Mass-customisation of custom-made medical implants

Project Information

INOVER21

Grant agreement ID: 768197

DOI

10.3030/768197

Project closed

EC signature date 16 June 2017

Start date 1 July 2017

End date 31 December 2019

Funded under

• SOCIETAL CHALLENGES - Europe In A Changing World - Inclusive, Innovative And Reflective Societies

Total cost

€ 2 267 398,75

EU contribution

€ 1 587 179,13

Coordinated by

UAB ORTHO BALTIC
Lithuania

Periodic Reporting for period 2 - INOVER21 (Mass-customisation of custom-made medical implants)

Reporting period: 2018-07-01 to 2019-12-31

Summary of the context and overall objectives of the project

"Custom-Made Implants (CMIs) are considered to be a superior solution for the treatment of patients with rare and severe clinical conditions since they ensure better fit, lower surgical invasiveness, shorter surgery time, faster healing, reduce risks of infection, joint dislocation and revision surgeries leading to lower total pathology treatment costs. Thus, CMIs provide added value for all - patients, surgeons, medical institutions and health insurance funds. However, CMIs currently fail to achieve large-scale commercial success due to high price, long lead times and dominated surgical approach oriented towards standard solutions.
The objectives of the Project were to solve two societal challenges.
The first project objective was to incentivize surgeons to apply personalized surgical solutions more widely. To support changes in a dominated surgical thought paradigm, it was decided that it is not enough to offer surgeons (and as a result to patients) premium quality patient-specific medical implants for competitive price. Together with them technology-based infrastructural solutions, such as 3D pre-surgery planning platform MICE (Medical Implants Customization Engine) with user access via Web browser, which would empower surgeons to describe in natural way the individual design solutions to be implemented in an implant that is going to be used in treatment of a specific patient, in a specific clinical case instead of continuing to twist and turn trying to solve the problem of ""how to make do with what we have"", has to be provided.
The second project objective was to develop technological solutions such as surgeon – manufacturer communication and co-creation platform MICE and MC Dynamics factory floor processes management system enabling the Company a) to make the transition from unitary to mass production more efficient than their competitors, and b) to make a premium-quality medical devices (patient-specific implants) more available and affordable to patients in price and supply terms. It was planned to integrate advanced surgery planning and manufacturing technologies into a single software-controlled technological platform for management and control of CMI & CMSG supply chain processes to ensure its effectiveness and CMI competitiveness with the respect to standard implants."

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

"The main results achieved:
1. The transition of MICE to a server on OpenGL platform with web browser interface for the surgeon, using WebGL libraries was completed reaching TRL9. MICE functionality to cover other CMI groups (cranial, facial, spinal and other implants of joints) was expanded. The system and its final configuration were tested in an operational environment under the expected range of environmental conditions in which it will be expected to operate. This include development of pilots for different CMI type with surgeons. In addition, MICE Trainer was redesigned and integrated into MICE system as TRL 9 level subsystems.
2. The transition of DISPATCH2 functionality from ASP.NET in set with Microsoft SQL Server DB to Java based Spring Framework instrumental platform in set with PostgreSQL DB to the newly developed factory floor management system MC Dynamics was completed. In addition multi-criteria logic of CMI order execution planning algorithm was improved through both load optimization on the most expensive parts of the technological chain, such as load on 3D metal and ceramic printer chambers, and employment of product-specific data for more precise resource planning and dynamic realization of order queue management. And automation of CMI documentation process through integration of report data of separate activities into a single document and implementation of software control of conformity of CMI technical characteristics to requirements of standards and CMI technical specifications was completed.
3. The integration of MC Dynamics with MICE and pilot testing using actual CMI orders data was accomplished. The mass-customization technological platform, consisting of factory floor management solution, supply chain management and cloud-based co-creation and communication solutions, which serve as infrastructure basis for SME oriented mass-customization business model of medical implants were tested and demonstrated in the operating environment to prove CMI value for patients, hospitals and surgeons and to create demand for CMI.
4. International curriculum ""Specificities of the use of patient specific implants in clinical practice"" was developed and pilot academic course was implemented during the project. Academic course has been run in Lithuanian Health Science University June 17-28th, 2019.
5. Project results dissemination and communication activities, including piloting of international curriculum, project-related conferences and trade shows, seminars for surgeons, video footage, press releases, project website development were implemented.
6. Project results commercialization activities, including promotion via ambassadors’ pilot cases, creating demand for CMI and improving surgeons’ skills via CMI trainings, patient engagement in the decision making, government support was implemented."

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Ortho Baltic strongly believes that the potential applications of CMI should include not only oncological cases but also treating clinical cases where the use of CMI leads to better treatment results than standard implants, avoids side effects or minimizes their impact, ensures fuller restoration of patient’s physical performance and quality of life and decreases the total accumulated pathology treatment costs for severe and moderate clinical conditions (one should not forget that the implant price is just one of the components of treatment costs).
By developing technological solutions that ensure effective management of CMI design, manufacture and validation processes such as surgeon – manufacturer communication and co-creation platform MICE and factory floor management system MC Dynamics, the company has ensured high efficiency of activity processes and currently offers CMIs for a price that is lower than those from modular standard implants, which are used to treat rare and severe clinical conditions. Lead time is currently up to 4 weeks, but with the transition to mass CMI manufacturing and at least 3000 patient-specific implants produced annually, their price will be twice as low by 2023 as it is today, and lead time will not exceed two weeks).
Already today Ortho Baltic offers CMIs for a lower price than those from standard modular implants because the price of standard modular implants is artificially inflated. The prime cost of CMI manufacturing by Ortho Baltic reaches up to 43% of the final price. Meanwhile the prime cost of standard implants is 10%, and only in some cases reaches up to 15%. Therefore, we understand that increasing the competitivity of CMIs will result in decreased prices of standard modular implants. The nature of mass manufacturing of standard implants ensures lower prime cost than those from designed, manufactured and validated CMIs. But if the comparative weight of the implant costs in general treatment outlay decreased, then the significant outlay economy from using patient-specific implants should ensure the competitive advantage of the latter in comparison with standard implants in the long-run.

Ortho Baltic boost in Med Tech 2018

MICE

MC Dynamics