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Meeting Regulatory Compliance for Medical Devices



With changes to regulations around medical device designs taking effect from this month, Tim McGinnis, VP of medical quality and regulatory affairs at Sanmina, explores the compliance challenges around manufacturing such products


Over the past few decades, medical device original equipment manufacturers (OEMs) have been turning to electronic manufacturing service (EMS) providers to help them navigate increasing quality and compliance rules and regulations during the manufacturing and launch of new products. Recent regulatory changes and the pandemic have further complicated matters, prompting even closer collaboration.

The challenges that medical device OEMs face cannot be underestimated. They are constantly under pressure to deliver innovative medical devices faster than the competition, without compromising quality. There is typically a small window of time to complete a design, advance it to prototype and NPI stages, start production and obtain all of the required regulatory approvals, all while trying to stay ahead of competitors. 

Starting in July 2021, new regulations will prohibit the use of lead as part of medical device designs following changes to the European Union’s (EU) RoHS (Restriction of Hazardous Substances) directive. As a result, OEMs are against the clock to update product designs and rework parts of their supply chains in order to remove prohibited materials from the process and ensure that declarations of the changes are completed in time. Additional EU regulations include the certification of products according to REACH standards, ensuring that toxic substances aren’t used in product designs. 

Along with regulatory challenges, the COVID-19 pandemic pushed activities such as audits and document reviews online in response to travel restrictions and social distancing rules. Luckily, major EMS providers have highly experienced quality teams that are battle tested at handling these complexities on behalf of OEMs. However, there is still a great deal of planning and logistics involved with setting up a new programme.

Kicking off a compliant programme 

When an EMS provider first begins to collaborate with a medical device OEM on a new product, there are several important factors to consider and steps that must take place. First off, there must be a detailed contract and quality plan that clearly defines the roles of each partner. A quality plan should also be developed in conjunction with the OEM design owner to supplement the contract. From there, it’s also important to ensure that the product is built at the right location. Sometimes an OEM has a specific plant or region in mind, but the facility might not have the proper qualifications and certifications from the FDA or other regulatory bodies.

It’s essential that the design transfer of the device master record (DMR) from the OEM to the EMS provider is transferred correctly, as the DMR includes all of the information needed to build the product. Critical-to-quality (CTQ) points must also be identified on all of the product prints for inspections. Once the EMS provider has the DMR, a new product introduction (NPI) process checklist is created in great detail to ensure that there are no questions about procedures that could compromise quality or the timeline. 

The process instructions, product work instructions, test plans, validation plans and sampling plans must all be developed soon after the product transfer has occurred. The EMS provider also needs to understand the key components within a medical device, especially any parts that could cause catastrophic failure. Suppliers must be qualified and agree to specific terms within a contract, with a supplier management programme established that includes score cards and regular meetings and reviews. There must also be backup sources available that can provide key components of the same quality.

Four steps to ensuring quality

Of course, all OEMs want to achieve 100 per cent quality during the manufacturing of medical devices, but in reality, a product may have elements not designed to achieve a perfect quality yield. This is where close communication on product design, testing, validation and inspection processes is vital to close any quality gaps:

  1. Design for manufacturability (DFM), design for testability (DTM) and process capabilities

The EMS provider must explain to the OEM how the product is running and provide feedback on what needs to be adjusted to improve performance or testability. The prototype designed by the OEM may operate as planned but functionality may not translate as intended when manufactured and tested at large volumes. A forum should be established to provide DFM, DTM and process capability data back to the design owner.

  1. Robust testing strategy

A top priority of any test strategy is point-to-point continuity testing of the medical device covering all major electrical circuits in order to identify any electrical failures and as far as possible, eliminate the need for human intervention. A systems level test is also essential to verify that the overall system works as intended in the application it will be installed in. If an OEM has designed their own prototype and tested it with their own equipment, it’s vital that the EMS provider use the same test strategy and equipment when it comes to undergoing regulatory audits and ensuring the product meets customer requirements. Without this, there must be a good understanding of the limitations of electrical tests performed by the EMS provider. The test strategy will also factor heavily into process validation.

  1. Validation of the entire manufacturing process

Validation of everything from the assembly, testing and inspection of the product, to the production equipment used and all processes involved in manufacturing must be performed to facilitate consistency and quality. The FDA provides guidance on how to ensure that each process can continuously meet established criteria, including the installation qualification (IQ) that ensures production equipment is installed properly, and everything operates according to the manufacturer’s recommendations. The operations qualification (OQ) validation makes sure a device operates as it’s supposed to – whether running at a certain speed or operating with certain electrical requirements. The performance qualification (PQ) proves that the product being created on the production line is done so in controlled and sequential runs that can be met repeatedly. 

  1. Layered inspection processes

There are several types of inspections that take place at various phases, including manual inspections performed by workers such as x-ray inspections, automated optical inspections (AOI) and electrical inspections. It’s ideal to ‘stack’ as many of these inspections 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 utilised. Inspectors must also be trained on all of the necessary inspection requirements. 

Packaging and repair considerations

Packaging and repair both have important quality elements that must also be maintained to ensure success over the lifetime of a product. A medical device could be perfectly designed, manufactured and tested, but if the packaging isn’t designed properly, it can be damaged by the time it reaches the doctor or patient. It’s generally the responsibility of the medical device OEM to make sure that the proper packaging is purchased based on the product specifications.

In addition, most medical devices can eventually develop maintenance issues due to extended usage or require an upgrade, so processes must be in place for refurbishment and re-testing. Requirements can vary from product to product and at times may require additional outsourcing, such as a device carrying a blood borne pathogen that may require decontamination. 

Maintaining excellence through ongoing communication

Throughout the development of a new product, frequent communication between the medical device OEM and EMS provider is critical to ensuring excellent quality. There should be weekly, monthly and quarterly meetings established to discuss how a product is proceeding. The OEM designer may have designed and built one or two prototypes, but the EMS provider might be building hundreds of thousands of products, making the process of ensuring consistent functionality and quality infinitely more complex. 

Realistic quality goals must be established at the beginning of the project, with the EMS provider proactively identifying any gaps and stacking in frequent testing and as many inspections as possible throughout production. Top EMS providers have built a strong track record in the areas of quality and compliance, with the flexibility to adapt to the latest rules and regulations and deliver the most compliant, safe and effective products to medical device OEMs. 

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