Medical Device: Development Phase

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

The development phase of drug discovery is the most important and arduous. Beginning with human trial protocol development and ending with the IND/ NDA submission to the FDA, the work to be completed and managed can become a company-wide effort. Small and mid-size companies are building out infrastructure, while ranking industry is adding significantly to its marketing and sales department, which can mean workflow changes while training new employees. The volume of documents to route and manage becomes monolithic in proportion, and waiting to organize it for the NDA submission can seriously jeopardize the quality of the submission and prolong the approval process. If companies have not organized and managed their documents from scientific research through each phase, the workload can shut down company operations by inhibiting critical processes, such as marketing, and keeping other pipeline products from moving forward. This is the phase when companies who don't have document and process management software may begin to feel really overwhelmed. Out-of-the-box software solutions for collecting, organizing, and managing all the documents generated during the development phase can rapidly produce results, as can Change Control and Audit software.

Watch Videos View Medical Device 3-Minute Demo (3:00) How MasterControl Makes Your Job Easier (3:50) MasterControl's Documents Module (2:02)

Development Phase Software Solutions

• MasterControl Out-of-the-box Software
• MasterControl Collaboration
• MasterControl Documents
• MasterControl Change Control

Controlled Documents Managed in the Concept Phase		Collaboration Workflows in the Concept Phase
Bill of Materials BOMs Manufacturing process documents Device History Records DHRs Standard Operating Procedures SOPs Inventory and supplier documents Equipment/calibration documents DMR documents Device Analyses documents and MDRs Nonconformances Customer complaints and CAPAs Change control documents Change control documents Compliance audit reports Publications for professional journals Research, design, and implementation documents Post-market surveillance documents Clinical claims testing documents and other DHF documents Productive derivative documents CE technical file documents for dossier Other submission documents needed to secure foreign regulatory approval Possible material review board (MRB) meeting documents		Biocompatibility and Stability Testing: Research engineers may need to assist the development team with biocompatibility and stability testing. Preparation of Regulatory Submission: The regulatory team extracts information for the submission from design and testing documents generated by the development team. Documents in DHF: Quality engineers help development engineers with verification and validation testing, data analysis, and other documents that will go into the DHF. Modifications to Manufacturability and Related Processes: Manufacturing engineers collaborate with development engineers if modifications to manufacturability assessments, equipment drawings, or process specifications are necessary. Product Labeling, IFUs, and Related Items: Sales and marketing professionals collaborate with the regulatory team and others on the development team on product labeling, instructions for use (IFUs), packaging, and related items.

Out-of-the-Box Solutions for Companies Who Don’t Have Software for Controlling Documents and Managing Processes

Both MasterControl DHF Express™ and MasterControl DHF JumpStart™ provide easy-to-install and implement solutions for collecting, organizing, and reviewing all the documents required to meet FDA standards.

• MasterControl DHF Express provides an easy-to-install and -implement solution for collecting, organizing, and reviewing all the documents required to meet FDA requirements. The software was specifically created for automating the design control process at a price that is affordable for start-up or small medical device companies. This solution can be upgraded later with MasterControl Document GxP Process Management Software and other MasterControl solutions that provide more sophisticated features such as flexible, fully customized document workflows, collaboration software, and training software.

• MasterControl DHF JumpStart is a preconfigured document control database that helps device developers quickly organize their work so that they spend less time with administrative responsibilities and more time in development. The software provides multiple simple routes for collaboration, approval, and review, and is an affordable solution for companies who want some customization in their document and process management solutions.
• MasterControl Change Control is another easy-to-implement solution that is needed during the development phase. In order to use Change Control, you must install MasterControl Forms which is the engine that runs Change Control (and all the other automated MasterControl processes).

MasterControl Collaboration Software

• Provides a web-based, virtual workspace for collaboration.
• Reduces the need for meetings among cross-functional team members collaborating on modifications to manufacturability assessments, equipment drawings, or process specifications.
• Enables offsite members of the team to collaborate.
• Facilitates collaboration with outside experts.
• The ability to chunk data for particular purposes further enhances the collaborative processes with outside experts.
• Creates system transparency, allowing manufacturing, for example, to see where modifications to manufacturability assessments are in the review process.