Cleanroom injection moulding is used for manufacturing a wide range of medical devices, from implantable components and surgical equipment to drug delivery components and medical packaging.
The process is widely used because it delivers a high level of accuracy and is cost-effective for medium to high-volume product runs. Furthermore, the materials used in the injection moulding process are highly durable, biocompatible and will be designed to be suitable for your intended sterilization method.
Given the important role of cleanroom injection moulding, it is critical that you are aware of what is involved in the process and that your contract medical device manufacturing partner has the capabilities and resources to deliver a consistently high-quality service.
Medical device injection moulding – what you need to consider
Is your medical component mouldable? The vast majority of designs can be 3D printed or prototyped, however, mass production via injection moulding has its limitations. The right outsourcing partner will have the skills and know-how to advise and assist you with any required design for manufacture, such as adding sufficient draft, coring out to remove thick sections that cause sink, or any basic design changes that can reduce tooling cost or improve the reliability of the tooling.
Does your partner offer all the injection moulding services you need? Sometimes your component may have features such as additives added to the raw material, insert or over moulding of another item, or a high degree of optical clarity. Your partner should have a range of machinery with different specializations that can carry out the manufacture of your device or component without deviating from their normal procedures.
Can your outsourcing partner handle complex injection moulding? Some injection moulded parts will require more complex processes, such as high processing temperatures or significant drying requirements, and other designs may be prone to warpage or process stress that cannot be designed out or avoided. Your partner should be aware of these complexities and prepare for them at the beginning of the project by using modeling software or prototype tooling. Processing issues caused by product or manufacturing complexities are best solved at the beginning of the project, not with an impending product launch.
Do your partner’s cleanroom injection moulding services comply with the relevant standards and regulations? It is highly advisable that your contract medical equipment manufacturer meets or exceeds the standards or regulations required to produce your component or device. As the sales of your device mature, you may enter other markets with different regulatory requirements or apply for tenders that request specific regulatory documentation. Having the right certification and approvals from the outset will enable you to be agile with regard to new markets and tenders, with minimal repeated regulatory work. Look for the latest certification to ISO9001 and ISO13485, and FDA registration if you plan to export to US markets.
Are your partner’s injection moulding cleanroom facilities regularly inspected, tested and validated? To meet the required standards, your supplier should be internally auditing their production facility and processes, as well as validating all equipment to prove they meet the design specification and are able to repeatedly produce the components and products time and time again. When your device supplier has a rigorous cleanroom facility inspection, testing and validation system, you can be more confident in your ability to successfully host planned and unannounced audits performed by your notified body.
Why it is key that your partner has advanced injection moulding facilities
The new product development journey of your injection moulded part from initial concept to cleanroom production can be relatively straightforward when using the right contractor. However, it is a complex process that requires expertise at every stage of the development process.
This is why, when choosing a contract medical device manufacturer, it is important to take the time to consider cleanroom injection moulding resources, expertise and experience, as well as any further assembly and packaging requirements.
Meridian Medical is an established and experienced contract medical equipment manufacturer specialising in a wide range of medical device design, development and supply services.
To find out more about how Meridian Medical can help you with your medical product design and manufacture, get in touch today by filling out our online form or contacting us on 01903 732344 or firstname.lastname@example.org.