IMPORTANCE OF EARLY FEASIBILITY STUDIES FROM AN INVESTOR POINT OF VIEW

Medical device development requires significant financial resources and extended timelines to navigate regulatory approvals, clinical trials, and market entry. The pathway from financial investment to financial returns is long and risky, whereas investors prefer short timelines to market and calculable returns. Investors are therefore concerned with mitigating risks as early as possible to increase the probability of a favourable return on investment. Early Feasibility Studies have the potential to play an important role from an investor's point of view to decrease risks with limited investments. Early Feasibility Studies are designed to evaluate the initial clinical safety and functionality of a novel device or a device with a new intended use. The primary importance of EFS lies in their ability to de-risk projects early in the development process, thereby reducing the likelihood of costly failures in later phases of development. EFS allow for early identification of technical and clinical challenges. By conducting these studies, companies can gather critical data on device performance, safety, and usability. This information is invaluable for making informed decisions about whether to proceed with further development, modify the device design, or abandon the project altogether. For investors, this means that their capital is allocated more efficiently, with a higher probability of a positive return on investment. Additionally, EFS facilitate early engagement with regulatory bodies, which can provide feedback and guidance on the development pathway. This early interaction helps streamline the regulatory process, potentially accelerating time-to-market and reducing associated costs. Early practical experience EFS also offers strategic benefits. It enables developers to build a robust clinical and commercial strategy based on real-world data. This can be used to attract further investment and strategic partnerships. For companies and investors, it is a big advantage if first clinical cases can be done in a well-known local environment, applying a streamlined study setup process and work with well known clinical centres. Early Feasibility Studies can be a vital component of medical device development, offering significant benefits in terms of risk mitigation, regulatory engagement, and strategic planning. For investors, EFS provide a mechanism to de-risk projects early, ensuring that their investments are directed towards viable and promising innovations in the medical device sector.