Cognition Cockpit Allows Medical Device Companies to Close the Gap Between CAPA, Complaints, Risk Management, and Requirements Management in Product Development

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Even with formal product development processes, risk management plans, design controls, and strict regulatory compliance mandates, medical device companies still continuously experience high costs, late release dates, irregular product performance and product recalls. The new Cognition Cockpit 5.6 goes a large way towards eliminating these problems through its unique approach of unifying all the critical data of product development into a real time Web 2.0 environment. It's the Facebook of product development.

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.

Cognition Corporation, a worldwide leader in Web 2.0 Product Development software, announced today their release of 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.

Read the Cognition Cockpit Executive Overview at: http://www.cognition.us/Presentations/ExecutiveOverviewSite.html

"Medical device companies struggle," said Michael Cronin, CEO of Cognition Corporation, "with the challenge of creating and maintaining a complete trace of all the decisions and interactions between each part of the system. A typical failure mode is when the corporate complaints system reports occurrences of certain failures that do not match the predicted levels in the teams' Risk Management Plan / FMEA. 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."

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 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," said Tim Sullivan, R&D Manager at Becton, Dickinson, and Company. "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 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 PRD (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 flowdown and connection automatically so the team always knows it has validated and verified the right requirements by 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 Mitigations and Design Controls are intimately connected with requirements and specifications so users see the real time interaction and impact of changes. Cockpit's Unified Model approach to product development puts teams in control of all critical aspects of their project in real time, all through 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.

About Cognition Corporation:
http://www.cognition.us
Cognition Corporation 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.

The Cognition team is made up of engineers with experience in marketing, product development, Six Sigma, CAD/CAE, PDM/PLM, object-based data management, and the most advanced web development techniques. Most technical staff are black belts in Six Sigma and Design For Six Sigma (DFSS). All staff are trained to think and act with a total systems engineering approach to all projects.

Cognition's goal has always been to provide engineers with collaborative solutions to problems they face every day, without adding overhead and additional time burdens to already heavy demands. Software should never "get in your way." Cognition is successful when people think of the software as just a part of the way they do their job. Just like email and the internet, Cognition’s software is designed to make what you want and need to do easier.

Related articles and events:

Medical Devices Summit 2010
http://www.cognition.us/news/industry_news_MedicalDevicesSummit2010.html

Managing Risk for Medical Device Design and Engineering
http://www.cognition.us/news/industry_news_ManagingRiskMarcusEvans.html

Critical Issues in Requirements Management - Panel Discussion with Executives
http://www.cognition.us/news/industry_report_142845a.html

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Cognition Corporation
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