Medical devices often measure a range of variables. The specific measurements a medical device performs and provides can depend on the device’s function.
All medical devices and related components must meet measurement requirements. To that end, those who manufacture these devices may perform measurement system analyses.
What is a Measurement System Analysis?
A measurement system analysis (MSA) determines how much variability there may be within a given measurement system. For a basic example, imagine your job involves weighing items on a scale.
Perhaps you and your coworkers don’t all use the same scale to weigh items. Some scales may be less accurate than others.
An MSA can determine the variation between measurement results (when the process itself varies slightly or not at all) to determine variation within the overall system. Naturally, in this example, a high level of variation would be undesirable, as it indicates the same system has the potential to yield significantly different results.
Why is Measurement System Analysis Important in Medical Device Manufacturing?
Accuracy of data is critical in a medical setting. If a medical device produces different results despite other details of a process remaining consistent, or if two devices of the same model produce different results despite neither one being defective, a device may not be reliable.
An MSA can determine whether a medical device generates an appropriate level of variability. Be aware that performing an MSA may essentially be a legal requirement.
The U.S. Food and Drug Administration (FDA) requires that medical devices provide valid results. Performing an MSA can generate the data needed to show the FDA a device meets its criteria. Without a thorough MSA, the FDA may not approve a device for sale.
Performing an MSA might also potentially guard against lawsuits. For example, perhaps a patient or other such party attempts to sue a medical device manufacturer, claiming its device failed to produce valid results, which had a negative impact on their treatment. The results from an MSA might show a patient’s allegations about a device’s accuracy are false. In this scenario, investing in a thorough MSA could save a medical device company a lot of money in the long run.
In addition, inaccurate testing can create large problems for companies as this can lead to complaints and demands for reimbursement from customers if it turns out that their products are unreliable. Companies may avoid these issues by performing MSAs.
The Importance of Partnering with the Right Manufacturing Teams
The companies selling medical devices may coordinate with partners to manufacture them. If your company enlists the help of manufacturers to create your devices, make sure they perform all necessary tests.
Such tests may include MSAs. Asking about this topic when choosing a manufacturer can give you peace of mind and potentially save your business a lot of money.
Learn More About Medical Device Manufacturing Solutions
At Coastline International, our medical device manufacturing team has been in business for 40 years and counting thanks to our commitment to providing quality services. Learn more by contacting us online or calling us at 888-748-7177 to discuss your project.