The role of early-stage research
Ideas for new or improved medical devices and health technologies can originate from various sources. Patients, caregivers, and healthcare professionals offer valuable perspectives on unmet needs in the care continuum, while scientists and engineers bring knowledge of emerging technologies with potential applications in healthcare. However, developing medical devices is typically a collaborative effort.
The innovation process begins with identifying an unmet medical need, which catalyses brainstorming and generates ideas. These sessions aim to craft creative solutions that address existing challenges in medical care. The goal of ideation is to generate a pool of ideas, and the aim of conception is to evaluate those ideas to select the best to pursue.
The output of ideation and conception is one (or more) viable product concepts with a defined intended purpose statement. These initial product concepts usually require substantial further research to determine their feasibility. Early research focuses on desk research, user research, risk management, and experimental studies:
- Desk research: Involves technology landscaping to explore clinical, technical, IP, competitive, market and funding landscapes to define design specifications. Regulatory and market access research refines product concepts, becoming more targeted as development progresses.
- User research: Includes clinical visits, surveys, and interviews to ensure product concepts meet user needs and expectations.
- **Risk management: ** Begins in this phase with risk analysis and assessment, identifying potential harms early to mitigate challenges later.
- Experimental studies: Cover in vitro, in vivo, or in silico experiments, prototype development, and testing to validate and refine disruptive medical technologies.
Best practices in early research
The evidence gathered during early research forms the foundation for future development activities. Some tips that can ensure early-stage research is successful and usable throughout the development lifecycle include:
- Develop processes for identifying and analysing evidence that are systematic and comprehensive.
- Use industry best practices and follow international standards and guidelines when available.
- Carefully consider the data sources used to gather information, prioritising reputable sources widely recognised in the industry.
- Document evidence systematically from the beginning of the ideation process.
- Use tools and processes that can be updated throughout the medical device lifecycle to ensure that evidence can be gathered and analysed through development, regulatory submissions, reimbursement and post-market surveillance.
Feasibility assessment
By the end of the early research 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. This information can be used to finalise the business case and plan for further product development.
The outputs of the early research 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.
- A complete business plan and accompanying strategies to implement the project.
When feasibility studies are complete, a review is 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 may be helpful to prioritise based on company resources and create a technology roadmap for future development projects.