Medical device contract manufacturing is the process where an OEM (Original Equipment Manufacturer) of medical devices outsources various aspects of the manufacturing process to a third-party manufacturing company. This can provide a number of benefits to medical device OEMs, including increased production capacity, decreased time to market, improved quality control, and reduced costs.
Additionally, by outsourcing the production of medical devices to third-party manufacturers, medical device OEMs can free up their own internal resources and capacity to focus on other aspects of their business, such as Research and Development (R&D) and commercialization. This can help to improve overall efficiency and productivity within the medical device manufacturer.
Other benefits of medical device outsourcing include:
Design: A medical device contract manufacturer will have a team of experienced engineers who can assist with the design of medical devices. This team is beneficial for medical device companies that can use and value outside input and expertise in developing a new product.
Development: In addition to design assistance, medical device contract manufacturing companies can also provide support during the development process. This creates the opportunity to refine and improve the project as it progresses.
Prototyping: Prototyping is an important step in the medical device development process. Most contract manufacturers treat prototyping as a after thought or a condition of securing production business. Ensure that the contract manufacturer you choose has the capabilities and desire to prototype your device.
Manufacturing Equipment: Medical device contract manufacturers typically have access to state-of-the-art equipment and facilities. This can be beneficial for companies that need additional capacity or would prefer to allocate resources to other areas of the business rather than building out their own manufacturing infrastructure. Reduced lead times: Contract manufacturing services can also help to reduce lead times. This is possible because they often have a team of experienced professionals dedicated to the project and can work quickly and efficiently to get the job done.
Testing and Quality Control: A contract medical device manufacturing company will also have extensive experience in testing and quality control procedures. Contract manufacturers are typically ISO 13485 certified. This means that they have a robust quality management system in place—helping to ensure that medical devices meet all the necessary safety and performance requirements.
Flexibility: A contract medical device manufacturer can provide a high degree of flexibility when it comes to manufacturing medical devices. This means that they can quickly ramp up production to meet spikes in demand or scale back production if necessary.
Cost-Effectiveness: Medical device outsourcing can also be more cost-effective than manufacturing devices in-house. This is because contract manufacturing services often have economies of scale and can pass on these savings directly to the medical device companies.
Contract Manufacturing Specialties
Not all contract medical device manufacturers offer the same services. Some may specialize in certain types of medical devices or manufacturing processes.
For example, when looking for a contract manufacturer, OEMs will want to look for manufacturers that have capabilities such as Turning, Milling, Wire EDM, Grinding, Laser Etching, Support Equipment, Finishing, and Prototyping.
It is important to partner with a medical device contract manufacturer who has the right capabilities for your project. This will ensure that they can meet specific needs and requirements that are important to the project.
Considerations When Choosing a Medical Device Contract Manufacturer
There are a few key factors that you should consider when choosing a medical device contract manufacturer.
Capabilities: As mentioned above, choosing a company with the right manufacturing capabilities is important for your project. Assess their capabilities in design, development, prototyping, manufacturing equipment, testing, and quality control procedures.
Communications: Good communication is essential when it comes to medical device outsourcing. Make sure to choose a company that is responsive and easy to communicate with. This will help to avoid any misunderstandings or delays during the project.
Experience: It is also important to partner with a company who has extensive experience in the medical device industry. This will ensure that they are familiar with the regulatory landscape and can help you navigate the approval process.
Flexibility: As your business grows and changes, you will need a medical device manufacturing company who is able to adapt and change with you. Choose a partner with the appropriate manufacturing facilities that can scale up or down production as needed.
Lead times: Lead times are important to consider when it comes to medical device manufacturing. You will want to choose a company that can complete the project in a timely manner.
Project requirements: Many large contract manufacturing companies have production minimums or large budget requirements that they place on medical device companies. If your project is small or has a limited budget, you will need to find a medical device contract manufacturer who is willing to work with you.
Reputation: It’s always best to partner with a medical device manufacturing company that has a good reputation and is known for providing high-quality products and services. Feel free to ask for references both from the company, and from other people in the medical device industry.
Ensuring Requirements and Expectations Are Met
The medical device industry is highly regulated, and there are a number of requirements that need to be met in order for devices to be approved for use. It is important to partner with a medical device contract manufacturer who is familiar with the regulatory landscape and can help you navigate the approval process. You want to ensure that they are ISO 13485 certified. This certification ensures that the medical device contract manufacturer has a robust quality management system in place. This helps to ensure that medical devices meet all the necessary safety and performance requirements.
If at all possible, it is a good idea to visit the supplier’s manufacturing facilities. This will allow you to see the operations and manufacturing process first-hand and assess whether they have the necessary capabilities and experience to meet your needs. A site visit will also allow you to meet with the team and get a better sense of their culture and values.
What Are the Steps Involved in Outsourcing to a Contract Manufacturing Partner?
There are a few steps involved in outsourcing the production of a medical device to a contract manufacturing partner. Initial consultation: The first step is to schedule an initial consultation with the contract manufacturing company. During this meeting, you will discuss your project requirements and objectives.
Design and development: Experienced contract manufacturers can typically provide a wealth of knowledge in design for manufacturing (to keep costs as low as possible) and mechanical design in general.
Prototyping: Not all contract manufacturers offer prototyping capabilities. Ensure yours does.
Request for Quote (RFQ): The next step is for the contract manufacturing company to provide a quote. This quote will include an estimate of the costs involved and the time required to manufacture your medical devices.
Manufacturing: Once your medical device has been successfully validated it will go into production. The contract manufacturer partner will handle all aspects of the manufacturing process, from sourcing materials to shipping the finished products.
Testing and quality control: The contract manufacturer will also be responsible for testing the medical devices to ensure they meet all quality standards.
Delivery: Once the medical devices have passed all tests, they are shipped back to OEM.
When it comes to medical devices, contract manufacturing is often the best option. It provides a number of benefits, including flexibility, cost-effectiveness, time savings design/development experience.
If you are looking for a reliable medical device contract manufacturing company with a great reputation, we would be delighted to discuss your project with you.
Contact us today to learn more about our services and how we can help you with your next project.
