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.
Resources
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There are no regulations governing feasibility assessments in medical device development.
However, the data compiled in a feasibility assessment will inform design controls. It is helpful to document evidence thoroughly and ensure compliance with any relevant standards such as IEC62366 (usability engineering) and ISO14971 (risk management).
Benefit-Risk Analysis: The comparison of a medical device’s benefits to its associated risks, often used in regulatory decision-making.
Clinical Context: The specific medical conditions, patient populations, and healthcare settings in which a device is intended to be used, influencing its design, functionality, and regulatory requirements.
Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Clinical Guideline: A systematically developed statement to assist healthcare practitioners and patients in making decisions about appropriate healthcare for specific clinical circumstances.
Conception The initial phase of product development, during which an idea is generated and conceptualised into a feasible product design, considering market needs, technical feasibility, potential benefits, and risks.
Equivalency: Demonstrating that a new device is as safe and effective as an already marketed device by comparing its technical and functional characteristics.
Healthcare Professional: An individual trained and licensed to provide medical care, treatment, and advice to patients, encompassing a range of roles such as physicians, nurses, pharmacists, and allied health professionals.
Ideation: The creative process of generating, developing, and communicating new ideas.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Medical Device: An instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease. Each regulatory authority has a formal definition of a medical device, which should be referred to for regulatory compliance.
Payer: An entity or organisation, such as an insurance company or government agency, responsible for reimbursing or funding healthcare expenses related to using health technologies.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Predicate Device: An existing on-market device that provides a basis for comparison or reference in demonstrating substantial equivalence for regulatory purposes.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Reimbursement: The process of receiving payment from insurers, government health programs, or healthcare facilities for the use of medical devices in patient care.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
State-of-the-art (SotA): The current knowledge or good practice acceptable in the medical devices industry.
Systematic Review: A structured and comprehensive synthesis of research studies that aims to identify, select, assess, and summarise the findings of all relevant individual studies on a particular topic.