Surgeon-Led Surgical Device Development Using Computer-Aided 3D Modeling

Abstract

Objective

To describe a surgeon-led workflow for developing customized surgical instruments using computer-aided design (CAD) software and to evaluate the clinical utility of the resulting devices.

Methods

Unmet clinical needs in spine surgery were identified by the operating surgeon, who then created three-dimensional (3D) models of five surgical instruments (windowed reamer, retractor blade for retroperitoneal or extrapleural approach, protect-guider, disposable sharp hook and holder, and flexible-tip retractor) using Autodesk Fusion 360®. Patient CT or MRI data were imported to determine key dimensions. Draft 3D models were provided to sales representatives, who relayed them to manufacturers’ engineers for assessment of manufacturability and refinement into production drawings. The finished instruments were used in clinical practice for at least 6 months. Three board-certified neurospine surgeons completed a structured usability survey (six Likert-scale items) and reported the frequency of use of each device in eligible cases.

Results

The windowed reamer and flexible-tip retractor achieved the highest mean satisfaction scores (27.7 ± 1.5 and 27.6 ± 1.5), followed by the retroperitoneal/extrapleural retractor (26.7 ± 1.5). These three devices are now used in almost all relevant procedures, effectively replacing their conventional counterparts at our institution. In contrast, the protect-guider and the disposable sharp hook and holder showed lower satisfaction and remain in mixed use with existing instruments.

Conclusion

Surgeon-generated 3D CAD models can substantially improve communication with manufacturers, enabling rapid development of customized surgical instruments that address specific intraoperative needs and, in some cases, replace standard tools in routine practice. This approach offers a practical pathway for surgeons to translate unmet clinical needs into manufacturable designs that can be integrated into conventional approval processes.