Features in Five: Risk Management

Jama Connect Features in Five: Risk Management for Medical Device

Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect’s powerful features… in under five minutes.

In this Features in Five video, Stephen Pink, Solutions Architecture Lead for the Medical and Life Sciences Team at Jama Software, provides an overview of Jama Connect’s Risk Management package.

Follow along with this short video below to learn more – and find the full video transcript below!

VIDEO TRANSCRIPT:

Introduction to Jama Connect’s Risk Management Package

Stephen Pink: Hello. I’m Stephen Pink. I lead the medical and life sciences solutions architecture team at Jama Software. And today, I’ll be giving an overview of Jama Connect’s risk management package.

Challenges of Traditional Risk Management

Pink: Risk management is the backbone of safe design, but for many medical device companies, ISO 14971 compliance is buried in static spreadsheets that are disconnected from the actual design data.

The problem with this approach is that risk management happens in a silo. When managing risk in traditional documents, it’s very difficult to manage the links between risks and their mitigations. And then every time a requirement changes or we identify new risks, it requires extensive manual review to understand the overall impact on our risk file and our product development lifecycle.

Missing the impact of those changes can also lead to unmitigated hazards that aren’t identified until much later in development, when it becomes much more difficult and costly to correct.

Dynamic Risk Management with Jama Connect

Pink: Jama Connect helps to solve this by allowing you to capture hazard analysis, calculate risk levels, and maintain Live Traceability™ from those hazards and their evaluations to mitigations and verifications, turning your risk file into a dynamic part of your development life cycle, sharing responsibility across the team, and giving you a live view of all the potential risks facing your product in real time.

RELATED: LEX Diagnostics Boosts Efficiency by Modernizing its Requirements Tool with Jama Connect

Global Library of Hazards and Harms

Pink: Jama Connect’s preconfigured structure allows you to manage a global library of hazards and harms.

If we take a quick peek at my global library, you’ll see I’ve established a global harm and hazard library that I am sharing across all of the different projects that I’m working on. This allows us to standardize a list of common hazards and harms. Jama Connect does come preconfigured with the hazard list from ISO 14971. We can also manage our own, including setting things like the severity of harm and the probability of harm from a hazard that will then be standardized on every product that we’re working on.

Integrating Hazards into Product Development

Pink: As we switch to that product development project where I’m developing the CLEAR three hearing aid, we’ll see as I look into my risk analysis and evaluation component, the harms and hazards that I pulled in from my global library, and then the evaluations of those harms and hazards that I’m performing for this specific product.

We can evaluate each hazard for a specific sequence of events, capturing severity and probability levels here or inheriting those from those related hazards and harms, and ultimately calculating that initial risk level based on configurable lookup matrices and custom logic. This view feels very similar to working in the spreadsheet you might already be using today, but it helps to reduce human error based on globalized configuration for these calculations and deriving the severity and probability level.

Traceability of Risks to Mitigations

Pink: Once the risks are identified, they can also be traced to mitigations if we’ve determined that risk controls are required. So if we come up and enter the trace view, this will show me how each risk is associated to mitigating requirements or even external resources like the instructions for use that will tell the patient how to safely use this hearing aid without exceeding the recommended maximum volume.

Once we have these traces in place, they can also be traced even further down to the verification of these requirements so that we have the full scope of traceability showing the identification of the hazard, the evaluation and risk level, the mitigation with requirements and other resources, and the verification of effectiveness.

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

Evaluating Residual Risk Levels

Pink: Once all of this is captured, we also can determine the mitigated probability level based on those new controls we’ve put in place, and the residual risk level has now been lowered.

Exporting Risk Reports

Pink: We can also export all of this out of Jama Connect using one of our out-of-the-box risk reports. This is lined with ISO 14971 will give us access to an Excel file here.

So now we can see, after we’ve exported that risk analysis trace, the full scope of hazard identification, pre-mitigation scoring and risk level, controls that we have put in place, and the post mitigation risk levels. We also have a benefit-risk analysis as applicable, and these reports are completely configurable to align with your existing process, your risk calculations, and all of the existing things you’re doing today in Excel, while maintaining a Live Traceability to those design inputs and design control processes that happen every day in Jama Connect. When you stop managing risk in disconnected spreadsheets, safety becomes an integrated part of your design process.

Conclusion and Further Resources

Pink: Thank you for watching this demonstration of risk management in Jama Connect. To learn more about optimizing your risk management process, visit our website at jamasoftware.com, specifically for our risk management package. And if you’re already a Jama Connect customer, your customer success manager or Jama software consultant can also provide additional insights. Thank you for watching.

Watch the Jama Connect Features in Five: Risk Management for Medical Device HERE

To view more Jama Connect Features in Five topics, visit:
Jama Connect Features in Five Video Series

Author
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Steven Pink

Senior Solutions Architect at Jama Software

I'm a creative thinker with a passion for technology. I use my skills in requirements gathering, process improvement, prototyping, and project management to innovate and leverage technology to achieve measurable ROI. I pride myself on professionalism, flexibility, and meeting deadlines while working in an Agile environment.

Jama Connect® Features in Five: Risk Management for Medical Device