When working on medical innovations, the focus is always on the overarching goal: the tool, device, or product that will enhance the lives of many. However, reaching that goal involves several steps, and a crucial component is clinical evaluation—not just at the end of the development process, but right from the start. Without clinical evaluation, a medical innovation will never make it to the market.
Holland Innovative's new training, "Clinical Evaluation," emphasizes the individual steps necessary to ultimately bring a product or service to the target audience. In a practical setting, participants not only understand the importance of clinical evaluation but also learn how to shape this process. The aim is to ensure that the claims associated with a product can indeed be substantiated.
Clinical evaluation is not an optional step; it is the key to successfully launching medical innovations. To emphasize this and support medical innovators, Lisanne Nannings and her colleagues at Holland Innovative have developed a training that delves into the intricacies of clinical evaluation. Nannings states, "We cater to both companies in the early stages of development and those who initially overlooked this aspect. For the latter group, we focus on post-market surveillance, which is a direct extension of clinical evaluation."
Meeting Diverse Needs
Holland Innovative's training is designed for both companies yet to conduct clinical evaluation and those already in the market seeking assistance in processing available data. Combining practical experience from the hospital with knowledge of laws and regulations, Nannings has guided various organizations in this area. She notes, "Through this experience, we identified a broader need, and this training aims to address that."
For those wondering why clinical evaluation is necessary, Nannings points not only to regulations ("It's a requirement") but also provides a compelling practical example. "Imagine being a passenger in an airplane that has never undergone testing. Sounds risky, doesn't it? Just as an airplane takes a test flight without passengers, you need clinical evaluation to safely bring your medical innovation to the market. It is the safety check for the medical world, and without this test, you risk unexpected turbulence and crash landings."
Smooth Test Flight
The training, titled "Clinical Evaluation and Data Analysis During Medical Device Life Cycle," offers participants the navigation map and skills to smoothly navigate this test flight. Nannings and her colleagues are finalizing details, with the plan to launch the first group in May 2024. The format will be a workshop with the option to bring in participants' cases.
With expertise in MedTech, data science, and regulatory affairs, Holland Innovative is the ideal partner for this training. "The combined knowledge of our team's experts allows us to assist participants quickly and concretely with their initial steps in the field of clinical evaluation. This is particularly valuable because it's not just about theoretical knowledge for us. Thanks to the varied competencies of our experts, we always have direct practical experience with relevant companies."
What You'll Learn in This Training:
- The impact of claims on the clinical evaluation process for medical products.
- Clinical data requirements throughout the entire life cycle of medical products according to EU-MDR.
- Conducting clinical evaluation and post-market surveillance (PMS) using a risk-based approach.
- Requirements for clinical research and when clinical research is mandatory.
- Basic statistical concepts for designing, analyzing, and reporting clinical research.
- Using PMS data for reliability analyses, performance evaluations, and trend analyses of complaints.
Join us on February 7th at the TechMed Centre in Enschede for our event "Life Cycle Management of a Medical Device". We will talk about the combination of MedTech and Reliability and discuss the benefits and applications of reliability in Design and Post-Market Surveillance with 4 different speakers. Moreover, we will address Clinical Evaluation and Reliability in the workshop given by our MedTech specialists Lisanne Nannings and Monique van Lier, and Scientific Director Reliability Coen Smits. Curious to learn more about Clinical Evaluation and the benefits of reliability in the life cycle management of your medical device? Register now and join us on February 7th!