Ortho Baltic has developed an advanced design and manufacturing practices for Custom-Made Implants (CMIs) and Custom-Made Surgical Guides (CMSGs) – premium quality orthopaedic products that currently fail to achieve large-scale commercial success over much inferior standard orthopaedic implants.
The main advantage of CMIs, compared to standard implants, is the patient-specific design, which matches the implant to the bone (not vice-versa) and individual alternatives for its attachment. It also encompasses the complete biomechanical harmonization of replaced joints and their connectors. Moreover, unlike standard implants, the CMIs are constructed as integral devices. All this ensures lower surgical invasiveness, shorter operation time, faster healing process, reduces risks of infection, joint dislocation and revision surgeries, fuller restoration of patient’s physical performance and quality of life; making CMIs much more suitable not only for complicated clinical cases. In addition, CMIs are produced using metal 3D printing technologies (additive manufacturing). This method as such gives implants added value because it almost has no limitations in realization in one peace most complex constructions and enables forming trabecular metal surfaces that ensure better secondary fixation of the implant. These functional surfaces may be injected with the mixture of tricalcium phosphate and hydroxyapatite enriched with patient-specific antibiotics encapsulated in microcapsules which provides controlling release of antibiotics in timely dosages, infection prevention, and treatment cost economy of scale.
During the Phase 1 “Mass customization of implants” project, a multi-part feasibility analysis was developed. The economic viability analysis suggests that after removal of some of industrial and market barriers to what the project is devoted, the CMI market grow will increase substantially (from 7% to 26% per annum). Once it finally accelerates, the technological viability modelling showed that the transition from a unitary to mass production would cut down unit production costs dramatically, ultimately lowering the product price to end-users.
An in-depth competition analysis revealed that no company on the market currently operates a mass customization business model for CMIs, nor has it the adequate systems installed to do so. Ortho Baltic will thus be able to gain competitive advantage upon: a) its surgeon-manufacturer communication tool MICE (Medical Implant Customisation Engine) implementation by offering value added services, such as 3D model-based CMI specifications configuration, design adjusting, CMI validation in the stage of pre-surgery planning and documentation processes, and b) implementation of its shop floor management system MS Dynamics (Mass Customization Dynamics) – Lean/TOC-based process optimization platform, specifically adjusted to the specific of digital in-nature CMI design, manufacturing and validation processes. These features will support the trend of personalized surgical solution while simultaneously make Ortho Baltic a superior quality CMI and CMSG producer.
The next steps for commercialization of CMI mass-customization business model are development of academic surgeon and medical student training programmes together with leading medical universities on CMI need identification and surgeon participation in CMI design and validation processes applying MICE software and corresponding CDSS (Clinical Decision Support System) MICE Trainer with user interface based on principles of gamification. These solutions should greatly contribute to a new surgical thought paradigm – one that is based on patient-specific decision making, CMI-based qualification, and incentives to wider use of CMI in surgical treatment and market growth. Moreover, both MICE and MICE Trainer would give Ortho Baltic access to the users of these systems and enable us to evaluate their readiness to use CMI and CMSG in surgical tre
