3D Printing of Bioresorbable Materials at Point of Care

Bioresorbable polymers have been known for over 50 years. Using such materials, implantable medical structures can be created that can provide a mechanical function within the body for remediation or replacement and ultimately be absorbed into the body tissue or degraded and replaced by natural tissue. This avoids the need to remove the implant at a later date. 

3D printing in healthcare is currently experiencing a period of significant growth (Innovative 3D Printing in Healthcare: From Design to Drug Delivery). These technologies enable the production of patent-specific implants; implants that have been designed specifically to fit a particular patient rather than selected from a limited range of sizes and shapes. 

Recent developments in bioabsorbable or bioresorbable polymers have provided such materials that can be 3D printed, allowing the benefits of both technologies to be combined. 

A recent article discusses combining these technologies at the point of care (Patient-specific implants made of 3D printed bioresorbable polymers at the point-of-care: material, technology, and scope of surgical application) so that the patient can be assessed, and the implant can be designed and manufactured, and implanted, all at the same location. This gives the potential to reduce time between assessment and treatment, with close coordination of surgical, design, and manufacturing considerations. 

Integrated procedures such as these face particular challenges from an IP perspective. While the assessment, design, and manufacture of the implant steer clear of the exclusion of patent protection for surgical, diagnostic, or therapeutic methods (e.g. Art. 53(c) EPC), the need for the coordination of multiple parties (surgeon, designer, manufacturer) and to focus on the optimization of known procedures to create bespoke solutions can make defining the contribution in terms of a patentable invention with useful scope complex. However, obtaining regulatory approval may offset this, making the entry for competitors more challenging even if there are no patents to consider.  

Despite being in its early stages, the integration of biodegradable 3D printing in PSI creation shows strong potential for improving the therapeutic outcome. Further innovation in this field is expected as 3D printing technologies and virtual surgical planning software are being further developed. It is crucial to consider regulatory requirements during the research and development phase to ensure compliance. However, since many hospitals currently lack the regulatory guidance to implement these processes, addressing challenges related to regulatory compliance and standardization becomes imperative.

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