There are many challenges that medical device OEMs face when developing innovative medical devices. They only have a small window of time to complete a design, advance it to the prototype and NPI stages, start production and receive all required regulatory approvals. They must do all of this faster than the competition. Add to the mix a host of changing regulations, new legislation, continuing COVID-19 disruptions and supply chain problems, and you’ve got a number factors testing the resiliency of the medical device manufacturing sector.
Even before many of these current issues began, medical device OEMs had begun collaborating more closely with leading EMS providers to navigate the intricacies of quality and compliance. EMS providers like Sanmina have highly-experienced quality teams that deeply understand the regulatory landscape from their work with hundreds of clients over many years. At Sanmina, we’ve built up a valuable arsenal of knowledge on how to seamlessly ramp up these programs.
Building a Compliant Program
When a medical device OEM collaborates with an EMS provider on a new product, there are several important actions required to properly structure a compliant program:
- Identify a qualified manufacturing site. An OEM may have a specific plant or region in mind for building a new product but that site must have established the right certifications (FDA registration, ISO13485, etc.). These qualifications are often very complex and time consuming to achieve, so it’s ideal to work with a partner that already has facilities with the needed requirements in place.
- Develop a thorough contract and quality plan. The contract between both parties must clearly define the roles of each partner, as the FDA regularly references the agreement for details. A quality plan should also be created to supplement the contract that describes the manufacturing workflow and how it will ensure quality during production.
- Ensure a complete design transfer. It’s critical that the transfer of the device master record (DMR) from the OEM to the EMS provider contains all specifics needed to build the new product. Close communication should occur as part of the design transfer and critical to quality (CTQ) points must be identified on all product prints for inspections.
- Document all manufacturing procedures. The new product introduction (NPI) process checklist should be very clear and complete to avoid any misunderstandings during production that could compromise quality or time to market. Process instructions, work instructions, test plans, validation plans and sampling plans must all be developed by the EMS provider soon after the first product transfer occurs.
- Establish a reliable supplier program. All suppliers must be qualified and agree to specific terms under contract. Backup sources must also be available that can deliver components of the same quality. Designing a supplier management program that includes regular meetings, reviews and score card ratings will help to keep supplier relations on track.
Closing Quality Gaps with Design, Testing, Validation and Inspection
All OEMs of course want to achieve 100 percent quality, but a medical device might have elements that aren’t designed to achieve perfect quality yield. However, close communication on product design, testing, validation and inspection can help close any gaps:
- Set up design for manufacturability (DFM), design for testability (DFT) process capabilities. The product prototype may function as intended but can it be manufactured and tested at high product volumes efficiently and with quality? The EMS provider must provide feedback to the OEM on a regular basis about how the product is running and what needs to be adjusted for better performance and testability.
- Create a robust test strategy. Point-to-point continuity testing of the medical device that identifies any failures across all electrical circuits is a top priority. A systems level test verifies that the overall system works as intended. If possible, the EMS provider should use the same test strategy and equipment as the OEM to make sure that the product meets both the regulator’s and customer’s expectations.
- Validate all processes. Validation of assembly, testing and inspection processes, along with the production equipment, must be performed to ensure consistency and quality. The FDA provides detailed guidance documents that illustrate how each process should continuously meet established criteria.
- Layer in multiple inspection processes. There are several types of inspections that take place at different phases during production – x-ray, automated optical inspections and electrical inspections. It’s ideal to stack as many inspections and tests as possible to constantly monitor quality levels and prevent any decline in quality.
Packaging and Repair Considerations
Both packaging and repair have important aspects that must be maintained to ensure quality over the lifetime of a medical device:
- Thoroughly evaluate the package design. If a product package isn’t designed properly, it may end up damaged by the time it reaches the intended user. Typically it’s the responsibility of the medical device OEM to make sure that proper packaging is used to achieve the right level of quality.
- Design a refurbishment plan. Medical devices may develop maintenance issues or need upgrades over time, so there must be a plan in place for refurbishment and testing. Requirements can vary between products and sometimes may require additional outsourcing, such as for when decontamination is required.
Communicate, Communicate, Communicate
Throughout the production of a new product, constant communication between the medical device OEM and EMS provider with weekly, monthly and quarterly meetings is essential to ensuring quality. The OEM designer may have built a few prototypes, but the EMS provider could be building hundreds of thousands of the same product, making the process of ensuring quality infinitely more complex. Realistic quality goals must be established from the onset, with the EMS provider identifying any gaps and stacking in frequent testing and inspections during production. Collaborating with top a EMS provider that has a strong track record of quality and compliance not only streamlines the process for medical device OEMs but also frees them to focus on their core competency – product innovation that can ultimately improve the quality of life for patients.