Medical AMOrthopedic Implants

How medical device companies use AM for production today, part 10: OssDsign

The latest episode of 3dpbm's new AM Focus Medical series

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Welcome to this month’s AM Focus: Medical. For the entire month of February, we’ve been zooming in on the many possibilities that additive manufacturing is offering today to medical companies. In this article, we’re turning our heads toward OssDsign, a Swedish cranioplasty specialist making titanium 3D printed implants. Upcoming articles in the AM Focus will continue to span from innovative startups to giant multinational corporations, all of which are using AM in exciting ways. At the end of the month, all the best content will be featured in 3dpbm’s Medical AM Focus 2020 eBook.

Cranioplasty, the repair of skull defects and deformities, is a notoriously difficult field of medicine, with patients at risk of strokes, seizures, infections and other problems as the surgeon operates within millimeters of the brain. That makes technical innovations in cranioplasty extremely valuable, and Swedish company OssDsign is doing its bit to improve patient outcomes via the development of implants made from 3D printed titanium and a bioceramic calcium phosphate material.

Comprising surgeons, scientists and engineers, Uppsala-headquartered OssDsign uses a tailor-made technology platform to develop and fabricate regenerative products for cranial and facial repair, using additive manufacturing to create patient-specific implants based on radiographic data. Its products include Cranial implants for the repair of cranial defects and CranioPlug “covers,” designed to plug holes drilled into the skull during surgery.

Visualization of an OssDsign Cranial implant

The partially 3D printed structures are designed to integrate with the surrounding bone and feature a mosaic tile design that allows for tissue ingrowth and vascularization. The foundation of the implant is a 3D printed titanium skeleton that is largely covered by “tiles” made from OssDsign’s proprietary calcium phosphate material. The implants can be fixed to the rest of the skull with arms and micro screws.

Kajsa Björklund, PhD, Technical Director at OssDsign, says that additive manufacturing has contributed to the company’s goals by “enabling patient-specific designs” for both implants and surgical guides. To make its implants, the company employs external SLS and DMLS service providers, who print using medical-grade titanium alloys and nylon. OssDsign also has two in-house printers reserved for R&D purposes.

Surgeons fitting an OssDsign implant

Björklund notes that “lead times, cost and availability of suppliers” all represented challenges during the company’s adoption of AM. However, with premises in Sweden, Germany and Maryland (as of February 2020), OssDsign is a company on the rise with a clear roadmap for success. In fact, the successful uptake of its cranial solutions inspired the company to develop implants for facial reconstruction. These implants can be used in the treatment of “post-traumatic skeletal deformities and congenital skeletal defects.”

Sales of OssDsign’s US products almost doubled between 2018 and 2019, and the FDA recently granted clearance for OssDsign Cranial PSI Accessories, allowing the company to expand further.

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