Medical Device Development Is Complex — But It Doesn’t Have to Be Difficult
Most medical devices involve some degree of complexity. Of course, that’s inherently true of high-risk and technologically sophisticated devices. But even the most straightforward medical device isn’t so straightforward when you consider the FDA requirements you must meet as part of the development process.
In many ways, your company’s ability to successfully bring a new medical device to market hinges on how well your team handles complexity. But here’s the thing: Complex doesn’t have to be the same thing as difficult. Running a marathon is difficult, but it’s not especially complex. And when it comes to medical devices, complexity is only difficult if you don’t have a streamlined process in place to handle it.
In order to meet your medical device’s complexity head on, you must be prepared to methodically untangle the interdependencies and unexpected issues that are sure to arise along the way. The best way to do that? With a properly managed Product Requirements Document.
What is a Product Requirements Document?
A Product Requirements Document (PRD) is like a written recipe for your device. It is a required part of the FDA submission package, and it can take many forms. However, most PRDs contain detailed information about all of a product’s many requirements, including:
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Intended market
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Features
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Functional requirements
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Performance requirements
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Field failures
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Safety and risk mitigation
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Labeling
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Instructions for use (IFU) requirements
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Manufacturing requirements
Your PRD should act as a living “source of agreed-upon truths” regarding your device’s current specifications, which are bound to change over the course of the development process.
We’ve likened the PRD to a recipe, but it’s important to note that it’s a recipe that is very much in process. When you first create a PRD for a newly ideated medical device, you almost certainly know that you’re hoping to make a cake as opposed to say, beef stew. But you can’t possibly know what sort of cake you’re making — will it be a strawberry shortcake or a triple-chocolate layer cake? Made with milk chocolate or dark? — until you get further along in the development process.
As such, the PRD isn’t a one-and-done planning document. Neither is it a static wishlist. You must treat it as a living, breathing document. One that you continuously update and refine as you learn more about your new medical device. All of the key stakeholders within your company, from marketing to engineering to regulatory, must contribute to and regularly review the PRD as it changes.
Your medical device “recipe” will start out relatively simple, with plenty of gaps and uncertainties baked in. As you work to flesh out your medical device, your recipe will get more specific but with conflicting requirements, therefore more complex. And that’s where the stirring spoon meets the bowl.
What Makes a Medical Device Development Process Complex?
In the context of medical device development, complexity can take more than one form. Any device has a certain level of complexity. But some are inherently more complex than others. For example, both pacemakers and tongue depressors are classified as medical devices. But the pacemaker is a far more complex instrument. So what is it that makes a device especially complex?
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Multiple, interconnected parts
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Unknown elements (this is especially common if you are innovating)
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Conflicting requirements (such as more durable and more cheaply)
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High-risk devices (such as that pacemaker)
Medical device development projects can also be more or less complex depending on the specific project logistics, which don’t necessarily have a direct relationship to the complexity of the device itself. Logistical complexities can take the form of:
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Resources that are not easily accessible, such as remotely located team members, different time zones, or non-native language speakers
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A pandemic or other current event that constrains your ability to make progress on your device
Your PRD Can Be Your Biggest Friend — or Foe — when Planning Your Medical Device
Your PRD has the potential to be your greatest ally in effectively managing your product’s complexity. But your PRD can only work for you to the extent that you take the right approach to building and maintaining it.
One common pitfall has to do with what’s included in the PRD. Like most required FDA documents, there’s not one official PRD template for companies to use. For inexperienced medical device companies, this can be a challenge. For example, many PRDs get so focused on the technical requirements that they forget to focus on their end-users. Who will be using the device? A very small infant? Or an elderly person with a limited range of motion? How will they physically interact with the device?
Medical device companies that fail to focus on user needs in their PRDs unnecessarily introduce a host of new complexities to their projects when the product goes to market.
Your PRD can also become a hindrance rather than a help if you fail to create a clear, consistent process for updating and approving changes to the PRD over the course of the project. This is what often happens:
A medical device company kicks off a new project and creates a PRD. They pass it around to all the departments for their inputs and requirements, as well as a few unvetted wishes. Then the design team takes the first draft of the PRD and runs with it. But as they start designing and testing, conflicts arise – some of the requirements listed have opposing needs. Or perhaps the technical team resolves one problem — and unwittingly creates a conflict with another.
Now what?
Too often, new information isn’t thoroughly vetted as it comes to light. Unless the entire company is proactive in reviewing the PRD and addressing issues as they arise, the project’s inherent complexity will morph into chaos.
How to Use Your PRD to Reduce the Complexity of Your Medical Device Development Project
Your PRD is a critical instrument in reducing complexity in your medical device development project. In order to fully leverage your PRD (and focus the design effort), you must make the PRD a well vetted, common meeting ground. Use the PRD as a tool for alignment and conflict resolution.
Plan to perform a Gap Analysis on your newly created PRD. The purpose of this analysis is to identify conflicting requirements and missing information that need to be addressed as soon as possible.
Next, as your project gets rolling, your entire team must commit to update the PRD with every new clarifying detail as it arises. No data crumb is too small.
Finally, you must put in place a process to have your entire team vet and sign off on each new addition to the PRD. This is a cumbersome and, at times, frustrating process, but it’s the only way to ensure that each new requirement is vetted appropriately. Review each change with an eye toward identifying conflicts with other requirements as well as issues related to schedule, innovation, and available resources (staff and funding). Conflicting requirements are sure to pop up. The earlier you catch them, the less damage they will do.
A complex medical device development project is nothing to be scared of. With the right process and PRD documentation, you can reduce your project’s complexity and ensure the success of your medical device.
