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What is a clinical investigation of medical devices: Devices must undergo numerous testing procedures before being approved for patient use, just like pharmaceuticals. However, trials for medical devices are usually more manageable and involve fewer stages. Clinical investigation for medical devices can be defined as the investigation of a medical device on humans to establish and verify the safety and performance of the medical device. The device being tested can be a new medical device or a medical device already marketed in any country. The objective of a clinical investigation is to assess the safety and performance/efficacy of the device in question and evaluate whether the device is suitable for the purpose(s) and the population(s) for which it is intended (ISO 14155-1:2020). The general guidelines for conducting clinical investigations are described in ISO 14155-1:2020 Clinical Investigation of Medical Devices for Human Subjects - General Requirements. Clinical investigation plans are described in detail in ISO 14155-2:2020 Clinical Investigation of Medical Devices for Human Subject - Clinical Investigation Plan. Clinical investigations must consider the accepted ethical standards surrounding the use of human subjects and the scientific principles underlying clinical data collection. The clinical investigation plan should include a description of the clinical investigation's goals and methodology.
What is a medical device: A medical device is any device that can be used by people alone or in combination (as defined by the manufacturer) for a medical purpose. This includes any equipment, software, materials, or other items. The term "medical device" refers to several items, including breast implants, walking sticks, and contact lenses.
• All Class III and Class IIb implantable devices in the EU are subject to clinical trials by EU MDR.
• The FDA demands clinical investigations for all Class III devices in the US as part of premarket approval (PMA).
• In India, Class B, Class C, and Class D risky medical devices are subject to clinical investigation without justification. Class A medical equipment may not require collecting clinical investigation data, with a few exceptions.
Factors to keep in mind while designing the clinical investigation for medical devices:
Sample size: It is often impossible to conduct a clinical study for a medical device involving the target population, particularly if the population size is indefinite. Instead, we conduct research using a sample of the population in the hopes that the data we gather will allow us to conclude the entire population. Therefore, calculating sample size for medical device studies involves figuring out the bare minimum of samples needed to make a study's outcome or outcomes statistically significant (more reliable in statistics).
Assessment of results for clinical trials on Medical Devices: The clinical trials of medical devices are funded mainly by the industry thus, are prone to report positive responses so that outcomes are in favor of the investigation. Therefore, it is important to report results based on scientific grounds.
Outsourcing the experts: Most medical device manufacturers do not have an in-house Clinical trial team, so they export the team or collaborate with other teams. As a result, there is an increased demand for clinical research organization (CRO) companies. Medical device manufacturers need to see the experience of the CRO before working as if they have experience in medical devices or related field.
Expert team: Manufacturers need an expert team with scientific knowledge to help them design the clinical investigation plan for a medical device.
Regulatory requirements: Besides these points, manufacturers must understand the different regulatory requirements of clinical investigation. After the new medical device regulations, the responsibilities of conducting clinical studies have increased. It is important that all the economic participants, including the producers of medical devices, authorized representatives, importers, and distributors, should have clearly defined interactions with one another.
Five essential Traits for medical device clinical trials:
Five vital traits in medical device clinical trials | Rationale |
Low participant enrolment | Endpoints that demonstrate a "reasonable assurance of safety and effectiveness" typically have small sample sizes. Other times, logistical difficulties make carrying out more extensive research impractical. |
Blinding | Blinding is one of the most crucial components of clinical trials because it lessens the measurement of bias caused by the partiality of the observer, the doctor, or the patient. Blinding is considered more challenging in randomized clinical trials of medical devices compared to the randomized clinical trials of pharmacological. The medical device manufacturer needs to keep in mind that the outcome of the blind assessment should be planned with trained staff who can assess the outcome. |
The design of the trial or procedure can be modified. | In some cases, the trial's design can be changed based on the feedback received from the researchers or patients. If it can be demonstrated that data from the original device or procedure is appropriate to leverage, validation of the changes may not require a completely new study but additional clinical data beyond the original plan. |
Existing data may occasionally completely or partially replace prospective trial data. | The clinical data readily available outside of prospective studies is considered by regulators like the FDA and EU-MDR to assist marketing applications. This is especially important when considering expanded indications for approved devices when there is a body of research supporting the "off-label" use, and it might be challenging or even immoral to assign participants at random. |
Numerous device trials evaluate incremental advancements over devices from earlier generations. | While some devices are novel, device development is typically an iterative improvement on current technologies as clinical experience and scientific knowledge increase. Clinical data are frequently needed, though they may not be as extensive as for the original device, to assess the risks and benefits of the new device. |
Conclusion: Designing and conducting clinical investigations for medical devices requires careful planning and adherence to established best practices. Several factors need to be considered to ensure the success and reliability of these trials. Successful medical device clinical trials require careful planning, objectivity in reporting results, collaboration with experienced CROs, the expertise of an expert team, and compliance with regulatory requirements. By following these best practices, manufacturers can establish the safety and effectiveness of their medical devices, ensuring their suitability for the intended use and population.
