Design and development should be a continuation of customer needs and requirements. the customer needs and requirements that you define should feed the design and development process. It is always good to define customer needs and requirements as comprehensively as possible. Always try to have enough clarity about what issue you are trying to solve before diving too deep into development.
Design and development processes include:
- Planning of Design and Development
- Design & Development Inputs
- Design & Development Outputs
- Design & Development Reviews
- Design & Development Verification
- Design & Development Validation
- Design & Development Transfer
- Control of Design and Development Changes
- Design and Development Files
PLANNING OF DESIGN AND DEVELOPMENT
This means understanding the scope of product development efforts. This aspect of design and development planning is to define the authorities and their responsibilities, who will be managing the process. You also need to identify all resources required and ensure those resources have the necessary competency and expertise. Planning should also describe verification, validation, and design transfer, as well as define how tractability of design and development activities will be addressed. Planning a complete product development process is not a best practice. Planning should be able to make necessary changes as the product development progresses.
DESIGN AND DEVELOPMENT INPUTS
Design and development inputs are where you capture and document all of the product requirements for the device being developed. This includes functional, performance, usability, safety, regulatory, and applicable standards requirements based on the defined intended use. Your customer requirements are important to understand so that you can properly define the design and development inputs. A risk management process needs to be incorporated as part of design and development, as well as the entire product realization process. And defining your product requirements goes hand in hand with product risk management.
DESIGN AND DEVELOPMENT OUTPUTS
As you progress from design and development inputs to defining specific details and characteristics about the product, you should be establishing drawings, specifications, manufacturing instructions, code, inspection procedures, purchasing specifications, and so on for the eventual medical device.
These items are your design and development outputs. Outputs describe all the components, parts, pieces, assembly, and inspection elements required to purchase, manufacture, and service the medical device. Design and development outputs can be used as means to establish risk mitigations and risk control measures too.
DESIGN AND DEVELOPMENT REVIEW
The timing of design and development reviews should be in sync with design and development planning. During planning, you identify the stages during product development when design reviews are necessary. The purpose of review is to ensure that the product you are developing is able to meet customer needs and requirements and product requirements. Reviews should include personal, team members, and resources pertinent to the stage being reviewed in order to make this assessment.
DESIGN AND DEVELOPMENT VERIFICATION
Design and development verification is about demonstrating that you have designed your medical device correctly. Your design and development outputs should meet your design and development inputs. Verification requires that the plans, methods, and acceptance criteria be defined before executing the activities.
DESIGN AND DEVELOPMENT VALIDATION
Design and development validation has quite a few similarities to verification. Validation means demonstrating that you have designed the correct product. Validation ensures that the medical device meets the customer needs and requirements. This means that products used for validation activities should be manufactured in the same manner with the same methods and techniques as what you anticipate for full production. Design and development validations should also be used as a means to demonstrate effectiveness of risk controls and captured as part of your product risk assessment.
DESIGN AND DEVELOPMENT TRANSFER
Design and development transfer is not a single moment in time event. The entire purpose of design and development is to progress a medical device through product development so that it can eventually be ready for manufacturing. Throughout design and development, as noted above, there are certain activities at many of the stages that pertain to design and development transfer.
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Design and development changes will occur throughout the entire product realization process. Any time a change occurs, you need to assess its impact on function, performance, usability, and safety.
Before design and development changes can be implemented, you must review, verify, validate (if required), and approve. Post design and development transfer, design and development changes should be part of your document management / change management practices.
DESIGN AND DEVELOPMENT FILES
All of your design and development activities shall be documented and maintained in a design and development file. Best is to keep your design and development file living throughout the entire product realization process. Use your design and development file up to date to represent the current product, including any and all changes.
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