Medical Device: Concept Phase

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

During the concept phase, document control/ management software and collaboration software are critical. Many documents and document revisions are generated, collaborated on, and must be managed. A secure document control system for organizing, storing, routing, updating, approving, releasing, and quickly locating critical marketing and research data (as well as collaboration documents, once the concept phase really gets underway), can make a huge difference to the success of the development team.

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Controlled Documents Managed in the Concept Phase

  • marketing research data concept designs (multiple revisions)
  • CAD documents product prototypes (multiple revisions)
  • basic documents for DHF
  • Microsoft Office documents
  • preliminary submission
  • pathway determination
  • preliminary patent information
  • finite element analysis studies
  • computational fluid
  • dynamics studies
  • bench-top testing reports

Collaboration Workflows

Conduct Market Research:

The Research team collaborates with the Sales Marketing team in the search for new ideas for products and product enhancements. Sales Marketing professionals also contribute by defining user and market needs

Obtain Outside Expertise:

Engineers and scientists collaborate with consultants, healthcare professionals, and other experts outside the company to ensure access to the most current research and breakthroughs.

Refine User and Market Needs:

Product managers collaborate extensively with development engineers, who develop requirements documents in an effort to refine user and market needs.

Ensure Quality:

The FDA's quality by design initiative encourages manufacturer's of medical devices to integrate quality at the concept phase of a product's lifecycle. This entails a collaborative effort among the research, development, manufacturing, and quality engineers.

Follow FDA Guidelines:

Regulatory specialists collaborate with development engineers to communicate crucial standards and guidelines affecting FDA approval.

Develop Cost-Effective Designs:

Development engineers collaborate with manufacturing engineers to ensure that their product prototypes are reasonable from a manufacturing standpoint. This benefits the company by ensuring cost-effective designs.

Explore Alternative Uses for Potential Product:

The cross-functional team may also collaborate with industry experts when establishing uses for a potential product. This information is necessary for developing patent claims, which typically occurs during the concept phase.

Benefits of MasterControl Document Management Software

  • Secure, centralized, virtual vaults provide effective management of documents created during this phase, such as marketing research, concept design, and product prototype documents, in addition to documents pertaining to intellectual property rights.
  • A centralized document repository makes search and retrieval easy 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 between the web browser and application software.
  • Concept design documents, protocols, etc., reside in the draft vault while being worked on, and, when approved, automatically move 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.
  • 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.
  • Because the software is web-based, potential device designs, test protocols, etc., can be accessed by authorized users from any location.
  • This makes it easy to collaborate with healthcare professionals, suppliers, and other experts outside the company.
  • It also enables authorized off-site employees to access collaboration documents.
  • Automatic archiving and cataloguing of outdated concept design documents and product specifications provides a GxP-compliant audit trail.
  • Reporting and analytics capabilities, including customizable reports and online charting, can be particularly useful during the concept phase to the research efforts of both research scientists/ engineers and the sales and marketing team.
  • Standard or customized reports in real time can be scheduled at regular intervals or requested on the fly to keep members of the cross-functional team up to date.
  • Online charting and analytics are also provided.
  • Autoload feature enables users to drag and drop new documents into preconfigured network folders, making it easier to load documents into the system.

Collaboration Workflows in Concept Phase

Provides a web-based, virtual workspace for collaboration

  • Provides a web-based, virtual workspace for collaboration.
  • Lessens the need for time-consuming face-to-face meetings among cross-functional team members to discuss design and quality issues.
  • Enables cross-functional team members to collaborate regardless of their physical location.
  • Provides critical early-phase feedback from manufacturing and suppliers on concept designs and product prototypes.
  • Facilitates collaboration between research engineers/ scientists and experts outside the company, ensuring timely access to the most current research and breakthroughs.
  • The ability to chunk data for particular audiences or purposes can facilitate the collaborative effort with outside resources.
  • Creates system transparency for authorized users, allowing senior management and members of the cross-functional team to see where a design concept is in the review process.
  • Notifies collaborators immediately when tasks are routed to them. This feature is helpful to all members of the cross-functional team, who are usually working on multiple iterations of a device design.

Contact MasterControl to Learn More About Concept Phase

Learn more about medical device concept phase solutions offered by MasterControl by contacting MasterControl representative today.