Medical device product development and risk management are often treated as entirely separate processes.
Sure, there is usually acknowledgement and understanding that these two processes are related.
But it is important to realize that product development and risk management are more than just related.
These processes both have the same overall purpose and intent: to help make sure medical devices are designed, developed, and manufactured to be safe and effective.
Yes, the documentation and records generated as a result of product development need to align with Design Controls.
Yes, documentation and records generated as a result of risk management need to align with ISO 14971.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
And all of these documents and records should flow and represent the overall picture of your medical device.
Now that you understand just how closely tied product development and Risk Management are, let’s dive into three tips you can use to incorporate Risk Management throughout the medical device product development process.
1. Understand the importance of Intended Use
Intended Useis the general purpose of the medical device or its function (what you “claim” the medical device does).
The intended use statement must be consistent with your labeling, advertising and instructions for use.
Indications for use describe the disease or condition the medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population.
For the record, there is a strong correlation between“indications for use” and “intended use”—so much so, that we can consider these terms to be synonymous.
In theory, the reason a medical device exists to begin with is to address specific indications.
And if you are in the midst of medical device product development, chances are you are attempting to address unmet clinical needs or address clinical needs in a better way.
Do you see the relationship between clinical needs and intended use?
Let me take this a step or two further and explain how intended use relates to User Needs:
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User Needs describe how your medical device is going to be used.
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User Needs help establish the framework for your medical device product design.
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User Needs are a series of statements that describe what is important about your medical device from the perspective of the end-user and patient.
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User Needs are an expansion of the Intended Use.
If you have read anything about Design Controls and/or are familiar with the infamous waterfall diagram, you know how User Needs relate to Design Controls.
Intended Use is also vital to product Risk Management.
In order to analyze, evaluate, assess, and control risks of your medical device, you have to know the Intended Use.
In fact, the Intended Use is necessary to define the scope of your product Risk Management.
Just like Intended Use is important to establishing User Needs and the start of Design Controls, Intended Use is equally important to being able to identify hazards and hazardous situations pertaining to the use of your medical device.
2. Product Risk Management is a cycle—even during product development
If you take ISO 14971 Risk Management standard literally, your high-level process steps will likely be something along the lines of:
- Risk Management Plan
- Risk Analysis
- Risk Evaluation
- Risk Control
- Overall Residual Risk Acceptability
- Risk Management Report
- Production / Post-Production
Risk Management activities definitely have a flow.
And an ideal flow involves making several “passes” through Risk Management as you progress through product development.
Risk Management Planning is about identifying the timing and risk activities planned.
Risk Analysis is about taking the intended use of your product and identifying hazards and hazardous situations. Once identified, you then estimate the risks of each hazardous situations.
Risk Evaluation is about determining acceptability of the estimated risks.
Risk Control is about identifying ways to reduce risks to an acceptable level and verifying the controls are effective.
Overall Residual Risk Acceptability is about evaluating the risks of the entire, finished device.
The Risk Management Report captures the results of the risk activities.
Production / post-production is about ensuring you have provisions in place after market release and design transfer to feed back into Risk Management.
You can see the cycle from an overall perspective.
And I’d like to suggest you treat your Risk Management process in a more cyclical manner during product development.
Rather than do a Risk Management Plan one day, followed by Risk Analysis another day, and then Risk Evaluation, etc. use Risk Management as a tool to help you.
Take a first pass from “beginning to end” near the start of a product development process. Use the risk estimates, evaluation, and controls as a means to help drive your medical device product development efforts.
Doing so will mean that you are truly taking a risk-based approach with product development.
As product development tasks and activities are checked off the list, revisit the Risk Management activities to confirm and update.
3. Risk Management & Design Controls have the same purpose
How can that be?
Design Controls are defined by FDA in 820.30 and ISO 13485 under section 7.3 Design & Development.
Risk Management is defined by ISO 14971.
And if you take that literal point of view, then you will fail to understand why Design Controls and Risk Management are essentially the same process.
Design Controls are about demonstrating your medical device meets the needs of the end-user, meets the requirements, and ultimately is safe and effective.
Does any of this sound at all familiar?
How would you describe the purpose of Risk Management?
Isn’t Risk Management all about ensuring the medical devices we design, develop, manufacture, and sell are as safe as possible for their intended uses?
I recently shared a story about my first-hand clinical experience with a medical device I had designed. At that time in my career, I knew very little about product risk management—at least in the context we know it today.
But I did know one thing for sure. I knew that the medical device I was designing had to address clinical needs while being safe and effective in the process.
Yes, Risk Management and Design Controls have the same purpose.
And there should be a flow between Risk Management and Design Controls.
Treating these as separate process flows is not the intent.
I already shared how intended use feeds User Needs and feeds Risk Management.
Consider these other important relationships that bind Risk and Design together.
Hazards and Hazardous Situations feed into your product development process to improve User Needs and Design Inputs.
Design Outputs, Design Verifications, and Design Validations feed into Risk Management process as Risk Controls.
Design Reviews are times to evaluate Design Controls and Risk Management.
Bottom line: The emphasis on your entire product development efforts is all about ensuring your medical device is as safe and effective as possible.
Ladies and gentlemen, welcome to the world of a risk-based approach for medical device product development.
Photo credit: Got Credit
