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Medtech Business Review | Friday, June 02, 2023
Researchers conduct clinical trials in which specific interventions are given to study participants based on protocols or guides created by them. Clinical trials are also necessary to test and develop many medical devices.
Clinical trials are studies in which specific interventions are administered to participants according to a protocol or guide developed by the investigators. Numerous medical devices are also interventions that must undergo similarly stringent testing and development via clinical trials.
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The Food and Drug Administration (FDA) has defined three regulatory classes that can be assigned to generic categories of medical devices.
Class I consists of noninvasive medical devices with the lowest risk level. The malfunction of these devices poses minimal risk to the user and patient. Class I medical devices include wheelchairs and splints, as examples. Most class I devices are 510(k) Exempt and do not require FDA approval.
Class IIa consists of invasive medical devices with low to moderate risk. Typically, these are applied to the body for at least one hour and no longer than thirty days. Hypodermic needles and dental fillings are examples of medical devices in class IIa.
Class IIb consists of invasive medical devices with moderate to high risk. Typically, these are administered to the body for more than 30 days. Lung ventilators and bone fixation plates are examples of medical devices from class IIb. All class II medical devices must obtain FDA approval, typically through the 510(k) process.
Class III contains invasive medical devices that pose the greatest level of risk. The malfunction of these medical devices poses a grave risk to both the patient and the user. Included in this category are pacemakers and prosthetic cardiac valves. Class III medical devices are severely regulated and require FDA pre-market approval based on substantial clinical evidence.
Medical devices and investigational drugs follow a comparable path to human testing
Before human testing can commence, a device prototype must undergo multiple cycles of preclinical testing to ensure that the final product has the safest and most effective design. Similar to preclinical pharmaceutical research, researchers can evaluate medical devices using laboratory testing, technical testing, computer simulations, and animal testing at this stage.
Before FDA approval, an Institutional Review Board must review and approve key study documents, such as the protocol and informed consent forms, for medical devices requiring testing in clinical trials. As with novel drugs, the trial cannot commence until the sponsor and testing site(s) have received all required approval notices. The approval procedure for medical devices typically takes three to seven years, whereas it can take up to twelve years for drugs.
Unlike clinical trials for pharmaceutical products, clinical trials for medical devices are divided into stages as opposed to phases
Both types of interventions may endure a Phase 0 study, also known as the first-in-human stage, in which 10 to 30 participants are recruited to collect preliminary safety and efficacy data. This is the only time medical device trials enroll as many or more participants as pharmaceutical trials.
Phases I and II aim to test early formulations of a drug on up to hundreds of healthy humans and patients with the indicated condition, respectively. In contrast, the conventional feasibility phase of medical device trials evaluates the safety and efficacy of a nearly finalized product in only 20 to 30 patients with the target indication.
New drugs and medical devices that reach Phase III or the pivotal stage are evaluated further to corroborate their safety and efficacy. Whereas blinding and placebos can be utilized in drug trials, device trials are frequently only controlled with a group that does not receive the intervention. Phase III pharmaceutical studies can include hundreds to thousands of patients with the target indication, whereas pivotal stage studies for medical devices only have hundreds.
In Phase IV or the post-marketing surveillance phase, the safety and efficacy of both categories of interventions in the general population continue to be monitored.
Various highly trained healthcare professionals administer clinical trials for medical devices.
Most drug site-based clinical trials necessitate an investigating physician, one or more clinical research coordinators or nurses, pathology personnel, and third-party vendors. Depending on the device, medical device trials also require specially trained technicians, programmers, medical imaging personnel, and psychologists or physiotherapists.
Many characteristics of clinical trials for medical devices and pharmaceuticals are shared. Despite their few distinctions, clinical trials for medical devices, like those for pharmaceuticals, play a crucial role in facilitating the approval of safe and effective clinical interventions through collecting high-quality data.
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