How to choose medical device injection moulding companies?
Selecting a medical injection moulding manufacturer is undeniably a key element of the manufacturing plan for any medical equipment, as it involves the stricter rules and regulations related to the healthcare industry. Ensuring that the chosen manufacturer meets all the desired expectations and requirements is crucial in guaranteeing the success of the project.
(Photo: Micro Systems)
Does the medical device injection moulding company have the required certifications and cleanroom facilities?
For OEMs, having a high-quality system and the necessary certifications, such ISO 13485 and ISO 9001, as well as a risk mitigation strategy in place, is vital. These essential certifications ensure that medical device contract manufacturers adhere to specific standards, enabling them to consistently meet regulatory requirements and fulfil client expectations, particularly when the finished devices are distributed globally. Furthermore, holding these qualifications demonstrates that manufacturers have invested significant time, resources, and effort to uphold their commitment to the quality and safety of all products they produce.
In addition, most medical devices require clean rooms for their manufacturing process, to reduce product contamination from airborne particles, contaminants, and pollutants. For instance, in an ISO 7 cleanroom, the particle density of particles smaller than 5 microns must not exceed 2,930 particles per cubic metre. To put this into perspective, a micron is approximately one-hundredth of the width of a human hair, which has a diameter of around 100 microns. The human eye can typically only detect particles that are at least 50 microns in size. Devices manufactured in cleanroom environments often exhibit superior quality, as manufacturers operating in such controlled settings typically possess extensive expertise and are committed to maintaining high standards throughout the production process.
Selecting a medical device injection moulding company that holds the required accreditations, complies with FDA regulations, maintains an appropriate manufacturing environment, and prioritises quality can ultimately save both time and money. This is because quality is often one of the most critical factors when making decisions regarding medical devices.
Does the medical device injection moulding company have the right technology and services?
It is crucial to take into account the expanded service choices and the unique technical needs of the production process when looking for a medical plastic injection moulder. Choosing a medical device injection moulding company that provides a wide range of services in addition to the typical ones, such as prototype, plastic component design, mould design, mould manufacture, mould flow analysis, mould testing, metrology and much more, is highly beneficial.
The selected medical device injection moulding company must also be capable of meeting your specific moulding process requirements, including over-moulding, insert moulding, two-shot moulding, and micro moulding. The manufacturer should possess not only the necessary machinery and optimal manufacturing conditions to perform these processes but also the relevant expertise and experience. Access to cutting-edge technology, including advanced machinery, design software, and metrology equipment, enables the injection moulding company to deliver projects with superior quality, reduced lead times, and greater cost-effectiveness.
Having the latest technology allows injection moulding manufacturers to stay ahead of the competition (Photo: Micro Injection Moulding machines at Micro Systems)
Does the medical device injection moulding company meet my production volume and timeline?
A more targeted selection of plastic injection moulding companies necessitates careful consideration of the scope and volume of your manufacturing needs. The required order volume—whether it be prototyping of fewer than 1,000 parts or mass production exceeding 100,000 components—demands distinct levels of production facilities and expertise. Not all companies possess the capabilities to accommodate both small-scale and large-scale manufacturing requirements.
Additionally, time is a critical factor to consider, as the design and manufacture of moulds can take several months to complete before injection moulding can commence. It is essential for clients to account for various time-consuming processes, including potential design revisions, component complexity, the time required for consultation with designers and engineers, and any unforeseen challenges that may arise during the injection moulding process. Medical device injection moulding companies with in-house mould design, mould manufacturing, and injection moulding capabilities are typically able to reduce lead times, offering greater independence in supporting clients and facilitating adjustments as needed.
Besides, the geo-location of the medical device injection moulding companies also significantly affect the overall timeline of the project, and companies with locations in different continents could support clients faster and more effectively.
Does the medical device injection moulding company have the potential for a long term supply chain relationship?
Selecting a medical device injection moulding company that is committed to establishing a long-term partnership from the outset offers significant benefits for both current and future projects. It is crucial that the chosen supplier understands your business objectives and is motivated to support your growth, with the intention of fostering a sustainable commercial relationship. Medical device injection moulding companies with extensive experience and expertise in the healthcare sector are well-positioned to advance their technology, knowledge, and quality standards to meet your evolving demands. Moreover, as the process of selecting a contract manufacturer is both time-consuming and costly, it is advantageous to partner with companies that can not only support a single project but also become your preferred choice for future initiatives.
(Photo: Micro Systems)
Micro Systems is a UK based manufacturer of medical moulds, micro moulds and medical injection-moulded parts. Having production facilities and offices in the UK and Singapore helps us to ensure flawless, fast and efficient service to our customers globally. We cater for our customers starting from mould design through mould manufacturing and development to validation within an ISO Class 7 cleanroom. We are ISO 13485 and ISO 9001 certified. All critical processes are backed by high-end Metrology equipment that can measure down to nanometer resolution. Micro Systems products include moulds for medical or high-precision plastic manufacturers and injection-moulded medical parts produced on-site at our Optimold facility. Contact us today to get the best quote for your medical injection moulding project.
