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Featured white paper: "Design Control in the Medical Device Industry"

Design Control in Medical Device

Design Control is used to control the design of medical device development with the purpose of ensuring that specified design requirements are met. Along with Risk Management, the Design Control is where a medical device’s journey starts. Design Controls and Risk Management should flow and blend together, and it’s important to establish this flow early in product development.

 

Minerva PLM for Medical Device In-Depth:

Medical device product development is a highly integrated and regulated process. Implementation of solution-based requirements tracking requires attention to a variety of nuanced topics.

Expand the fields below to read how Minerva Medical Device PLM can address some of the biggest business challenges in the industry. 

Minerva PLM for Medical Device, Powered by Aras is designed for interoperability, critical in the increasingly collaborative and networked world of health care systems. Our solution allows you to deliver value in multi-tiered networks while avoiding the disruption, risk, and cost of a “rip-and-replace” approach.

 

Minerva PLM for Medical Device:

  • Works across systems and functional boundaries such as ERP and provides access to mechanical and electronic designs, software, requirements, technical documentation, process plans, and quality documents.
  • Leverage and extends your existing investments in ERP, PLM, and MES through application mashups.
  • Rapidly prototype and deploy medical engineering applications that monitor, manage, and control connected devices.
  • Engineers independent and secure connectivity between devices.

Based on our decades of systems and model-driven engineering experience, Minerva PLM for Medical Device, Powered by Aras ensures all disciplines and functions are working from the same requirements and systems model. It enables the multidisciplinary development of devices that are systems of systems – integrating hardware, electronics, software, and formulated components.

 

Minerva PLM for Medical Device:

  • Allows hardware and software deliverables to be structured in the same composite Bill of Materials (BOM), ensuring accuracy at critical hand-offs like Engineering to Manufacturing.
  • Enables multiple engineering disciplines to collaborate with one another in design reviews and adhere to the same change management processes.
  • Enables traceability. It means anyone connected to the platform can select a part and instantly view the related CAD model, requirements, change history, manufacturing execution data and in-service field data.
  • Supports devices throughout the entire lifecycle by re-using data and connecting it via digital threads to quickly respond to inquiries during regulatory reviews or sustaining incremental engineering changes.

With Minerva PLM for Medical Device, Powered by Aras you will be able to manage all phases of the product lifecycle, especially the evolving product configuration and associated changes process.

This process can begin as early as the requirements and systems modeling stage, flowing through and eventually providing context for the industrial internet of things (IoT) data and supporting quality, manufacturing planning, and service documentation processes.

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 are 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.

 

The solution:

Minerva PLM for Medical Device, Powered by Aras 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 DHF and DMR, etc.).

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 have to 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.

Have a look at how more than 2 decades of knowledge are packaged in one place!