Challenges of medical device outsourcing
There are several elements to medical device outsourcing, which can be challenging to overcome without previous experience. When working on mass production for medical devices, processes such a medical device design and medical device prototyping are essential for getting set up correctly before volume manufacture takes place.
Using a contract manufacturer with extensive experience in the mass production of medical devices is vital. With over 60 years of experience, we wrote this article to share some of our expert knowledge on how to get medical devices produced at scale and within budget.
Project planning before mass production commences
Any successful production run needs a flexible, easy to follow plan. The plan designates stages to your production phases, giving you a working timeline and manageable goals. It will help ensure that you meet all of your legal and medical requirements, too.
The planning stage includes risk management, beginning at the concept, considering production and distribution, down to patient use. Covering all aspects of mass production will allow a more efficient process, and using our specialist technical knowledge, we can help you mitigate risk as you progress through the production process.
Concept, definition and feasibility
This stage, done professionally and thoroughly, ensures that design, engineering and manufacture are easier processes. We start by defining the product’s function uses and build. This includes materials, manufacturing processes and finishing processes. Clearly defining the product’s application helps define these choices, depending on the characteristics needed for the use.
Europlaz has extensive knowledge and experience in feasibility studies and can help you produce a comprehensive concept definition.
Design and engineering for mass production for medical devices
Europlaz uses the ‘Design for Manufacturing’ approach to this stage, which we believe is beneficial to mass production initiatives. Using DFM could save you a costly redesign at a later, more critical production stage, as you will test viability in this stage. We will support your design team in these stages, including process selection, material identification, component design, mouldflow analysis and medical device assembly design. If you want to find out more about these stages, we outline them step by step here.
Medical Device Prototyping
A crucial part of the medical device manufacturing process is prototyping, which allows you to see how the “Design to Manufacture” stage pays off. Our rapid prototyping procedure ensures that your product is effective, as well as time and cost-saving. Polymer selection makes sure you are using the best possible materials for your product, and mouldflow analysis gives quick and useful suggestions on improving mouldability. Our manufacturing prototypes are fast-acting and accurate or choose our 3D printing for insight into tactility and functionality. As this is in-house and provided for our customers, the same experts working on full-line manufacturing will produce these prototypes.
Pilot production
Much like prototyping, pilot production is a way to test production methods and how the manufacturing process runs. By ironing out any kinks in production, you will save money on a volume-produced manufacturing run. You can also test the packing and inspection stations at this stage.
Streamlining Production for Medical Devices
Volume manufacturing is a central part of the process, where you mass produce your product. Prototyping and pilot production all means this will go as smoothly as possible. Our seven cleanroom facilities, covering 60,000 sq ft, are set up with the latest stringent medical requirements in mind.
With digitally controlled machines providing accurate and rapid results, and Europlaz’s experienced team, we can deliver quality products at volume. We can utilise our 24 medical Injection moulding machines, which can deliver cycle times between eight and 60 seconds, and a variety of moulding techniques, to give you the best properties for your purpose.
Validation
We offer a range of validation services around design, tooling, process, and equipment, meeting your customers’ various needs and requirements. See our page here to read more about the technical aspects of our service.
Logistical Fulfilment Implementation
Delivery of the product includes packaging, labelling and order fulfilment. Our packaging solutions offer safe, reliable and sterile barriers to preserve medical standards. We also offer the creation of labels with custom barcodes or pre-validated pouches to speed up production. We can also source other packaging materials for a new medical device design if your product needs it.
For order fulfilment, we use third-party logistics (3PL) and outsource our storage and shipping, like many organisations, as in-house management can be complicated, costly and time-consuming. Using 3PL can help mitigate this and provide a better service. After we manufacture your product, we provide you with a comprehensive order fulfilment process that includes suitable storage solutions, order fulfilment, transparent inventory control and product traceability. For a breakdown of the process, see our page here.
Contact us to find out more about our mass production of medical devices and how we can help
If you found this guide helpful and want to know more about medical device outsourcing and how our specific working processes can help you produce your product, contact us today. With our seven cleanroom facilities designed and certified to produce class I and II medical devices based on cleanroom classifications, automated production lines, over 60,000 square feet of premises alongside the knowledge and experience of our team, we are in a perfect position to facilitate producing your product to a high standard and at scale.
To learn more about our capabilities directly from our customers, check out this article on why customers choose Europlaz.
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