There are critical steps to effectively manage – and minimize – the risk involved in the design, manufacture, and assembly of custom medical cables to ensure the cable assembly is not the system’s Achilles heel.
An impactful new medical device is released to the market, only to be recalled months later due to the discovery of bioburden breeding amongst the organic filler that was inadvertently utilized within the reusable cable component of the device.
This example, and others like it, occur each year, putting patients at unnecessary risk and costing the healthcare system and the companies supporting it millions of dollars. Good manufacturing practices governed by design control protocols and FDA oversight are meant to avert these types of disasters from occurring and have been extremely impactful overall. However, in today’s cost-conscious environment focused on outsourcing many of the subcomponents of the final product, there are some critical steps that OEMs and their partners can take to effectively manage – and minimize – the risk involved in the design, manufacture, and assembly of custom medical cables.
This includes actively identifying those risks up front and taking proactive steps to lower the risks. Naturally, it is imperative to choose an experienced and knowledgeable partner. An OEM’s vetting process for a cable assembly partner should also examine the quality system to which the cable supplier is certified. In the medical device world, an ISO 13485 quality system certification is the base requirement needed to demonstrate an alignment with the OEM and an understanding of the importance of the downstream documentation approach this quality system entails. The critical procedures of Process Failure Mode and Effects Analysis (PFMEA) creation; device history record documentation; subcomponent supplier lot control records and audits; incoming as well as outgoing component inspection criteria; process control; and in-process inspection for quality assurance are all necessary and must be well established by a cable assembly partner in order to substantially reduce risk and ensure positive and repeatable outcomes for medical device cable assemblies.
Quality system adherence, although critically important, cannot guarantee a flawless outcome on its own. Once an experienced cable and assembly manufacturing partner has been chosen by the OEM, it is best if they are able to work hand in hand with the custom cable manufacturing and assembly partner’s engineering group to reach the best outcome (from a price as well as performance standpoint) of the assembly being outsourced.
Many cost-down considerations are missed in the early stages of cable assembly development, as OEM engineering groups make subcomponent choices based on their own limited time and minimal exposure to the connector and cable market. An expert cable assembly outsource partner consulted during the design stage can save OEMs critical time and expense by avoiding eventual re-evaluation and re-qualification of alternate subcomponent connectors and perhaps even custom cable extrusion for cost-saving purposes. These savings can amount to hundreds of thousands of dollars as volumes increase for successful devices that gain market momentum over years.
In summary, it is important to make an informed choice when looking for a custom cable assembly supply chain partner. Quality system certification is only the first of many important considerations that come into play. By outsourcing medical cable assemblies to a seasoned expert, risk can be substantially reduced due to factors including depth of industry and materials knowledge.
Lee Clermont is the quality assurance manager at Global Interconnect Inc.