Best Practices for Designing Medical Device Clinical Investigations

What is a clinical investigation of medical devices?

Devices, much like pharmaceuticals, must go through extensive testing processes before gaining approval for use on patients. However, Medical Device Clinical Investigations tend to be more manageable and involve fewer stages compared to pharmaceutical trials. Clinical investigation concerning medical devices involves examining a medical device’s safety and performance on human subjects. This investigation can involve either a completely new medical device or one that is already available on the market in any country.

The primary aim of a clinical investigation is to assess the device’s safety and effectiveness, evaluating its suitability for the intended purpose and target population (as outlined in ISO 14155-1:2020). ISO 14155-1:2020, titled “Clinical Investigation of Medical Devices for Human Subjects – General Requirements,” provides overarching guidelines for conducting clinical investigations. Furthermore, ISO 14155-2:2020 delves into clinical investigation plans, offering detailed guidance.

It is imperative for clinical investigations to adhere to ethical standards governing human subject participation and the scientific principles governing data collection in clinical settings. The clinical investigation plan should comprehensively outline the investigation’s objectives and methodology, ensuring that it aligns with accepted standards and regulations.

What is a medical device?

A medical device encompasses any device that, according to the manufacturer’s definition, is intended for medical use either individually or in conjunction. This category encompasses a wide range of objects, such as equipment, software, materials, or other related items. The designation “medical device” encompasses a variety of products, including breast implants, walking aids, 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.

Best Practices for Designing Medical Device Clinical Investigations

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

Meticulous planning and adherence to established best practices are essential when designing and executing clinical investigations for medical devices. Several critical factors must be taken into account to guarantee the efficacy and dependability of these trials. Achieving success in medical device clinical trials necessitates thorough planning, unbiased reporting of findings, collaboration with experienced Contract Research Organizations (CROs), the involvement of a proficient team of experts, and strict compliance with regulatory mandates. By adhering to these best practices, manufacturers can validate the safety and efficiency of their medical devices, confirming their appropriateness for their intended purpose and target population.

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Best Practices for Designing Medical Device Clinical Investigations

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