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SYMBIONICA - Reconfigurable Machine for the new Additive and Subtractive Manufacturing of next generation fully personalized bionics and smart prosthetics

Periodic Reporting for period 2 - Symbionica (SYMBIONICA - Reconfigurable Machine for the new Additive and Subtractive Manufacturing of next generation fully personalized bionics and smart prosthetics)

Reporting period: 2017-04-01 to 2018-09-30

Symbionica objective is to make technically feasible and economically sustainable the production of orthopaedic smart implants/prosthesis with a level of customization never seen before: geometrical and morphological customization to tailor the implant to patient interfaces for endo-, exo- and hybrid implants made in multiple materials; functional customization to adapt prosthesis dynamic and static behaviour to patient needs (responsiveness to loads, condition based drug delivery, etc.) across the patient life.

Symbionica main objectives:
- A novel certified machine for Multi Material Additive Manufacturing specifically adapted to the need of medtech devices able to produce complex (in geometry, functionality, composition) customised, multi material prosthesis, at minimum 150 cm3/h, in true net shape (no final machining needed), with closed loop controlled and certified quality (zero faulty parts delivered).

- A novel Cooperative design platform including the hereinabove CAD templates and interfaces with medical diagnostics (CT), with CAD/CAM and CAPP system of suppliers involved. This will allow involving all relevant stakeholders: doctors, patients prosthesis (sub)suppliers in the development of a bionic prosthetic solution fully tailored on the patient expectations and physical characteristics.

- Fully personalized prosthesis: an accurate patient-specific implants produced using the 3D scan data can reduce the removal of healthy bone, eliminate the need for bone grafting, promote effective planning of implantation/surgery, shorten the time of anaesthesia, reduce criticalities of post-surgery phase, reduce patient learning phase, etc.

- Symbionica implements an advanced hybrid 3D laser scanner that, combined with a novel laser source system, will support different laser based additive and subtractive technologies. For the first time ablation technology will complement the AM fabrication process for metal and composite manufacturing to allow surface finishing, micro texturing and micro holes that would be otherwise unfeasible in one processing step
• Collection, analysis and summary of the project work data. The use of resources has been continuously monitored and the consortium circulated the information among the partners (WP1).
• Development of the product design on the basis of pre-implantation data and definition of a design approach that include some nested sensors (WP2)
• Definition of the Round Robin Parts (RRPs). They are test features that can be used to further develop equipment and process. The RRPs were designed in three phases which allowed the their complexity increase gradually (WP2).

• Definition of the Symbionica manufacturing process on the basis of geometric features, material requirements and functional properties summarized as Round Robin Parts (WP3).

• Development of the laser source for the Symbionica machine. It results from the combination of a continuous wave emission (for sintering) and a pulsed laser source (for ablation) (WP4).

• Definition of the Symbionica machine design to produce the medtech components. Based on the RRPs, the minimum machine working cube and DoF was calculated and then the whole structure was selected (WP5).
• Mechatronic machine integration (WP5). The following elements were integrated: gantry, PKM head, laser head, primary and secondary material in-feeding and auxiliary systems. Commissioning tests that include the verification of mobility and capability to cover reachability space followed.

• Integration of product, process and machine (WP7). The product and process information developed in WP2 and WP3 have been integrated in a software infrastructure to make sure that the machine be always able to reach the quality targets in terms of product and process.

• CNC architecture designed (WP8). CNC architecture determines with the CAx chain, the capability of the machine for the assigned operations given a desired accuracy, productivity and responsiveness.

• Symbionica machine integrated (WP9). The mechatronic solution comprising the laser head, PKM, gantry and auxiliaries) has been integrated with the CNC, automation and middleware systems and the sensing system

• Full scale industrial pilot finalized (WP10). It is the full size machine that is capable of processing the whole set of products and requiring the entire set of technologies and metal powders

• Standardization and best practice procedures defined (WP11). It is a standardization strategy based on the procedure addressing strict medtech requirements to ensure the Symbionica machine produce medtech labelled products.
• Exploitation program defined (WP11). This plan targets several categories of equipment, services and areas of business, and explored new industrial usage scenarios to maximize the benefit from the adoption of this new technology
Symbionica developed a “through life” Sensing System SW, i.e. an optional service of customer care to follow the patient after implantation or sale of the prosthesis. This will be possible thanks to fact that the bio, endo and exo-prostheses will have “smart”features, i.e. sensors able to transmit useful information on performance and status. This will enable both the patient and the specialists to check and control remotely the prosthesis through e.g. applications on smart devices or web-based systems.

Symbionica developed a laser sources and other components of the optical chain in accordance with the requirements identified in WP3. The laser source results from the combination of two sources, one with 1kW high brightness Continuous Wave (CW) emission and one with Pulsed Wave (PW) emission in the few nanosecond / hundreds of picosecond range.

Fast production and delivery of patient specific prosthesis to rapidly follow the market dynamics
A very important step toward this objective is the development of the Co-Engineering platform which is software through which the users of the Symbionica tools can exchange the data required to drive the tools and, ultimately, create the machine control files required to manufacture products.

Scientific Impact
- Symbionica enabled new product generation. The development of the Symbionica manufacturing solution opens new opportunities for prosthetics design whose realization had not been possible up to now as a result of technological and economic bottlenecks
- Small defects may be detected during material deposition. To eliminate them, a combination of additive and subtractive techniques have to be used. Computer vision assisted monitoring of the manufacturing operation, allows to identify/correct any errors. A closed loop CAx process requires a connection between vision systems, CAD geometry, and tool path planning package.

Following are the most important steps toward this objective
- Identification and categorisation of defects that can appear during manufacturing. This requires a description what a particular defect may look like and how it can be distinguished from other defects (and non-defects); additionally, we must have a strategy for removing each class of defect.
- Developing the software required to: identify defects based on their established descriptions;
- Generate machine control files to drive the corrective process
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