In our previous article, Phases in clinical trials, we talked about how clinical research is broken up into a series of phases, each with a different purpose and distinct hurdles to clear before moving forward. We then focused on phases I-IV in IP trials.
In this follow-up article we will discuss medical device clinical investigation, also known as MD trials. The approach to testing medical devices is fairly similar to testing drugs and is also divided into phases (here: stages), typically three main ones.
The 3 Stages For Medical Device Clinical Investigation
Based on the risk assessment, medical devices can move through three general stages of clinical development. Each stage is designed to answer specific questions and needs to be completed successfully before moving on to the next stage.
Pre-market (before market approval of the investigational device)
I. Pilot Stage
II. Pivotal Stage
Post-market (following market approval of the investigational device)
III. Post-market Stage
I. Pilot Stage
The first stage for clinical development evaluates the limitations and advantages of the investigational device. The main goal is to gather preliminary information.
The Pilot Stage has three phases:
- Product Viability
The first phase answers the question: Is the medical device (financially) viable and feasible? It outlines the (unmet) needs that the investigational device will satisfy, how it 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. - Preclinical Research and Prototyping
The second phase answers the question: Does the device work? It’s a proof of concept study via prototyping and consist of testing the prototype within controlled laboratory environments. At this stage, the device isn’t ready to test on human subjects yet. - Product Development and Testing
The third phase answers the question: Is the device ready for approval? It consists of fine tuning the design and developing a device that meets all the regulatory requirements.
This is also the phase that, depending on the device’s risk classification, First in human clinical investigations, Early feasibility clinical investigation 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.
During this phase, medical device clinical investigations compare the safety and effectiveness of the investigational device against the current standard treatment.
II. Pivotal Stage
The second stage for clinical development evaluates the clinical performance. It answers the question: Is the device safe and effective for patients? It consist of submitting the device for testing, review and approval. Documentation might include details on laboratories and facilities for production and the results of related clinical and nonclinical studies.
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. For lower classes (I and A), you’re allowed to approve products yourself.
III. Post-market stage
After receiving approval, the investigational device moves into its final stage. Stage III for MD trials is the same as the last phase for IP trials: post marketing surveillance.
This stage answers the question: What else do we need to know? The medical device is monitored for possible safety and performance issues and additional information is gathered about long-term safety, efficacy and optimal use.
Stage III’s main goal is to establish performance, to confirm effectiveness and to provide additional information after approval, including risk, benefits and best use.
- Medical device clinical investigation example
Diagram is the CRO for the PARCADIA trial, a prospective, multi-centre, clinical trial to provide prospective data on the relationship between appropriate ICD intervention and LGE-CMR imaging in a MADIT II population with ischemic cardiomyopathy and prophylactic ICD. (Sponsored by BIOTRONIK SE & Co. KG , Contract research organization Diagram BV, ClinicalTrials.gov Identifier: NCT04014946)
We support your medical device clinical investigation
Are you a producer or manufacturer and do you need a clinical evaluation, clinical evidence or a performance study?
Get in touch today, the first batch of Diagram employees received their ISO14155 certification: Clinical investigation of medical devices for human subjects – Good clinical practice and we’re ready to support you.