Along with Risk Management, the Design Control discipline is where a medical device’s journey starts. Design Control is used to control the design of medical device development with the
purpose of ensuring that specified design requirements are met.
Design Controls and Risk Management should flow and blend, and it’s important to establish this flow early in product development.
Managing information like the Design History File (DHF) and the Device Master Record (DMR) is important in improving efficiency, device visibility, and traceability. However, to have a bigger impact on reducing time to market and speeding up new product introductions, there is a need for additional improvements in the area of earlier collaboration and better global project and portfolio management.
Most common design control challenges in the industry
The typical industry practice is to design and print: create the design and then print to paper and store that document in a binder. Very often, the documents are printed, scanned, and
stored both electronically in file folder structures as well as in physical binders.
Unfortunately, this is the landscape seen in many companies, with file systems, spreadsheets, and silo systems.
Anyone can very easily see the inefficiencies, the data duplication, lack of traceability, and opportunities for error. This provides for a situation where design control is full of risk.
The level of collaboration is low, visibility into what is being done across the different departments is not good, and this makes it difficult to make sure that everything is aligned and that all possible impacts are assessed and accounted for so that the deliverables for the design control are delivered at the correct time with the correct content.
You should try to work smarter
The Aras Medical Device solution targets these challenges and more. The essential is that the project plan is linked to deliverables, which again are connected to the product data management (e.g. through the DHF and DMR, etc.).
By centralizing and creating a transparent structure in all product-related information through the DHF and DMR, Aras Medical Device can coexist with existing document management
systems.
This allows the company to develop templates of their phase-gate model where the project plan is connected to deliverables with templates of what documents, CAD models, and much more must be finished where and when.
The status of the project is automatically driven by the user’s actions. Activities are completed when users check in with their deliverables which are then routed through an approval
workflow with electronic sign-off.
Unlike normal document management systems, Aras Medical Device offers structure and relation in all documentation, ranging from specifications, Standard Operating Procedures (SOP’s), drawings, test instructions, bills of material, and more.
Everything is gathered in the Device Master Record and Design History Files. all in one system - with full traceability.
If you want to know more about best practices in Design Control workflow, watch this webinar.