The traditional model of medical device prototyping often involves outsourcing to specialized facilities, leading to lengthy lead times, communication bottlenecks, and limited design iterations. These challenges impede innovation, escalate costs, and hinder the timely delivery of life-enhancing technologies to patients in need. However, the advent of CNC machines has ushered in a new era of medical device prototyping, empowering developers to reclaim control over their innovation process.
CNC machining offers benefits that are tailor-made for the intricate requirements of rapid prototyping medical devices. With unrivaled precision down to micrometer-level accuracy, CNC machines can quickly reproduce complex geometries and intricate details. Whether crafting miniature components for implantable devices or refining the ergonomics of surgical instruments, CNC machining ensures the execution of every design with utmost precision.
With all that being said, it’s time to dive into what rapid prototyping is, the process of rapid prototyping medical devices, and its benefits.
What is Rapid Prototyping?
Rapid prototyping is a process that allows for the quick creation of a physical model or prototype of a device or product using computer-aided design (CAD) software and manufacturing technologies like CNC machining. Unlike traditional manufacturing methods, which often involve lengthy lead times and high costs, rapid prototyping enables engineers and designers to iterate on designs rapidly and produce functional prototypes in a fraction of the time.
Read More: What is Rapid Prototyping?
Rapid Medical Device Prototyping: Process & Benefits with a Milling Machine
Before we explore the benefits of bringing prototyping medical devices in-house, let’s first discuss the process. From the design phase to material selection, programming, and machining process, there are many ways to make rapid prototyping more efficient, saving you time and money.
Design Phase
First up is the design phase, which is arguably one of the most critical phases of this project that you will encounter. This process begins with the conceptualization and design of the medical device. This stage involves collaboration between engineers, designers, and medical professionals to outline specifications and functionalities needed for the product, allowing you to have the necessary information to move forward to the next few steps of the process.
In this phase, Computer-Aided Design (CAD) software is employed to create detailed 3D models of the device where the design is optimized for manufacturability. Being designed for manufacturability means considering factors such as material properties, structural integrity, and ergonomics and applying them to the process.
Material Selection
You must select the materials once you have completed the design phase. CNC machines can work with various materials suitable for medical applications, including metals (e.g., titanium, stainless steel), plastics (e.g., ABS, polycarbonate), and composite materials. The diversity offered by CNC machines is an advantage for rapid prototyping medical devices, as you are not limited in the materials you can use to create the devices.
When selecting a material, considerations include biocompatibility, sterilization compatibility, mechanical properties, dimensional stability, and regulatory requirements. Choosing materials that meet the specific needs and standards of the intended medical application is essential. Additionally, prototype testing and validation should be conducted to ensure the medical device’s functionality, safety, and effectiveness.
Programming
CNC programming for medical devices requires a combination of technical expertise, knowledge of machining processes, and an understanding of the specific requirements of medical device production. Once the design is finalized and the appropriate materials have been selected, the CAD model is translated into machine-readable instructions using Computer-Aided Manufacturing (CAM) software. The programming stage involves specifying toolpaths and tools used, cutting parameters, and machining strategies to achieve the desired geometry and surface finish.
Machining
Next up in the process is machining the part! Machining is where the CNC machine translates the programmed instructions into precise movements of cutting tools to shape the raw material into the desired form. Advanced CNC machines offer multi-axis capabilities that can produce complex geometries with high accuracy, which is crucial for medical device prototyping. During machining, operators monitor the process, making adjustments as necessary to ensure quality and dimensional accuracy.
Finishing and Post-Processing
Finishing and post-processing may be a requirement for any CNC project. Once the initial machining is complete, the prototype may undergo additional finishing processes such as polishing, deburring, and surface treatments to improve aesthetics and functionality.
This step includes essential post-processing like heat treatment or surface coating for improved biocompatibility, matching the application’s needs.
The process for rapid prototyping medical devices may vary depending on the type of device you are trying to make; however, it can become more streamlined and proficient once you have mastered the steps!
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