Implantcast’s vast manufacturing and clinical knowledge base now joins LifeHealthcare’s already comprehensive One At A TimeTM portfolio. A key addition is the inclusion of the only TGA approved silver coating for joint replacements. Silver coatings have been shown to mitigate the risk of infection induced implant loosening and more severe complications that can lead to revision surgery or in the worst case, amputation.
The One At A TimeTM process has been in operation now for almost three years and has demonstrated significant clinical history and has been used in cranial, complex orthopaedic and spine cases. The process utilises X-ray and CT data for implant design and surgical approach optimisation to potentially reduce surgical complications such as reoperation, implant migration, subsidence or delayed fusion, and total procedural cost.
Whilst the design and production of a PSI from request to implantation has many ‘behind the scene’ stages, the surgeon’s inputs are relatively concise.
The process starts with scans and surgeon prescription that outlines the patient’s pathology. The scan data is uploaded and then converted into a 3D virtual model in preparation for a design planning session.
The design planning session is where the surgical plan and implant requirements are defined in detail. Utilising specialised software, implants and instruments can be designed in real time. This allows the surgeon to manipulate the PSI design on the fly to optimise their surgical plan and outcome.
Following the design planning session, a report is produced that outlines the surgical plan and implant design for the surgeon to approve. In addition to surgeon design approval, a PSI requires financial approval to proceed to manufacture.
LifeHealthcare has dedicated internal resources focused on the regulatory and reimbursement process for PSIs that aid in streamlining approval.
LifeHealthcare also understand the challenges of treating patients with complex needs, and work with payers on healthcare economics to ensure the most appropriate treatment.
Once design and financial approval is received, the part goes into production. Production involves raw manufacturing, finishing, cleaning and quality assurance.
A team of highly-trained and specialised employees are required for each element of this process. Much of the work undertaken in the finishing department is done manually as machinery does not always achieve the best result, this is especially true when it comes to polishing of joint articulation surfaces. Once ready, the PSI is then shipped to LifeHealthcare.