A Simplified Introduction to Medical Device Design ControlAriel Pollock Star
A Simplified Introduction to Medical Device Design Control
Often, when working on developing a medical device, designers and engineers find themselves stuck or having to repeat the same processes, again and again, to fix and perfect their design. Considering these seven common steps for design and control of medical devices can help a team avoid some of the most common pitfalls.
Since 1990 and 1993, the US (21 CFR 820.30) and EU (MDD 93/42/EEC) respectively included Medical Devices in their GMP (Good Manufacturing Practices) set of rules and regulations, with the International Standards Organization (ISO) following suit in 1996 by publishing their voluntary ISO 13485 standard.
These regulatory requirements help assure medical devices are safe and effective for their intended use and have been constantly updated and amended since their initial publishing, to include new regulations and adapt to new technological advancements.
Basic stages of Medical Device Design Control
Design and development planning
This stage includes a description for all of the Design Controls, from the initial project plan and user needs, all the way to product market launch. It includes tasks descriptions, team members, external vendors or collaborators, and their responsibilities. This plan is essential and serves as a roadmap and project management tool, so it is constantly updated to include any plan changes throughout the whole medical device development cycle.
Design Input includes the features, requirements and performance criteria of a medical device. This stage is very important as the better the design inputs are, the more effective and efficient the medical device will turn out to be. For this reason, medical device developers should define clear, measurable, and objective Design Inputs, that aid medical device development down the line. Sources for Design Inputs can be:
- User needs (also known as customer attributes)
- Industry standards and manufacturing capabilities or limitations
- Rules and regulations
- Competitive products features
Factors that may influence the medical device’s design input can be:
- The device complexity, whether it includes software, mechanical, electrical, or other subsystems
- The criticality of the medical device’s application and the degree of specialized requirements pertaining to its use case (eg medical devices used in plain skin contact vs devices for surgical use)
Design output derives from Design Input and lays out every necessary detail for manufacturing the medical device. The finished design output in its totality consists of:
- Engineering drawings
- Device specifications
- Required construction materials, components, and sub-assemblies
- Processing and assembly instructions and processes
- Device packaging and labeling
Design Output also includes design evaluation of conformance assessments. These are the Design Verification, that confirms design output meets design input requirements, and Design Validation, which ensures medical device conformity to its intended use and to the user’s needs.
The Design Review is a stage that runs throughout the whole medical device prototyping cycle. Its purpose is to formally document reviews of the design that have been planned and are conducted at appropriate stages of the device’s development.
Design Review details the concerns arising throughout the device’s development and tracks relative Corrective And Preventive Actions (CAPA’s) pertaining to those concerns. Early reviews happen during the design input and output stages along with solutions evaluation to any such issues, followed by design output such as material & manufacturing issues, and finally verification, validation & device production issues.
The purpose of the Design Transfer stage is to ensure that the device design has been correctly translated into production specifications. This means that the manufacturing plans, drawings, and specifications that were initially laid out in the Design Output stage, have been properly detailed according to the medical device’s production facility manufacturing capabilities. The completion of the Design Transfer stage means the medical device’s product development cycle has been completed and it can now be mass produced.
The goal of Design Changes is to establish and maintain procedures that document, verify, and prompt for approval of design changes, prior to their implementation. Design changes can occur throughout the whole device development cycle. As is to be expected, the earlier on a design change occurs, the less it will cost to implement down the line, as opposed to a design change made near the end of the device development that may call for upstream revisions and changes.
Every stage and change performed during medical device development should be documented in the design history file (DHF). A completed DHF contains a compilation of records describing the design history of a medical device and is absolutely necessary for documenting and demonstrating medical device development in accordance with rules and regulations to governing authorities in every jurisdiction.
World Class Medical Device development
In your journey to Medical Device Development, you need a partner with the necessary means and experience to help you in proactively dealing with complexity. Contact Quasar to discover how we combine regulations, device development, and manufacturing into one turn key solution, relieving you of costly delays and medical device development halts.
This blog post is for educational purposes only.