There’s growing expectation throughout the industry, and with regulatory bodies, to propagate risk management ever deeper into the supply chain since decisions made lower in the supply chain can result in potential hazards that may not be readily apparent to the OEM. ISO 14971 is the guiding standard, but it is not written from the perspective of a component manufacturer, as some of the requirements necessitate knowledge and information that is only available to the OEM. This article explores how OEMs can work with their component manufacturers to properly address risks lower in the supply chain.

When a hospital implements a new medical device, everyone from the nursing staff to the patients expect it to deliver the highest quality of care. Ensuring the device meets those expectations falls on the shoulders of the original equipment manufacturer (OEM). However, the FDA has been driving certain quality controls further into the supply chain. Instead of simply looking at the design and manufacturing done by the OEM, the FDA has identified instances in recent years where the root cause of a patient injury occurred at lower levels of the supply chain, even as low as the raw material-level suppliers. This has heightened the importance of collaborating with your component manufacturer to mitigate risk.

The medical device industry currently operates under ISO 14971 for the application of risk management. Yet, this standard is written for the OEM to help determine the safety of a medical device during its lifecycle. and it does not relate directly to component manufacturers. This is often why component manufacturers are left out of the risk management plan, however design and manufacturing cannot operate in silos. Moreover, OEMs can benefit from their component manufacturers being involved in risk management by making sure they have the right information to support OEM design and manufacturing engineers.

Include Component Manufacturers in the Design Phase

Starting with the basics, OEMs cannot eliminate risk through the medical device design alone. In fact, the more the component manufacturer knows about the functionality, measurements and critical features in the overall design, the more they can help ensure that they are building components in a manner to minimize risk. At the core, everything is interwoven, so sharing information about the intended use or user needs, as well as critical and non-critical features and tolerances, can influence the component manufacturer’s controls to ensure that the production process will help minimize risk. This information not only helps prevent non-conforming parts from getting farther into the manufacturing cycle, but also influences the processing and component materials used during production.

The following are some other ways your component manufacturer can help to mitigate risk.

Critical Parameters Impact on the Manufacturing Process

Once the design is finalized and a component manufacturer is ready to prototype, they approach risk management based on what the OEM deems important—including understanding critical and non-critical parameters. Risk is composed of severity and occurrence. Severity factors in the likelihood a patient could be harmed if the component is not manufactured correctly, and the occurrence rate looks at the probability of a non-conforming piece escaping from the facility. Anything deemed critical is given the highest risk level, and the component manufacturer operates under the assumption that it could cause harm to a patient if it is non-conforming. Non-critical characteristics are assigned a lower severity rating. Yet, only sharing whether it is critical or non-critical without further context to some extent leaves the component manufacturer in the dark.

Component manufacturers understand the sensitivity around this topic, as OEMs see this information as proprietary. Yet, sharing more information with the component manufacturer on the function of the device and its inherent risks can help guide better decisions during the component manufacturing process. As an example, there are at least three different ways to calculate a diameter of a feature. For a round hole, they are equivalent. If the hole deviates from round, how the part is used dictates which method is correct. Without knowing how the part is used, the supplier is left to guess or, most likely, use the common least squares method, which might not best represent design intent. To really understand the implications, here are three ways this information can impact the component manufacturing process.

• Component Risk Assessment: Component risk assessment evaluates the potential the process will allow non-conforming product to escape to the customer. Take for instance a scratch on a tube. If it’s listed in the print notes, in the absence of further information, a component supplier may assume that a scratch will result in harm to the patient. This assumption may or may not be correct and a scratch might be considered a minor cosmetic defect—undesirable but not harmful. But with limited insight, the component supplier may commit resources to scratches that would be better spent on improving more critical features. When measuring the diameter, for example, the likelihood of shipping a part that does not meet design intent is different depending on which algorithm is used to calculate diameter. However, understanding how the part will be used can help the component manufacturer ensure the process produces product meeting the customer’s design intent.
• Normalization of Deviance: Normalization of deviance is when practices change slowly and incrementally over time, with the end result being common acceptance of an improper practice. The concept of “normalization of deviance” is not unique to medical device manufacturing. However, in the medical device industry, it is critical that manufacturers understand this concept and monitor their practices closely to ensure it doesn’t impact device components. “No change” agreements are standard in the medical device industry. As written, they often leave room for interpretation regarding what magnitude of change requires notification or approval. Understanding how the device is used makes it easier for a component manufacturer to interpret and apply these agreements to ensure that a practice doesn’t change, without notice, that could ultimately impact the device.
• FMEA Guidelines: Process Failure Modes and Effects Analysis (PFMEA), from the perspective of a component manufacturer, identifies and assesses all of the ways a nonconforming product can be produced and possibly escape to the customer. Component manufacturers do not typically have the in-depth information to assess patient risk—such as whether a failure could potentially leave foreign material in a patient’s body or cause damage to an artery—and are often relegated to assuming that failure to meet any customer-identified critical parameter may result in patient harm. Oftentimes, the OEMs are conservative in what they share and, in cases, this can result in over-design or over-constraint of a process. Worse, an OEM could fail to list a characteristic as critical in which case the component manufacturer may not afford it an adequate amount of attention. The more the OEM is willing to share about the device information, the more effective and accurate the PFMEA will become. Some component manufacturers make it easier by using the OEM’s rating scales when available.

Communicating Transition from Prototyping to Production

Another way to mitigate risk is clear communication when transferring designs to production status. Since prototype and/or pre-production controls are often not as strict as controls on production-level product, it is critical for the OEM to clearly communicate to the supplier the point in time at which production-level process controls are required. Failure to communicate this requirement could result in changes made to the process without adequate review and approval.

Providing the highest quality device to deliver the highest quality patient care takes a concerted effort from all parties involved. When designing and manufacturing medical devices, make your component manufacturer part of the solution to help mitigate risk.