Ensuring Regulatory Compliance for Medical Device Manufacturing

Medical device original equipment manufacturers (OEMs) are constantly under pressure to deliver innovative products faster than competitors without compromising quality. Typically, there is a small window of time to complete a design, advance it to the prototype and NPI stages, start producing a device, and receive all required regulatory approvals, in order to stay ahead of competing new products.

At the same time, OEMs must continuously adapt to evolving regulatory standards. For example, recent changes to longstanding RoHS (Restriction of Hazardous Substances) medical exemptions will prohibit the use of lead as part of medical device designs starting in July. OEMs are rushing to update product designs and rework parts of their supply chains to ensure that prohibited materials are removed from the process and declarations of the changes are completed by summer. In addition, OEMs must certify products according to EU REACH standards, ensuring that toxic substances are not part of product designs. They are also responding to additional legislation for MDR (medical device requirements) and IVDR (in-vitro device requirements) that require OEMs to actively pursue supplier declarations on materials of concern.

On top of all of these industry challenges, medtech’s supply chain flexibility has been tested by the COVID-19 pandemic. Besides implementing several new processes to protect factory workers, many quality and regulatory processes such as audits and document reviews had to be moved online to accommodate travel restrictions and physical distancing rules.

Even before many of these challenges surfaced, medical device OEMs were increasingly turning to electronic manufacturing service (EMS) providers to help them navigate the intricacies of quality and compliance so they could focus on product innovation and IP. EMS providers have highly experienced quality teams that intimately understand the regulatory landscape for developing safe and effective medical devices, based on their work with hundreds of clients over the years.

Compliance Checklist
When an EMS provider first begins to work with a medical device OEM on a new product, there are several important steps required to kick off a compliance program.

Qualified manufacturing location. The first priority is to ensure the product is built at the right location. Quite often, an OEM has a particular plant or location in mind but the facility must have the proper qualifications, whether it’s an FDA registration, an ISO 13485 certification, or other requirements.

Detailed contract and quality plan. The OEM-EMS contract must adequately define the roles and responsibilities of each partner, and the FDA commonly references this document for specifics. A quality plan should also be developed in conjunction with the OEM design owner to supplement the contract, with all details and manufacturing workflow controls that ensure product quality throughout production.

Complete design transfer. The design transfer of the device master record (DMR) from the OEM to the EMS provider includes all necessary information to build the product. It’s essential the product design be transferred properly and with close communication. There must be critical to quality (CTQ) points identified on all product prints for inspections.

Clear, thorough manufacturing procedures. The new product introduction (NPI) process checklist must be extremely clear and complete to ensure there are no questions during production that could compromise either product quality or its launch timeline. The process instructions, product work instructions, test plans, validation plans and sampling plans must be developed by the EMS provider soon after the initial product transfer occurs.

Supplier program that ensures supply chain stability. The EMS provider must understand key device components, especially parts that could cause catastrophic failure. Suppliers must be qualified and agree to specific terms within a contract. A supplier management program can then be established with score cards and regular meetings and reviews. There must also be backup sources available that can provide key components of the same quality.    

Closing the Quality Gap: Design, Testing, Validation and Inspection
All OEMs want top-notch quality during their product’s manufacturing, but a device may have elements that are not designed to achieve a perfect quality yield. This is where close communication on product design, testing, validation, and inspection processes can help close any quality gaps.

Design for manufacturability (DFM), design for testability (DTM) and process capabilities. The OEM’s prototype design may function as intended but can it be manufactured and tested at the required production volumes efficiently and at a high quality level? The EMS provider must explain to the OEM how the product is running and provide feedback on the necessary adjustments for better performance or testability. There should be a forum set up to provide DFM, DTM, and process capability data to the design owner.

Robust test strategy. A top priority of any test strategy is point-to-point continuity testing that covers all major electrical circuits to identify any electrical failures and eliminate the need for human intervention, whenever possible. A systems level test is also essential to verify the overall system works as intended in the application in which it will be installed. If an OEM designed and tested its own prototype, the EMS provider must use the same test strategy and equipment to ensure the product not only passes all regulatory audits but also meets customers’ requirements. If not, there must be a good understanding of the limitations of electrical tests that will be performed by the EMS provider. The test strategy will also factor heavily into process validation.

Manufacturing process validation. Validation of everything from assembly, testing, and product inspection to the production equipment used and all manufacturing processes must be performed for consistency and quality purposes. FDA guidance documents are available to assure each process can continuously and repeatedly meet established criteria, including the installation qualification that ensures all production equipment is installed properly and operates according to the manufacturer’s recommendations. The operations qualification validation guarantees devices operate as intended—whether running at a certain speed or with certain electrical requirements. The performance qualification proves the product created occurs properly with controlled and sequential runs that can be repeatedly met.

Layered inspection processes. There are several types of inspections that occur at various phases including manual inspections performed by workers at certain process steps, including X-ray inspections, automated optical inspections, and electrical inspections. It’s ideal to “stack” as many inspections and tests as possible throughout production and constantly monitor quality levels to prevent any decline in quality. When designing an inspection process, all CTQ points should be identified on the assembly drawing and the correct sampling/inspection plan must be utilized. Inspectors must be trained on all necessary inspection requirements.

Packaging and Repair
Finally, both packaging and repair have important quality elements that must be maintained to ensure success over a product’s lifetime:

Package design. A medical device could be perfectly designed, manufactured and tested, but if the package isn’t designed properly, it may end up damaged when it reaches the doctor or patient. Typically it’s the OEM’s responsibility to make sure the proper packaging is purchased, based on product specifications, to achieve the right quality level.

Refurbishment processes for a returned product. Most medical devices may be used for some time and can eventually develop maintenance issues or require an upgrade, so processes for refurbishment and re-testing must be in place. Requirements can vary between products and at times may require additional outsourcing, such as for a device carrying a blood-borne pathogen requiring decontamination.

Collaboration is Key 
Close communication between the OEM and EMS provider is critical to ensuring excellent quality throughout new product development. This involves weekly, monthly and quarterly meetings about how a product is proceeding. The OEM designer may have designed and built one or two prototypes, but the EMS provider may be building hundreds of thousands of products, making the process of ensuring consistent functionality and quality infinitely more complex.

There must be realistic quality goals established at the project’s onset, with the EMS provider proactively identifying any gaps and stacking in as many inspections and tests as possible throughout production. Top EMS providers have built a strong track record in quality and compliance, with the flexibility to adapt to the latest regulations and deliver the most compliant, safe and effective products to OEMs. 

---

Tim McGinnis joined Sanmina in 1998 and has served in several roles relating to engineering, quality, and regulatory management. He helped develop the QMS now used by the Medical division, has successfully supported 20 FDA audits, and has supervised ISO 13485 certifications at more than 15 Sanmina facilities.