Last time, I shared that Design Verification is all about designing your medical device correctly. What about Design Validation?
Design Validation is proof that you have the correct medical device.
What do I mean by this?
Design Validation demonstrates that the medical device you developed meets the needs of the end user. It is a critical step in the Design Control process.
The role of User Needs
Without a doubt, the user needs for your medical device product development project have a significant impact and relationship on Design Validation.
Keep in mind you capture user needs at the beginning of a project (or at least you should). User needs are a way to express what is important about the medical device from the perspectives of the doctors, nurses, clinicians, and others who will use your product. User needs should also consider the patient and others who will interact and use your product.
User needs are tied to indications for use and intended use you claim for your medical device.
In my experience, though, user needs are rushed and haphazardly defined. Usually user needs seem to be more of a wish list.
When you capture and document your medical device’s user needs, realize the importance they play in medical device product development.
User needs are the pre-cursor to Design Inputs.
Design Validation proves the user needs are met.
When capturing your user needs, you are best served to think down stream for your project. How will this user needs be beneficial at later stages in the medical device product development efforts?
Design Validation proves user needs are met
Let me make the following statement: The quality of your user needs will have a direct correlation to the quality of your Design Validation.
When you get to the point when you are ready to conduct Design Validation, this often means Design Transfer and market launch are right around the corner.
Needless to say, your company is probably very anxious at this stage. There is probably a strong desire to push through Design Validation as quickly as possible. This is especially true if you already have regulatory clearances necessary.
But remember Design Validation is part of Design Controls.
Yes, the good ol’ Design Control waterfall diagram.
Design Validation closes the loop of your medical device product development efforts.
Why does Design Validation even matter?
Once you get your regulatory submission cleared, this means you can go to market.
You might not have completed Design Validation yet. But since you got the okay from FDA, do you need to?
Design Validation is a MUST.
Don’t fall into the trap of trivializing it and dismissing the value of Design Validation.
Knowing you rocked it!
Don’t you want to know that you rocked medical device product development before going to market?
Design Validation is a way for you to know this with some certainty.
Design Validation is a time for actual end-users to use and evaluate the medical device you developed.
In my experience as a medical device product developer, there is nothing more thrilling (and scary) than having the actual end-user use your product.
Doesn’t matter if the end-user evaluates in simulated use or in actual use.
What does Design Validation involve?
There are a few components you need to incorporate to ensure successful Design Validation.
- Design Validation planning
- Determining Design Validation methods
- Evaluating Design Validation results
Design Validation planning
Who will conduct Design Validation? How many end-users should be involved?
Will Design Validation be simulated use or require actual clinical use?
How many devices are required?
Defining how many end-users and how many devices will be required for validation efforts is very important. You also need to start thinking about the acceptance criteria, or how you will be able to prove success, as part of planning.
I recommend you start Design Validation planning early in the project. It makes sense to start the framework for validation planning when you are defining those user needs.
Plan your Design Validation too late and things will be rushed.
Design Validation methods
For most medical devices actual clinical use is not required. If actual clinical use is required, it likely means you will need to know about this very early in a project. Clinical use will likely require an IDE submission.
If you can push for simulated use. Just make sure that simulated use is an accurate representation of the actual use environment and conditions.
Design Validation will involve testing. And the testing should demonstrate that your medical device works, as intended.
The testing required should be defined in an approved test protocol or test method. The protocol must include acceptance criteria too.
Note, be sure to include packaging, labeling, and instructions for use as part of your Design Validation.
Evaluating Design Validation results
How do you know if Design Validation was successful?
First measure is this: Did your results meet the established acceptance criteria?
If for some reason you did not, then you will need to evaluate what course of action to take.
Getting Design Validation right before you launch if critical. If you accept so-so results and push to market anyway, it is likely that you are setting yourself up for headaches down the road.
Things like product complaints and design changes will quickly become more common than any of us would prefer.
We all want a clean break from product development to manufacturing. Successful, thorough Design Validation is definitely a way to help ensure this.
Jon Speer has been in the medical device industry for over 16 years. In 2007, Jon started Creo Quality to help medical device companies with project management, quality systems, and regulatory submissions. As a result of his experience in the medical device industry, Jon had an idea to develop a software solution to improve how companies handle Design Controls. Because of this greenlight.guru was born. You can find him on Google+, Twitter, and LinkedIn.