When designing a medical device for mass production and distribution, it is important to keep in mind that there is a more intensive process than the development, sourcing, and production. Before being put to use in the field, a medical garment needs to go through extensive clinical trials before being certified for distribution and application by the FDA.
While designing a medical garment or device from scratch, there are many steps you must go through before it hits the market. One of the most important and influential steps is putting the product through a field test. The official definition of a field test is “to test something in the environment in which it will be used”. This is perhaps the truest way to ensure the reliability and future successes of your product. If there are any faults that occur during the field test, this also provides a foundation from which you can build future improvements for your device.
Field testing and clinical testing can go hand-in-hand when it comes to developing a medical device. While field testing tests how the product holds up against the elements, a clinical trial could be conducted simultaneously, but would test that the product actually does what it promises to do to improve quality of life.
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Clinical Trials and Classes of Medical Devices
The U.S. Food and Drug Administration (FDA) define a medical device as “any healthcare product that does not achieve its principal intended purposes by chemical action or by being metabolized” (Source). A medical device can be something as small as a pair of medical gloves, or as innovative as an implanted wearable organ; any medical device needs to undergo testing to prove that they will be able to uphold the standards and quality that they claim to have with small margin of error or failure. With reason, the tests that a wearable organ undergoes will be far more rigorous than those of the medical gloves. There are two major tests that the FDA requires devices to pass: the 510(k) Premarket Notification, and the Premarket Approval Application.
Medical Devices Classes
There are three main classes of medical devices. Class I devices require the least testing, as they are not devices required to sustain life (ex: medical gloves). Class II devices are devices that require additional testing, as Class I testing would not be sufficient trial to assure the safety of the product. Class II devices are oftentimes used to improve the quality of life, but not designed to directly sustain life (ex: powered wheelchair). Class II devices require the 510(k) test. Class III devices require the highest level of testing and regulations, and are high-risk devices (ex: artificial replacement heart valve).
510(K) Testing Requirements
Testing in order to receive the 510(k), or premarket notification, can change based on what you are testing. The goal of your testing should be to prove the soundness and safety of the clinical features, the biocompatibility of the materials, the durability, and any other applicable areas of your device. Though it may seem straight forward, there are many stipulations to the 510(k) testing (Source). For example, where and for what purpose the device was developed can depend on the extensiveness of testing. This test regulates mainly Class II devices and can be run on Class III devices as well.
The Premarket Approval Application is the process that allows the FDA to regulate the development and distribution of Class III medical devices. The PMA procedure is the strictest testing process run by the FDA, as Class III devices are those that sustain human life. It’s crucial that these devices function without error, as failure could be fatal. A PMA is essentially the highest safety certification granted by the FDA that allows you to distribute and market your device.
The easiest way to conduct clinical trials is working with an experienced consulting firm. We advise working with a firm that prides themselves on providing affordable and high-quality clinical research services and auditing. This will aid in the data collection necessary to the submission of 510(k) or PMA applications to the FDA. (Read more about working with a consultant below.)
The clinical trials of medical devices can sometimes add years to the development of a product before distribution and production, but the FDA certification is necessary for the safety of any and all users – and will undoubtedly be a selling point for your brand.
Working with a Consultant
The most efficient and common way to go about running a clinical trial is to work with a clinical trial consultant. Working with a consulting team is not only efficient, but it is a “one-stop-shop” for recommendations on development on your product, planning and execution, and thorough testing in order to make sure that your device meets regulatory standards despite what class device it is. We recommend working with a consultant through the developmental stages of your project all the way through the clinical testing. Their input during the preliminary stages of your product can alter the way it is created, and therefore alter the work that you do with your manufacturer.
At Fieldtex, we have experience working with clients and their consultants, and have developed a Field Testing system that involves producing short-run clinical and field testing production lines of 25 (or more) products in order to allow any potential issues (material or technology wise) to be found and checked against the device regulations prior to any further steps. This expedites the approval process of the FDA as well, as you have been working with guidance the entire way from development to mass-production, and will also expedite production, as it is a pattern that is already developed with the manufacturer and they have already experienced the production process of your device.
Clinical trials and Field Testing are a way for you to not only assure the safety of the users of your Medical Device, but also assure that the performance of your device is up to standard as well.
Additional Reading for those who are changing their Medical Device Technology: Changing your medical device: 6 things you need to know