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Cognition Corp.

FDA Compliance

Product News: Software Unifies Product Development for Medical Device Companies

Cognition Cockpit allows companies to close the gap between CAPA, complaints, risk management, and requirements management.

Published: Wednesday, February 10, 2010 - 14:38

(Cognition Corp.: Bedford, MA) -- Cognition Corp., a worldwide leader in Web 2.0 product development software, has released Cognition Cockpit 5.6, providing medical device companies a system that captures the breadth of their product development data in a single, unified model. Information from risk management flows together with information from the complaints database, requirements documents, test methods, marketing research, and cost estimates.

“Medical device companies struggle with the challenge of creating and maintaining a complete trace of all the decisions and interactions between each part of the system,” says Michael Cronin, CEO of Cognition Corp. “A typical failure mode is when the corporate complaints system reports occurrences of certain failures that don’t match the predicted levels in the teams’ risk management plan or FMEA [failure mode effects analysis]. It used to be that someone had to manually check to make sure the information coming from the field was properly updated in the product risk plans and then manually enter a change and make the proper notation,” Cronin adds. 

With the Cockpit, this type of disconnect is avoided by having the complaints system automatically flow together with the project risk management plan. Any incoming field data updates the appropriate risk data in real time and keeps track of the change so users have a permanent trace and record of changes.

“For the first time, members of our product development core teams actually know what they need to know in real time,” says Tim Sullivan, research and development manager at Becton Dickinson and Co. “Cockpit has brought us a fast, lean, single web environment for our project teams to interact with and manage requirements, risks, tests, complaints, and all the key information needed to help them make good decisions. I am confident that by using Cognition Cockpit, our teams will reduce time to market and reduce design problems both during and after product launch. This supports a more robust design control system and higher quality products.”

Cockpit’s Web 2.0 brings a real-time dashboard to everyone through a standard browser.

Every stakeholder has immediate access to all project information with no new software installed on their computer. This lean approach means everyone, in every location, works in real time with the same information, same documents, same analyses, and the same automated links between each piece of the product development environment.

Cockpit uses a unique new template technology to create real-time documents that share information.

For example, a test plan document is automatically populated with the appropriate acceptance criteria from the product requirements document. This ensures all requirements that need testing are indeed tested. There is no manual step needed by the test team to find and populate the requirements for their tests. Cockpit does the flow down and connection automatically so the team always knows it has validated and verified the right requirements using the correct methods.

This same template structure permeates the entire Cockpit model.

Market surveys and customer voices are automatically flowed by Cockpit down to the development team that does prioritization. Risk mitigation and design controls are intimately connected with requirements and specifications so users see the real-time interaction and the effects of changes. Cockpit’s unified model approach to product development puts teams in control of all critical aspects of their project in real time, using just their browsers.

With FDA focusing on medical device companies to demonstrate a complete understanding of the entire device there is a strong desire for a single system to bring together all the information in a real-time environment. Cognition Cockpit does just that, on the web, across all functions of the device team, from FMEA to complaints to requirements to tests.

For more information, visit www.cognition.us.

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Cognition Corp.

Cognition Corp. has been offering solutions for product and process development for more than ten years. Cognition offers two core products: Cognition Cockpit™ and Enterprise Cost Management™ (ECM). Thousands of people worldwide have used Cockpit and ECM to manage their product development and to meet performance, cost, risk, compliance, and schedule targets.