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来源： Regulatory and Compliance by Jamie Hartford
The medical device industry is chock full of terminology and acronyms that are important to know and understand.
Two terms that are often a source of confusion (and often mistakenly treated as interchangeable) are “intended use” and “indications for use.”
Product development engineers and regulatory professionals, this one’s for you. Recently, I had a chat with Mike Drues, president of Vascular Sciences (who will speak on the topic of designing device labeling at the upcoming MD&M East conference on June 14, 2017), about this topic, and we discussed advice for engineers dealing with it.
Here’s what you need to know and should consider when developing your medical devices.
Why the Difference Matters
Imagine if you had a path to get to market faster, as long as you have your intended use and indications for use defined accurately? No one wants to get their terms in a tangle and put the timeliness of a product release and regulatory compliance at risk.
There’s another very important factor you should keep in mind: Your stated intended use will affect your regulatory product classification. Now, anyone who has dealt with classifications of medical devices will realize what a big deal this could be. “How is this medical device classifed?” is one of the first items you need to figure out as part of your regulatory strategy. There will be vast differences in terms of the burden placed on you depending on the classification.
As an example, let’s say you’ve got a new scalpel you’d like to get to market. You’ll find if its intended use is stated for cutting of flesh (in general terms), it will be a Class I device, yet if it is stated as being specifically for use on an eyeball, it will be Class III. This latter classification leads to a much greater risk to patients, higher regulatory burden—including possible clinical trials—and greater expense to get to market.
Which brings us to “intended use” and “indications for use”...
What is 'Intended Use'?
"Intended use" is one of the most commonly used phrases, yet it’s so often misunderstood. It is not what your device is designed to be used for or even what it could be used for. It’s about what your label claims—what you say your device is meant to do.
As stated, the intended use you claim in labeling will affect the classification of your device. Most companies walk a balancing act there. For example, if it’s about that scalpel, how can they bring it to market as Class I but somehow encourage surgeons to use it for that Class III use on the eyeball?
Another consideration is medical reimbursements. Codes for reimbursements work on a strict system and can lead to all sorts of regulatory headaches. Perhaps reimbursements won’t be made unless the labeling says the scalpel should be used on the eye.
It’s a bit of a conundrum for medical device manufacturers to work out, but we suggest you make reimbursements an early consideration in your development, along with regulatory and classification strategies. Ideally, you want to somehow strike a balance that satisfies them all. A simple, yet difficult solution, I know!
What are 'Indications for Use'?
Indications for use cover the reasons or situations in which someone would use the device. Under what conditions will the product be used? This is a term that is also commonly used in other areas, such as for classifying drugs and medications.
So, simply put:
Intended use = what you say on the label that the device is to be used for.
Indications of use = the conditions or reasons for using the device.
'Intended Use' and the 510(k)
FDA wants you to be very “to the point” about your stated intended use on your 510(k) submissions. This is more of a trend among assessors rather than a regulatory requirement; however, it can be burdensome on companies when it comes to labeling the product correctly.
You do have the right to push back if you see that something might be unjustified; however, you are best advised to pick your battles. It’s not usually a good idea to be that “difficult” company. You might find that other elements are treated with additional scrutiny.
“Little words matter” is a mantra you should take up when designing your labeling. What are the nuances of the wording and how will the wording be interpreted? For example, we will often design five or six indications for use statements then perform an assessment on each one. You have to look at it from liability and reimbursement perspectives.
Each statement might have a different affect on design controls, risk management, and quality requirements. What you say about your product affects what you need to get done and may or may not add to your regulatory burden. It certainly affects your classification.
'Me Too' Strategy
Why do we see so many similar products out there on the market? One reason is the “me too” strategy. While I’m a huge advocate for, and a fan of, innovation in medical devices, let’s face it, it’s hard getting something brand new out there.
Honestly, one of the easiest paths to get a product to market quickly is to copy a previously cleared 510(k). If it was already approved, then the chances are it will be again, but the unfortunate side effect of this is all of those “me too” products.
If you were going to leave it at the “me too” product, you might have something that is worth money to your company, but, chances are, what you really want to do is innovate. Because of this, Drues and I have another strategy we like: using the “me too” product as a means to getting something on the market that is generating revenue but working in the background to improve features and prepare a second submission.
We like the analogy to baseball: You can either choose to swing for a single or a home run. When you take the big swing for the home run, there’s a much higher risk of striking out, whereas if you take the slower route of hitting a single, you can work your way around to home base with the risk being more mitigated.
Your strikeout risk is mitigated with the “me too” product because you’re generally able to get this product to market faster, allowing you to help patients sooner and generate revenue.
You can always be working on a label expansion for later on, where you add in new intended use to the labeling. This would be like taking that swing for second base. Ask yourself, what is your risk appetite? Do you want to swing for a single or a home run? Considerations might include who your team members are —any power hitters? Do you try to hit a homerun with nobody on base? Or only if you have everyone on base?
Key Takeaways
The most important thing to remember is to apply the same concepts and philosophies in product design to label design and regulatory submissions. There is a big difference between writing and designing a submission. Engineers will be very familiar with this concept from their work on product design and design theory.
Understand that intended use and indications for use have an impact on design controls and quality measures. How much, or how little, you need to take care of can be determined by that label.
Everything you do will affect product classification, and this should be an early consideration, along with reimbursements. Know your terms and know the implications they have on your regulatory requirements.
Jon Speer is cofounder and vice president of QA/RA at greenlight.guru. Hear his presentation on why design inputs go wrong at MD&M East in New York City on June 14, 2017.
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