How to leverage a supplier partner for change validation

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.

Is the supplier well-versed in quality management system (QMS) p…
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Consolidation Innovation: Creating New Opportunities for Medical Devices

By Dan Aicher, CEO of EmbedTek, LLC

Medical device designs are complex – from the technological advancements that created them and interconnects between different functional facets, to their enclosures and regulatory requirements. When you add scalable manufacturing to the mix, medical device OEMs are faced with a complex burden to manage. Third party partners experienced in medical product design, supply chain, manufacturing, and regulatory can help OEMs streamline design without sacrificing integrity.

Consolidating multiple elements of a design into one single product can provide significant benefits to OEMs in ergonomics, regulatory, cost, and quality. Device consolidation improves the supply chain and, most importantly, the customer experience.


Ergonomics go beyond the look and feel of a device and can improve the customer experience in the field. Enhancements can be made across the board, from the device itself to how it is…

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