knee replacement surgeries.
Project Team
Responsible for identifying requirements, curating a design approach, completing milestones & associated tasks on time and to a high standard, solving problems, facilitating communication amongst stakeholders & ultimately producing value for the client
Previous Project Team
The research & project deliverables by this team, along with all other contents of their repository, has laid the foundations for the current project team and will be used as the primary project resource.
Universities or Manufacturing Companies
Access to a 3D printer capable of manufacturing the clamp from titanium will most likely require another university or manufacturing provider. While not necessarily engaged in this phase, they will be critical to project delivery in future phases.
University Teaching Team
Review & grade the project team's work, but also provide guidance, resources and expertise in stakeholder engagement and technical & systems engineering concepts.
Knee Replacement Patients
As the subjects of the surgeries that will use the clamp, patient safety is paramount. Lack of safety or mechanical error caused by a sub-optimally performing clamp would negatively impact the patient's quality of surgery directly.
Shadow Team
Responsible for reviewing the project team's work. Aside from Tom, they will act as the primary feedback providers and will therefore contribute to guiding the team's progress and improving our work.
Academics/ Researchers/ Experts
Concepts relating to mechanical and biomechanical design & analysis, sensor working principles, and validation of 3D models through FEA models will all be facilitated most effectively through engagement with relevant disciplinary experts.
Constraints & Boundaries
Technical
Clamps should not restrict the degrees of freedom of the knee while operating
Sensors should be technically valid & suitable for surgical use
Materials used must comply with the Australian Regulatory Guidelines for Medical Devices
Design failure should be considered & analysed prior to finalising for printing
Sensors should be in alignment with the 3D model design and should not overlap any design features
Reliability
3D model must be properly validated by FEA methods before printing a prototype
Printing should not be done until the client is satisfied with & has approved the model
Clamps & prototypes should not be implemented in surgery until tested & certified according to the TGA pre-market conformity assessment and authorisation
Safety & Security
Clamp design must not disregard forces & damage analysis on the femur before using on patients
Clamp must not cause any damage to the patient's bone
Patient should consent to the use of the prototype during surgery
Secure data collection procedures must be in place