By By Dan Aicher, CEO, EmbedTek, LLC
Supply chain disruptions are forcing an inordinate amount of change to critical components of medical devices. The burden placed on medical device OEMs to validate these changes distracts engineering, quality, and operations teams from more strategic activities. Reacting to an unpredictable supply chain endangers new development as well as ongoing production.
Seeking partnerships with supplier organizations that have the resources, organizational discipline, and structure to help execute change validation can be part of the answer. A third-party resource, especially one already familiar with the product and OEM’s processes, would be able reduce the burden on the OEM’s internal departments giving them the opportunity to focus on more strategic projects. Following are questions to keep in mind when determining which suppliers can step up to the task.
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- Is the supplier well-versed in quality management system (QMS) protocols and are they accustomed to the documentation and traceability that is required with every change?
A supplier’s quality credentials are a result of integrated design and manufacturing processes, as part of a seamless value stream, delivering consistent and quality products to their customers and end users.
EmbedTek, a manufacturer and supplier of embedded computers and integrated displays, currently holds certificates of registration for ISO 9001:2015 and ISO 13485:2016. We are also registered with the U.S. Food and Drug Administration as a Contract Manufacturer of Medical Devices. EmbedTek provides extensive support during the introduction of new systems for medical device OEMs. This has only expanded given recent demands on customers.
- Is the supplier experienced in validation testing? And do they know your product well enough to perform the level of testing required?
Trusting a supplier partner with change validation doesn’t happen overnight. Ask them to outline the breadth of their capabilities, share examples of how they have conducted validation procedures before, and compare how they propose running a validation on your product with how your internal team would approach it.
In one recent circumstance at EmbedTek, an embedded computing/visualization system required a significant update due to the end of life of a high-performance GPU and increased use of AI. We collaborated with the customer – a neurological surgery device manufacturer – to develop the test scope and expected output of the process to validate the new system.
This included electromagnetic interference (EMI), electrostatic discharge (ESD), shock and vibration, thermal, performance, functionality (including regression testing of earlier revisions), and output verification. Scripted tests and sample output of earlier testing was provided to EmbedTek so that we could perform the testing in compliance with the medical device OEM’s quality system and, when complete, it flowed smoothly through their system.
- Does the supplier have the capacity to take this on permanently?
Providing support in a supply chain and QMS pinch is certainly a life saver. But once an OEM and supplier partner are coordinated with change validation, why stop? When production becomes more predictable, OEMs should consider using this relationship to their advantage for the long run.
In the scenario above, EmbedTek performed the testing and provided the output, while the medical device OEM focused on work only they could do. This was possible because of the close partnership that existed before the more extensive need developed due to the supply chain disruption and its impact on the medical device OEM’s resources. The validation was a success and will now be the new operating method going forward. In addition to much needed help during this current environment, EmbedTek now knows considerably more about the intricacies of the OEM’s device, which allows for better communication and collaboration in the future.
- Is the supplier well-versed in quality management system (QMS) protocols and are they accustomed to the documentation and traceability that is required with every change?
Whether required now or not, having supplier partners that are able to pivot in the current environment – or unknown situations to come – makes for a stronger supply chain and a more competitive company.
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