In our previous article, Research Phases in Clinical trials, we discussed how clinical research is divided into a series of phases for investigational medicinal products, new drugs, biologic products and/or methods/therapies.
In this follow-up article we focus on clinical trial investigations for medical devices, also known as Medical Device trials.
The Research Stages: Medical Device Trials
Based on the risk assessment, medical devices can be divided into three general stages of clinical development. The medical devices trials are typically divided into the following: pilot, pivotal and post-market stages. Each stage is designed to answer specific questions and needs to be completed successfully before moving on to the next stage.
Stage I: Pilot Stage
The first stage for clinical development evaluates the limitations and advantages of the investigational device. During this stage, preliminary information is collected, and the medical device is tested for its feasibility and safety. Further, the design of the medical device and its technical parameters are evaluated.
The aim of a Pilot Stage is to determine:
- Risks and benefits of the investigational medical device
- Firs in human, early feasibility and/or traditional feasibility clinical investigations
The pilot stage has three different phases: product viability, preclinical research and prototyping, product development and testing.
Product Viability
This phase outlines the needs or unmet needs that the investigational device will fulfill/meet, how the device would work and in which markets, the potential risks the device would pose to patients, the expected risk classification with necessary risk management procedures, and estimated timelines and costs.
The question of this phase:
- Is the medical device viable, financially viable, and feasible?
Preclinical Research and Prototyping
The second phase is a proof of concept study via prototyping and consists of testing the prototype within controlled laboratory environments. At this stage, the device is not ready to test on human subjects yet.
The question of this phase:
- Does the device work?
Product Development and Testing
The third phase consists of fine tuning the design and developing the device that meets the regulatory requirements. In this phase, the effectiveness and safety of the investigational medical device is compared to the current standard treatment. Depending on the device’s risk classification, first in human clinical investigations, early feasibility and/or traditional feasibility clinical investigations are performed.
To receive approval in the next stage, medical devices with class III risk classification need to submit scientific evidence showing that the device’s benefits outweigh its risks and that it will help a significant portion of the population. In order to translate these techniques to clinical practice, the next step would be to conduct a pivotal trial.
The question of this phase is:
- Is the investigation medical device ready for approval?
Stage II. Pivotal Stage
The pivotal stage for clinical development evaluates the clinical performance and effectiveness of the investigation medical device in a greater patient population. Clinical performance reflects to the ability of the device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose, thereby leading to a clinical benefit for patients. Documentation for clinical performance might include details on laboratories and facilities for production and the results of related clinical and pre-clinical studies.
The aim of a Pivotal Stage is:
- To evaluate clinical performance of the investigational medical device
- To submit device for testing, review and approval
Medical devices in risk classes IIa, IIb, III and IVD B, C, D must be tested and approved by Notified Bodies, like the FDA, and the MHRA.
Stage III. Post-Market Stage
After receiving approval, the investigational device moves to its final stage. Stage III for Medical Device trials is the same as the last phase for IP trials: post-marketing surveillance. The medical device is monitored for possible safety and performance issues and additional information is gathered about long-term safety, efficacy and optimal use.
The aim of a Post-Market Stage is:
- To confirm effectiveness
- To provide additional information including risk, benefits and best practice
Keywords: Research Compliance, Research Operations, Clinical Development, Clinical Operations.
References
- National Institute of Biomedical Imaging and Bioengineering (NIBIB). (n.d.). Medical devices. Retrieved May 2025, from https://www.nibib.nih.gov/programs/medical-devices
- European Medicines Agency (EMA). (n.d.). Human regulatory overview: Medical devices. Retrieved May 2025, from https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices
- U.S. Food and Drug Administration (FDA). (n.d.). Medical devices. Retrieved May 2025, from https://www.fda.gov/medical-devices
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