Introduction
User requirements in medical device development are specifications outlining end-users needs (such as healthcare professionals, patients, and caregivers) for a medical device to perform its intended purpose effectively and safely. User requirements are defined through user research.
Why is user research necessary?
Defining user requirements is not just a step; it’s the cornerstone of medical device product development. User requirements are a Design Control. They inform the development of design input (or technical specifications), which define the device’s technical and functional requirements. They reflect the intended purpose of a medical device, and all development activities ultimately link back to them. Accurately defining user needs has further benefits in device development, including:
- User Safety and Efficacy: Ensuring the device is safe and effective for all users.
- User Satisfaction: Enhancing the user experience and satisfaction by meeting their practical needs.
- Regulatory Compliance: Aligning with regulatory standards that often mandate a focus on user needs.
- Market Success: Increasing the likelihood of market acceptance and commercial success by addressing real-world needs.
Collecting data to inform user requirements starts early in the device lifecycle, often in the ideation phase. These early requirements undergo many iterative rounds of refinement as more evidence is collected through the research and feasibility stages.
User research methods
Stakeholder Analysis:
- Identifying Stakeholders: Determine who will use, maintain, and be affected by the device. This includes patients, healthcare providers, technicians, and regulatory bodies.
- Engaging Stakeholders: Conduct interviews, surveys, and focus groups to gather insights from all relevant stakeholders.
Contextual Inquiry:
- Observations: Observe users in their natural environment to understand how they interact with similar devices and identify pain points.
- Task Analysis: Analysing tasks for which the device will be used to ensure it meets practical needs.
User Stories and Scenarios:
- User Stories: Creating user stories describing how users interact with the device.
- Scenarios: Developing scenarios to visualise the device in use helps understand context-specific requirements.
Prototyping and Feedback:
- Early Prototypes: Creating prototypes based on initial requirements and testing them with users.
- Iterative Feedback: Collecting user feedback on prototypes and iteratively refining the requirements and design.
Conclusion
User requirements are a cornerstone of medical device development, guiding the design and functionality of devices to meet the practical needs of end-users. Developers can create safe, effective, and user-friendly devices by systematically capturing, analysing, and documenting these requirements based on robust user research. This ensures regulatory compliance, enhances user satisfaction, and increases the likelihood of market success.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
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.