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Introducing Risk Solutions: A New Era in Risk Management for MedTech

May 9, 2023

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In our day-to-day lives, most of us manage risk in a pretty haphazard fashion. 

Decisions to put on a seatbelt or reapply sunscreen after a few hours on the beach aren’t made with hard data. They’re the result of a bewildering number of variables—facts, anecdotes, intuition, and emotions—that we all rely on to come to a conclusion about the risk of doing, or not doing, something.

Risk management in MedTech is meant to be different. 

It’s meant to be a systematic and ongoing activity that uses the best available data and methods to discover, analyze, and mitigate the risks inherent in any medical device. 

The problem is that it’s too easy for MedTech companies to fall short of that ideal. It’s too easy for risk management to be incomplete or ineffective. And it’s not because risk isn’t a priority for MedTech companies; it’s because they don’t always have the right tools for the job.

Scouring databases and compiling information into spreadsheets, shared drives, and even generic software solutions for risk—these aren’t up to the task of true risk management in MedTech. This current approach to risk is disconnected, time-consuming, tedious, and filled with potential for preventable errors or missing information. 

That has to change. 

And now, with the launch of Greenlight Guru’s new Risk Solutions, MedTech companies around the world are about to transform the way they approach risk management. 

For the very first time, MedTech companies have technologies at their disposal that not only helps them manage risk throughout the product lifecycle, but also capture and assess risks they may have otherwise missed. 

The new Risk Solutions, is a complete risk software for MedTech that’s made up of two powerful elements:

  • Risk Intelligence: Leverages AI and advanced statistical models to provide insights and recommendations for identifying the most relevant device hazards and patient harms with probabilities based on the occurrence of real-world adverse event data.
  • Risk Management: Provides workflow software that is aligned with ISO 14971:2019 and is used for creating risk matrices, documenting risk, and providing complete traceability throughout the entire device lifecycle.

Together, these two powerful solutions will revolutionize the way that MedTech companies assess, document, and manage the risks associated with their medical devices. There is no other solution like this available on the market today. 

Risk Intelligence: AI-powered insights to transform the way you approach risk

You can’t control what you don’t know. 

And for too long, the process of identifying hazards and patient harms, and then calculating the probabilities and severities of those harms, has been tedious at best. At worst, it’s also created gaps (those unknown hazards and harms) and increased uncertainty in the risk estimation process. 

So, at Greenlight Guru, we set out to build something that would help eliminate those gaps and give you the most detailed and refined view of the probable hazards and harms your device may pose to patients using real-world adverse event data. 

The result is Risk Intelligence.

Greenlight Guru’s novel search engine leverages machine learning and natural language processing to aggregate industry data from sources like the FDA MAUDE database. With applied statistical models and AI, Risk Intelligence enables searches by product codes, indications for use, and intended use to identify and recommend potential risks. And it does it all in seconds. 

According to Brad Cunningham, Director of Quality Assurance from Pirouette Medical: 

This will save lots of time normally spent brainstorming, researching, and documenting hazards, patient harms, and trying to estimate probabilities and severities. I love that Risk Intelligence lets us combine our existing expertise with AI-driven insights derived from FDA databases to best evaluate risk for our device.

What would have been months of looking through databases, reading through clinical research, moving data manually, and banging your head against spreadsheets and other cumbersome tools now happens with the click of a mouse.

This isn’t just an endless list of possible hazards or harms, either. Risk Intelligence will generate a provisional risk matrix along with interactive data visualizations that show you spatially where the risks to patients may lie. 

The value of this novel AI technology goes beyond an initial risk evaluation. This is about accelerating product development and saving resources while increasing your understanding of your device’s risks. 

Every company that uses Risk Intelligence can feel confident that they’re starting risk management on the best possible footing, avoiding the kinds of preventable edits, reviews, and investigations that happen when a device goes to market without a strong foundation in risk.

Risk Management - Efficient and compliant risk across the device lifecycle

Risk Intelligence will accelerate and improve some of the most difficult parts of risk management, but it can’t help satisfy compliance requirements for documenting and managing risk by itself. That’s why we’ve paired Risk Intelligence with our powerful dedicated software for Risk Management, helping MedTech companies put insights into action for managing risk. 

Risk Management is a dedicated workflow in Greenlight Guru’s Quality Management (QMS) platform, fully traceable and linkable to other information throughout the system like design controls. This gets MedTech companies out of spreadsheets and other generic tools that aren’t built for the processes and compliance requirements they face.

The intuitive graphical interface (optionally linked to your design matrix) in Risk Management makes it easy to establish risk acceptability criteria and configure probability modes that best suit your device. Just as important, the Risk Matrix itself comes with in-line editing, a must-have feature for teams to collaborate and work efficiently. 

On top of that, because Greenlight Guru has built our entire QMS platform specifically for medical device companies, Risk Management is the only solution in the industry aligned with ISO 14971:2019, as well as the risk-based requirements of ISO 13485:2016.

There’s simply no reason that MedTech companies shouldn’t have tools that were purpose-built for their needs—and their success. There are too many evolving regulatory requirements. Too many must-haves that are specific to the MedTech industry. And too much on the line not to have the absolute best means for risk management at your disposal.

That’s why we built Risk Solutions for you. That’s why we believe it will transform the way you approach risk management. 

Ready to experience the new era of risk management? Get your free demo of Greenlight Guru’s Risk Solutions today ➔

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle. Greenlight Guru’s...

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