Jeanette Demorney
Director, Clinical Development – GBA Key2Compliance
Ever wondered how a MedTech Contract Research Organization (CRO) like GBA Key2Compliance can streamline your journey in the medical device and In Vitro Diagnostic (IVD) landscape? Let’s dive into how our critical support during clinical evaluation and strategic development can propel your project towards success.
Understanding the Terminology
In the world of medical devices and IVDs, terminology can sometimes be confusing.
Here’s a quick guide to help you navigate:
- Clinical Evaluation (Medical Devices): This refers to the ongoing process of assessing and analyzing clinical data pertaining to a medical device to verify its safety and performance.
- Performance Evaluation (IVDs): For In Vitro Diagnostics. It involves assessing the analytical and clinical performance of an IVD to ensure it meets its intended purpose.
- Clinical Investigation (Medical Devices): This term is used for clinical investigations conducted to assess the safety and performance of medical devices.
- Clinical Performance Study (IVDs): Similar to clinical investigations, but specific to IVDs, focusing on their performance in a clinical setting.
In this blog, we will use the terms associated with medical devices, but the steps described in this blog are essentially the same for IVDs.
It’s also important to note that the regulatory frameworks are different: Medical Devices are governed by the Medical Device Regulation (MDR), while In Vitro Diagnostics fall under the In Vitro Diagnostic Regulation (IVDR). The standards for conducting these studies also vary, with ISO 14155 applicable to medical devices and ISO 20916 for IVDs.
Clinical Evaluation and Strategy
The first step is all about setting a solid foundation. At GBA Key2Compliance, we evaluate your medical device or IVD against the current market and clinical landscapes. This isn’t just about ticking regulatory boxes; it’s about crafting a clinical strategy that aligns with both your business goals and the relevant regulations. Our job is to map out a clear roadmap for clinical development, starting with a Clinical Evaluation Plan (CEP). This plan details the scope, methods, and data sources that will be used to assess your device’s safety and performance throughout its lifecycle, ensuring ongoing compliance and market relevancy.
The Clinical Development Process Life cycle
Concept and Feasibility: Setting the Stage
Before diving into the deep end, we conduct a thorough assessment to ensure your project’s scientific and practical feasibility. This phase includes creating a Clinical Development Plan (CDP), an integral part of the CEP, which outlines the specific studies necessary to support your device’s safety and performance claims.
Pilot, Pivotal, and Post-Market Clinical Study Stages Simplified
Each phase has its own time and place, much like gathering clinical data. Let’s break down these steps and their significance:
- Pilot Stage: We start by answering the question “Will it work?” Here, we assess both practical feasibility and initial safety concerns to establish a strong basis for moving forward.
- Pivotal Stage: Next, we tackle “Does it work as we planned?” This involves rigorous testing to validate both the safety and performance of the device, preparing it for a successful market launch.
- Post-Market Stage: Finally, we ask “Is it still working?” Post-launch, we continuously monitor the product’s performance and safety, ensuring it remains effective throughout its market life.
Clinical Studies: From Plan to Action
Transitioning from planning to action, we focus on designing and executing clinical studies for your medical device or IVD.
Our steps include:
- Study Preparation and Design
We set clear objectives based on the CEP, ensuring alignment with regulatory needs and market demands. Key steps involve defining endpoints, choosing appropriate study populations, and integrating statistical and data management methods from the outset. At this stage, the clinical study plan, which underpins the entire study execution, is developed. For medical device studies, this is called the Clinical Investigation Plan, and for IVD studies, it’s the Clinical Performance Study Plan. Additional study documentation, such as consent forms and the Investigator’s Brochure (if not already available), is also prepared. - Application to Competent Authorities
To conduct a study on a non-CE-marked product (or where the product will be tested outside its intended purpose), approval from ethics review boards and medical product agencies (or equivalent authorities) is required. This process can seem complex to the uninitiated, with various factors influencing requirements and application processes. Essentially, it involves demonstrating that the benefits of testing the product on humans outweigh the risks and ensuring all necessary measures to protect human welfare have been taken. According to ethical guidelines, clinical studies involving humans should only be conducted when no alternative methods are available to obtain the necessary data to demonstrate the product’s benefits and necessity for users. - Study Execution and Analysis
We manage clinical studies with a focus on protocol adherence and data integrity. A key aspect during the study is ensuring the quality of collected data and the safety and integrity of trial participants. Monitors (CRAs) and data managers ensure everything proceeds according to the study protocol. At the study’s conclusion, we compile all data for statistical analysis, ultimately preparing a Clinical Investigation Report. This report underpins any publications about the study’s conduct and results. Finally, the Clinical Evaluation Report is updated with new data, substantiating your device’s safety and performance claims.
Navigating Regulatory Submission and Market Strategy
Navigating the complex regulatory environment is smoother with a strategic partner. We prepare your submissions to the Notified Body with an eye towards compliance and efficiency, ensuring your go-to-market strategy is robust and responsive to regulatory feedback. Our market strategy expertise extends beyond compliance, helping you understand competitive dynamics and developing a compelling value proposition for your product.
Post-Market Surveillance – Continuous Improvement
Our support doesn’t end once your product hits the market. We implement ongoing surveillance strategies to monitor safety and performance, feeding insights back into your lifecycle management. This ensures your product remains at the forefront of quality, safety, and efficacy throughout its market life.
By integrating clinical evaluation and strategy into every phase of development, a MedTech CRO not only ensures compliance but also enhances your product’s potential for success in the marketplace.
Interested in turning your innovative ideas into market-ready solutions?
Contact us today and let’s talk about how we can work together to implement strategic clinical planning and bring your project to reality.