Top Factors in Designing Effective Clinical Investigation for Medical Devices

Key Considerations for Designing a Successful Clinical Investigation for Medical Devices

Short Description

For a medical device to be effective and successful, it needs to go through medical device clinical trials. Clinical investigation for medical devices are indispensable in ensuring the safety and efficacy of medical devices so they meet regulatory requirements and become a part of healthcare technologies.

They are not just about gathering data; they provide assurance for regulatory approval and give healthcare professionals confidence in the devices’ safety and performance. There’s a lot involved in designing a successful medical device clinical trial. To understand clinical trials in India, we suggest reading the following post.

A Quick In-Depth to Medical Device Clinical Trials

Medical device clinical trials constitute rigorous testing and evaluation of medical equipment before they are made available to be performed on human subjects. They require systematic study of the device’s performance, safety, and potency in a controlled environment.

Clinical investigations follow the strict guidelines and protocols laid out by the regulatory bodies, as compliance with them is non-negotiable. The trials are conducted in multiple phases, from the small, controlled group to large-scale individuals.

The magnitude of medical device clinical trials doesn’t end here; these investigations help identify any risks or challenges associated with device usage, giving manufacturers a window to rectify the issues before seeking approval.

Different Phases of Clinical Investigation for Medical Devices

The clinical trials for medical devices are classified into various stages:

Phases	Explanation
Pilot Studies	Pilot studies for medical devices are conducted on a small population who have the condition or disease being studied. These studies aim to provide initial insights into the device’s performance and safety on subjects.
Pivotal Studies	Pivotal studies involve testing medical devices in a large population to obtain conclusive evidence of the device’s safety and effectiveness for intended use.
Post-market Surveillance Studies	Post-market surveillance studies are done to monitor the device’s performance and safety on participants after the device is marketed to confirm its long-term safety and performance.

Key Elements of Medical Device Clinical Trial Design

A crucial part of clinical trials is the study design, which establishes the methodology and data collection. The protocol ensures uniformity and strict standardization in the research process by outlining the objectives, methodology, goals, and statistical analysis strategy for the experiment.

Failing short on any of those could result in device manufacturers producing low-quality data. Let’s take a look at make-or-break factors in medical device clinical investigations that are fundamental in advancing patient care.

Sample Size

Think of sample size as one of the foundations of a medical device clinical trial process, as an incorrect sample size can produce unreliable conclusions, either by giving false positives or by failing to detect a true defect in the medical device. This could make the entire trial invalid. Suppose the sample size is too small; the trial may not have the statistical power to ensure the medical device’s efficacy.

Conversely, if the sample is larger than required, it could lead to a waste of resources without producing useful data. Hence, it is highly crucial to carefully do the sample size calculation based on the device’s required population size for the expected performance.

Primary and Secondary Endpoints

In a clinical trial, the primary endpoint is the main measure used to assess the effectiveness of the device being tested. Secondary endpoints, on the other hand, offer additional information about the device’s impact and how it works. It is essential to clearly define both primary and secondary endpoints in advance, within the trial’s protocol, to ensure accurate and r0eliable results.

Blinding

Blinding plays a quintessential role in medical device clinical investigations by reducing measurement bias, but it also comes with ethical and practical difficulties. When blinding isn’t possible, the alternative approach is to have the trial outcomes evaluated by experienced and certified people who are blind to the treatment details, which will ensure objective assessment.

Important Constituents of a Clinical Trial Design for Medical Devices

Fig. 1: Important Constituents of a Clinical Trial Design for Medical Devices

Clinical Trial Team

Since many manufacturers don’t have in-house clinical trial personnel, they prefer outsourcing services from CRO companies. A dedicated clinical research organization (CRO) helps manufacturers with their medical device investigations through protocol development, statistical analysis, data management, regulatory affairs, and other clinical trial aspects.

For a medical device clinical trial to be performed successfully and with perfection, manufacturers must remember to validate the experience of the CRO in medical devices or fields related to the same before proceeding with the investigations, so the reports are delivered on scientific grounds.

Skill Level and Training of the User

When planning a medical device investigation, it’s essential to take into consideration the skill set required for the safe intended use of the device. The expertise of study investigators should reflect the skill set of the intended user when the market sets foot in a real-world setting.

Additionally, the hands-on training provided to the trial team in the pivotal study should also be provided in the post-market setting. Some medical devices require considerable training to use the device safely and properly. For instance, medical implants require a specific skill set of a trained surgical specialist, especially when the use of the device is complex (1).

If the marketed device does not require any formal training, then the study personnel should also not be trained specifically for the device’s operations to ensure accurate results similar to post-market usage conditions.

Control Group Selection

Assembling the right control group is critical to the success of a medical device clinical investigation. Depending on the medical device’s nature as well as ethical considerations, the control group could range from a standard treatment group to a placebo group or a sham group.

Methods of Evaluation

For a clinical trial to be factual and transparent, the use of appropriate statistical methods is vitally important. Correct statistical approaches warrant that any differences observed between control groups in the trial are statistically concrete and not due to chance. Employing varied statistical analyses under various assumptions can help provide reliable results.

However, there’s a catch. Too much insistence on data collection through various statistical analyses can overwhelm the clinical staff, such as clinical investigators, nurses, and coordinators. This is commonly observed in early-stage companies and those with massive R&D budgets.

Fig. 2: Key Objectives of Medical Device Clinical Trials

Takeaway

Embarking on a clinical investigation for medical devices is a journey that requires precision and expertise at every step of the way. Here’s what we learned:

The clear and sound objectives and hypothesis of the clinical investigation is important for establishing a statistical analysis plan.

Medical device clinical trials involve effective enrollment strategies, data collection and management, and quality control.

Responsible clinical trials must be conducted within ethical considerations with strict adherence to guidelines laid by regulatory bodies.

The CDSCO and CLA are the regulatory bodies for medical device clinical trials in India.

All medical devices belonging to classes B, C, and D require medical device clinical investigation.

Successful clinical investigations for medical devices require meticulous planning, closely working with regulatory bodies, hundreds of hours of manpower, and adherence to the best practices—all to have safe and effective use of the devices in real-world usage conditions.

Although the process is complex, it is rewarding in the long term, ensuring the flow of cutting-edge technologies in the market and safeguarding the health of millions of people.

Reference

Design Considerations for Pivotal Clinical Investigations for Medical Devices; FDA; https://www.fda.gov/media/87363/download; November 2013

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Key Considerations for Designing a Successful Clinical Investigation for Medical Devices

Sample Size

Primary and Secondary Endpoints

Blinding

Clinical Trial Team

Control Group Selection

Methods of Evaluation

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