Medical Device Concept Phase: Research Department


How Can MasterControl Support the Research Department Team of During the Medical Device Concept Phase?

After a medical device firm has identified a need for a new product and decides to develop it, the firm enters the rigorous concept phase. Research scientists and engineers will work together with other teams in identifying technology platforms, such as an anti-microbial coating for catheters or a disposable chip for diagnostic devices, which could be applied across multiple product lines. The research team will study and test all possible combinations of the materials or components for the new product until it can come up with viable results. This phase may last 12 months for some, or up to several years for others. The concept phase is a time of rapid iterations of the product.

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MasterControl offers software solutions and services that can help lay a foundation for industry best practices, Quality System Regulation (QSR) compliance, and efficient workflows and processes that will help you save time and money from the get-go.

Collaboration in Medical Device Concept Phase

Research scientists need to work with project engineers, product managers, and others during this phase. Senior management needs to be apprised of how the product iteration process is progressing. The legal/intellectual property team may be working on patent applications based on the results of the research effort.

Medical device development requires a true team approach, from concept to launch. In this kind of environment, MasterControl can facilitate collaboration by providing:

  • Virtual workspace for collaboration among research scientists, project engineers, product managers, and other teams regardless of location.
  • Secure and centralized virtual vaults for effective management of the collaboration lifecycle. A document will reside in the "draft" vault while team members are working on it, then automatically move to the ?released? vault upon approval.
  • Capability for the collaboration leader to choose collaborators without any limit in the number of people invited. He or she may include a deadline, or leave the collaboration open.
  • Automatic routing of tasks so all collaborators are immediately notified of their tasks.
  • Capability for electronic signature and approval that lays the foundation for QSR compliance throughout the product lifecycle.
  • Time-stamped audit trail and security features that meet software-related requirements of 21 CFR Part 11.

Document Control for Research Department

Documentation generated during the concept phase will be the basis for many of the documents that will be used in the design history file (DHF) or electronic DHF (eDHF). While document control requirements during this phase are not as strict as later in the product development cycle, there is a need for the different teams to be able to route, review, and approve documents efficiently.

The MasterControl GxP process and document management software automates a paper-based or partially electronic document control process and connects the research team with other departments involved during the concept phase. It offers the following benefits:

  • Automates and streamlines routing of tasks and documents, review, escalation, revision control, and approval.
  • Provides a secure, centralized Web-based repository for all documentation, making tracking and comparison of revisions easier.
  • Provides robust workflows.
  • Provides electronic signature capability.
  • Provides capability to manage documents created using other software such as 3D CAD applications, Finite Element Analysis, Computational Fluid Dynamics, and Microsoft Office.

Training Control for Medical Device Concept Phase

During concept phase, the entire organization needs to be to be trained on SOPs and other basic documentation about the new product. MasterControl helps ensure adequate and continuous personnel training. Here are some of MasterControl's features:

  • Automates training management, including routing, tracking, escalation, and verification of training tasks.
  • Automates grading of online exams, which could be used as proof of personnel competency during inspections and audits
  • Connects training with quality and other processes, so any course or linked document that has been revised and approved will automatically trigger training tasks for all affected trainees.
  • Provides a secure, centralized, and Web-based repository for all training-related documents.
  • Offers group sign-off feature for companies with hundreds of employees being trained at once, so the course verifier can sign off once for large groups of trainees.

Software Validation for Research Department

The FDA's software validation requirements make it imperative to think about validation as early as the concept phase. While the research team is engrossed in product iterations, the IT team will be thinking of validating any software used during this phase.

MasterControl provides comprehensive software validation products and services, including:

  • MasterControl Transfer OQ: Provides completed validation and support documentation of IQ/OQ tests performed at MasterControl for companies with low-risk assessment.
  • Full-Cycle Validation Execution Services: Provide onsite support, including IQ, OQ, and PQ validation tests.
  • PQ Validation Execution Services: Create a custom PQ protocol, as well as provide onsite assistance for execution of the protocol.
  • MasterControl GxP Documentation Services: Provide critical documentation throughout the lifecycle of a validation project, from planning stage through final reporting and acceptance of the system.

At a Glance: Concept Phase Challenges and MasterControl Solutions and Benefits

Document Control/Managing the following documents: Solution: Benefits:
  • DHF
  • eDHF
  • CAD data
  • Finite Element Analysis documents
  • Computational Fluid Dynamics documents
  • Microsoft Office documents
  • Patent application
  • MasterControl Documents
  • MasterControl Forms
  • MasterControl DHF Expres
  • MasterControl DHF JumpStart
  • Automatic routing, tracking, escalation, approval of documents
  • Automatic revision control
  • Electronic signature
  • Time-stamped audit trail
  • Centralized, Web-based electronic repository
  • Secure virtual vaults for documents
  • Automatic lifecycle management
  • Capability to manage documents created using other software
Collaboration:
  • Research scientists
  • Project engineers
  • Product managers
  • Regulatory specialists
  • Quality engineers
  • Manufacturing engineers
  • Senior management
  • Legal department/intellectual property specialists
  • All of the solutions above
  • MasterControl Collaboration
  • MasterControl Projects
  • Virtual workspace
  • Redlining
  • Tracking of collaborator's comments
  • Electronic signature
  • Time-stamped audit trail
  • Secure, centralized, Web-based repository for all drawings, DHF, eDHF, CAD data, and other documentation resulting from collaborative work
Training Control:
  • Entire organization
  • MasterControl Training
  • Automates routing, tracking, escalation, verification of training tasks
  • Automates online grading of tests
  • Provides centralized repository for all training records
  • Connects training control with other processes
Integration with or Complements Other Systems:
  • PLM
  • PDM
  • MasterControl Document Connections
  • MasterControl Toolkit
  • Integration with PLM, PDM
  • Integration with other enterprise solutions
  • Complements e-lab notebooks
Software Validation:
  • For all MasterControl applications
  • MasterControl TOQ
  • Full-cycle execution services
  • MasterControl GxP documentation services
  • Significantly reduce the time involved in software validation
  • Significant cost savings by reducing validation time
  • Expertise to ensure successful validation project

Learn More About Medical Device Concept Phase

In order to have comprehensive details about medical device concept phase for research departments, feel free to contact MasterControl representative today.