Contract manufacturers produce and assemble a range of parts and components for a wide span of medical uses. And while some of these components appear simple, like a catheter tube that transports medicines, fluids, or bodily excretions, the processing methods of the component play a critical role in the device’s success in delivering the highest quality of care. In fact, nearly every patient admitted to a hospital has a peripheral intravenous catheter at one point or another, according to a study published in the Journal of Infusion Nursing, underscoring the importance of these devices and their components that have direct contact with patients.
The medical device manufacturing industry operates under ISO 14971. This standard for risk management helps determine the safety of a medical device during its product lifecycle, from production to the operating room. It is currently written for the OEM, however, and doesn’t directly relate to component manufacturers. In order to reduce risk of patient injury, the FDA is looking at all levels of the supply chain, including the raw material level supplier, making it more important than ever to give contract manufacturers a seat at the table.
Contract manufacturers do not need proprietary information, but sharing the product information, including the function of the device, critical features, and its inherent design risks, can help them make better-informed decisions and ensure patient safety further down the road.
The following outlines how contract manufacturers can apply information about the overall functionality and critical features of a device to minimize risk while producing its components.
When it comes to functionality, the following questions often arrise:
- What is the purpose of the end product?
- What does each part need to do?
- Does the device come into contact with the body or reside within the body for an extended period of time?
How and where a device operates and what it will be used for impacts the processes used to build parts and components, and the quality measures and risk management procedures required. Therefore, information about the functionality helps contract manufacturers ensure processing aids the intended purpose and the manufacturing process meets with the final design specifications. For example, there are three different ways to calculate the diameter of a feature. The contract manufacturer’s task might be to drill a hole with a high tolerance for a catheter, but without knowing how the part will be used, the contract manufacturer is left to guess or, most likely, use the common least squares method, which might not result in the most appropriate measure for that particular feature.
Understanding the functionality can also impact the development process, including how a component manufacturer approaches “no change” agreements and how they monitor their process to account for “normalization of deviance.” “No change” agreements are standard in the medical device industry. Yet, contract manufacturers often have to interpret what magnitude of change requires notifying the OEM or seeking approval. The ambiguity of how “no change” agreements are written raises the importance for understanding the final medical device functionality. For example, if the contract manufacturer knows one characteristic is a critical feature, customer approval is automatically sought before making a change to how it is measured or developed. The more insight the OEM can share about the device functionality, the easier it is for the component manufacturer to interpret and ensure a practice that could ultimately impact the quality of the device doesn’t change without OEM consent.
Similarly, understanding the functionality can help contract manufacturers monitor and be aware of changes to their internal processes. For example, practices can change slowly and incrementally over time, ending in a common acceptance of an improper practice. While the concept of “normalization of deviance” is not unique to medical device manufacturing, it can impact the outcome of a device if it is not monitored. The more insight contract manufacturers have into the function of the device, the more likely they will stop or notice a change to their process that could change the outcome of the device before it gets too far into the development process.
When contract manufacturers are developing their risk management plan, they have to base their approach on what the OEM has deemed a critical and non-critical parameter. All critical design features are given a high-risk level and all non-critical characteristics are assigned a lower severity rating. With that information, the contract manufacturer analyzes the risk of critical components based on 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 manufacturing facility. Therefore, unless the OEM will share severity rating scales or similar information, contract manufacturers have to assume failure to meet any customer-identified critical parameter may result in patient harm and this can mean they may commit more resources and time to manufacturing these critical components.
Contract manufacturers assess all of the ways a non-conforming part can be produced and escape to the customer with a Process Failure Modes and Effects Analysis (PFMEA). Understanding what the OEM deems a critical parameter can help them assess whether a scratch on a tube will result in harm to the patient or if it is simply a minor cosmetic defect. Knowing how the part will be used can further ensure the component manufacturer’s process produces a product that meets the customer’s design intent. Without knowing the critical parameters and potential harm to patients, it might result in over-design or over-constraint of a process. On the contrary, if a characteristic is not labeled as critical by an OEM, the contract manufacturer may not implement an adequate quality assurance procedure. The more the OEM is willing to share about the critical and non-critical parameters of the end device, the more effective and accurate the PFMEA will become. To further ease the process, some contract manufacturers will adopt the OEM’s rating scale.
While some device components, like a catheter tube, may appear simple, they play a crucial role in delivering quality patient care and leave little room for error. The more contract manufacturers know about functionality and critical parameters around the components they develop, the better equipped they are to help mitigate risk early in the process to ensure these devices are ready to perform.
Kevin Becker is the quality manager at Spectralytics Inc., a laser cutting and processing contract manufacturer serving the global medical device industry. As the quality manager, Becker trains the company’s employees in quality and reliability methods, statistical analysis, and risk management. He is a graduate of the University of Maryland with a Master’s in Reliability Engineering and is an ASQ Certified Quality Engineer and Certified Reliability Engineer.