SurgiNovi is a highly talented group of multi-national orthopaedic surgeons, scientists, engineers, researchers and software specialists, who have joined together to provide a solution to the main obstacle in the provision of total joint replacement operations worldwide.
This inhibiting factor is the customary requirement for each hospital to invest in large numbers of expensive, capital equipment in the form of highly specialised surgical instruments and trials (often amounting to hundreds of items for just one procedure) along with the extra cost of their mandatory sterilisation which can be prohibitive, if not impossible, in some parts of the world which lack the infrastructure to do this on a regular basis.
An added complication is that every joint replacement manufacturer supplies sets of instruments which can only be used with their own design of implants thereby reducing the operating surgeon's learning curve which inevitably adds extra minutes to the length of the operation due to the lack of standardisation between instrument sets.
This can have the effect of increasing both operating theatre costs and the duration of hospital stays which reduces the overall number of procedures a hospital can perform due to these financial restraints. We have expanded upon and further developed the highly efficient and novel concept of hospital based PSIs where all processes are done under one roof including CT scanning, preoperative planning, 3D printing, and instrument sterilisation.
In 2018 SurgiNovi was awarded ISO 13485:2016.[View Certifications]
We apply all the latest Quality Assurance and Quality Control regulations in all of our design and manufacturing processes. Although our patient specific custom-made products are exempted from CE marking, we are working towards this certification by the end of 2022 in order to follow international standards.
All of our manufacturing materials have passed the relevant ASTM and ISO standards for biomedical and biomechanical performance tests. All of our certificates are available upon request.