Medical device contract assembly manufacturing refers to the bulk production of medical devices, such as digital thermometers, ultrasound imaging, glucometers, and heart rate monitors.
The medical device contract manufacturer uses a wide range of processes to make these devices. Some of the processes include injection molding, ultrasonic welding, CNC machining and laser marking.
In this article, you will find out some of the important pieces of information about medical device contract assembly.
What is Medical Device Contract Assembly?
It refers to the series of production processes that an electronic manufacturing company uses to manufacture devices for the medical industry. However, it is not a straightforward process, because two different parties are required for the assembly to happen.
The Medical Device Company
The medical device company needs to contract a contract manufacturer for the job. This is done to help the company transform its medical device ideas to the manufacturer to produce, according to the specifications.
The Contract Manufacturing Company
The work of the Contract Manufacturer (CM) is to take the medical company’s orders and make sure that the specifications are met.
Ideally, the Contract Manufacturing (CM) process allows for the manufacturing company to make or produce either the medical device components or the medical device itself. Either way, the job of the CM is to manufacture these items and have them shipped to the medical company for usage or resell.
Why Do Medical Device Companies Reach out to Contract Manufacturers?
The contract manufacturing companies are called upon to produce these outsourced medical devices and related components for some reasons.
First, it is because the medical device companies either have limited facilities, equipment or the technical know-how to produce these devices and the components.
Second, the Contract Manufacturer (CM) is hired because of the experience, streamlined process and improved design it offers.
Generally, the medical device companies want to work with the CM for the following reasons:
- Convenience
- Maintenance of quality control
- Flexible medical device production and;
- Flexible payments for the manufactured devices.
- Medical device Contract Manufacturers (CMs) are also contracted because of the excellent management of the devices’ upgrades.
- The need to stick to the industry standards and regulatory guidance is also another reason.
What Does the Medical Device Contract Manufacturer Do?
The manufacturer handles anything from designing, developing, testing and shipping the medical devices.
Here is a breakdown of the medical device CM’s job description:
1. Supply Chain Management
On getting the orders from the Original Equipment Manufacturer (OEM), the contract manufacturer proceeds to procure the components for the job.
Often times, the CM has access to an extensive network of component suppliers. This gives the medical device company (the OEM), better deals, in terms of affordable components and quality standards.
In addition to negotiating for better rates and sourcing the best components, the CM also handles the real-time shipping of the completed devices.
Other aspects of the supply chain that the medical device Contract Manufacturer (CM) handles are:
- Production schedule management
- Hiring and contracting of talents, such as engineers, assembly workers and technicians.
- Managing the lead time or delivery timeframe.
- The provision of warehousing facilities for the devices.
2. Design and Development
Once the components or parts are sourced, the CM starts working on the initial designs or prototypes. The company, on the completion of the designs, starts developing the “working version” of the medical devices.
The following are some of the scopes of the design and development:
- Sterilization
- Small-scale or prototype productions
- Welding
- Packaging
3. Regulatory and Compliance Assistance
The medical device CM also helps the OEM with meeting the requirements for the medical devices. These include meeting the minimum industry standards and guidelines set by the Food and Drug Administration (FDA).
The following are some of the standards and guidelines:
- ISO:13485: This spells out the quality certification of the medical devices. In addition, this standard also specifies how the structure of the devices’ quality management should be. The ISO:13485 standard also specifies different provisions, such as monitoring, product realization planning, measurement, production, design, component sourcing and medical device development.
- ISO:14971: This standard has to do with the medical devices’ risk generation and execution plans.
- FDA 21 CFR Part 807: This spells out the registration of all the parties involved in the production and distribution of the medical devices.
- IEC 60601: This spells out the safety requirements for the electrical medical devices.
Based on the FDA guidelines for medical device production, all Contract Manufacturers (CMs) are required to:
- Meet up with the changing requirements for the production of medical devices.
- The CMs are also required to have standardized equipment and procedures for the production of medical devices.
4. Class-Centric Compliances
Medical devices are categorized into classes, based on the usage, with Class III devices being the most-regulated.
The medical device contract manufacturing assembly is required to meet the minimum requirements of these classes, as well as having the capabilities to meet the increased constraints.
5. Quality Compliance
This is where the Contract Manufacturer (CM) is expected to meet the medical devices’ quality standards. Quality-related issues can be addressed via the following measures:
- Sticking to meeting the minimum quality requirements for the medical devices.
- Testing and validating the devices’ performance.
- In addition to inspecting the medical devices, it is also imperative for the CM to identify areas that need improvements during the production phase.
- The ISO:13485 guidelines are required here for the following purposes: process validation using protocols like PQs, IQ and OQ; and ensuring the medical device components’ quality.
6. Design Upgrade
The Original Equipment Manufacturer can also hire the Contract Manufacturer to upgrade the existing designs. This becomes imperative when there is a new competing variant of such devices, and when there is a need to refine the design and manufacturing process of the device.
7. Setting-Up On-Site Medical Labs
The medical device Contract Manufacturer (CM) needs to have a combination of on-site labs and on-site engineers. Having this two helps the manufacturer to achieve the following:
- Validation and verification of new medical devices.
- Real-time facilitation and implementation of necessary design changes.
