At ISS AG, collaboration isn’t just a buzzword – It’s the backbone of our work. Efficient collaboration between medical writing and risk management is crucial to ensure patient safety and performance of medical devices and IVDs. Our integrated approach combines expertise across disciplines normally not found within one team or company, delivering services that not only assure compliance, but also are more efficient. To explore how this collaboration works, we spoke with ISS AG experts Laura Doyle, Scientific Writer, and Thomas von Arx, Senior Project Manager and Risk Management Consultant. Curious about the challenges they face, the keys to seamless teamwork, and their take on terms like technical documentation and compliance? Read on – and stick around until the end to find out which fictional characters they would recruit to their dream team!
Why Early Collaboration Matters
Risk management is often thought of as a purely engineering-driven task, but engineering is just one aspect of it. As Thomas explains, “Risk management may be based on engineering principles, but critical questions about a device’s purpose and clinical implications can’t be answered in isolation.” This is where Laura and the team of medical writers come in.
Medical writers play a crucial role by analysing the state of the art (SOTA) and defining clinical risks to ensure that devices align with regulatory requirements and patient needs, with a key focus on their safety. Early collaboration between medical writers and risk managers is essential, as it streamlines processes, enhances efficiency, and minimizes the likelihood of potential missteps. Together, they establish risk acceptability criteria, evaluate the benefit-risk ratio in alignment with the device's intended purpose, and ensure compliance with relevant standards and regulations. This collaborative effort results in a comprehensive risk management file that prioritizes patient safety and achieves regulatory success.
The Power of Purpose: Defining the Intended Purpose
In medical device development, defining the intended purpose is more than a box-ticking exercise; it’s the foundation that leads you in the right direction. Laura explains, “The intended purpose shapes compliance and risk management – it’s the compass guiding the device’s design and market strategy.”
Thomas adds: “For every ‘yes,’ you have to say ‘no’ ten times. Without a clear scope driven by the intended purpose, the process becomes unnecessarily complex, and your compliance efforts become so complicated that you risk losing sight of your goal.” Defining the intended purpose goes beyond marketing language. It sets clear boundaries for the device’s design, ensuring it is safe, effective, and compliant. And when the intended purpose changes – whether due to new features or regulatory shifts – it has significant implications for risk management. Without this clarity, proving the safety and performance of a function becomes an uphill battle. As Laura puts it, “How can you prove the safety and performance of a function if you can’t articulate what it’s intended to do?”
Laura, what are your best practices and recommendations to ensure efficient collaboration with risk management?
– Clarify Risks vs. Clinical Harms: It’s vital to distinguish between risks, which are identified and mitigated in RM, and clinical harms, which are actual adverse effects supported by clinical data. The two are linked but distinct. Early clarification of this difference can help streamline the process.
– Have a basic understanding of the Risk Management approach: Risk Management is heavily standards-based, which differs slightly from the approach taken in medical writing. Medical writers should be curious and open to collaboration. Understanding risk management concepts, including risk categorization, helps writers communicate the context and findings more clearly.
– Find the common ground: Risk management and medical writing share the same ultimate goal – ensuring device safety and performance. We’re on the same side, not in competition. Neither risk management nor medical writing is effective in isolation; both rely on each other’s context and interconnection to achieve their purpose.
Embracing Collaboration
Collaboration between medical writers and risk managers is not without its challenges. Laura emphasizes the importance of understanding each other’s frameworks and approaches: “Medical writers should grasp the basics of risk management, like how risks are categorized. It makes communicating findings much more effective.” Thomas, on the other hand, stresses the importance of simplicity in risk management: “If you overcomplicate risk management, it becomes unmanageable, and you lose the people involved mentally. Key are abstraction and categorization, which makes the process more effective and allow for better collaboration that in return improves the results of risk management activities.”
Their shared advice? Find common ground. Medical writing and risk management aren’t competing forces but complementary tools working toward a shared goal: patient safety and device performance. Both Laura and Thomas emphasize that their roles are deeply intertwined, and both can profit greatly from the experience and knowledge of the other. As Laura puts it, “We’re on the same side, not in competition.”
Risk Management: Simplifying Complexity
At its core, risk management focuses on the interplay between probability and severity to identify, assess, and mitigate risks. While Thomas views risk as a combination of these factors, Laura points to the need to distinguish between risks and clinical harms. “Risk management evaluates risks, while clinical harms are actual adverse effects supported by data,” she explains.
Both agree that the goal isn’t to create the perfect system from the start, but to build a solid, manageable foundation. “Risk management should simplify complexity, not add to it,” says Thomas. This iterative approach allows for refinement as the project evolves and more information is gathered, ensuring that the resulting device profits from the risk management process and not just ends up as a theoretical exercise.
Thomas, what are your best practices and recommendations for risk managers?
– External Insights: Risk managers also benefit from external perspectives, whether through cross-department collaboration or external experts. Bringing in external support with an untainted view on the topic early on can often help identify gaps or assumptions that might otherwise go unnoticed.
– Simplicity and Flexibility: RM is not necessarily an exact science during implementation, and it’s okay to simplify or generalize. When starting from scratch, the first iteration of risk management documentation doesn’t need to be perfect; it should provide a solid foundation. As the development progresses, more specific and complex details can be added. This is more beneficial than an RM so complex that it becomes unmanageable.
Navigating Buzzwords: Risk, Compliance, and Technical Documentation
Buzzwords like "technical documentation," "risk," and "compliance" can spark heated debates. Laura and Thomas shared their thoughts:
Technical Documentation
Laura
It's a complex and overarching task – you try to integrate input from various areas (development, testing, PMS), while finding the common thread that ties everything together. The challenge is creating a clear, usable, and cohesive TD.
Thomas
It’s a concise overview of the documentation you already have, structured according to regulatory requirements. A TD is a summary, not a full design history file (DHF).
Risk
Laura
When I think of a risk, I tend to focus on the potential harm – what could go wrong. As a result, I often struggle to remember that, by definition, it's the risk itself, not the harm, that needs to be evaluated.
Thomas
A risk is the combination of probability of occurrence and severity.
Compliance
Laura
It’s essential but not always intuitive and if not done properly it can sometimes feel overly bureaucratic. This can lead to creating documents solely to meet compliance requirements, distracting from what truly matters – proving whether something is actually safe.
Thomas
Compliance is a legal construct and, therefore, both crucial and unintuitive at the same time. This makes it easy to mix it up with our personal understanding of compliance. For this reason, you might overlook important parts, while possibly doing things that aren’t actually required.
Superpowered Collaboration
Managing risk and ensuring compliance isn’t magic, but teamwork is the key ingredient. If Laura could recruit a fictional teammate, she’d choose Sherlock Holmes for his unmatched analytical brilliance and ability to distill complex information into clear, actionable insights. Thomas, on the other hand, would bring on Dr. Jekyll & Mr. Hyde: “Their duality mirrors what’s needed in risk management – a mix of analytical precision and focus while keeping an outside perspective to see the big picture schizophrenically separated to not negatively influence each other.”
Interestingly, while their fictional picks highlight unique traits, both agree that the real superpower lies in recognizing what you don’t know and harnessing the collective expertise of the team to bridge gaps and drive success.
The Real Superpowers: Communication and Collaboration
Managing risk and documenting clinical insights aren’t solitary endeavours – they thrive on teamwork. Laura and Thomas emphasize that success comes from setting egos aside, fostering open communication, and sharing knowledge. By joining forces, medical writers and risk managers ensure that medical devices not only tick the regulatory boxes but also deliver on safety and performance. Their collaboration is a great example of teamwork turning complex challenges into successful outcomes.
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