Patient-specific implants (further – PSI) currently fail to achieve large-scale commercial success over much inferior standard orthopaedic, maxillofacial and neurosurgical implants due to high price, long lead times, surgical approach oriented towards standard solutions, as well as existing long-standing relations between surgeons and manufacturers of standard implants. PSI are currently used almost exclusively to treat clinical conditions that cannot be treated with standard implants.

But Prof., Dr Julian Poukens, cranio-maxillofacial surgeon at the Medical Center Sittard / Heerlen in the Netherlands strongly believes that the potential applications of PSI should also include treating clinical cases where the use of patient-specific implants 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).

From the other side, PSI manufacturers are taking great efforts to reduce the cost of their production and shorten the lead terms. Lithuanian company Ortho Baltic has already ensured high efficiency of activity processes by developing technological solutions that ensure effective management of PSI design, manufacture and validation processes such as surgeon-manufacturer communication tool MICE (Medical Implants Customization Engine) and real time factory floor management system MC Dynamics (Mass Customization Dynamics). The last one is specifically adjusted to mass-customization of medical devices and ensure both M2M communication and processes automation, adjusted to the specific of digital in-nature supply chain processes. This allows the company to offer PSI for a price that is lower than those from modular standard implants. Lead time is currently up to 4 weeks, but with the reaching of economy of scale with at least 3000 patient-specific implants produced annually, the company promise the price twice as low as it is today, and lead time will not exceed two weeks.

This competitive advantage is not just due to high efficiency of Ortho Baltic’s supply chain processes. It is no secret to professionals in the field that prices of modular standard implants, which are produced in limited editions, are artificially inflated. When other manufacturers of patient-specific implants will be able to demonstrate the same competitiveness, increase the competitivity of PSI will result in decreased prices of standard modular implants as the nature of mass manufacturing of standard implants ensures lower prime cost. But if the comparative weight of the implant costs in general treatment outlay decreased, then the significant outlay economy from using PSI should ensure the competitive advantage of the latter in comparison with standard implants in the long-run.

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