Cognition’s 11 Most Popular Risk Management Blog Posts of 2018
The Cognition blog had a very busy 2018, and it was all thanks to readers like you. We discussed many pressing topics in life science industries, the latest FDA updates, things happening at Cognition, and so on. In reviewing blog performance in 2018, we found a number of blogs related to risk management that were very popular with our readers, and we wanted to share that list with you.
1) Applying Design Thinking to Risk Management in Life Sciences
By far the most popular risk management blog post we’ve posted to date, “Applying Design Thinking to Risk Management in Life Sciences” explores how early stage design thinking activities can influence risk management throughout the product development process. It also emphasizes the importance of repetition when it comes to the intersection of design thinking and risk management.
2) What is (Inherent) Safety by Design?
FDA’s (inherent) safety by design principle can be confusing for life science organizations to fully grasp, as there is no clear definition provided by the agency. In our “What is (Inherent) Safety by Design?” blog post, we unpack FDA guidance on this principle and what needs to be taken into account in complying with it.
3) 3 Ways Rapid Prototyping Empowers Medical Device Risk Management
As another aspect of design thinking, rapid prototyping can be very effective when it comes to building medical devices. Our “3 Ways Rapid Prototyping Empowers Medical Device Risk Management” blog post—which has been very popular with our regular readers—touches on just a few of the ways this design thinking tool can encourage more insightful and improved risk management.
4) The Relationship Between Design Reviews and Risk Management
One of our passions here at Cognition is the integration of design controls and risk management—in fact, it’s one of the fundamental cornerstones of the Cognition Cockpit® Platform. We like to use our blog to talk about this integration, and it inspired our blog post on “The Relationship Between Design Reviews and Risk Management.” This post was very popular in 2018 and well worth the quick read.
5) 5 User Needs Considerations in Life Science Risk Management
User needs are the lifeblood of Agile product development. They inform and focus the process from day one. However, to satisfy those needs, there are a number of risk factors that must be managed. In our “5 User Needs Considerations in Life Science Risk Management” post, we discuss just some of these risk factors and how to account for them in your risk analyses.
6) How Can Risk Libraries Benefit Your Risk Management Activities?
We know a thing or two when it comes to risk libraries in life science risk management. In our “How Can Risk Libraries Benefit Your Risk Management Activities?” blog post, we discuss some of the benefits of these tools and how they can transform your life science product development.
7) 3 Reasons to Conduct Preliminary Hazard Analysis on User Needs
Preliminary Hazard Analysis (PHA) is a powerful risk management tool. It lets your team apply prior knowledge and experience of hazards, hazardous situations, harms, and failures to your product. And while it gets overlooked sometimes, applying PHAs to user needs is actually a very useful exercise. In “3 Reasons to Conduct Preliminary Hazard Analysis on User Needs,” we discuss just a few of the benefits of leveraging this risk tool early on in the process.
8) Use Error and Medical Devices: Did You Consider These Four Scenarios?
Since we’re still on the theme of users, let’s talk about our blog post titled “Use Error and Medical Devices: Did You Consider These Four Scenarios?” In this post, we explore different usability scenarios worth evaluating in your risk management activities. While not a definitive look at all scenarios that could influence use error, this blog post offers a jumping-off point for organizations like yours.
9) 3 Overlooked Risk Areas in Your Life Science Product’s Life Cycle
It’s easy to get so caught up in managing the risks of your product design that other areas of its life cycle can become neglected. In our “3 Overlooked Risk Areas in Your Life Science Product’s Life Cycle” post, we tease out some areas of your product’s total life cycle most commonly left unaddressed or not thoroughly analyzed for risk.
10) Evaluating the Cybersecurity Risks of Your Medical Device
Cognition has written a lot about cybersecurity and risk management in the past, and for good reason: it’s one of the most pressing concerns for life science organizations today. Especially after the WannaCry attack that compromised medical devices, as well as healthcare organizations, medical device manufacturers need to be more vigilant than ever. In our “Evaluating the Cybersecurity Risks of Your Medical Device” post, we discuss just a few of the best practices and resources out there today for handling this growing concern.
11) Risk-Benefit Analyses: The Importance of Context and Iteration
Last on our list, but not least, is our “Risk-Benefit Analyses: The Importance of Context and Iteration” blog post. In this post, we dive into how the contextual nature of the risk-benefit analysis can impact how regulators assess this balance in relation to safety and effectiveness. Likewise, we talk about the importance of doing these types of analyses in a cyclical fashion, and how that can improve quality, safety, and compliance.