Does Your Medical Device Need Design Controls? Here’s What You Need to Know.
New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. Who wouldn’t be excited about that?
But medical devices also carry varying levels of risk that must be carefully managed. As the product manufacturer, it’s your job to ensure your device is both effective and safe for users whose health may be on the line.
For all but the lowest-risk medical devices, the Food and Drug Administration requires proof that you have done just that. The first step in meeting the FDA’s requirements is to develop your medical device under Design Controls.
Design Controls, which are mandated by the FDA, represent a formalized approach to the development of Class II and Class III medical devices. This process includes many layers of required documentation that show the FDA exactly how you have provided for the safety and efficacy of your new device.
In this article, we’ll explore the basics of Design Controls, including whether or not they apply to your situation and an overview of how they are typically incorporated into product development.
Does My Product Need to Be Developed Under Design Controls?
First things first: You need to determine whether or not Design Controls are required for your planned medical device. To do that, you need to be crystal clear about what your device is intended to do. What problem will it solve? What assistance or therapy will your planned device deliver as a point of value to the end user? How will it work? The answers to these questions will determine the way the FDA will classify and therefore regulate your device.
The FDA recognizes three separate classes of medical devices: Classes I, II, and III. The individual classes take into consideration a product’s intended use, indications for use, and the level of risk associated with the product. Design Controls are required for all class II and III devices (these are the medium- and high-risk groups). The majority of class 1 devices, meanwhile, are exempt from this process.
Class I products comprise 47% of all medical devices. These low-risk products are intended to promote health and wellness in a general way. Examples include everything from bedpans and elastic bandages to many wellness apps. Most Class I devices are exempt from Design Controls, but they are also limited in how they’re used and in the claims they can make. For example, a Class I device can claim to promote weight loss, but it can’t claim to treat type 2 diabetes.
Class II, which includes 43% of all medical devices, represents medium-risk, non-invasive products. Examples include pregnancy testing kits, surgical needles, and x-ray machines — as well as the latest Apple Watch (more on that later).
Class III products, meanwhile, represent the highest-risk devices. These are typically invasive. Examples include implantable pacemakers and breast implants. Only about 10% of medical devices fall in Class III.
If you’re uncertain which class your planned product will belong to, you can check out our “Guide to FDA Device Classification” above, or look at the FDA’s classification database or device classification panel. Additionally, we recommend contacting a regulatory consultant who can walk your team through the FDA requirements that will apply to your particular situation.
Design Controls for Class I Devices: A Lesson From Apple
Hopefully your interest was piqued when we mentioned that the Apple Watch is now considered a Class II medical device. In taking this additional step toward a Class II designation (including Design Controls), Apple gained a meaningful new advantage over competitors like FitBit. At the same time, Apple set itself up for a lateral move into both the medical and home health markets.
Make no mistake: A watch that is also a Class II medical device reflects and foreshadows a larger trend toward increasingly medical consumer home health care products. In many ways, this is the future of medical device design.
The takeaway for medical device companies? It’s worth considering Design Controls for certain consumer home health products that have traditionally been categorized as Class I devices. Pursuing Design Controls at the outset of the development process leaves the door open for a future Class II designation without having to reinvent the wheel in terms of meeting FDA requirements.
For devices like the Apple Watch, making the leap to Class II status may be key to beating the competition.
Design Control Basics
Once you determine the need for Design Controls, it’s time to frame your development process around these requirements.
Following are the core components of Design Controls, which must be included in your product design process:
User Needs. In this phase, your team must clearly define the needs of your intended users and define how your device will meet those needs.
Design & Development Planning. Next, your team will need to prepare a design and development plan. This plan should reflect the specifics of how your team plans to handle each of the Design Controls in the development process.
Design Inputs. Design inputs describe the exact specifications of your product, including what it will do and how it will perform. As you might expect, these inputs are directly informed by your product’s User Needs.
Design Outputs. Design outputs document the exact design, materials and components that are required to physically build your medical device. Outputs may take the form of drawings and diagrams.
Design Review. At various points in the process, your team must conduct and sign off on formal design reviews. Design reviews give your team the opportunity to evaluate the design requirements and make sure that your product is on track to meet them.
Design Verification. In this step, your team will test the product in various ways to ensure that it has been developed correctly. In essence, design verification seeks to prove that your device works as intended.
Design Validation. Design validation is another way of testing your product to see if it works. However, in this case, you want to prove that your device works to actually meet your users’ needs as defined earlier in the process. Design validation is all about user testing.
Design Transfer. Design transfer is another way of saying design production. In this phase, which overlaps with design validation, you begin the process of actually producing your medical device.
Design Changes. Design Controls apply to the entire lifespan of a medical device, not just the initial development. Any revisions to a product’s original design must also follow Design Controls.
Each of the above Design Controls components must be included in your development process. However, it’s important to note that the FDA allows medical device companies the freedom to specify the exact processes by which they will do so.
The most common approach to Design Controls is captured in what is known as a waterfall diagram. This diagram shows the relationship between each of the Design Controls over the course of a product’s development:
Regardless of how you approach product development, your firm must compile the documentation from your Design Controls activities in a master file called a Design History File (DHF). The DHF is ultimately made available to the FDA and must be kept up to date in the event of an audit.
The Design History File doesn’t just show all the steps taken in product development process to ensure the safety and efficacy of a product. It must also make clear the links between the various Design Controls. It’s your firm’s responsibility to ensure that the Design History File demonstrates the traceability of all the various Design Controls throughout the development process.
By now it should be clear that Design Controls will touch on every aspect of your product development process. It is therefore imperative that you identify the need for Design Controls early on and make a clear plan to execute them.
This process is challenging, to be sure. But the good news is that Design Controls don’t just pave the way to FDA approval. They also pave the way to better, safer medical devices.
This article was originally published on October 4, 2021. It was reviewed for accuracy and updated on June 20, 2023.