During my internship, I recently learned about measurement system analyses (MSA) also known as gage R&Rs (repeatability and reproducibility) and how important it is to perform them when prototyping, researching, and/or testing a device. The intent of an MSA is to inspect the measurement system used to acquire data during testing and confirming if data is consistent between tests, hence repeatability and reproducibility. MSAs are not used to determine the efficacy of a device, just the variability in data to reason if the measurement system is accurate. Depending on the amount of tests that need to be run to determine the efficacy of a device, MSAs can take heavy amounts of computation, documentation, and overall time to complete.
Besides pre-market approvals, 510(k)s, and designation requests, do you believe that much of the slow down behind approving a medical device through the FDA lies in the testing that must be done to ensure claims are accurate? How much preparations should be made before contacting the FDA about a new device?
I think that it's great that MSA are being utilized as they can keep track of any inconsistencies and to ensure the integrity of the data. I do think that the slowdown in approving medical devices lies in the testing. While this can be frustrating for companies, I do understand the need for testing that is thorough and not rushed to ensure the safety and efficacy of the product. There have been drugs that have been taken off the market such as Ritonavir, a drug that was found to have a polymorph that had lower bioavailability. If further screening and research was done, the temporary removal of the drug from the market could have been avoided. While this applies to a drug and not a device, the same could occur for a device if thorough research and data is not obtained. While I cannot quantify how much preparation should be made before contacting the FDA about a new device, I do think it is important to exhaust all resources you possibly can to ensure a rather smoother process when it does come time to contact the FDA.
I have mentioned a drug that has temporarily been taken off the market which could have been avoided if further research and data was done, are there any devices in which something similar has occurred and what could have prevented it from being taken off the market?
I agree with the previous commentor: MSA is critical to making sure that you are providing exactly what you said you would. Without MSA, there would be no consistent or reproducible data to show that your device should be on the market. It takes time, yes, but that time is necessary to make sure that any relevant data is verifiable. One such device that was recalled is a defibrillator made by Physio-Control. It was recalled because there were over 30 cases of the device not delivering the needed electricity because of a loose connection between the battery and the device's electrical components. This was mainly seen in non-rechargeable devices. This device certainly could have benefitted from more wear testing being done. The problems with the battery and electrical component connection could have been noticed and those 30 cases of life-threatening situations may not need to have happened.
I absolutely believe that the slow moving process of the FDA approval process of a medical device is a sign that the system works. It is the FDA's duty to ensure that every product out on the has been throughly tested and analyzed to guarantee that what is claimed is true, the product does not cause any unintended harm, and to police corporations from cheating. Although slow moving, it also allows companies to innovate with a restrictions margin to create a safer more thoughtful product.
It is absolutely important that every claim made is verified to a certain percentage agreement in order to prevent a false product being put on market. Of course, exceptions can be made for emergency approvals or the like, but most medical devices or products should follow their applicable guidelines to gain government approval before declaring their product a market-viable option for consumers to choose from.
Although testing is a significant component of the slowdown behind the FDA process of medical devices, other components also impact the deceleration of the process. One of the components is meeting the quality standard of the manufacturing process for the medical devices. In other words, it is imperative to ensure that the device meets the quality standard and complies with FDA regulations before it can be put out for real use. Ensuring quality can therefore cause a delay in the FDA process. Another component that can cause a delay is the documentation throughout the process. Preparing extensive documentation for the steps taken during the manufacturing of the device can take a while and can slow down the process of FDA regulation.
In terms of preparation before contacting the FDA for manufacturing a new device, it is important to ensure that one has adhered to the FDA regulations and is compliant with all the paperwork at hand. Additionally, it is important to have accurate testing measures and results in place, as this is one of the biggest components of FDA regulation processes that allows the device to go through the regulations if it were to be put out in public. Lastly, it is also important to have proper documentation in place as this is another component that the FDA regulation process relies on when going through a medical device manufacturing process.
