Cockpit Crew Blog

Multi-Day, Core Development Team Off-Site

Cognition held two strategic off-site multi-day meetings in a stunning area of Cape Cod with members of the core development and application engineering leadership teams. Whenever Cognition holds these events, we use the time to get our leadership groups to talk about what the company can do to improve business and employee satisfaction.

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3 Obstacles Hindering Innovation

Innovation is imperative in the medical device and pharmaceutical worlds. Dr. Arnold Kadish’s experiments with the first prototype of a 'pump'—worn like a backpack—that delivered glucagon as well as insulin in 1963 led Dean Kamen to invent the first wearable infusion pump only a decade later. Thanks to those innovations, Medtronic released its MiniMed Pump, the first of its kind, in the mid-90s, and in 2012, trials for the first implanted artificial pancreases in the US took place. Innovation is imperative, yet many obstacles appear in its way:

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3 Difficulties in Design Controls

  1. Human Factors

Human error, presumably, is the most common cause for failure. Either the user failed to implement a device correctly, or the company producing the product failed to predict improper use. The goal for companies is to minimize those failures. In order to do that, they must think through the many ways devices can fail through human error and strive to design around them to produce the safest device possible.

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21 CFR 820.30 for Dummies (i.e. Me)

21 CFR 820.30 is the bread and butter of the medical device world. It governs over all Class II and III devices and a handful of Class I devices. FDA classifies devices based on the associated risk. There are three categories: Class I, Class II and Class III. Dental floss is Class I because it is low risk. A condom is Class II because there needs to be reasonable assurance of its safety and effectiveness. Class III are the highest risk devices, such as a replacement heart valve.

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The Power of Cockpit: Talking 820.30 Design Controls

We’ve built several templates for a particular client to track device design from user needs, to design outputs, to validation. The customer has many standard operating procedure documents that they must follow. We built each of these documents into Cockpit™. The user logs into Cockpit then navigates to the document they care about (user needs, design inputs, design outputs, etc.). Once at the document, Cockpit provides a GUI where the user can see the document as a whole or select from a choice of views. These views provide the user with different options or actions to do work. The user can see traceability, enter new data, and connect different needs to design inputs and design outputs including verification and validation items, just to name a few options.

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