Currently, CMIs account for only 1.4 % of the implant market, despite the added value for patients, surgeons and medical institutions. This commercial failure is due to the high cost, long lead times and need for patient-oriented surgical approaches.
An online platform for the design of CMIs
To assist in the mass customisation and design of CMIs, the EU-funded INOVER21 project developed the medical implants customisation engine (MICE), a surgeon-manufacturer co-creation and communication tool. This was coupled with the mass customisation dynamics (MC Dynamics) factory floor management system generated for efficient mass production of CMIs at affordable prices and fast lead times. “Offering premium quality patient-specific medical implants at competitive prices is not enough; we need to empower surgeons to design the implant that is going to be used in a specific patient,” explains project coordinator Gediminas Kostkevičius. In this context, INOVER21 partners created MICE, a free 3D platform accessible over the web, which can be used for surgery planning of patient-specific or standard implants, regardless of manufacturer. The MICE platform is the only available one on the market, and it includes a wide range of functionalities for interactive surgery modelling. It combines anatomical and clinical data from the patient alongside semi-automatic anatomic structures, and it allows surgeons to search for similar cases in the clinical database of the platform. To ensure effective management of CMI design and manufacture, MICE is combined with MC Dynamics, specifically tailored to mass-customisation of medical devices. That means that a virtual implant design can become an order with only a few clicks. Clinical engineers are readily available to provide the necessary support.
Virtual planning is becoming the gold standard in surgery, as it offers 3D visualisation of a patient's anatomy. Especially for patients suffering from severe congenital or acquired deformities, or those undertaking tumour excision, developing a surgical plan prior to entering the operating room is critical. Existing 3D pre-surgical planning software comes with expensive licences, while its limited accessibility renders it practically unusable. Moreover, current software does not always allow for a holistic view, but rather is specialised in specific body parts, meaning that surgical planning requires the combined use of several different pieces of software. The INOVER21-generated MICE tool overcomes all these hurdles, offering surgeons a freely accessible 3D surgery planning tool that can be combined with CMI manufacturing to assist them in joint replacement, facial reconstruction, and cranial and spinal surgeries. Importantly, MICE addresses the cost issues and lead times associated with the manufacturing of patient-specific implants and surgical guides. Following platform implementation, Ortho Baltic manufactures 3 000 CMIs annually at lower prices than modular standard implants, and with a lead time of 2 to 4 weeks. With a view to the future, Kostkevičius hopes “to exploit the generated data for machine learning to develop an AI-based functionality in the MICE pre-surgical planning tool.” With more than 2 million knee-and-hip-replacement surgical operations held in the EU alone, undoubtedly there is a big niche for surgical tools to support patient-tailored treatment.
INOVER21, custom-made implants (CMIs), MICE, surgery planning, MC Dynamics