The process of medical devices manufacturing entails the creation of medical equipment through various methods. Adherence to the standards established by pertinent associations is crucial to ensure proper manufacturing and processing. This article will give a glimpse of the overview of the industry and the processes involved in manufacturing medical devices.
What is a medical device?
Medical devices encompass instruments, equipment, tools, in vitro diagnostic reagents, calibration materials, and other similar or related items, including necessary computer software, used directly or indirectly on the human body. These devices include medical equipment and medical consumables.
Their primary purposes are to diagnose, prevent, monitor, treat, or alleviate diseases; to diagnose, monitor, treat, alleviate, or compensate for injuries; to examine, substitute, regulate, or support physiological structures or processes; to sustain or maintain life; to manage pregnancy; and to provide information for medical or diagnostic purposes by analyzing samples taken from the human body.
In this article, we only discuss medical equipment but not medical consumables.
What is medical device manufacturing?
Medical devices manufacturing involves making medical equipment, instruments, and devices designed for use in healthcare settings. This field covers a broad spectrum of products for treatment, monitoring, and diagnosis, including reconstructive devices like artificial joint replacements and implantable monitors for cardiac and diabetes care.
In this industry, adhering to best practices and meeting strict production standards and regulations is crucial to ensure product quality, safety, and regulatory compliance. Manufacturers are increasingly adopting advanced technologies and processes, such as additive manufacturing and digital transformation initiatives, to improve efficiency, asset utilization, and product integrity.
By leveraging cutting-edge technologies and following industry best practices, medical device manufacturers can deliver high-quality, safe, and compliant products that contribute to improved patient care and outcomes.
What are the processes for manufacturing medical devices?
There is a wide selection of manufacturing methods of medical devices. It depends on the type of device, quantities, materials used, and the desired functionality.
The CNC machining process is a type of computer numerical control machining that is used to manufacture metal and plastic parts. A variety of techniques are used to create the components of the medical device, including milling, turning, grinding, and drilling. It is featured with high tolerance, fast turnaround time, and a wide range of material choices. CNC machining can be utilized in both the prototyping and production stages.
Vacuum casting, sometimes called urethane casting, utilizes soft silicone molds to produce plastic-like and rubber parts. The material proprieties can be similar to ABS, PC, PMMA, PC, PA, soft rubber, etc. As one mold can last 20 to 30 shots, it is the ideal solution for a small series of medical devices manufacturing because of its cost-effectiveness and high efficiency. The over-molding technique of vacuum casting also allows the rubber material to be covered on the plastic material, making it easy to realize the design as rubber handles.
Unlike CNC machining, the substantive manufacturing process, 3D printing is an additive manufacturing process. It involves layer-by-layer material deposition to create complex components and structures that may be difficult to achieve using traditional manufacturing techniques. 3D printing techniques are developing very fast these years. Companies and institutions are also keen on studying new materials. In the case of manufacturing medical devices requiring rare materials, 3D printing is an excellent option.
Sheet metal fabrication
Sheet metal fabrication is a manufacturing process that involves cutting, bending, and assembling metal sheets to create various parts and components with a uniform thin wall thickness of no more than 6mm. It is usually applied in making parts such as enclosures and housings, brackets and supports, instrument trays and carts, ventilation and airflow components, etc. Sheet metal fabrication is an economic production method.
Die casting injects molten metal under high pressure into a mold cavity to produce metal parts. The materials are usually bronze, zinc, aluminum, aluminum alloys, etc. However, as the die-casting equipment and molds are expensive, die-casting is more suitable for the mass production of medical device components.
Reaction injection molding
Reaction injection molding (RIM) mixes two or more reactive components, usually a polyol and an isocyanate, which then react and cure within a mold to form a solid plastic part at room temperature and pressure. RIM is ideal for large-sized lightweight plastic enclosures with uneven wall thicknesses. Therefore, it enjoys a wide application in small-batch manufacturing of medical devices. The part properties can be like injection-molded ABS, PP, structural foam, or rubber.
Injection molding is one of the most traditional manufacturing processes for plastic parts. This method involves injecting molten plastic into a pre-designed mold, which is then cooled and solidified to form the desired product shape. Injection molding allows manufacturers to easily create devices with precise dimensions and complex shapes in large-scale manufacturing. It can utilize various medical-grade plastics, such as PC, PP, PE, and PA. These materials offer properties such as biocompatibility, non-toxicity, and antimicrobial resistance, making them suitable for medical environments. It is applied in the production of various products such as surgical instruments, drug delivery devices, diagnostic equipment, prosthetics, and implants.
In some cases, several processes need to be applied in the manufacturing of one medical device if different materials or special designs are involved.
How to select the right medical device manufacturer?
In the whole stage of developing a new medical device, two stages involve creating physical parts: prototyping and end production. The latter requires the manufacturer to have relevant certifications for end use. The purpose of prototyping is to verify the design or for the demonstration situations. So certifications don't matter.
Experience and expertise
It’s better to look for a manufacturer with a proven track record and expertise in manufacturing of medical devices similar to your product. It will help ensure they have the necessary knowledge and skills to meet your requirements.
Certifications and compliance
If you intend to manufacture your medical device and put it on the market, ensure the manufacturer has the required certifications, such as ISO 13485 (medical device quality management system), and complies with relevant regulations like FDA, CE, or other regional requirements.
Quality management system
The manufacturer should have a robust quality management system to ensure consistent product quality, safety, and regulatory compliance.
Assess the manufacturer's capabilities in terms of production capacity, technology, equipment, and processes to ensure they can meet your production needs and timelines. CNC machining, vacuum casting, and 3D printing are mostly applied in the rapid prototyping of medical devices. For low-volume production, vacuum casting and reaction injection molding are employed. Die casting and injection molding are for mass production. Sheet metal fabrication can be used in different manufacturing stages.
Material sourcing and supply chain management
The manufacturer should have reliable material sourcing and supply chain management processes to ensure the availability of high-quality materials and components.
Design and engineering support
Some manufacturers offer design and engineering support, which can be helpful if you need assistance with product development or design optimization.
Get started today
At X Rapid Technologies, we offer all the above manufacturing methods for the prototyping stage for medical devices to verify new designs and structures. Contact us today to get the ball rolling!