With the continuous development of the medical industry and the increasing demand, the design and manufacturing of medical devices is a complex and multi-step process, involving multiple aspects such as technological innovation, clinical needs, regulatory compliance, production processes, and market considerations. The following is a comprehensive guide aimed at providing you with the key information you need to know during the design and manufacturing process of medical devices.
Design and manufacturing of medical devices
The design and manufacturing of medical devices is a professional field that involves interdisciplinary integration and high technological intensity. The design and manufacturing process involves the intersection and integration of multiple disciplines, requiring comprehensive consideration of multiple factors such as medicine, engineering, and materials science.
1.Design philosophy and objectives
The design of medical devices should always adhere to the patient-centered concept, aiming to meet clinical needs, improve treatment effectiveness, and reduce medical risks. At this stage, manufacturers need to fully understand market and patient needs, while combining medical knowledge and technology to propose innovative medical concepts and product designs. Ensure that the designed product complies with medical principles and is easy to operate and maintain.
2.Human computer interaction and user experience
On the basis of understanding medical needs, designers need to pay attention to the latest technological trends, conduct in-depth research on the feasibility of products, and improve the performance, safety, and reliability of medical devices by introducing new materials, processes, technologies, etc., to bring better treatment effects to patients.
3.Fine tuned design and simulation verification
Fine tuned design is a crucial aspect of medical device design. Designers need to comprehensively consider multiple aspects of the product, such as structure, function, and appearance, in order to carry out refined design. Then, on the basis of refined design, simulation verification and optimization are also needed. By establishing a virtual model to simulate the actual usage scenarios and performance of the product, potential problems are identified and optimized. This helps to reduce trial production costs, shorten development cycles, improve product success rates and market acceptance.
4.Manufacturing process and equipment selection
The manufacturing of medical devices requires the selection of suitable manufacturing processes and equipment. Based on the characteristics and requirements of the product, choose appropriate processing methods, forming processes, and testing equipment to ensure the accuracy and consistency of the product.
Manufacturers also need to establish a comprehensive quality control system and conduct strict quality inspections on raw materials, semi-finished products, and finished products. By adopting advanced testing methods and techniques, we ensure that the product meets relevant standards and requirements, ensuring the safety and interests of patients.
5.Regulatory compliance and registration certification
The design and manufacturing of medical devices must strictly comply with relevant national and international regulations and standards. Manufacturers need to understand and follow the process of medical device registration, licensing, certification, etc. to ensure that their products are legally marketed and comply with regulatory requirements. At the same time, it is also necessary to pay attention to the dynamic changes in regulations and adjust product strategies in a timely manner to cope with market changes.
Manufacturing processes for medical device production
The complex process of medical device manufacturing typically involves multiple manufacturing processes to produce various parts. Then, these parts are assembled under strict supervision and meet the high standards required for medical device production. Among them, CNC machining, sheet metal fabrication, injection molding, and 3D printing are four common manufacturing processes.
1.CNC machining
CNC machining technology is based on computer numerical control systems to carry out machining operations. By converting machining processes into digital instructions and inputting them into the numerical control system, computers automatically control the movement, cutting, and processing operations of machine tools. This technology provides high-precision, high-efficiency, flexibility, and reliability solutions for medical device manufacturing.
In medical device manufacturing, CNC machining technology can achieve precise machining of complex geometric shapes. Whether it’s ultrasound systems, cardiac monitors, or surgical instruments, CNC machining ensures the precise manufacture of components, enhancing equipment performance and reliability. CNC machining is compatible with biocompatible materials, meeting the requirements of medical devices for biological safety and ease of disinfection.
Furthermore, before mass production, CNC machining can be used to manufacture prototype devices, helping manufacturers eliminate any design flaws before large-scale production. This prototyping approach not only helps shorten the product development cycle but also reduces waste, efficiently utilizes materials, thereby saving costs and bringing environmental benefits.
2.Sheet metal fabrication
Sheet metal processing involves cutting, bending, forming, welding and other operations on metal sheets to manufacture various sheet metal parts required for medical devices. Due to the involvement of multiple processes in sheet metal processing, the technical requirements for operators are extremely high. Improper operation can affect the quality of medical devices, for example, the outer shell, bracket, and internal structure of surgical instruments need to be welded to achieve the connection between components. If operated improperly during welding, a common defect can occur – welding undercut, which can reduce the structural strength and sealing of medical devices.
In the manufacturing of medical devices, sheet metal processing has a wide range of applications. For example, medical equipment such as operating tables, surgical lamps, and surgical instrument racks can be manufactured into various shapes and sizes of medical instrument components through sheet metal processing to meet the needs of different products. Meanwhile, sheet metal processing can achieve automation and mass production, improve production efficiency, and reduce production costs.
3.Injection molding
Injection molding in medical device manufacturing involves heating and melting plastic materials, injecting them into the mold, filling them into the mold cavity under high pressure, and cooling them to form the required medical device or component.
Through automated production lines and mass production methods, injection molding can quickly produce a large number of medical device components, improving production efficiency. Meanwhile, due to the high utilization rate of materials in the injection molding process, it can reduce the waste of raw materials and lower production costs.
4.3D printing
3D printing technology in medical device manufacturing is an innovative and efficient manufacturing method. Besides the aforementioned CNC machining, 3D printing is the most popular manufacturing technology for medical device parts production. Also known as additive manufacturing, this technology is a rapid prototyping technique. It constructs objects by layering powdered metal or plastic and other bindable materials based on digital model files. This technology requires a digital model, which can be created using computer-aided design (CAD) software or obtained by scanning existing objects with a 3D scanner. Once a digital model is available, printing can commence.
Traditional manufacturing methods struggle to achieve the fabrication of complex structures, whereas 3D printing technology can easily accomplish this task. For instance, 3D printing technology can manufacture orthopedic implants with specific porosity and surface structures using materials compatible with human tissues, facilitating better integration with the body’s tissues. 3D printing technology enables the customization of medical devices such as surgical aids, orthopedic implants, dentures, etc., based on the specific needs of patients, such as body data, medical conditions, etc.
Summary
Medical device manufacturing is a field that demands utmost precision and attention to detail, requiring manufacturing processes to be flawlessly accurate, and product consistency to be strictly ensured. In such a context, choosing Boyi as a partner for medical device manufacturing is a wise decision. From CNC machining to sheet metal fabrication, injection molding to 3D printing, all processes can be completed with the highest precision and accuracy. This means that no matter how complex your medical device design is, Boyi can swiftly, efficiently, and accurately translate it into reality with its professional team and advanced technology.
