Navigating Clinical Evaluations and Investigations in MedTech

In an era where technological advancements and regulatory requirements are constantly evolving, the MedTech industry faces the critical challenge of enhancing both safety and performance in clinical evaluations.

This blog delves into the insights and experiences I shared, during one of the webinars with Greenlight Guru, where I offered a comprehensive understanding of the complexities involved in ensuring sufficient clinical evidence to adhere to regulations.

BONUS RESOURCE: Click here to access a free PDF with questions received during the live webinar on ‘’Align Your Clinical Claims with Your Clinical Investigation Safety and Performance Endpoints’’ answered by Helene Quie.

Understanding the criticality of safety and performance in clinical evaluations

In the MedTech industry, the criticality of safety and performance in clinical evaluations is paramount. My 25+ years of experience with numerous clients in this field highlights that the safety and performance of medical devices are not just technical milestones but are fundamental to the successful clinical evaluation and eventual acceptance by regulatory bodies.

These elements are integral to the trust and reliability placed in medical devices by healthcare professionals and patients alike.

The core objective: demonstrating compliance and presenting robust clinical evidence

The core objective in MedTech clinical evaluations revolves around demonstrating compliance with regulatory standards and presenting robust clinical evidence. This involves collecting and managing clinical data effectively in various study types, such as pre- and post-market studies, registries, and human factor testing.

The goal is to meet the regulatory requirements of regulatory bodies, like the FDA and the EU and ensure compliance with standards such as GCP and ISO 14155:2020 in order to establish the device's safety and efficacy in a clear, comprehensible manner.

BONUS RESOURCE: Click here to access a free PDF with questions received during the live webinar on ’Align Your Clinical Claims with Your Clinical Investigation Safety and Performance Endpoints’ answered by Helene Quie.

Common challenges: detailed data analysis and consistent documentation

In my experience, a recurring challenge lies in the meticulous analysis and presentation of clinical data. Often, there is a noticeable lack of detailed analysis and a coherent presentation, especially in the tables and references that form the crux of the data narrative. 

This leads to a disconnection between the conclusions drawn and the actual data presented. Additionally, inconsistencies are frequently observed across various documents, such as the clinical evaluation plan, clinical evaluation report, and risk management files, highlighting a lack of alignment in data collection and analysis strategies.

The role of post-market surveillance data

Post-market surveillance  data plays a crucial yet often underutilized role in MedTech clinical evaluations. This data, derived from both similar and the company's own products, needs to be analyzed with the same rigor as the primary data.

Such an analysis is essential for integrating this valuable information into the overall clinical assessment, providing a more comprehensive understanding of the device's performance and safety in real-world settings.

BONUS RESOURCE: Click here to access a free PDF with questions received during the live webinar on ‘Align Your Clinical Claims with Your Clinical Investigation Safety and Performance Endpoints’ answered by Helene Quie.

Bridging gaps: from clinical objectives to investigative data

A critical aspect in MedTech clinical evaluations is the clear definition of clinical endpoints within the clinical development plan. Often, there is a gap between the state-of-the-art, defined safety and performance objectives, and the actual data collected during clinical investigations.

As highlighted in the webinar, this gap can lead to discrepancies between the intended clinical objectives and the outcomes of the investigations, underscoring the need for precise and well-defined clinical endpoints.

Addressing clinical benefit and claims: a regulatory perspective

From a regulatory perspective, distinguishing and accurately representing clinical benefits and claims is a critical aspect of MedTech evaluations. The EU MDR and MDCG stress that claims about a product's intended purpose, safety, and performance must be supported by factual evidence and data.

This process therefore involves close collaboration between regulatory teams and marketing departments to align the product's market expectations with its actual clinical benefits. Such alignment is crucial for adherence to regulations like the MDR which mandates that medical device claims must not be misleading and should be supported by concrete clinical evidence.

Risk management and benefit-risk assessment

Risk management in MedTech, as guided by standards like ISO 14971:2019, is central to identifying, analyzing, and assessing the risks associated with medical devices. This process is intertwined with the benefit-risk assessment, which is a pivotal part of the regulatory framework, including the MDR.

The benefit-risk assessment involves a thorough analysis of the identified benefits and risks of the medical device, ensuring that the benefits outweigh the risks. This assessment is not only a critical component of the design and development process but also plays a significant role in the clinical evaluation and post-market surveillance of the device, helping to ensure its safety and efficacy throughout its lifecycle.

BONUS RESOURCE: Click here to access a free PDF with questions received during the live webinar on ’Align Your Clinical Claims with Your Clinical Investigation Safety and Performance Endpoints’ answered by Helene Quie.

Balancing safety, performance, and intended use

Defining the right performance criteria and data to support the intended use of a medical device is a complex yet crucial task. The intended use, as defined by the EU MDR, encompasses the purpose, users, patient population, medical conditions to be addressed, and the device's operational principles.

Manufacturers must meticulously detail this intended use, ensuring it aligns with the device's description, indications, and functionalities. This process, though seemingly straightforward, often becomes intricate, requiring a careful balance between the device's intended use and the performance data needed to demonstrate its safety and effectiveness.

Seeking guidance from regulatory bodies like the FDA can be beneficial, especially when determining what performance data to collect and the methods to use, supported by both preclinical and clinical investigations.

Best Practices for Defining Outcome Parameters

Defining outcome parameters in MedTech clinical investigations requires a collaborative and multidisciplinary approach. It involves engaging clinicians, patients, and subject matter experts to ensure the relevance and feasibility of these parameters.

Conducting pilot studies and seeking feedback from regulatory agencies are essential steps in refining these parameters. This approach ensures that the outcome parameters are not only theoretically sound but also practically applicable and aligned with the needs of end-users and regulatory requirements.

Maintaining a dynamic, circular regulatory pathway

The journey of bringing a medical device to market is intricate and multifaceted, demanding a deep commitment to comprehensive evaluation and continuous improvement. In this complex and ever-evolving MedTech landscape, the importance of aligning clinical evidence with regulatory requirements cannot be overstated.

Companies must adopt a holistic approach that encompasses not just the initial clinical evaluations but also continuous post-market surveillance and feedback mechanisms. This ensures not only compliance with regulations but also the delivery of safe and effective medical technologies that truly meet the needs of patients and healthcare providers.

Partner with Greenlight Guru and Qmed Consulting

Navigating the complex landscape of clinical data in MedTech is a challenging endeavor, one that requires precision, compliance, and an understanding of nuanced regulatory requirements. This is where Greenlight Guru Clinical and Qmed Consulting can help!

Greenlight Guru Clinical is designed with the MedTech industry's unique needs in mind. Our EDC software solution simplifies the process of collecting and managing clinical evidence, as well as safety and performance data, across all phases of the medical device lifecycle. From pre-market studies to post-market surveillance, our tool is adept at handling diverse data requirements with ease.

If you're looking to elevate your MedTech study's data handling capabilities, get a free demo of our software and experience firsthand how it can transform your clinical investigation process.

Should you require strategic consulting services in connection with device approval in Scandinavia or internationally, Qmed Consulting is your best bet! A full-service CRO, Qmed helps clear the path for new medical devices and new ideas based on project management, best-in-class expertise in clinical trials, clinical development, regulatory affairs, quality management and commercial healthcare.

When you partner with Qmed Consulting, you acquire direct access to a team of highly skilled professionals with more than 100 years of experience working in the field of medical device and IVD approval.