Medical device contract manufacturers are a critical component of the medical device manufacturing process for original equipment manufacturers (OEMs). Outsourcing to medical device contract manufacturers (CM) often occurs when OEMs need a particular area of expertise including joining, casting and molding, or R&D design. Custom fabrication, of course, must be done professionally, so choosing the right medical device contract manufacturer is vital to an OEM’s success.
Criteria for choosing a medical device contract manufacturer helps OEMs ensure they have made a good choice. The criteria should include:
- Quality focus with ISO 13485 certification
- Cleanroom capabilities
- Responsiveness and on-time delivery performance
We look into each of these criteria a little more fully below to guide you through the process of choosing the right medical device contract manufacturer.
Quality Focus with ISO 13485 Certification
A comprehensive quality system with the appropriate credentials, such as ISO 13485, makes medical device contract manufacturers much more appealing. ISO 13485 stipulates certain requirements for quality management systems when organizations provide medical devices and related services to consistently meet customer and regulatory requirements. These organizations may be involved in any stage of the device lifecycle, regardless of the organization’s size or type.
Other accreditations should include FDA compliance and risk mitigation plans, demonstrating that the CM has a quality focus. A medical device contract manufacturer with these accreditations obviously has invested time and money into creating quality systems; the CM also most likely has high standards for its own staff and procedures and does not need external guidance for creating a quality system. And, quality often is the most important factor in any decision regarding medical devices. In most cases, choosing a CM with a quality focus and ISO 13485 certification means that you save time and money when looking at the big picture.
OEMs should select a medical device contract manufacturer that has cleanroom capabilities because there is a lower risk of contamination when devices are fabricated in cleanrooms. OEMs reap the benefits of devices made in cleanrooms because they often are better quality; cleanroom personnel often have higher skill levels than other manufacturing staff and are more apt to care for the devices throughout the manufacturing process.
When selecting a CM with cleanroom services, narrow the pool to those certified to ISO 13485 and compliant with ISO 14644 and ISO 14698 standards for cleanrooms. The CM also should offer cleanrooms rated Class 10,000 or better and be equipped with Class 100 laminar-flow workstations when fabricating and assembling devices that require the utmost cleanliness, according to Quality Tech Services sales and marketing director Bob Lord.
OEMs should ensure the CM has a robust quality control system, complies with regulatory requirements, demonstrates cleaning capabilities for both devices and components, operates separate gowning areas to reduce the risk of contamination, and maintains systems that deliver pure water, clean air, and filtered nitrogen. The OEM should note whether the CM has a dedicated production and customer team available to guarantee quality control for each and every medical device project.
Responsiveness and On-Time Delivery Performance
The relationship between an OEM and a medical device contract manufacturer should involve a great deal of communication. OEMs cannot waste time or money waiting for answers from CMs. The responsiveness of the CMs you look into partnering with from the very beginning of your communications with them serve as a good indication of what you can expect from them on a daily basis. Make contact, tour the facilities, ask specific questions, and meet with the quality team. Look for their levels of knowledge and note their methods of communication. All of their communications with you, and their rates of responsiveness, will give you more than enough information to know how they will communicate with you if you establish a partnership.
Along those same lines, look for CMs that have exceptional rates of on-time delivery (OTD) performance. Determine what level of OTD performance you are comfortable with and look for those CMs that meet your expectations. OTD performance rates also become important to OEMs that need to stay on time and budget throughout the entire manufacturing process. On the other hand, if you need to get devices to market quickly, look for CMs offering rapid product development. It is important to match the CMs capabilities to your needs.
Overall, choosing the right medical device contract manufacturer is a critical component of an OEM’s success. While there are many criteria to consider when making your decision, quality focus, accreditations, cleanroom capabilities, and responsiveness and on-time delivery performance are the most important factors to consider when choosing a manufacturing partner for your medical device.