Medical device manufacturing: Best practices, applications and regulations

Introduction

The term medical device covers an extensive range of applications from tongue depressors and latex gloves to x-ray machines and further to custom hearing aids and biomedical implanted devices such as heart valves. Traditional manufacturing processes including CNC machining and injection molding are typically used for the many existing medical devices such as prosthetics, surgical tools, and general equipment/tools used by medical professionals.

The field of medical device manufacturing is rapidly growing and, given the advantages offered by additive manufacturing – highly customizable geometry, low-cost, and a wide variety of possible materials – these processes are well suited to fill the demand for the emerging needs of medical device manufacturing.

This article covers the processes commonly used to manufacture medical devices, as well as applications, best practices to follow and regulations to pay attention to when designing and manufacturing medical devices, in addition to a quick look forward to what the future of medical device manufacturing could look like in a few years. Feel free to skip through to specific sections using the list below.

Processes used to manufacture medical devices

Whether additive manufacturing or traditional manufacturing processes is the best solution for medical devices depends on a number of factors including overall schedule and application. Critical questions should be considered such as:

• Is this a unique or low volume part?
• Is the part geometry complex or custom for each patient?
• Is this a [prototype](https://www.hubs.com/blog/rapid-prototyping/), proof-of-concept, or final product?
• What is the expected material to be used?


The answers to these critical questions will aid in determining the best choice for your project – [additive manufacturing](https://www.hubs.com/knowledge-base/additive-manufacturing-technologies-overview/), CNC machining, or injection molding.

In general, traditional manufacturing processes such as CNC machining or injection molding are best suited for higher volume parts because of the higher start-up costs and longer lead times for tooling. Additive manufacturing is better suited for unique or low volume parts as well as prototypes or proof-of-concept designs.

The part geometry and required material properties should also be considered. Injection molding and additive manufacturing are typically more advantageous for complex part geometries and the material properties vary between all three categories.

More information on common processes used to manufacture medical devices, covering CNC machining, injection molding, and additive manufacturing, is summarized below.

Best practices for designing and manufacturing medical devices

Following best practices for all types of manufactured products is always an important part of the manufacturing process and even more so for medical devices which are directly related to the health and safety of patients. As such, the regulations for medical devices are typically more stringent than for general manufacturing. In addition, best practices generally improve a company’s performance by increasing quality and decreasing waste, rework, and accidents. The following examples are best practices for manufacturing medical devices.

→ Know and understand the applicable regulatory standards and guidelines

Research the US Food and Drug Administration (FDA) regulations to avoid violating applicable laws and unnecessary redesign or rework. The FDA regulations are detailed in Title 21 US Code of Federal Regulations (CFR) Part 800 and more information is available on the FDA website.If manufacturing outside the US or shipping to another country be aware of the laws in that jurisdiction as well.

→ Consider design controls for product development

Design controls are criteria required to be met before moving to the next design phase and final approval of a design. They’re critical for medical device manufacturing because of the multi-step process required for certification and the ensure that the medical device design is on-track to meet the stringent manufacturing regulations applicable to medical devices. Criteria should be developed – which are typically specific to the product – and may include internal/customer requirements and applicable statutory regulations.

Design reviews can be used to evaluate the design against the design control criteria based on the design maturity – design team members and other stakeholders are typically involved in design reviews and this is a great opportunity to gather feedback from all team members. Design controls are an effective way to track major design milestones and ensure the design meets the applicable requirements throughout the design process.

→ Consider Electronic medical device reporting (eMDR)

The US Food and Drug Administration (FDA) requires incidents involving a medical device including certain malfunctions and incidents that resulted in serious injury or death to be reported.

An eMDR process can be used to automate and streamline the reporting process and allows for efficient and effective tracking to identify trends and implement effective corrective actions. Implementing an eMDR process results in standardized reports and can be used to ensure regulatory compliance for FDA reporting regulations.

→ Follow quality system practices

Consider what processes are necessary for your operation from design to delivery, particularly processes required by applicable medical device regulations such as Quality System guidelines, labeling, and reporting. Make sure the processes are written down for all employees.

Include inspection processes before a product is ready for shipping and the process for correcting any deficiencies (including reporting processes to learn from deficiencies and identify and correct trends). Make sure to include inspecting parts/materials from other suppliers and inspecting final products before shipping.

If a robust Quality System does not exist, the best place to start is to develop checklists and flowcharts that outline your process from design to delivery.

→ Follow rigorous change management procedures

Change management procedures are important during the design phase but also throughout the life of a product to account for changes based on customer demands or corrective actions to the design or manufacturing process.

Consider using a standardized procedure that tracks change requests, stakeholder approval or requests, and implementation of approved change requests. It may also be helpful to include potential impacts to other products or processes as part of your standard change management process to ensure consistency and improve quality across your company.

Regulations for manufacturing medical devices

In the United States, the US Food and Drug Administration (FDA) regulates medical device manufacturing and distribution. The FDA regulates medical devices based on three categories – Class I, Class II, and Class III – with Class I devices considered lower risk and Class III devices considered the highest risk. The FDA regulations are detailed in Title 21 US Code of Federal Regulations (CFR) Part 800.

There are eight main areas covered by the FDA regulations:

• Registration
• Medical Device Listing
• Premarket Notification
• Premarket Approval
• Investigational Device Exemption
• Quality System Regulation
• Labeling
• Medical Device Reporting

Outside of the United States, the European Commission have their regulations for medical devices which can be found here.

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