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The success of a medical device company is driven by its ability to bring innovative products to market faster whilst controlling and reducing costs.
Design Control is a procedure 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 discipline 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.
Medical device manufacturers need certain procedures during design with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety.
Design Control is our holistic solution for integrating requirements, risk management, test planning, execution and design output management, including Design History Files (DHF) and Device Master Records (DMR).
Medical Device PLM 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 health care networks, while avoiding the disruption, risk and cost of a “rip-and-replace” approach.
Medical Device PLM helps organizations avoid overlooking common problems by guiding the tie off all risks and requirements, at all levels of detail, across all disciplines.
Our solution enables you to respond to issues and resultant changes, managing complexity at each phase of the development process with agility, efficiency, speed and accuracy.
Medical Device PLM 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.
Medical Device PLM 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.
Medical Device PLM:
- Works across systems and functional boundaries such as ERP and provide 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.
- Manages devices and sensors.
- Collects and analyzes data from connected devices.
Based on our decades of systems and model-driven engineering experience, Medical Device PLM 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.
Medical Device PLM:
- 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.
Avoid the risk by leveraging and enforcing best practices for product development teams. With Medical Device PLM 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 modelling stage, flowing through and eventually providing context for 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.
Minerva Medical Device PLM 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. If the approval is a part of the device, it is placed in the right areas everything is within the same solution.