Cockpit Crew Blog

4 Benefits of Agile Product Development in the Medical Device Industry

Agile is an umbrella term for several iterative and incremental software development methodologies. Each one is unique in its approach; however, they all share a common set of core values which incorporate continuous feedback, planning, testing, and integration of the project and software used to facilitate the this process. It is, simply, a way to organize information efficiently when developing a product. It can be applied to product development outside of software as well.

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UMass Lowell’s 6th Biomanufacturing Summit 2017

Cognition was excited to co-sponsor UMass Lowell’s 6th Biomanufacturing Summit 2017 with industry giants and leaders such as Merck, Pfizer, Shire, Biogen, and FDA. The event was located at the elegant University of Massachusetts Club at One Beacon Street in Boston--the views were breathtaking, some of the best in the city. President and CEO of the Massachusetts Life Sciences Center, Travis McCready, kicked off the event with gusto.

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Epinephrine Auto-Injectors, What a mess!

With events like big price hikes and major recalls, the recent industry news for epinephrine auto-injectors is messy. Although only so much is possible while dealing with the politics of the industry, some of these issues could potentially be alleviated in the early stages of development when prices could be reduced and recalls prevented more easily. Otherwise, the consequences can be harsh.

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The Global Unique Device Identification Database (GUDID)

FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use,” according to the FDA’s website. It is currently in the middle of a seven year undertaking, which started in 2013 and is expected to end in September 2020, called the FDA Global Unique Device Identification Database (GUDID). It is an endeavor to mitigate clinical error and risk, while also yielding better data for a more robust post-market surveillance system. GUDID would also make product recalls more efficient in being able to pinpoint exactly the devices that went awry.

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Can your DNA affect the healthcare Industry? It just might...

What is DNA? Deoxyribonucleic acid (DNA) is a molecule that carries most of the genetic instructions used in the growth, development, functioning,[DMC1]  and reproduction of all known living organisms and many viruses. DNA forms chromosomes; each person has 23 pairs of these. These chromosomes make people who they are. It will decide what hair, eye, and skin color a person is, how their body is shaped, and all the other things which make people individuals.

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Three biological parents? So what?

Having three biological parents probably sounds out of the ordinary to society, but the idea might not be so unheard of with mitochondrial transplants. There have been claims against its safety, claims against its efficacy, even claims to say it is the next step towards eugenics. First, a brief explanation of what is happening. These are mitochondrial transplants for people with mitochondrial disease, which is when the mitochondria are unable to supply enough energy to the nucleus. This can cause many problems.

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Quality or Carelessness?

“It typically takes 20 to 40 years or more for scientific discoveries to trickle down to benefit human lives in a meaningful way… This is unacceptable.” - Sandra Bond Chapman, founder and director of the Center for BrainHealth at the University of Texas  

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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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