Blog Items - How is Surgical Precision Additive Manufactured for Serial Production via Inkjet 3D Solutions?

HOW IS SURGICAL PRECISION ADDITIVE MANUFACTURED FOR SERIAL PRODUCTION?

July 11,  2024

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A case study of XJet’s approach to creating new production methods for previously unviable geometries

As the medical device industry continually seeks competitive advantages, additive manufacturing (AM) has begun to make significant inroads. Traditional production methods like injection molding often struggle with the unique geometries and smaller production quantities required in medical device manufacturing. However, many mainstream AM technologies have also fallen short in meeting these needs, raising questions about whether AM is the right path forward and if there might be better alternatives. applications that can then be scaled.

 

Surgical forceps produced pre-assembled, unpolished with XJet metal additive manufacturing solution
Surgical forceps produced pre-assembled, unpolished with XJet metal additive manufacturing solution


A prime example is the surgical forceps medical operations, which have stringent requirements to ensure precision, durability, biocompatibility, and functionality. These forceps must be miniaturized to fit through tiny incisions or ports and feature integrated components such as hinges or articulation points that function smoothly and precisely.

The Last Mile towards Precision Production

Traditional production of surgical forceps via CNC or MIM entails a journey from design to production, often extending over months. While AM solutions could cut the process shorter with faster production for smaller quantities, they still involve laborious post-processing steps like curing, de-powdering, infiltration, debinding, and machining, and some may require a good number of iterations before the system produces quality parts. This has prolonged production times and demanded significant investments in manpower and equipment, while assembly is still needed. The manufacturing lead time is still at about months, at relatively higher cost of ~$10/piece.

Additionally, current AM technologies, typically binder jetting that is gaining in adoption across industries, struggle with achieving the high precision and complex geometries required for innovative medical devices. Limitations in powder size and surface roughness restrict design engineers from fully utilizing AM’s potential. Some other existing AM solutions do offer high-precision AM printing, yet they typically support small-scale production better suited for prototyping rather than mass production runs.

Manufacturers therefore need solutions capable of producing tens of thousands of parts quickly to meet market demands and shorten turnaround times.

Enhanced Precision and Design Freedom – An Alternative Approach via Inkjet 3D Solutions

Over the years of exploring metal and ceramic AM markets, XJet has secured a leading position in mid to high volume production of small and complex parts, particularly benefitting medical device manufacturers by bringing previously unviable designs to reality. The key lies in XJet’s comprehensive end-to-end solution, which includes the AM system, soluble support removal technology, materials, and software, all empowered by its unique NanoParticle Jetting™ (NPJ) technology.

Unlike common AM solutions that use powders or slurries, XJet’s NPJ technology jets build and support materials simultaneously in the form of dispersion ink at the sub-micron level. This ensures unparalleled precision and quality. For example, surgical forceps with dimensions of 25*6.8*6.3mm can feature teeth and holes made with accuracies of less than 50 microns and surface roughness of N6-N8, meeting the high precision and quality demands of medical manufacturers.

Beyond precision, XJet’s proprietary soluble support material can be removed in a fluid environment, enabling the production of complex inner cavities and features that are impossible elsewhere. Geometries that traditionally require assembly, such as forceps, can be made in one piece as pre-assembled, at high resolution and without compromising part quality. It has therefore unleashed endless possibilities for product designs, empowering the industry to reach new levels of innovation and capability.

Illustration: XJet soluble support structure in cross-sectional view

The Last Mile towards Precision Production Story of Over 10,000 Parts – Inkjet AM Adoption for Serial Production

Current mainstream technologies, such as SLM and SLS, produce high-quality, complex parts but are hindered by long production processes, rough surface finishes, and build size limitations. When it comes to small parts, or parts with tiny features for quantity production, AM vendors are again looking away. These drawbacks diminish the advantages of AM for high-complexity medical device production.

XJet’s end-to-end solution, comprising three simple steps—Print, Wash, Sinter—shortens production cycles and speeds time to market for medical device manufacturers.

It all starts from the tray design, where parts layout can be positioned to the optimal space efficiency with intuitive drag-and-drop actions and easy multiplication within clicks. As the shrinkage is isotropic, tray layout can be calculated automatically without additional preparation. Orientations can be adjusted based on desired features and dimensions at minimal limitations, as the build and support materials are jetted simultaneously at high accuracy and thin layer thickness during the printing process.

 

Illustration: Layout of Forceps Tray in XJet's System

Support removal, an integral and crucial stage for the production of complex geometries in XJet’s process, performs better with its soluble support material. Printing trays can then be easily placed in the water-based, non-acid “bathtub” for fast, hand-free support removal that that takes down to only 6 hours. This contrasts with other AM technologies that require labor-intensive manual support removal, risking damage to delicate parts. It brings the overall job cycle down to within 4 days only.

 

Illustration: XJet's Production Process v.s. Powder-Based AM Processes

The high printing quality and soluble support materials eliminate the need for extensive finishing. Unlike common AM processes, which require lengthy handling involving multiple steps such as infiltration, debinding, depowdering, and machining, XJet’s solution requires only debinding and sintering. As a result, preassembled parts, small cavities, and highly complex geometries are produced with shortened lead times, uncompromised end-use quality like in traditional methods, and at a scale unmatched by other technologies – the surgical forceps, for example, can be produced at a quantity of 16,500 per year per system.

Looking at the side of cost, which is tied to material, energy and labor consumption, XJet’s solution is ahead of its time too. Material waste is minimized, as the usage of build and support material is on demand at highest accuracy. The whole process requires minimal labor intervention, and energy consumption is optimized with a lower sintering temperature of less than 1300℃. All these factors are reflected in the production cost of parts, which is less than $3 for a preassembled surgical forceps.. Imagine how much it could elevate your production efficiency when it’s done in mass quantities!

In a world where medical devices, especially surgical devices, are constantly exploring breakthroughs to secure a competitive edge, XJet’s advanced AM solutions have successfully addressed the existing challenges in the emerging AM sector, paving the way for a new era of innovation and efficiency. By shortening time-to-market and enabling production at scale, XJet empowers manufacturers to build their competitive edge in an ever-evolving market. Now’s the right time to adopt!

 

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