- Establishment and usage of cleanrooms. These rooms serve a variety of purposes, such as utilizing hermetical sealing, and specialized clothing for keeping the medical devices free of contaminants.
The Medical Device Contract Manufacturing Process
For the Contract Manufacturer (CM) needs to discuss with the OEM before any further step is taken. Here is a breakdown of the steps involved in the contracted or outsourced process of manufacturing medical devices:
Device Prototyping
Depending on the specifications the OEM provides, the CM will start working on the early-stage designs (prototypes). This is done to get a “blueprint” that serves as a basis for building the rest of the device, as well as saving costs.
The prototype has to be realistic, comply with the existing standards and be scalable.
Prototype Expansion
Expanding the prototype means building it based on the changes made. It also involves the development of the medical devices’ components, using any of the following processes/techniques:
- Electrical Discharge Machining (EDM)
- Injection molding and;
- CNC machining/milling
Medical Device Production
The production goes both ways: manufacturing and assembly. The former is done first before the latter, where the components are assembled or placed on the device.
Other processes that go into medical device production are:
- Pad Printing: this is the process of giving unique identifiers and markings for the devices. Examples are engraving serial numbers, barcodes and logos.
- Soldering: it entails the joining of multiple metals via the melting of one of the metals into the other metal’s joints.
- Ultrasonic Welding: this is a systematic process of joining several plastic medical device parts, without having to use either adhesives or solvents.
Medical Device Packaging
The medical devices must be packaged or packed in accordance with the FDA’s guidelines. The goal is to validate the compatibility of the package with the medical device.
Medical device packaging options cut across pouches, childproof usage, blister packaging, header bags and smart packaging.
Supply Chain Management
Covered here are the shipping and Product Lifestyle Management (PLM). The PLM has to do with the medical device contract assembly company’s capabilities to manage the supply chain (components sourcing and device shipping), upgrades to the existing designs and coming up with commercialization strategies.
How OEMs Benefit from Medical Device Contract Assembly
Medical device companies tend to benefit a lot from hiring a Contract Manufacturer (CM) to handle their products designs.
Here are the different advantages to this arrangement:
Expansion Capabilities
The CM can help you expand the line of medical devices, especially if you intend on creating competitive devices.
Depending on the manufacturer’s scope, your medical device company could benefit from expanding the distribution to newer territories.
Savings All the Way
From buying and maintaining specialized equipment; the cost of producing medical devices is higher.
By using the services of a professional Contract Manufacturer (CM), your company tends to save costs.
The cost-saving mechanisms include:
- Cleanroom Requirements: building and maintaining cleanrooms come at some additional expenses. Your medical device company is better off hiring a Contract Manufacturer (CM) to help save costs on building and maintaining a cleanroom.
- Reduced Production Costs: the costs of producing the medical devices are considerably lower if you are using a CM. You get to optimize the costs across the following facets: costs of acquiring relevant machinery, resource costs and costs of procuring the device components.
- Regulatory Assistance: your medical device Contract Manufacturer (CM) also helps to certify the devices as per the several regulatory policies. Besides, satisfying these policies can also aid the expansion of your company’s medical devices to newer markets.
Experience to Upscale
Your medical devices will benefit from the Contract Manufacturer (CM)’s years of experience. This is a major boost towards the upscaling and upgrading of the devices across different segments.
Quality Compliance
Since most medical devices are directly used for different life-related activities; they need to be safe. Thus, the ability to meet the different quality compliance is a major benefit of working with a Contract Manufacturer (CM).
In addition to modifying the devices according to the industry standards and FPA guidelines, we also make an individual testing of the devices. In the event that design-related and quality issues are noticed, we would fix those before finalizing the devices’ final design.
Medical Device Contract Manufacturer Selection Guide
Choosing the best company for designing and assembling the devices come with a lot of brainstorming sessions. How about we take away the guesswork and intimate you with the factors to look out for?
1. Manufacturing and Assembly Process
The Contract Manufacturer (CM) should have an agile manufacturing and assembling process for the medical devices.
This provides for faster production, transparency, reduced risks of board quality issues and development of quality medical devices.
2. Production Capabilities
The CM’s production capabilities range from the type of equipment used, the production capabilities, such as low, medium and high-volume orders.
3. Excellent Supply Chain Management
The CM is there to make the job easier for your medical device company. The efforts made in this regard include sourcing for the components, reducing the lead time and overseeing the devices’ shipping.
4. Consider the Medical Device Assembly Capabilities
The Contract Manufacturer (CM) should also exhibit the capabilities to enable functional assembly of the medical devices.
Here are some of the efforts to expect in this regard:
- Automated equipment can be used to make the process seamless and drive down costs of manual labor.
- The Contract Manufacturer (CM) may also want to migrate some existing product lines to design yours. This works best if the previous product lines have been proven efficient.
5. Transparency
Your Contract Manufacturer (CM) should be able to keep you in the know of the latest details of your medical device.
From having an open communication channel to being clear about the processes used; the manufacturer should be able to carry you along.
Final Words
The medical device contract market continually expands due to the advanced technologies that improve the way medical devices are produced. To produce the best of these devices and to have the target audience get value from it, do not hesitate to work with a professional Contract Manufacturer (CM).
