By Dan Aicher, CEO, EmbedTek, LLC
Supply chain disruptions force an excessive amount of change to critical medical device components. 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 puts new developments as well as ongoing production at risk.
Partnering with vendor 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 someone already familiar with the OEM’s product and processes, would be able to reduce the burden on the OEM’s internal departments by freeing them up to focus on more strategic projects. Here are questions to keep in mind when determining which vendors can take on the job.
- Is the supplier familiar with the Quality Management System (QMS) protocols and familiar with the documentation and traceability required with each change?
A supplier’s quality credentials are the result of integrated design and manufacturing processes, as part of a continuous value stream, delivering consistent, quality products to their customers and end users.
EmbedTek, a manufacturer and supplier of embedded computers and embedded displays, currently holds registration certificates for ISO 9001:2015 and ISO 13485:2016. We are also registered with the United States Food and Drug Administration as a contract manufacturer of medical devices. EmbedTek provides extensive support when introducing new systems for medical device OEMs. This has only expanded given recent customer demands.
- Does the vendor have validation testing experience? And do they know your product well enough to perform the required level of testing?
Trusting a vendor partner to commit changes doesn’t happen overnight. Ask them to describe the scope of their capabilities, share examples of how they have conducted validation procedures before, and compare how they propose to run validation on your product with how your team internal would address it.
In a recent circumstance at EmbedTek, an embedded compute/visualization system required a significant upgrade due to the end of life of a high performance GPU and increased use of AI. We worked with the client – a neurosurgical device manufacturer – to develop the scope of the test and the expected outcome of the process to validate the new system.
This included electromagnetic interference (EMI), electrostatic discharge (ESD), shock and vibration, temperature, performance, functionality (including regression testing of previous revisions), and output verification. Scripted tests and sample results from past tests were provided to EmbedTek so that we could perform the tests according to the medical equipment manufacturer’s quality system, and upon completion, it ran smoothly in their system.
- Does the supplier have the capacity to do this permanently?
Providing support in a QMS supply chain and pinch is definitely a lifesaver. But once an OEM and supplier partner are coordinated with change release, why stop? As production becomes more predictable, OEMs should consider using this relationship to their long-term advantage.
In the above scenario, EmbedTek performed the testing and provided the output, while the medical OEM focused on the work that only they could do. This was possible due to the close partnership that existed before the larger need developed due to supply chain disruption and its impact on medical device OEM resources. The validation was a success and will now be the new modus operandi for the future. In addition to much-needed help in this current environment, EmbedTek now knows much more about the intricacies of the OEM’s device, allowing for better communication and collaboration in the future.
Whether needed now or not, having supplier partners who can pivot in the current environment – or unfamiliar situations ahead – strengthens the supply chain and makes the business more competitive.
Content sponsored by EmbedTek