The process of manufacturing medical components is often complicated and faces some unique challenges. Quality is paramount since a faulty product could even mean the difference between life and death. Given this, compliance with stringent regulatory guidelines is also part of the territory. As the demand for medical components goes up and their complexity increases, traditional manufacturing processes can no longer cater to industry requirements. The adoption of new-age technologies and processes is critical for medical component manufacturers to survive and thrive in this industry.
Addressing increasingly complex machines
Take the case of FMI, a Netherlands-based contract manufacturer for the global medical device industry that specialises in the serial production of orthopaedic implants and instruments. FMI historically programmed parts at the machine control until it realised that it was unable to maximise the potential of the increasingly complex machines it acquired. Also, the company had grown rapidly from just two people to a large operation with three shifts with several employees and machines. It became more important than ever to get jobs right the first time by maximising the technology that drives them.
The company produces medical parts such as spinal hooks, rod and screw systems, bone screws, and hip stems, in addition to surgical instruments such as pliers, grippers, retractors, and spinal-screw insertion devices. These are specialised parts, often with tolerances of ±0.0002. The company needs to work with solid models supplied by customers and modify them. In these circumstances, achieving on-time delivery for each customer and ensuring a superior quality of parts was always challenging. To address these issues, the company purchased computer-aided manufacturing (CAM) software to program its Mazak millturn and Citizen Swiss-turn machines.
Software tools now offer a build preparation workflow within the CAM environment to provide a single, streamlined platform for both the additive build and finishing operations with a part-to-build workflow. In series production, a given part is typically produced hundreds of times with the same build plates, orientation, support structure generation, and exposure strategy assignment. A part-to-build workflow addresses part preparation and job preparation with dedicated functionality within one piece of software, making manufacturing smarter by enabling volume efficiencies and automating repetitive tasks such as slicing.
CAM software provides the digital tools needed to prepare 3D-printed components for manufacturing using powder bed fusion (PBF) technologies. Today, PBF is the most mature Additive Manufacturing technology for industrial production and represents 86% of the worldwide machine install base.
Software can read and manipulate all popular parametric CAD formats and automatically identify those surfaces that require support. The software can also assist with the creation of support structures, generating parametric surfaces with teeth, fragmentation, and perforation. Once a part is sliced, it can be imported into the software’s job preparation environment and reused whenever needed.
Smart manufacturing solution for machining application
Esprit is an example of a high-performance CAM system for CNC programming, optimisation and simulation, supporting any class of CNC machine via a common user interface and workflow. Using a digital twin of the CNC to simplify the programming process, this application Esprit delivers edit-free G-code. Combined with the company’s ability to solve workflow challenges with individually tailored automation solutions. Medical component manufacturers have integrated the company’s CAM software to solve many machining difficulties related to tight tolerance intervals, weak machines, and refractory materials. By default, they choose complex and high-accuracy machines to produce their components. In the real-world, Esprit CAM supports high-end, complex, and multi-tasking machines.
Higher levels of automation
Combining build preparation in the CAM environment is the first step on the journey to true computer-aided manufacturing using additive methods, enabling higher levels of automation and productivity. Such an approach brings several advantages to the manufacturing and machining process for medical components.
Eliminating human error and ensuring consistent quality
Eliminating operations can also help eliminate mistakes from human error. Also, since one can check the entire part for quality in complete dimensions instead of making guesses, the quality improves drastically since it eliminates mistakes made due to back-figuring dimensions that will be machined on a second or third operation. The application software offers post processors, which are built in the machine tool factory to test and eliminate any sort of errors in the post-processor which makes edit-free G-code with a higher confidence level of programming, it also eliminates unwanted dry run in the machine to test the G-code before cutting the component, altogether there is great savings of programming time, testing time using the software.
Efficient machining and improved turnaround time
Knowing that a program is done and correct before it goes to the machine helps ensure faster set-up times. Also, identifying areas that first need to be turned makes the machining much more efficient. At the same time, the elimination of manual calculation reduces the number of programs required to get the job done. The software’s powerful feature recognition tool offers an easy programming method to any user, which saves a lot of programming time.
Digital machine package allows toolpath verification
With software’s digital twin, machinists’ & programmers’ lives become easy with the virtual machine models, controller emulators, machine parameters, and post processors — the system delivers accurate simulation and machine-optimised G-code. Factory-developed post processors that produce edit-free G-code are available for your machine tools, allowing you to take full advantage of your machine tool investment. The company offers accurate cutting tools and machine tool simulation with a dynamic stock-aware toolpath that reduces the unwanted air passes offering the program highly optimised in the first go and keeping the machine concentrated for the product.
Ability to produce more complex parts
The powerful combination of machines and software can enable the machining of increasingly complex parts with tight tolerances. This frees up designers to design more complex parts since the software can accommodate all sorts of complex machines to support any complex design.
Competitive advantage with CAM software
With increasingly complex parts, success hinges on the ability to be versatile and deliver quality products on time. CAM software can help ensure that machines are leveraged to make parts that they are designed to make. This makes the manufacturing process smoother and gives them a competitive advantage.