ISPO UK ASM 2023 - Blatchford Lecture

The role of clinical investigation in medical device innovation

 

Presenter:     Jóna Valgerður Kristjánsdóttir, Clinical Evaluation & Investigation Specialist,
                       Medical Office, Research & Development, Ossur, Iceland

E-mail:          jvkristjansdottir@ossur.com

 

Jóna Valgerður Kristjánsdóttir has been working as a clinical investigation and evaluation specialist in research and development in Össur, Iceland, with a focus on lower limb prosthetics for the past six years. She holds a bachelor's degree in Biomedical Engineering from Reykjavík University and a master's in Biomedical Science from the University of Iceland. Jóna Valgerður has excellent experience in human subject research from the master's program at the University Hospital in Iceland and from designing and leading multiple studies on products under development within Össur.

 

 

Abstract

This presentation will cover the importance of overall clinical evaluation and high-quality clinical evidence to support the medical device's intended use and claims made by the manufacturer. The focus will be on clinical investigations during the developmental phase of a medical device. The importance of the study design and the use of suitable instruments able to reflect on the benefits that are important to the end users and other stakeholders, including payers.

As a manufacturer in the medical device industry, continuous innovation is inherent in our operations, focused on developing novel products and solutions and improving existing ones. The challenges targeted may pertain to service enhancements or aspects related to the user's health and daily life. It is essential to gather clinical evidence that substantiates the intended clinical performance of the product and its efficacy in resolving the targeted issue. The strongest data is gathered during clinical investigations on the actual device, including users from the intended user population. It is necessary to acknowledge the variety of variables and stakeholders that significantly influence this process. This presentation will focus on a personal journey through this process, emphasizing the different variables that play a role.