Building and then bringing a medical device to market as quickly as possible – all while preserving acceptable levels of quality and regulatory compliance – requires adept risk management. By minimizing potential risks such as mislabeling and software-related issues, medical device manufacturers make each product safer for the patients who will use them. All of these risks and others are present through the product development lifecycle, where they must be addressed through specific risk management activities
The ISO 14971 standard, as encapsulated in ISO 14971:2007 and then revised in ISO 14971:2019, is the modern framework for such efforts. An FDA Recognized Consensus Standard, it has a nine-part structure defining the criteria for medical device risk management during production and post-production. ISO 14971 is also required by higher-level regulation under ISO 13485. All medical device companies follow ISO 14971, but their individual approaches to the risk management standard will vary, based on not only product type but the actual tools used for handling risk analysis and control measures as well.
Risks as requirements: What’s the best approach to medical device management?
Effective medical device risk management is integral to patient health and safety. A study published by The British Medical Journal found that one in 20 patients experiences preventable harm when receiving medical care. Moreover, many medical devices in active use are many years old, meaning that even flaws implemented long ago can continue to pose risks to patients. That means risk must be curbed at every stage of the product lifecycle.
Another way to look at it: Risks are central requirements when it comes to the medical product development process, and safely managing them in accordance with ISO 14971 requires a comprehensive modern solution capable of delivering the necessary coverage, speed and preparation. Risk management is requirements management in the medical device industry. Accordingly, it’s crucial to have the capacity to, for instance, connect eventual verification tests back to requirements, so that teams can be confident of adequate risk mitigation.
However, many existing workflows and tools cannot consistently ensure acceptable compliance, leading to the possibility of recalls, or inadequate workarounds such as alterations to the label or instructions-for-use. Spreadsheets exemplify the limitations of older approaches to requirements management and risk management during the medical device lifecycle.
The problem with document-based processes
Medical device manufacturers may rely on Microsoft Excel to capture risk data and fuel their risk management planning and reporting activities. The potential problems with this approach include:
- Limited scalability to teams working at multiple locations.
- Siloed data sources that take time to comb through and reconcile.
- Human factors such as miskeyed entries or inadvertent deletions.
- Difficulty proving compliance, due to lack of end-to-end traceability.
Taken together, these issues make it onerous to maintain and execute on a medical device risk management plan that fulfills all provisions of ISO 14971. This standard requires a combination of risk analysis, evaluation and control – all processes that a risk management plan helps simplify by documenting all of the potential risks across the product lifecycle.
How to more reliably put a risk management plan into action
The risk management planning process should produce a plan that contains product-specific data and follows all standard operating procedures in the domain. The plan should also be a living document that can be continually updated as requirements and risks evolve, as it will serve as the blueprint for ongoing risk management activities such as reporting on hazards and risk control measures and also linking back to requirements. Ensuring acceptable levels of detail and accuracy in the risk management plan is much easier with an all-in-one solution than with a collection of discrete documents.
Let’s say a hypothetical medical device company was developing an MRI machine. If it were centering its risk management processes within a massive Excel sheet, lots of valuable time would be lost to stakeholders on the development team having to constantly review the requirements in the shared asset.
Plus, this highly manual, error-prone process can itself create further complications for overall medical device risk management, such as a risk going initially overlooked due to outdated data in a spreadsheet cell. Going back later to write a report about the risks is not a great alternative to building in risk management throughout the development process – but the right tools are needed for the latter strategy.
By switching to a more modern solution, this development team could instead:
- Take advantage of risk plan templates to ramp up more quickly.
- See live risk mitigation data, not outdated entries.
- Avoid the various administrative risks of Excel, like splitting/merging cells.
- Easily adjust probabilities and severities of the defined risks.
- Enable real-time collaboration between teams.
- Visualize and trace risks across the whole product development lifecycle.
- Prove ISO 14971 and other regulatory compliance more easily.
At the end of the development process, the team making this hypothetical MRI machine would be able to see clearly how its verification tests traced back to the risks and requirements it initially set. More specifically, they would know if the product could move the right amount of air, survive the expected transport and storage conditions and comply with all applicable rules and regulations.
Demonstrating ISO 14971 compliance with Jama Connect
Jama Connect offers a modern alternative to document-oriented processes for medical device risk management. Jama Connect is built to help streamline compliance with ISO 14971.
For example, Clause 7 of ISO 14971 requires attention to residual risks, or those risks that exist even if after all risk control measures have been implemented. In Jama Connect, those measures can be efficiently defined and linked to corresponding risks for maximum traceability. That way, teams can spot potentially unacceptable risks early on in development and mitigate them before the associated costs and logistics become impractical.
There are many other features within Jama Connect for complying with all clauses of ISO 14971 and modernizing your general approach to medical device risk management to keep up with changes such as the FDA’s Safety and Performance Based Pathway. To learn more, connect with an expert today.
To learn more on the topic of risk management, we’ve compiled some helpful resources for you.