Blog Feature

Thought Leadership

Can Color be a Risk Factor in Medical Device Design?

By: Nick Schofield
August 1st, 2017

When we talk about risk in regard to usability, we usually center the conversation around the physical interaction with the device. User capabilities or disabilities, tactile functionality, device setup—all of these have a tangible impact on how the device is handled and used. However, multiple perceptive and cognitive forces behind usability can also have an effect. One that can get easily overlooked is color.

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cockpit | Cockpit Crew | New Employees | Intern

Welcoming Summer Intern Cyrus Dastangoo

By: Michael J Lowe II
July 27th, 2017

Cognition is excited to welcome Cyrus Dastangoo to our Summer Internship Program. Each year, we accept a handful of students looking for real world experience in the sales, marketing, engineering, or development worlds. In total for summer 2017, we have invited three interns into the program, all landing in the development department.   Cyrus Dastangoo

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How to Approach Usability Engineering & Use Error Analysis

Learn how activities like Use Error Analysis can lead to more dynamic, impactful risk management.

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Blog Feature

Thought Leadership

At-Home Medication Errors Are On The Rise: Why?

By: Nick Schofield
July 18th, 2017

Why are people having trouble with medication at home?

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cockpit | Cockpit Crew | New Employees | Intern

Welcoming Summer Intern Isaac Macrae

By: Michael J Lowe II
July 13th, 2017

Cognition is excited to welcome Isaac Macrae to our Summer Internship Program. Each year, we accept a handful of students looking for real world experience in the sales, marketing, engineering, or development worlds. In total for summer 2017, we have invited three interns into the program, all landing in the development department. Isaac Macrae

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Thought Leadership | Risk Management

The Complication of Risk Priority Number

By: Nick Schofield
July 11th, 2017

Risk scoring has been, historically, a significant part of many risk management activities. It is a method for evaluating which risks are the most critical to control. Successive scoring of risk controls allows teams to see how the level of risk on the evaluated design, process, function, operation, etc. may improve over time. Within risk exercises such as failure modes effects analysis (FMEA), risk scoring is a multiplicative process involving three factors: severity of harm (S), probability of occurrence (O), and detectability (D). These will yield a risk priority number (RPN) that, depending on the guidelines a business has in place, will determine whether a risk is acceptable or requires risk control measures. Because these scores are often expressed on scales between 1 and 10 (least to greatest), the RPN for FMEAs has a potential scoring range between 1 and 1,000.

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Thought Leadership

New Part 11 Guidance: What You Need to Know

By: Nick Schofield
June 28th, 2017

As part of its 2017 agenda, FDA has released new guidance on compliance with 21 CFR Part 11. The new guidance document revolves around the use of electronic records and electronic signatures in clinical investigations of medical products. It also helps clarify earlier guidance on the scope and application of Part 11 for medical device and pharmaceutical product development teams.

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Industry Updates

The Implications of WannaCry on Medical Devices: How Interconnected Devices Can Exacerbate Cyber Attacks

By: Michael J Lowe II
June 13th, 2017

Ransomware can be frightening. It holds all the data in a device hostage until the victim pays a sum of money, and even then, there is no guarantee thedata will return. To be more specific, ransomware takes advantage of a security flaw and locks the user out until said ransom is paid. Initially, over 200,000 victims were affected by the recent WannaCry attack worldwide, which exploited a flaw in Microsoft Windows 7 and demanded a ransom in Bitcoin. Worryingly, WannaCry infiltrated the computer systems of London hospitals. WannaCry even took its first medical device hostages in the US during the major attack. This is the heart of things: connected medical devices, on these networks, can expose them to risk if they're not well protected.

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Research & Development

4 Benefits of Agile Product Development in the Medical Device Industry

By: Michael J Lowe II
June 8th, 2017

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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Cognition | 2017 | Intern

Sean Berube's Internship Overview

By: Michael J Lowe II
June 6th, 2017

This week, we say goodbye to our latest Marketing intern, Sean Berube. He is in his final year at UMass Lowell, working towards his bachelor’s degree in English with minors in computer science and mathematics. On the side, Sean is a singer/songwriter, currently working on his latest song, “Royalties,” and hopes his future endeavors will allow him to explore music more. Sean wants to pursue a career in business, similar to what he experienced here at Cognition. He helped us write a good handful of blog and article material in his time here and we hope he will be coming back sometime to work with us again! We sat down to reflect with Sean about his time here with Cognition, figuring out what he learned and enjoyed.

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