If you are an engineer in the medical device industry, you probably have a love/hate relationship with the FDA-mandated design controls process. While implementing design controls can feel like a major damper on your creativity and productivity in the design process, they're still a legally mandated requirement for every medical device company.
This area of regulation tends to be full of misconceptions and misgivings, along with a dash of frustration when it seems that design control documentation is that one thing holding your company back from compliance and preventing you from getting to market.
In reality, design controls should be something that helps your business, especially if you work on the documentation early in your design process. This article includes the best tips and advice that will help you implement design controls in a way that benefits your product development efforts. By the end, you will view design controls not as a burden, but as an asset - a process that adds genuine value to your final product. Let us take a look.
Recognize the Value of Design Controls in Your Business
For starters, it is important that you and your team fully recognize, acknowledge and accept the value of design controls in your business.
Many people feel that design controls are nothing more than a heavy load of FDA-mandated documentation, and who wants to be doing paperwork when they could be contributing something useful? People with this type of thinking also believe statements like "Design controls take too long, we should spend our time creating the product and worry about documentation later" and "We don't have the time and resources to do all of these steps, this will stifle innovation in our business.”
While it is correct that design controls take up extra time, there is no need for yours to be overly burdensome. Design controls are mandated so you can prove that your product is safe, effective, and meets its intended use requirements. This can all be summed up in an "intended use statement" about your device that forms the basis of defining user needs, a process which directly informs your design inputs.
Design controls don not just aid product development, they are product development.
What is more, they have a real impact on the success of your medical device. A study published by the FDA analyzed voluntary product recalls over a six-year period and concluded that 44 percent of the studied recalls could have been prevented by adequate design controls.
Design control documentation is also proprietary. When you build a new device, you are going where nobody has ever gone before, and any information you generate by doing so is of inherent value to your business, including new innovations that will enable your final product.
Finally, remember that the FDA guidelines are there to help you build a product that fits consumer need. If your medical device does not meet its intended use requirements, you have wasted all of your time and money for nothing. To someone who asks "How can we afford to implement design controls?" I reply "How can you afford not to?"
Start Your Design Controls Early
Creating a product from scratch is like setting out on a great adventure. You may be excited about the fortune that awaits you, but you're wrong if you think you know your final destination from the outset.
Imagine that you and your product development team are setting sail to search for uncharted territory. You ask your navigator to chart a course and he says "Charting a course is a lot of work, let's just start sailing and make it up as we go along. Whenever we land somewhere, I'll get out the map and compass and figure out where we are."
If that sounds like an awful plan to you, you are probably starting to see the benefits of starting your design control documentation early. There are two major problems with trying to document design controls once you are well into your design process.
First, it is difficult to play "catch-up" when your design has a lot of moving parts and special considerations. Working from memory, you are bound to forget plenty of crucial details and end up with incomplete documentation that does not actually cover the steps in your design process adequately.
Second, you miss out entirely on the benefits associated with the design control process. Product design is an iterative process - you are supposed to learn and discover things along the way that will inform your final product, and design controls are how you document that knowledge. This knowledge is inherently valuable and crucial to effective product development, but you can not leverage it without recording it in the first place!
Recognize the Most Important Terminology for Design Controls
The terminology of design controls can be confusing, and it is easy to get mixed up. To successfully lead a product development team that adequately documents design controls, it is important to have these definitions crystal clear and to understand the differences:
• User Needs - If you know the intended use of the medical device you are trying to build, the next step is to identify user needs. The user needs your medical device to be safe and to satisfy its intended use effectively, but what that looks like will depend on the specifics of your device. Think about how the end user will interact with your product and understand exactly what problems you are solving by creating your device.
• Design Inputs - These define the performance criteria and feature requirements of your medical device. Design inputs are the most time-consuming aspect of design control, and effective documentation here is crucial for the ultimate success of your product development process. Design Inputs are directly informed by user needs - they are a specific and actionable plan for building a device that meets the user needs you identified.
• Design Outputs - Design Outputs are like a recipe for your device, consisting of all the parts, components, inspection procedures, material requirements, and testing protocols that are needed to create your device. Design outputs are the end result of synthesizing your design inputs into a cohesive production plan for your device.
• Design Verification - The goal of design verification is to prove that your design outputs satisfy the requirements of your design inputs. This is where you document the testing, analysis, and inspections that prove your medical device has been designed in a way that meets user needs and satisfies your design inputs.
Keep Your Design Plans Fluid and Flexible
Plans change, and it is likely that your business will have to pivot away from your initial design plan more than once. That is all part of the process, however, and it's important to remember that your design planning documentation is a living document that you update as you go along, not a static or monolithic document that cannot be altered.
Effective design is an iterative process, and that has two major implications for medical device companies that iterate effectively.
First, you will be learning and changing plans a lot. Plans and documentation will get updated, and you will go off in a totally new direction. You will find out things you didn't know before that will send you totally off course, and you will have to adapt and change directions as you work towards an adequate, functioning prototype for your final product.
Second, you will build something fantastic. Iterative processes work by filtering out bad ideas from good ones, and when you make constant iteration a focus, you get rid of so many bad ideas and all you are left with is the collection of great ideas that make up your final product.
The ultimate risk of a poor, ineffective, or non-existent design control system is that you will leave too many "bad ideas" as part of your final design and end up with a costly product recall. Do not let it happen to you.
Make Design Controls Work for You
You do not work for the FDA, so why would you make a design control system just for them?
Many companies make the mistake of preparing design controls documentation just to achieve regulatory compliance - in my opinion, they might as well not be in the business. Design controls aren't just there to protect the consumer and satisfy the FDA - they protect your business too.
Not only are design controls a natural aid to your overall product development process, they help to ensure that your final product satisfies consumer need, which means that someone will pay for it.
Instead of envisioning design controls as a regulatory hurdle, think about great design controls as an insurance policy against accidentally building a product that nobody wants. Implement design controls to ensure a truly iterative design process and you're much more likely to have a successful product launch and avoid costly recalls.
Design controls do not have to be seen as an encumbrance to your product development team. Setting your design controls up to support an iterative design process that achieves a great final result can be one of the best ways to limit your risk and help your medical device company launch a successful product.
Start documenting design controls early, follow your processes earnestly, and you're much more likely to get a desirable end result.
Editor’s note: Jon Speer is the founder and VP of QA/RA at greenlight.guru, a software company that produces a modern quality management software solution for medical device companies. Device makers in more than 350 cities in 26 countries use the software to get safer products to market faster with less risk while ensuring compliance. Speer is a medical device industry veteran with over 19 years experience having helped dozens of devices get to market over his career in a variety of roles including product development, project management, quality and regulatory. He is also a thought leader, speaker and regular contributor at numerous leading industry publications like MedCity News, MD+DI, Quality Digest and more.