What are feasibility studies in medical device development?
Feasibility studies in medical device development are preliminary investigations to assess a proposed device’s practicality and potential success.
Feasibility aims to determine whether the device concept is viable and worth pursuing further. The output of the feasibility phase is a complete business plan outlining the novel device’s technical, clinical, market, regulatory, operational, and financial aspects.
Key aspects of feasibility studies
Technical Feasibility
The technical feasibility of a medical device is determined by creating prototypes to test the device’s functionality and design. Prototypes can be used in a limited way to demonstrate that the device can achieve its intended function under controlled conditions. This is an opportunity to identify and address potential technical and engineering challenges. Technical feasibility is fundamental in determining if novel materials, technologies, or manufacturing processes are included in the device design.
Clinical Feasibility
Clinical feasibility assesses the unmet medical need and how the device addresses current gaps in the clinical landscape. This is achieved through clinical evidence gathered during state-of-the-art evaluations, market research, and user research. Gathering feedback from healthcare professionals and potential users ensures the device meets their needs and expectations. Some limited clinical or usability studies may be performed to determine clinical feasibility.
Market Feasibility
Market feasibility is often linked to the reimbursement landscape and determining whether the device is likely to be covered by insurance and healthcare payers. Evaluating the market potential, including the size, growth prospects, and competitive landscape, is also critical. So is assessing the demand for the device among target users, including healthcare providers and patients.
Regulatory Feasibility
Identifying the regulatory requirements and pathways for approval in different markets and ensuring the device can meet these standards.
Operational Feasibility
Assessing the feasibility of producing the device at scale, including the availability of necessary materials and manufacturing capabilities. Evaluating the logistics and supply chain requirements for delivering the device to market.
Financial Feasibility
Cost and pricing are often neglected components of feasibility studies. Estimating the costs of developing, manufacturing, and marketing the device should be established before a development decision is made. As pricing is intimately linked with costs, potential pricing strategies and models must be analysed in different markets. The financing of the development project should also be assessed, and possible funding sources and investments needed to bring the device to market should be identified.
Conclusion
Feasibility studies help medical device innovators identify potential risks, refine their device concept, and make informed decisions about whether to proceed with full-scale development. By the end of the feasibility phase, the innovation should have a complete business plan to secure funding, gain stakeholder support, and form the groundwork for subsequent development and regulatory approval stages. At this stage, the innovation has evolved considerably from the initial idea and concept. This is a critical milestone in the medical device innovation lifecycle. Medical device manufacturers hold a formal review at this junction to decide whether the product should enter the design and development phase.