A medical device starts its life like any other product, as an idea.
Ideas for new or improved medical devices or other health technology products can come from almost any source. Patients, relatives, carers and medical professionals have unique insights into unmet needs in the care continuum. Scientists and engineers know of emerging technologies that could apply to health innovations. However, medical device development is rarely a solo endeavour.
Medical device innovation is a collaborative journey that starts with identifying an unmet medical need. This initial recognition triggers brainstorming sessions, where ideas and concepts for new or improved medical products craft innovative solutions to existing medical problems. The objective is not just to find easier, cheaper, or more effective ways to address medical challenges but to do so in a way that benefits us all. It’s a goal we all share, and it’s what drives us forward in this journey.
The goal of ideation is to generate a pool of ideas, each of which must be evaluated for their potential and prioritised for further development. An initial evaluation narrows down the ideas to those with the highest potential. In the concept development phase, selected ideas are fleshed out into viable concepts. This involves defining the product’s intended purpose, features, and functionality at a high level.
A clear and detailed concept grounded in evidence is necessary to guide further development. Recognising a problem or gap in the current medical landscape involves understanding the clinical characteristics, natural history, patient population, and care journey. Early research efforts aim to gather information and document assumptions. Research into existing solutions should draw on a solid evidence base, including information from scientific literature, patents, medical device databases, and market research. Many first-time developers fall into the trap of identifying false unmet needs or trying to solve a problem that has already been solved. Gathering evidence to support the existence of unmet needs and understanding the existing clinical and market landscape is critical, even in the early stages of ideation.
The medical device industry is strongly process-driven. These early ideation and conception activities are the most creative and free from regulatory oversight. The ideation and conception phase is not explicitly covered by Quality Management System (QMS) requirements (such as ISO 13485:2016). However, structured innovation processes can still help to guide productive creative brainstorming. Early evidence gathering and analysis should comply with relevant international standards or regulations. The deliverables of these early-stage activities impact the later phases of the medical device lifecycle, and it is best practice to use systematic processes and document activities thoroughly.
The primary deliverable at the end of the ideation and conception phase is a draft of an intended purpose statement to explore further in the research and feasibility phase. It is expected to develop several product concepts simultaneously, each with an intended purpose statement. Early-stage research is highly iterative. It is common for innovators to conduct several technology landscapes in parallel, adjusting product concepts and intended purposes as they learn.
Refining product concepts for design and development
Research and Feasibility studies focus on developing the draft intended purpose statement to define the medical device’s user needs and design specifications. If several versions of the intended purpose were developed during ideation and conception, this phase would narrow the options for innovators to consider in Design and Development.
The research stage involves deep investigation to define the potential product’s intended purpose, features and functionality. Early-stage research activities involve desk research, bench studies and prototyping.
Research and Feasibility involve deep research to define the potential product’s intended purpose, features, and functionality. By the end of the phase, innovators should have sufficient technical, clinical, market, IP, regulatory, and economic information to determine the feasibility of the intended purpose statements generated during the conception phase.
The outputs of the Research and Feasibility phase are:
- Determination of the feasibility of the product from a technical, clinical and financial perspective.
- User requirements for Design and Development.
- Design Inputs (or specifications) outlining the device’s technical and functional requirements, including performance criteria, dimensions, materials, and safety features.
After feasibility studies, a review should be performed to decide whether the medical device concept should proceed to Design and Development. At this point, the product concept enters a formal process, and Design Controls, including documented Design & Development Planning, apply. If several product concepts show merit, it is helpful to prioritise based on company resources and create a technology roadmap for future development projects.