Guide to Medical Device Manufacturing Services

 

Medical devices have a vast range of applications. A simple device such as a tongue depressor to a complex x-ray machine is machinable. At Creatingway, we use the traditional manufacturing processes including injection molding and CNC machining. Another option is the additive manufacturing processes. The methods allow us to make many medical devices that already exist. For example, prosthetics, hearing aids, and surgical tools. The medical device manufacturing industry is rapidly growing and demand has to be met. Additive manufacturing methods offer significant benefits based on their low cost, customization, and wide compatibility with materials. Thus, the employed methods must be able to meet increased demand due to emergent needs for medical devices. The article will cover the common manufacturing methods used, their applications, and regulations to follow.

Medical Devises Manufacturing Processes

The ideal process is dependent on several factors. At Creatingway, question four critical questions in every medical device manufacturing quote. Such as:

• Is the part geometry customized to every patient?
• Is the device proof of concept, prototype, or the final product?
• It is a low volume or high volume part?
• What material will be used?

Answering these key questions provides an important insight in finding out the best method for your project. Generally, the traditional manufacturing processes are best for making higher volume parts. This is because it cost more to start-up and longer lead time in tooling setup. In contrast, additive manufacturing is best for low-volume or unique medical parts. this is due to the low cost of setting up. Remember making prototypes or proof of concept designs should not be a large part of your budget. In achieving complex geometries, injection molding and additive processes are ideal.

Here Is A Summary of The Processes Used For Your Projects

• CNC Machining

CNC machining uses a wide range of cutting tools and machining processes to make parts. Factors impacting its application include part material and part geometry. It is a very flexible method that can suit most complex part geometries quoted. In terms of material, hard metals do not stand a chance against this method. It is also highly dimensionally accurate.  It also offers continuous operations capabilities reducing hands-on involvement. However, it not good for making low-volume parts. Also, it has a long lead time due to the CNC programming needed.

• Injection Molding

Injection molding is ideal for achieving high-volume part production. Parts made include plastic surgical parts, containers, syringes, lab equipment housings, beakers, and test tubes. Its wide range of handling materials makes it versatile. They range from high-strength durable plastics to flexible ones. This ensures the parts made have no limits in use. Sterilization practices help the parts achieve biomedical implantable levels. The process also has high dimension accuracy levels making it good from complex geometries. Additionally, it is repeatable while achieving consistency in finish and part geometry of parts. Its short production time makes it a good choice for urgently needed parts. However, the method has a limited range of compatible materials. Thermoplastic materials such as silicone work best with this method. Also, the high cost to set up makes it no good for low volume or custom parts.

• Metal Printing

Metal printing is ideal for medical parts that need high strength and complexity in design. It is an additive manufacturing method that prints biomedical compatible implants. The method can make custom parts while still maintaining a lower number of components needed in assembly. However, it is a quite costly option. Thus, should not make parts that be easily made using traditional processes.

Application for Medical Device Manufacturing

• Complex Geometries or Custom Devices

Additive manufacturing allows this application to be possible. Notable, the human body variates from person to person thus inducing customization. This option is low in cost making it more ideal. It also makes use of CAD design files and 3D scanning technology resulting in more accurate parts. Examples of medical devices made include custom prosthetics, innovative surgical instruments, and biomedical implants.

• Prototyping of Devices for Modeling and Validation

New or unproven medical devices need approval by regulation bodies. Especially, devices with a high risk of causing health-related injuries during the trial. Additive manufacturing is a quick way of developing 3D parts and models to test out for safety. This allows the R and D department to have enough trial data for approval.

• Making Personal Protective Equipment

The demand for PPE has been on the rise ever since the COVID-19 pandemic occurred. This has resulted in the creation of innovative ways of making face shields and face masks. The methods have to be fast enough and cost-effective to meet increased demand. Injection molding has become helpful in upscaling the production of this vital equipment.

Regulation for Manufacturing Medical Devices

It is important to regulate medical device manufacturing due to its relation with patient health and safety. Good practices also improve the company’s performance. This we see in improved quality, decreased waste, accidents, and reworking of already made devices. The best practices to follow include:

• Knowing and understanding the regulatory standards and guidelines.
• Following quality system practices.
• Following stringent management procedural changes.

Contact Creatingway now for your medical device manufacturing needs.

Creatingway is concentrated on CNC machining manufacturing, prototype machining, low-volume manufacturing, metal fabrication, and parts finishing services, provide you the best support and services. ask us one inquire now.

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