As we had previously highlighted, it is past the Research and Development phase where having a proper Quality Management System (QMS) becomes essential. You are able to maximise efficiency as you keep a structured QMS which clearly defines and standardises your business processes. With Design and Development (D&D) being a core process of your business, having a clear D&D work structure is important. Here are 5 items to be set in place at the start of your D&D work structure:
1) Establish Design Controls / Design and Development Procedures
While the product development objectives are clear, D&D activities must also be coordinated in an orderly manner. These design controls and D&D procedures are to be established according to your company’s operations.
For medical devices, the ISO 13485:2016 (Clause 7.3) outlines the standard of what controls need to be in place. Similar requirements can be found in FDA 21 CFR 820.30. With these guidelines, your company can craft and properly document your Standard Operating Procedures (SOPs) accordingly. Product development team members must be trained on these SOPs so as to carry out their defined tasks.
2) Outline Design and Development Plan
To implement your D&D procedures, a D&D plan needs to be drawn out. Your product development team would need to identify major milestones and timeline, as well as define general responsibilities of various project members. This D&D plan helps to clearly describe the interactions of different groups or activities that would lead to the fulfillment of design inputs. To keep your whole product development team on the same page, it is important to maintain updated plans that describe or reference the D&D activities and relevant responsibilities.
3) Identify product user needs
A user-need statement helps to establish the framework for product design. This is made up of the intended use and indications for use of the medical device and it is important to understand their differences.
An intended use is the general purpose of the medical device or its function (what you “claim” the medical device does), while the indication for use describes the disease or condition that the medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population.
Determining user needs and intended use of the product is important for product risk classification and your company’s regulatory strategy. More importantly, doing so allows for focus on the product development objectives. Having user needs defined and clearly documented, your team would be in a good position to move on with D&D activities.
4) Define Design Inputs
In line with the above 2 points, design inputs for the product needs to be defined.
Design inputs are specifications that describe the product requirements (physical, functional, etc.) necessary to meet the identified user needs. Fulfilment of design inputs is the aim of your D&D plan. As such, design inputs are to be defined in measurable and objective terms. This clear definition of design inputs would help facilitate the verification activities to be performed as part of product development, and hence enhance your business.
5) Maintain a Design History File (DHF) / D&D File
The D&D File contains all Design Control information. This includes the documentation and records of user needs, design inputs, D&D Plan, and much more design details (e.g., D&D verification and validation activities) of the medical device.
Besides keeping details of the latest records of this information, it is also crucial to store archived versions of the documents. Given the continuous changes and developments made while producing your medical device, such records are important for traceability and risk management purposes.
For more in-depth details, we will further cover the concepts of traceability in design control and risk management activities in upcoming blog posts! These 5 key points are the first to start with when looking into proper D&D processes.
In the meantime, you can learn more about how this ties in with the ISO 13485:2016: