Medical Device Risk Management: Our Holistic Approach
Medical Device Risk Management: Our Holistic Approach
This post is not about industry standard tools like Failure Modes and Effects Analysis (“FMEA”) or Validation Mater Plans (“VMPs”).
There is a lot of literature that already covers these topics.
FMEA and VMPs are important tools to be used as part of development, but how do you approach planning and managing an entire project to result in a safe and profitable product launch?
In this blog post, we’ll talk about how to organize a project plan for the development of a medical device that appropriately accounts for risks and positions you for success.
Different Types of Risk in Medical Device Development
When considering a medical device risk assessment, we too often focus on only one type of risk: product or design risk.
There is a reason for this.
If the device does not work, nothing else matters.
If the device is not safe, nothing else matters.
However, in addition to product risk there is another type of risk that causes medical devices to fail in development: project risk.
I will tackle each of these two topics below and discuss ATL’s expert approach to handling each.
Project Risk
“There is no way that this schedule is going to work.”
As a project manager, I can’t tell you how many times I have heard that statement.
Another assertion I tend to hear is, “we have to do it faster.”
There is nothing inherently wrong with either of these statements.
Rather, it’s what you do with them that is important.
ATL will listen to your needs, help you define the scope of the project, and then, based on decades of development experience, build a project schedule.
In the first drafts of the project schedule, ATL will not add any undue risk by trying to shorten the schedule.
This is very important as it serves as a tool to perform the first of three stages of risk management: risk identification, risk analysis, and risk evaluation.
Risk Identification
After drafting a project schedule, ATL will meet and review it with you.
As we identify places to shorten the schedule, we will document the associated risks.
For example, let’s say we need to shorten the schedule by two weeks.
The schedule currently shows that you will receive your first set of samples next week.
You then have two weeks to test and approve the samples.
Upon approval, ATL will start building a second set of samples.
In order to cut two weeks from the schedule, you decide to build the second set of samples immediately after completing the first.
There is obvious risk in building the second set of samples before you complete the testing—if the first set are not approved, the second set will be of no value.
However, this is not uncommon and is often referred to as a “Risk Build”.
At this point we have identified a risk.
This sets the scene for the next two stages of risk management.
Risk Analysis and Risk Evaluation
With each risk identified, ATL will draw on decades of experience to analyze the impact if the identified risk were to occur, and to evaluate if the risk is acceptable or not.
In addition, ATL will develop response plans for identified risks so that we are ready to address them quickly should the occur.
This collaborative effort will result in a risk management plan.
The collaboration makes sure that everyone is aware and aligned on project risks and sets the expectation for open communication during the project.
Before I continue, it’s important to recognize that the schedule is only one of the tools used to help identify project risk.
In general, there are three areas where project risk can manifest itself: scope, schedule, and budget.
ATL’s goal in project planning is to find all project risks.
Product and Process Risk
There are three important questions that everyone should ask during the development of a medical device.
The first two address the product or design risk.
The third addresses the process of how it is made:
- Will it work?
- Does it work?
- Can we make it?
ATL answers these questions by breaking down the work into three key groups.
These groups are sometimes referred to as the second level of a Work Breakdown Structure (“WBS”):
- Engineering Verification (“EV”)
- Design Verification (“DV”)
- Production Validation (“PV”)
These groups are often mistaken to be sequential because they are sometimes referred to as “phases.”
While a conservative project schedule would see these groups as almost entirely sequential, because that is lowest risk, they rarely are.
Doing so would create an unacceptably long project schedule.
You can learn more about our EV/DV/PV product development process here.
For now, we’ll discuss the three questions posed above in a little more detail.
Will it work?
We want to get the product design risk to an acceptable level by properly engineering the product.
This ensures the best possible design and reduces project budget risk before making investments in things like production tooling.
EV activities include things like concept generation and selection, prototyping, finite element analysis, tolerance stack analysis, mold flow analysis and other computationally intensive activities.
Does it work?
If we have quality components built in a controlled environment, does the product do what it is supposed to do?
To answer this, ATL builds and qualifies the tools used to manufacture the components that go into the final assembly.
When appropriate, this includes using installation qualification (“IQ”), operation qualification (“OQ”), and/or process qualification (“PQ”) practices.
Once the quality of the parts has been established as acceptable, ATL assembles the parts in a controlled way to limit variability due to the assembly process.
At this point the goal is to test the design not the assembly process.
This often means that these assemblies are built in a lab and not on a production line (this can be adapted based on individual needs) where they are then tested.
Can we make it?
PV uses the same IQ/OQ/PQ methodologies employed in DV but this time the focus is on the assembly process and not on components.
Assemblies will be built on a production line and not in a lab.
The function and quality of the parts is then verified before approving the production line for mass production.
There is an important and sometimes overlooked interplay between DV and PV efforts that is key to making sure we correctly assess risk: DV efforts are focused on components and function, while PV efforts are focused on assembly processes and final inspection.
Additional Resources
By taking a holistic approach to risk management and leveraging our judgement and experience, we work with you to reduce risk in bringing your device to market.
ATL will work to actively manage your schedule risk, scope risk, and budget risk throughout your project, giving you a better development experience and faster time-to-market, while achieving the ultimate goal of meeting doctor and patient needs while ensuring their safety.
To learn more about our approach to medical device risk management, download our free ebook.