The FDA Updates You Need to Consider for Your Next-Generation Medical Device

 In Design Strategy, Medical Product Design

Medical device regulation gets more stringent all the time. It’s harder to get FDA approval now than it was just five years ago. For good reason.

All that to say, as you’re developing a next-generation version of your existing medical device, there are almost certainly new and complex standards you’ll need to account for to make it to market once more.

You shouldn’t let the thought of new standards keep you from updating your legacy medical device. All products do need a refresh in order to keep pace with the latest technology — and to continue to compete in the marketplace. Just don’t assume your device’s regulatory path will be the same as it was the first time around.

Ready to dive back into the world of medical device regulation? Here’s what you need to know about the FDA’s current top concerns and your own next-gen product’s regulatory journey.

Plan Your Regulatory Path Early to Avoid Costly Surprises

There’s so much to think about as you’re developing a new version of your product. It’s easy to delay discussing regulatory requirements until late in the game. It’s also easy to walk into this with a sense of false confidence because your current device already has FDA clearance.

But the last thing you want is a letter from the FDA requesting additional information in response to your submission for approval. Instead of focusing on the final steps to launch, you’ll have to redo testing and resubmit to the FDA, causing schedule delays and cost overruns.

Planning early for how your next-gen product will go through regulatory testing is key to success. A solid understanding of the standards and guidance documents that will apply to your updated device allows your team to allocate resources properly — and bypass costly surprises.

Understand Which Standards Apply to Your Updated Medical Device

You know now that planning early means a better chance at the FDA’s seal of approval. But how do you figure out which standards will apply to the new and improved product? Your regulatory knowledge is largely limited to the standards you learned about during that initial launch. And clearly, so much has changed since then.

Determine Your FDA Classification

It starts with discerning your medical device’s FDA classification. The FDA recognizes three categories of medical devices: Classes I, II, and III.

The FDA’s three classifications fall on a scale, with Class III being the highest risk and Class I the lowest. Examples of a Class I device include bandaids and tongue depressors. Class II (where most products land) includes wheelchairs and pregnancy tests. Lastly, Class III devices include anything critical to sustaining life, like implants.

You need to know your device’s FDA classification ASAP because it informs which standards it must adhere to. Note that you may need outside help from a regulatory expert to guide you.

FDA Trends Impacting Medical Device Development Today

Figuring out which standards apply to your updated medical device is foundational to your process and specific to your device. Big picture, the FDA has been focused on a few areas these past several years that affect all medical device developers:

  • Usability

  • Risk management

  • Data security

The FDA has always put stock in all three of these areas. It’s just that, recently, they’ve expanded existing standards and added new ones cracking down on devices that don’t follow their latest (and strictest) rules. You’ll likely need to take a more comprehensive approach to all three than you did during your initial product launch.

Usability Continues to Gain Favor with the FDA

The FDA does not care if your next-gen product is better than its legacy predecessor. They only care about its usability in terms of safety and effectiveness for your intended users in its intended use environment.

To prove that your product is safe in users’ hands, you should conduct a series of evaluations beginning with formative usability evaluations and concluding with summative usability testing.

Your Next-Gen Device Still Needs Testing

Some companies skip formative evaluations for next-generation medical devices because they think their update is similar enough to their old version that users will interact with it in the same way.

But that’s the wrong approach.

You’ll never truly know how users will react to an update or what they need from a new version that they’re not getting now unless you have them evaluate it.

Also, summative usability testing — completed on your final product at the end of development —  informs your Usability Engineering File for FDA submission, which is required to gain their approval. Conducting formative usability testing first better prepares you for this high-stakes summative validation testing.

Risk Management Is a More Central Concern

To satisfy FDA requirements, you must focus on risk management throughout your whole process, including early on, to ensure the all-important user safety.

The FDA likely closed ranks on risk management in the past couple decades because of excessive incident reporting — what the FDA calls complaints or Medical Device Reporting (MDR). They keep a running database of every complaint lodged against any medical device. Depending on the severity and number of complaints, a company may be asked to issue a recall or warning.

In sum, ascertaining potential user risks as you develop your product instead of assessing risks at the end of your process lessens the chance of a hidden risk going unnoticed.

Hazards, Hazardous Situations, and Harm in Practice

The FDA uses the terms hazard, hazardous situation, and harm to talk about and diagnose risk. Hazard refers to a potential risk, and a hazardous situation could arise because of that hazard. Harm is the damage done to the user because of the hazard in the hazardous situation.

Let’s take an example. Your medical device is reusable. Therefore, it has to be cleaned in between each use. If it’s not cleaned properly or frequently, bacteria could grow on the device’s surface. Bacteria on the device is a potential hazard, and that bacteria actively growing on the device due to poor cleaning is the hazardous situation. A patient could then contract pneumonia — the harm — from that device.

If you hadn’t considered risk management in the early stages and throughout development, you might not have developed cleaning protocols for your product, which heightens the chance for this hazardous situation occurring. This is only an example, but you can see that a risk management plan is more important than ever to ensure your product is safe and, as a result, fulfills your FDA obligations.

Increasingly Sophisticated Technology Means Stricter Data Security Standards

As our world continues to leverage digital technology, the FDA has adapted their data security regulations accordingly. If you developed a medical device with buttons and knobs that now has a smart screen and bluetooth capability, you have a lot more data security concerns than before.

There are many ways your data could be compromised, but it helps to think about data security in two categories:

  • Hacking into devices. Now that seemingly every medical device is an open system (connected to the internet or equipped with software), there’s a chance a hacker could breach software. There was even an infamous incident at an industry conference where researchers were able to hack an insulin pump and change its settings!

  • Stealing personal information. As mentioned, the FDA values user safety above all else. This includes protecting their personal information. Imagine an instance where patient data — social security numbers and other confidential identifying information — is compromised because of a breach in a medical device at a hospital.

All this to say, there’s of course an FDA standard you will have to meet pertaining to data security. And this standard becomes more comprehensive all the time.

Your legacy medical device might have met the FDA’s guidelines in its time. However, the FDA changes — and intensifies — its standards rapidly. Your next-gen medical device will need to forge its own regulatory path to succeed.


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