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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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.
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.
Provides a web-based, virtual workspace for collaboration
Learn more about medical device concept phase solutions offered by MasterControl by contacting MasterControl representative today.