Like all products in the medical field, medical devices undergo intense scrutiny and clinical trials before they’re given the ok. In general, the process of approval for medical devices is similar to that of new drugs produced by pharmaceutical companies. Hospitals, the FDA, and other medical institutions simply cannot risk using unproven or unsafe medical devices on patients. However, there are certain exceptions to this rule, as we’ll soon discover.
What are Medical Devices?
There is a wide range of medical devices used in medicine today. Medical devices are any pieces of technology, software, or equipment used explicitly for medicine. These devices can range from simple scalpels or bedpans to complex pieces of machinery used for robotic surgeries.
What are the Different Classifications of Medical Devices?
Because there’s such a broad range of medical devices and they’re very different, there are different classification systems to divide them into categories. This classification system is useful for dividing devices according to their level of risk.
Class I Medical Devices
Class I medical devices are the most low-risk devices used in medicine. They consist of bedpans, bandages, tongue depressors, crutches, etc. They present little to no risk of hurting a patient, which often doesn’t require a clinical trial.
Class II Medical Devices
Class II medical devices are slightly more dangerous and high-risk than Class I devices. They consist of scalpels, hypodermic needles, gauze bandages, insulin pens, lung ventilators, or knee prostheses. Depending on the specific device in question, you may need a clinical trial for Class II medical devices.
Class III Medical Devices
Class III medical devices are the devices that present the highest risk to a patient if they don’t work or if they malfunction. Medical devices considered Class III are things like pacemakers, spinal cord stimulators, and defibrillators. Essentially, any medical device listed as Class III is a life-sustaining or vital piece of equipment that will cause death or severe injury if it malfunctions.
Are There Some Medical Devices That Don’t Require Clinical Trials?
Depending on the country where you’re developing your medical device, you may or may not need a clinical trial before it goes to market. It probably goes without saying, but all Class III devices require extensive clinical trials. These devices will cause death or life-threatening injuries if they malfunction.
It’s somewhat hit-and-miss whether your Class II medical device requires a clinical trial. Lower risk ones, such as needles, gauze dressings, or TENS devices, often don’t require a trial. Lung ventilators or ultrasound machines, however, most likely will.
Class I medical devices often don’t require clinical trials save for notable exceptions in the United States and many countries worldwide. However, in the EU, all Class I devices require clinical trials before going to market. In other places, such as Australia, a special organization must approve your medical device before it can be used. This is similar to how the FDA operates in the United States. While your device may not require a clinical trial, it must receive FDA approval before you can send it to market.
What Do Clinical Trials for Medical Devices Look Like?
Most Class I medical devices don’t require clinical trials, so they are excluded from this process. However, for all Class III devices and the Class II devices that require trials, here’s how the process works.
Pre-Clinical Research
Pre-clinical research involves developing a prototype and a series of tests. This stage typically involves animal studies, simulations, bench testing, and technical testing, all of which are useful to determine the safety and capabilities of the product.
Early Feasibility Study
The early feasibility study is a small, preliminary study that uses 10 to 40 volunteers. The general safety and workability of the device are studied during this stage of the clinical trial.
Pivotal Study
The pivotal study is a larger version of the early feasibility study. It usually incorporates several hundred volunteer subjects and is used to better understand how your device will perform on a broad stage.
Regulatory Review
This stage is essentially used to decide if the medical device is ethical and effective at its intended purpose.
Market Approval
Once you’ve passed all your required clinical trials necessary for your specific device, you are then approved to request market approval and move forward in selling and distributing your device.
The process may vary slightly depending on the device and where it’s marketed. However, this is generally what to expect during the clinical trial process.
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