Risk Management Means So Much More than EU Medical Device Regulation Compliance
Risk management has been a popular topic given expectations in the new European Medical Device Regulation (MDR). But regulatory compliance shouldn’t be the main driver. Medical device manufacturers should manage risks methodically during each stage of the design and manufacturing process, including the concept level, according to Perry Parendo of Perry’s Solutions LLC. The benefits include risk mitigation, better project execution, better clinical and field experiences, and improved profitability, in addition to regulatory compliance.
Parendo will share best practices for risk management during the upcoming MD&M Minneapolis conference session, “Risk Management For Project Execution & MDR Compliance,” on Wednesday, November 3, at 1:45 PM – 2:30 PM.
MD+DI asked Parendo a few questions ahead of his presentation.
What challenges do medical device manufacturers face today regarding MDR compliance?
Parendo: When companies take any standard too literally, it creates excessive confusion. This can easily happen with risk management as many simply comply but do not understand the possible value and the intent. Throwing away existing systems to match the standard eliminates the history and experience gained. It is practical to augment your system with the new ideas but may not be obvious how to do it. Companies do not need to settle for apparent compliance.
Can you explain the new expectations for risk management in the new MDR?
Parendo: The expectations can be boiled down to 1) Have a risk plan 2) Analyze the risks 3) Review and report on the risk results and actions 4) Provide a feedback loop from the field. It is a framework for comprehensive risk understanding.
Are these different from FDA’s expectations? If so, how? Have they evolved over the past few years?
Parendo: The expectations are very similar. The primary difference related to risk is regarding reduction of risk “as far as possible.” This wording is new in the MDR.
Is there a way to pursue a risk management plan that could satisfy expectations for both markets?
Parendo: Meeting the needs of both markets is certainly realistic. For those companies who stay ahead of the standards, they will find these adjustments to be subtle.
How can manufacturers overcome these challenges?
Parendo: On one hand, they need to keep the idea of simplicity and intent in mind. What is needed to be carried forward, and what needs to be eliminated from our processes. On the other hand, companies should aim to stay ahead of the standards. A well-thought-out and -understood system can save considerable development effort and provide a competitive advantage.
Are there any common pitfalls in meeting these expectations?
Parendo: When companies only do the minimum to comply, and only focus on complying, then the new expectations can appear overwhelming. Adding the intent from the standards within your existing system is the least disruptive and the best value for an organization.
You mention “inserting risk assessment into the manufacturing process.” Can you explain this further?
Parendo: When risk management is only addressed as a deliverable, it tends to be performed at the end of the project. The value comes from identifying tasks and resources early in the project, and as the project evolves. This is for both design and manufacturing activities. Inserting risk management periodically helps ensure a new product development stays on track and is efficient with resource use.
I understand you’re speaking at MD&M Minneapolis this November, could you tease your presentation?
Parendo: Yes, this is a great time for industry to reflect on risk management and how Product Development can benefit. Many consider risk management to be a burden and a waste of time but this does not need to be true. As a project manager, I was able to leverage the power to benefit my team, my project, and my company. This has allowed product development speed records at multiple companies. For years, I have been bringing the same benefits to clients. Some of the core risk elements will be discussed during the time at MD&M!
What do you hope attendees will learn and do differently after attending your session? How will your best practices help?
Parendo: Companies need to understand the intent of the standard and how they can obtain the value. Simply mimicking the language of the standard does not translate the risk management system to the specific needs of the organization. I want people to want to be involved in the risk management process, because it makes their job easier and the product better.
What excites you most about engaging with your community at the in-person event?
Parendo: In-person events are powerful because you can go beyond the script, and deal with specific situations from the audience members. Often times, this takes place in the hallway or during lunch. Plus, I am always running into someone I already know and we are able to catch up with what has been going on. Both experiences provide insights that can’t be gained in other forums. Especially considering how many of these interactions are compressed into such a short period of time. It is high value and extremely efficient.
Article source：Qmed and MD+DI