Medical Device: Feasibility Phase


How MasterControl Supports the Cross-Functional Development Team of a Medical Device Company during the Feasibility Phase

When the concept designs have been narrowed down to a handful of possibilities, the concept phase ends and the feasibility phase begins. During the feasibility phase, development engineers begin working on the design input requirements (DIR) necessary for the final product design. The development team also works on intellectual property documents and assists quality engineers with drafting the design Failure Mode & Effects Analysis (FMEA) document(s). A secure document control solution for organizing, storing, routing, updating, approving, releasing, and quickly locating design documents, as well as the intellectual property, FMEA, and other documents greatly facilitates the cross-functional team's efforts.

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Feasibility Phase Software Solutions

  • MasterControl Documents
  • MasterControl Collaboration
Controlled Documents Managed in the Feasibility Phase Collaboration Workflows in the Feasibility Phase
  • Design input requirements and specifications
  • Intellectual Property documents
  • FMEA document(s)
  • Regulatory documents
  • Quality documents
  • Resource plans
  • Procurement plans
  • User/market needs documents
  • Collaboration documents
  • Design and development plans
  • Develop DIR:In their effort to construct the DIR, development engineers collaborate with virtually every other department during the feasibility phase.
    • Research engineers help by providing feedback on the implementation of new technologies.
    • Regulatory team members provide feedback on potential regulatory hurdles.
    • Quality engineers provide input on critical risk factors.
    • Manufacturing engineers collaborate with the development team in a design-for-manufacturing(DFM) effort to ensure the manufacturability of a potential product.
    • Sales and marketing professionals, assisted by the manufacturing team, provide input on economic considerations such as anticipated market size, cost of manufacturing, potential revenue, time to market, etc.
  • Begin developing FMEA document(s): Quality engineers collaborate with development engineers on the FMEA documents, which define the actions to be undertaken to prevent potential product failures.
  • Ensure proper procedures are followed: Quality assurance specialists collaborate with both quality engineers and development engineers to ensure that the proper procedures pertaining to the design control process are followed. For example, quality assurance specialists make sure that the appropriate design inputs template is used, and that the finished document is complete.

Benefits of MasterControl Document Management Software

  • Secure, centralized virtual vaults provide effective management of DIR, FMEA, and intellectual property rights documents, as well as documents generated by the sales and marketing team.
    • A centralized document repository facilitates search/ retrieval for authorized users.
    • It also makes it easy to retrieve documents during inspections and audits.
    • Security features such as dual passwords, password expiration, and industry-standard SSL and 128-bit encryption capabilities secure data communications operations.
  • Concept design documents, protocols, etc., reside in the “draft” vault while being worked on; once approved, they are automatically moved to the approved/ released vault.
    • This prevents unauthorized concept designs or product prototypes from being prototyped and potentially wasting time and money.
    • It also avoids duplicated effort. A document under revision can be locked to prevent multiple users from simultaneously making the same changes to the document.
    • It makes it easy to locate a particular design document to determine its status.
  • Because the software is web-based, design control documents, FMEA documents, etc., can be accessed from any location.
    • This makes it easy to collaborate with senior management and other authorized users regardless of their physical location.
    • It also enables authorized off-site employees to access collaboration documents.
  • Automates routing, delivery, escalation, and approval of documents and tasks.
    • Provides the ability to create both linear and embedded workflows (where multiple employees sign off on the same step before proceeding to the next step).
    • Provides electronic approval capabilities and signature manifestation (per FDA requirement).
    • If necessary, escalates tasks to next level of responsibility to avoid bottlenecks.
  • Automatic archiving and cataloguing of outdated design documents, as well as intellectual property rights documents or documents created by the Marketing team, provides a GxP-compliant audit trail.
  • Through reports and tracking capabilities, members of the cross-functional team get a real-time view of the current status of all documents relevant to the feasibility phase: design control documents, etc. Reports can be customized and printed on a regularly scheduled basis, or they can be requested by a team member and generated on the fly.
  • Analytics capabilities and online charting are also provided.
  • Autoload feature enables the cross-functional team to drag-and-drop new documents into preconfigured network folders, facilitating the loading of documents into the system.

MasterControl Collaboration Software Benefits

  • Provides a web-based, virtual workspace for collaboration.
    • Avoids the need for time-consuming cross-functional team meetings to discuss issues (for example, material selection) related to the feasibility of a particular product design.
    • Enables offsite members of the cross-functional team to collaborate on important issues pertaining to the feasibility of a design regardless of their physical location.
    • Provides critical, early-phase feedback from manufacturing and suppliers on the manufacturability of a potential product design.
    • Facilitates collaboration between all members of the cross-functional team on important issues related to the feasibility, thereby avoiding wasted effort and unnecessary meetings.
    • Enables development engineers to collaborate, when necessary, with outside engineers or other experts on a design issue.
    • The ability to chunk data for particular audiences or purposes facilitates the collaborative effort with outside experts.
    • Creates system transparency for authorized users, allowing senior management and members of the cross-functional team (who may not be involved in a particular collaboration) to see where design control documents are in the review process.
    • Notifies collaborators immediately when tasks are routed to them. This feature can be very helpful during the feasibility phase, when members of the cross-functional team may be involved in signing-off on multiple iterations of a design control document.

Learn More About Feasibility Phase of Medical Device

To have a comprehensive view of how MasterControl supports medical device companies in feasibility phase, feel free to contact MasterControl representative today.