Step-by-Step Guide to FDA Approval for Medical Devices

by | Apr 1, 2024 | Product Development, US FDA Regulatory Requirements | 0 comments

From Concept to Market: A 7-Step Process to FDA Approval for Medical Devices

So, you have this great idea, tech, or prototype. Let’s call it Product X. And you are sure it’s going to revolutionize the medical device industry. Maybe it’ll make surgeries twice as fast, or it’ll help a healthcare provider make more informed and accurate decisions. Maybe it’ll even cure cancer! Either way, you’re ready to release it into the world, have people use it, and show what a great inventor you are. First thing’s first, you have to get FDA approval. That shouldn’t be too difficult, right?

Let us walk you through the 7 steps that will take you from med device idea to FDA approval. Buckle up for a journey through the intricacies of medical device development and regulatory compliance with Fission Consulting as your trusted guide.

The journey to FDA approval may not necessarily be difficult, but there are a set of predefined steps that you’ll need to take in order to prove to the FDA that you have a safe and effective product ready for use. These steps encompass the product development process needed for medical device approval in the United States (depending on the classification of your product…we’ll get into that in another Fission Episode).

Step 1: User Needs Analysis

First things first…wait what comes first? Similar to other industries’ tagline of “the customer is always right,” medical device development always starts with user needs. User Needs are a set of requirements that detail what the end-user expects from your product. These should all be framed from the user’s perspective, NOT from an engineering perspective.

For example, let’s say Product X was a simple Band-Aid. You might think that a user need would be that it has to be sticky. “Band-Aids should stick to a person’s skin, right?” While that may not be incorrect, the user may not care if it’s sticky; it just needs to not fall off for the expected duration. 

You’ll need to go through each aspect of the product from the user’s perspective and define what those needs are.

Step 2: Risk Analysis and Risk Management

Another item to begin discussing in earnest at this point is defining the potential risks associated with the product (Risk Analysis). 

Not all the requirements and outputs are completed at this point, but it is still a great time to begin considering safety aspects and items of concern even from the user perspective. This analysis should be revisited at each step in the process, and additional requirements or updates should be made based on findings. 

Comprehensive risk management will need to be incorporated in your overall plan. Throughout the development process, identifying, analyzing, and mitigating potential risks associated with your medical device is essential. This involves continuously assessing risks related to usability, design, manufacturing, and post-market performance to ensure the safety and efficacy of your product.

Step 3: Defining Product-Specific Requirements (Design Inputs)

Step 3 is to focus on the product-specific requirements, or Design Inputs, and link each of them to a user need. Let’s stay on the Band-Aid example for now. If we defined a user need to be, “the product must not fall off during expected duration,” a possible Design Input could be, “product should have an adhesive surface that adheres to the skin.” The adhesive aspect of your product is the embodiment your design takes to address the user need. A Design Input should detail enough about the product to guide the development towards an end vision, but should not be SO specific as to pigeonhole your future development team. Being specific enough but also broad enough in your Design Input requirements is the art form of medical device product development (and will also be covered in another Fission Episode). Once you have each Design Input and a link to a User Need (could also be multiple design inputs that contribute towards a user need, or vice versa), you’re ready for Step 4.

Step 4: Designing the Product (Design Outputs)

Step 4 is actually designing your product, or coming up with Design Outputs. Each Design Output should be linked to at least one Design Input, and they should be much more specific and detailed than Design Inputs. Think engineering drawings with dimensions and specifications, detailed material requirements, assembly drawings to indicate what the final product may look like, or the code for the software itself; anything that would be needed to define the manufacture or build of your product. For our Band-Aid example, Design Outputs could be a drawing, a specification of the adhesive coating, a material callout for the gauze pad, etc.

Step 5: Verification Testing

Step 5 is the first true test of all the work you’ve done up to this point. It includes Verification testing, which essentially means verifying that your Design Outputs actually meet all of your Design Inputs. For that specification for the adhesive coating on your Band-Aid, is it actually sticky and does it adhere to the skin (the likely linked Design Input)? You should go through this activity for each Design Output and confirm it fulfills the requirements of the Design Input. These Verification activities may be as simple as objective evidence, they may require extensive testing on a statistically significant number of samples/prototypes, or somewhere in between. It all depends on your company’s risk acceptance criteria and the type of product it is.

Step 6: Validation Testing

After all the Verification activities, Step 6 includes Validation. How is Validation different from Verification? Well, in step 5, we verified that the Design Outputs fulfill the Design Inputs. For Validation, we need to confirm that the Design Outputs or product as a whole fulfills the User Needs. Back to Band-Aids: you may have confirmed that the adhesive specification (Design Output) was in fact sticky and adhered to the skin (Design Input), but you do not know if it adheres to the skin for the expected duration (User Need). Think about Validation as confirming whether or not you made the right product for the end user, not just if you made the right product based on your Design Inputs (which is what Verification is).

Step 7: FDA Submission

Finally, armed with thorough documentation of your development process, you are most likely ready to submit all of the work you’ve done to the FDA in the form of a regulatory submission to approve your product to be marketed in the US! Congratulations!

Streamline FDA Approval with Fission Consulting: Your Trusted Partner in Medical Device Compliance

Navigating the FDA approval process for medical devices may seem daunting, but by following these step-by-step guidelines and ensuring thorough risk management and documentation, you can streamline the path to regulatory approval. 

Fission Consulting is here to support medical device companies at every stage of the journey. With our expertise in regulatory compliance and product development, we can help you navigate the complexities of FDA approval and ensure your product meets the highest standards of safety and efficacy. 

Don’t hesitate to reach out to us for guidance and assistance. Together, let’s revolutionize the future of medical technology.

Written By Jeremy Moore

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