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How Medical Device Companies Can Leverage Real-Time Traceability to Speed Up Development, Increase Accuracy Blog Feature
Dale Gallaher

By: Dale Gallaher on December 18th, 2023

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How Medical Device Companies Can Leverage Real-Time Traceability to Speed Up Development, Increase Accuracy

Medical Device | Risk Management | Compass | Design | compliance | Regulations

When it comes to medical device development, efficiency, speed, and accuracy are gamechangers. The faster you can move without sacrificing safety or quality, the quicker your time to market and the sooner your impact on patient care. 

Over the past year, I’ve spoken to dozens of leaders at medical device companies, and I’ve noticed a common theme: Most organizations (I would estimate as many as 75%) are overlooking a critical lever that can significantly streamline and accelerate design development while enhancing data integrity and accuracy. 

What is it? Real-time traceability

The trace should not be something you have to author, it should be something that is created automatically. This capability is available right now, but many companies are not yet leveraging it.

In contrast to the traditional method of creating traceability as an extra and time-consuming step after design development, real-time traceability is the ability to automatically create traceability during the design process. This saves significant time, and results in the ability to instantaneously view and create traces wherever and whenever needed. The trace information is displayed without any additional work required.

Real-time traceability can only be created with an effective medical device design control software platform—it’s not something that can be accomplished with Excel or other manual processes. With real-time traceability, as you are collecting all the data, creating all of your requirements, building cascades and links within the platform, you are simultaneously creating traceability. As I often say, the traces build themselves. 

Three Benefits of Real-Time Traceability 

Often, it’s easier to gain the full picture of how real-time traceability works when aligned with an exploration of the benefits it provides. While there are several advantages, three of the most impactful are: 

A Common—But Costly—Misstep

A recent national survey of 100 medical device development company leaders revealed that roughly 70% of organizations still rely primarily on manual processes, or utilize a mix of manual processes and third-party solutions, for design control—indicating that the majority of companies lack real-time traceability capabilities. In addition, only 25% of survey respondents said they are extremely satisfied with their organization’s current practices for traceability. The survey was commissioned by Cognition and conducted independently by Sage Growth Partners, a healthcare consultancy.

1. Improved efficiency and faster time to market.

Making real-time traceability a natural byproduct of the design process eliminates the need to create traceability as a final and tedious step. In addition to saving time, companies with real-time traceability also experience efficiency gains when managing changes to inputs during development and post-development. When updates are made to one input within the system, that change is reflected across the platform. Without real-time traceability, that change needs to be captured manually across every single instance.

Real-time traceability also enables more efficient data entry, as the software automatically creates a continually growing library of inputs, as well as streamlined audit responses and reporting (as explored further below). 

2. Enhanced accuracy and safety.

With real-time traceability, every input throughout the design and development process is linked to create one source of truth. When a change is made within the system, as noted previously, that change is automatically captured throughout. This ensures that the traceability is always accurate. That’s not the case with manual processes, which require updating that input within every instance of documentation. If one edit is missed or overlooked, it can jeopardize the entire process and result in product failures, compliance issues, patient injury, or worse.

To underscore the benefits of real-time traceability when it comes to making changes, I often point to the experience of one of our customers. Before transitioning to Cognition, this customer was using a manual approach for design development, and found that they had to change the risk level for a certain situation from a 3 to a 5. To accomplish this, the customer had to find every instance of this documentation and manually make the change. It took the customer 10 months, 1,600 documents, and cost $77,000 to complete this work. With real-time traceability, they could have completed the whole endeavor in one hour. 

3. Streamlined audit responses and report creation.

When conducting audits, auditors will almost always ask for traces. Companies with real-time traceability are in a much better position, since all of their information is properly organized, linked, and highly accurate. They are much less likely to encounter missteps and they are much more likely to comply with requests quickly. The most effective medical device design software partners also make it easy to accommodate data and report requests from various parties, for example, by providing export capabilities in compliance with FDA requirements. We had a customer who was recently audited by the FDA, and had to provide a trace for more than 18,000 inputs. Because they had real-time traceability, they were able to do this extremely quickly and accurately. 

Tips for Finding the Right Partner

If your organization is ready to experience the benefits of real-time traceability, there are a few key things to keep in mind when evaluating device design control software platforms. While most offer real-time traceability, not all are equally effective at meeting the needs of medical device companies. For this reason, it’s critical to seek out a platform that has been designed specifically for medical device development. 

If your organization wants to trace a system requirement to a user need, you might have 1,000 requirements to pick from. That’s a ton of information to sift through. With a program built specifically for medical device companies, you’re going to be able to filter data more efficiently, and as a result, look at a much more precise set of data than if the program is built for more general use.

Take Cognition, for example. Cognition is deeply ingrained in medical device development and the platform was engineered specifically for medical device companies. We understand how the process works; the various needs, inputs, and outputs required; system requirements; and more. The system is highly intuitive and efficient for medical device developers, and provides filterable data specific to their needs. 

For many organizations, transitioning to a new design development platform can be daunting—whether that entails moving from Excel spreadsheets and Word documents, or shifting from a general software platform to one designed for medical devices. Still, the long-term benefits the transition provides are clear. Find a partner that will fully support your journey and your unique needs, and that will provide an incremental implementation process, so that it is more manageable for you and your team to make the switch. 

 5 Key Questions to Ask When Evaluating Design Development Platform Partners

  1. Was your solution designed specifically for medical device companies?
  2. What capabilities do you provide that can support the unique needs of medical device companies?
  3. How configurable is your solution? How will you adapt to our processes, workflows, and needs during the planning and implementation phases?
  4. How easy will it be for us to export content from the platform in the format required for submission to various organizations? Please walk me through that process with an example.
  5. Do you provide a consolidated platform for design control data, test data, and risk management? If so, what risk capabilities do you provide, and how is risk integrated with design controls?


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