Accelerate your next product development project with confidence.
Product design is fraught with uncertainties. The design team must challenge assumptions and resist making decisions based on fear, bias, or lack of information – from the initial concept design and feasibility through final approval and release to manufacturing. Engineers and designers rely on a simple and proven design process to move projects forward. Establishing and following a process dramatically improves the likelihood of acting on validated information and releasing a better product that people will want to use.
Designing products for medical applications may have the additional responsibility of adhering to ISO 13485 and FDA standards. Design validation and quantifying decisions becomes a critical part of the design process. Sustaining a clear and thorough design process as shown in Figure 1, can serve you well as you progress through the various iterative stages in-route to product launch.
Define User Needs
Sometimes conjuring an idea for a new product is easy. Collecting input and data from various sources to define the features and functionality can be sticky. What unmet market need does this technology satisfy? What functions will the device perform and what critical features will enhance its value in the addressable market space? The majority of inputs will come from clients and potential users with input from marketing; which will have performed a competitive analysis to ensure product differentiation. The resulting product requirements document will serve as an overarching road-mapand will evolve through the design process.
During the design input stage, the fundamental assumptions created in the requirements document are used to create a product specification. The concept is tested within a feasibility study or phase 0 development project. Along with testing the underlying product technology and concepts, the study ideally addresses any early stage development uncertainties or potential manufacturing challenges.
The product specification is typically developed with input from R&D, engineering, manufacturing, and supply chain. A thorough design input phase guides companies from entering a formal design cycle too early. By reducing bias in the early stages of the design process and identifying potential challenges early in the process, you avoid spiraling into a documentation bureaucracy and additional iterative verification steps.
With the feasibility study and product specification completed, the formal design process begins. Product requirements are documented, and the engineering concept is fully developed. This typically includes multiple rounds of advanced prototyping and design reviews. When the design inputs are well understood and documented, the number of prototype iterations can be minimized. DFM (design for manufacturing) keeps the goal of developing a better product that can be manufactured efficiently and cost effectively. The design review process keeps all invested parties involved and provides visibility and accountability.
Referring to Figure 1, in the design output phase, the product design is verified against the specifications developed in the design input phase. During design output, all of the production processes and procedures are developed in preparation for product launch. With the right experience and planning, design teams can advance through verification in one iteration.
Releasing your medical device to manufacturing means you have validated that the product meets the criteria established in the product requirements document. Have you developed the right medical device? Has your device addressed the user needs and functionality? The design process provides a traceable documentation trail that contributes to the medical device file and any FDA submissions that may be required.
A design control process enables a smooth and efficient transfer to manufacture – providing documentation that typically includes the drawing specifications, assembly instructions, labeling, testing, supply chain information, and final packaging. Following a clear design process allows designers and engineers to minimize uncertainty and bias, verify and validate their decisions, and allow companies to make better products people will want to use.
Gray Optics can helpassess and advance your new product development projects. Contact us and see how we can assist in the design and development process before spending valuable time and resources.