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July 27, 2023
6 Min Read
DamianPalus / iStock via Getty Images
Chris Miller, Harness IP
In the high-stakes and competitive world of medical device innovation, one could argue that inventors need a secret weapon just as powerful as their genius.
In order to reach their primary goal of improving patient treatment, medical device developers must, among other things, consider the type of patient class and their out-of-pocket costs for receiving treatment. When developing a medical device, engineers essentially must think about it backward — figuring out how or whether a patient can get insurance coverage for a device before they’ve even engineered it. Navigating that reimbursement strategy process requires a good understanding of insurance coverage, medical coding, and regulatory requirements, all of which can impact how a device is engineered and whether it will be lucrative enough to attract investment funding.
However, investors not only consider the market, but also whether measures can be taken to protect the device from competitors through patents and other intellectual property. Medical device developers should not wear blinders and miss the opportunity to use lessons from their engineering, reimbursement, and regulatory work to improve patent claim coverage and reduce costs down the line.
Here are the most common pitfalls medical device inventors face during the development process — and how to avoid them.
1. Being shortsighted on insurance
This is the nightmare scenario for medical device manufacturers: You’ve dreamed up a new device — let’s say it involves a pump that connects to a tube — and the device is engineered in a way that means the tube isn’t detachable from the pump. Later, you discover that only the detachable version is typically covered by insurers, even though there’s virtually no difference between the functionality of the product either way. But without insurance coverage, doctors are not likely to recommend or prescribe it, rendering the entire enterprise a failure.
Engineers can avoid this by familiarizing themselves with insurance codes ahead of time to get a solid understanding of what is and isn’t covered. That way, they can incorporate necessary features into their designs on the front end, or, alternatively, apply for a certain feature to be coded or recognized — saving time and money.
2. Racing to the patent office too early
We’ve all heard some version of the saying, “Do it right or don’t do it at all.” It’s a philosophy that also applies to the patent process. Many engineers are understandably anxious about the possibility of competitors claiming the rights to innovation before they do, but moving too fast on a patent without a long-term strategy can be just as detrimental.
It’s an inherently competitive process: Whoever gets to the US Patent and Trademark Office (USPTO) first gets the patent. But in that mad rush, engineers can overlook important design elements, resulting in a half-baked idea. Patent attorneys are then forced to take that incomplete idea and seek the broadest possible coverage they can, including various magic words in the application that will hopefully align with the end product. But without knowing exactly how the product will ultimately function, they’re forced to predict the future — meaning the patent might end up being effective, or it might not.
In some cases, it’s best to wait to file a patent application until the details have been hammered out and a marketplace for the invention is secured. If research on the engineering, reimbursement, and regulatory side reveal that certain designs are not feasible for a competitor to pursue, for example, due to lack of insurance coverage or significant regulatory hurdles, is there really any need to rush to the USPTO? Patents are a competitive tool, after all, so what if there’s no competition?
That said, there are certainly products in some highly competitive markets where waiting isn’t an option, even when an invention isn’t fully formed. In those cases, it’s typically best to keep filling on a rolling basis, filing provisional applications in tandem with your progress to ensure your design remains protected. However, that can be the more expensive approach.
3. Conflating an idea with an invention
One common misconception in the business world is that a unique idea is the same thing as an invention. In reality, an idea is merely the seed of an invention. If a successful outcome is desired, it will take plenty of watering and nurturing for it to come to fruition and be ready to present to the USPTO.
Sketching out an idea and building a product that corresponds to that idea are two very different things, as many engineers will know. So, during that process, prepare for unexpected challenges that require tweaks to the design or functionality. Brainstorming and planning for potential hurdles and adjustments with your team and partners ahead of time will save precious time, money, and disappointment down the line.
4. Engineering the device in a vacuum
This might sound simple, but once the design process gets underway, it’s easy to put the blinders on and lose sight of the forest for the trees. Keeping your patent attorney informed of changes — the same way you would your development team — can reduce costs significantly.
If an attorney has a better understanding of what the final product will look like, they can produce a more accurate and effective patent application more quickly. It also avoids a situation where your application falls short because the developments or changes made weren’t included.
This is crucial because, in most jurisdictions, including the US, patent applications end with a series of numbered claims that define what it is that you’re patenting. Each claim comes with a governmental fee to cover the time it takes to review them.
So, if your application casts a wide net of claims including options or features that your development efforts indicate aren’t going to end up in the invention, that could make your application thousands of dollars more expensive, unnecessarily. And that’s not counting attorney fees; this is money going directly to the government. What’s more, larger companies will typically file patent applications in six or more foreign jurisdictions, multiplying that cost several times over.
The solution could be as simple as a phone call, a drawing, or an email with a few bullet points communicating design changes to your attorney as and when they occur, preferably early in the development process when this information first becomes available. For example, a good time would be while reimbursement and regulatory hurdles are being considered.
By anticipating and preparing for potential issues before they appear and maintaining an ongoing dialog with attorneys throughout the process, medical device engineers can save time, energy and attorney and filing fees, resulting in products that are more likely to attract investors, secure patent protection, and be commercially successful.
Chris Miller is a patent attorney in Harness IP's Metro Dallas office. He works with inventors and attorneys around the globe to protect valuable IP assets.
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