Concept development
Concept development is where the selected ideas are fleshed out into viable concepts. This stage involves research to define the product’s intended purpose, features and functionality at a high level. Creating a clear and detailed concept grounded in evidence is crucial to guide further development.
The main output from the conception phase is a draft of the intended purpose statement. Innovators often develop several versions of the intended purpose to explore further in the research and feasibility phase.
Conception activities
Conception bridges the gaps between ideation and formal research phases of the development lifecycle. Promising ideas are investigated further to determine whether they could realistically become a product. This is also an essential phase for terminating ideas that do not hold promise. Investigations typically build on the evidence gathered during the ideation phase. They become more targeted towards identifying high-level requirements and highlighting potential challenges or barriers to a successful product launch.
The main activities in the conception phase centre on desk research, user research and exploratory experimental studies.
- Desk research: Technology landscaping of the clinical, technical, IP, competitive, market, and funding landscapes forms the basis of defining design specifications as part of the conception phase. Researching regulatory and market access requirements is critical for refining a product concept. These activities may start early in ideation and become more focused through the development lifecycle.
- User research: In-depth consultations, visits to clinical settings, surveys, and interviews are all helpful user research tools during the conception phase. The goal is to determine whether the product concept(s) will meet user needs and expectations.
- Experimental studies: These studies vary widely depending on the technology underpinning the medical device innovation. They may include in vitro, in vivo, or in silico experiments. Highly disruptive breakthrough medical devices may require early-stage research to establish their scientific validity. Creating prototypes is also a key part of the conception phase, as they allow for early testing and iterative improvements.
Risk management is a process that occurs throughout the medical device lifecycle, usually beginning in the conception phase. Early-stage risk management activities include risk analysis and assessment. Beginning risk management early helps identify harms and hazards that could hamper the innovation later in the development lifecycle.
Intended purpose development
Developing an intended purpose statement for medical devices is a critical process that ensures the device is clearly and accurately described for regulatory approval, clinical use, and market placement. This statement forms the foundation for regulatory and health technology assessment (HTA) submissions and guides the device’s use and marketing claims.
The intended purpose is the most essential document for a medical device. Use clear, concise, and unambiguous language to describe the intended purpose. Ensure the language aligns with regulatory standards and terminology and avoids unnecessary technical jargon.
The data gathered during the conception phase develops draft intended purpose statements. These statements are further researched and refined in the following lifecycle phase: Research and Feasibility.