Speaker
Description
Introduction
This contribution aims to present the design and implementation of an innovative image treatment and 3D printing lab for the production of customized medical devices within a hospital facility.
Methods and Materials
In 2016 a charity from Bank of Italy to Fondazione Santobono Pausilipon (active in assistance, research, training and improvement of the quality of life of pediatric patients) was spent in a project to create in reverse engineering and 3D printing personalised plastic casts to be experimented at Orthopaedics and Traumatology Dep. of the Santobono Pediatric Hospital. To develop this study the know-how and multidisciplinary competences from different CNR Institutes (IC now ICCSB, IBB, IPCB) has been involved to produce the proof of concept and the consequent clinical application. Following the design phase1 in 2017 the Ethics Committee authorized a clinical trial of the developed device on 40 patients2. In the meanwhile the project was awarded by Italian Convention of Public Health (ForimPA Sanità). The success of clinical trial3 brought researcher and hospital management to awareness that the scientific outcomes are ready to be transferred to the real clinical use.
This led to the establishment of an innovative company (Santobono Innovatin srl) operating within the Santobono-Pausilipon Foundation in wich CNR was consultant to optimize manufacturing workflow. The company structured two models of 3D printed devices ad submitted itself to the certification process for the production of medical devices. In June 2019 the ISO 13485 certification and the exposure on market of public companies (MEPA).
Conclusion
The collaboration between researcher from CNR and clinical practitioners inside a health facility produces real innovations and represent a great opportunity to promote new collaborations and research projects among stakeholders. Indeed the introduction of image processing, reverse engineering and 3D printing techniques is rapidly spreading to exploit the advantages given by the design flexibility and low-cost production of prostheses, medical devices and anatomical models.
References
1. Clemente F et al. I Congresso IDBN, Bologna 2017, Biomodello 8001-08
2. Ethics Commetee AA.OO.R.N “A.Cardarelli/Santobono Pausilipon, clinical trial:. FSP1/2016 and Italian Ministry of Health, clinical trial: 0002535-13/01/2017-DGDMF-MDS-P.
3. Guida P et al., Jour Ped Orthop Part B, 28 (3), 2019, pp: 248-255
