Medical device OEMs face numerous challenges not only in the development of their device but also ensuring reliability of the device while in service. Trusting your medical device to a third-party service and repair provider can be stressful. You have spent so much time developing and marketing your device to ensure patient safety, now, who will you trust to maintain and upgrade your device?
Service and repair of established products requires knowledge of the original manufacturing processes and equipment. Device support for the customer falls to the OEM to provide MRO services, with many choosing to partner with an outsourced provider. There is no room for error when selecting a service and repair provider, especially for medical devices. Many OEMs trust the initial manufacturing of their electronic medical devices to full-service contract manufacturer. It can be beneficial to continue repair depot services with them due to their existing experience with the product, but what if your EMS partner doesn’t offer repair & service?
Consider an EMS with Maintenance and Repair Depot Flexibility
When evaluating an electronic manufacturing service provider, an OEM should look for one that has proven experience as a repair depot with various levels of service and repair capabilities. These levels should range from simple routine maintenance to complete device overhaul. From the initial inspection to the full service of the device, have confidence that regardless of the situation, your repair depot can provide the following value-added service to keep your medical device performing at an optimal level.
Routine Service & Maintenance
In any service agreement, the first level should consist of annual or routine maintenance of the device. Typically, the device is operational and does not need additional rework. This service can include replacement of standard parts that may have worn out or are disposable. After arriving for service, the device is decontaminated and inspected before the manufacturing service team restores the device to the original specifications.
Already an extension of your manufacturing operations, a full-service contract manufacturer partner that can keep your device up and running provides the reliability needed while an OEM works on the next generation of the device. The service team can also bring the device to an advanced level if the changes do not alter the performance or safety of the medical device.
Medical Device Upgrade
The second level of service that should be provided is the upgrade of the device. Upgrading extends the life of a medical device that has ceased production or while work is being done on its successor. The upgrade process includes replacement of standard and unique parts, as well as upgrading the software and/or firmware to the latest revision as required. An upgrade can bring the device to the current generation of product without altering the original functionality, which requires a high level of experience.
The benefit of sourcing repair at a medical electronic contract manufacturer with service experience is their strong support capability when compared with a standalone repair depot. From expert knowledge of the device to obsolescence management, a repair and service CM can easily upgrade the device without facing the technology and sourcing challenges that third party independent repair depot might face.
Medical Device Repair
As the OEM, you have various medical devices in service that could experience a technical failure. A repair agreement with a medical electronic contract manufacturing partner enables them to take over the repair of the device while you, the OEM, continues, working on the design and development of its next generation.
This third level of service provides rework of defective units due to worn-down components or failure in the field. The value provided with an electronic medical contract manufacturer with repair depot operations and strong engineering resources can be sizable. Having this extensive manufacturing and testing experience allows the service team to analyze the fault, discover the cause of the failure, and repair or replace the existing components. With a repair & service agreement in place, the repair cost would be less than the cost of new units, resulting in significant savings for the OEM and longevity in the marketplace for the product.
An Experienced Full-Service Contract Manufacturing Partner
Many factors go into the initial design and development of your device, and they should be included in the service of them as well. From decontamination to traceability, who you trust with the service and repair of your device should follow set of predetermined criteria to ensure the highest quality repair and refurbishment available. Electronic Medical Device Contract Manufacturing partners have a working knowledge of your device and the built-in support to take on the task of servicing and repairing it, so you don’t have to.
At Valtronic, we are committed to the entire life cycle of your medical device. From design to manufacturing, our skilled engineers are also dedicated to maintaining your device within its original specifications. Our services extend beyond electronic medical device design, development, and manufacturing with the inclusion of aftermarket device service and repair.
Reduce risk with superior commitment and quality by servicing your device with a partner that knows it as well as you do.
For more information on Valtronic’s medical device service and repair solutions, please complete our contact form and contact us today!