What to know before overseeing the manufacturing, patenting process for clinical devices

Scleral lens wear has grown steadily in recent years, but the application and removal process remains a common barrier for patients. Mile Brujic, OD, a partner at Premier Vision Group in Northwest Ohio, identified that gap firsthand and spent 2 years developing a solution: the ScleralEase, a dual-function tool that combines a scleral lens applicator and remover in a single device. In this Q&A, Mile Brujic, OD, FAAO discusses what drove him to pursue the project, how he partnered with Contamac to bring it to market, and what advice he would offer to other clinicians who see unmet needs in the space.

Transcript

Edited lightly for clarity and length.

Can you provide an overview of what we will be discussing today?

Mile Brujic, OD, FAAO: My name is Mile Brujic. I'm a partner of a 2-location practice in Northwest Ohio, Premier Vision Group, and just a passionate clinician. One of the things we're going to be talking about today is the inception of the ScleralEase, which is a dual applicator and remover tool for scleral lens wearers.

So what drew you to spearheading this design and product, and what did that process look like?

Brujic: So just like most things, there was a there's a gap. I was actually asking myself after patients kept asking if there's a more convenient way to apply and remove the lenses. And I realized that what they were really asking was, “Is there something that we can do to simplify the process?” And I realized that very infrequently, do we clinically ask ourselves, “What can we do to simplify that process?” So I was looking to ask ourselves, “Is there something where there's an applicator and a remover on the same device?” I was expecting to find something online, and I didn't find anything. So what I did was I just asked myself, “Well, what would it take to engineer something like this?” The first prototype drawing was created and made. I actually cut 2 of the devices and put them together, just to give myself a 3D representation of what it would look like. And from there, the rest was history. We developed it and we created it and it was remarkable. Even with early prototypes, patients immediately were telling me how much they liked it, just because it was the convenience of having 2 of those tools in 1 device.

What partners did you work with to have this device come into fruition? What has that process looked like for you?

Brujic: It's an interesting process whenever you're manufacturing something, because you can either do 1 of 2 things, go-to source this and try and find a place to physically manufacture it, or go-to entities that are well established within eye care who currently have the capabilities to do that. So the first logical conversation came from Contamac, which already has manufacturing facilities in place, and when we described and talked about the idea, they immediately said, “Yes, we want to be able to do this, and we think we can do this.” They've really pulled through on their promise with the ability to actually manufacture this design.

So say that there is an OD who is interested in implementing this tool in their practice. What steps should that OD take, and what does the patient education piece look like in terms of usage?

Brujic: Yeah, so that's the great part about this. From a clinician's perspective, all they have to do is literally purchase it from the Contamac website, and again, it's available for wholesale there. If they want to retail it to patients, they can do that as well too. But the cool thing about it is there's not a lot of explaining that needs to be done. It's very logical. This is the removal. This is the applicator. What sometimes people ask about is the holes in the side for the suction. And what's interesting about the suction here is it works the exact opposite as traditional suction. So you have to actually press place lens on and then just subtly release, while keeping some pressure on there, to have the suction on there. So it works in the exact opposite order that a traditional large DMV suction actually works. But everything's pretty logical from there. The only thing – and I've asked several doctors about this – is that little lip on there, and again, that's the one thing that does need explaining. That's there intentionally; it's there if we need that squeegee effect on the surface of the lens.

Touching back on that manufacturing process, say there is a clinician that is seeing a gap similar to what you had seen, and would be interested in going through that manufacturing process and designing a tool. What tips would you have for them to streamline that process?

Brujic: Yeah, so a few things. One: there are clinicians, and it's remarkable to me … how familiar they are with manufacturing processes across the board. So some people are very, very familiar with it. Some people may even have industry background where they really understand the process, and others may not have any background on this. So I think it really depends on the clinician's background and also their connection to manufacturing facilities. If they really don't have any manufacturing facility connections, they really have to start building those. They can build those 1 of 2 ways: go directly to the manufacturers and do it on their own, or create some type of symbiotic relationship with companies that already have that established and available. So what I decided to do was say, “Hey, if there's somebody that's already doing it, let's leverage that.”

One of the things that you should be aware of, if you're a clinician and you see a gap somewhere, and you're openly having this conversation, is 2 things. One is making sure that you have an NDA – which is just an acronym that stands for “non-disclosure agreement” – in place that's just a respectful mutual agreement that says, “Hey, if there's anything that's not in the public domain and we're sharing it with you because we're potentially partnering on this, we just want you to keep it quiet and just to yourself.” The other thing that clinicians need to be thinking about is, is it something that they feel is unique enough that they want to patent on it? And the patent process is a really interesting process. There's 2 phases to it. One is a provisional patent, which is the temporary patent that you get just to say, “Hey, I'm reserving my spot with the patent office.” Then the second is the full utility, and that's where you submit the final documentation and paperwork that you feel is going to be supportive of a unique role in this, and all of these things need to be thought of. It shouldn't be an intimidating process, because what I don't want is the process to intimidate somebody from moving forward with it. But they're all things that you need to keep in mind when you're seeing a gap, thinking about something that might need to be in place, and then starting to move forward with that process.

Anything else that you wanted to touch on that we haven't touched on?

Brujic: I'm so proud of this. This has been 2 years in the making, and it officially launched this January. So it's been a super interesting process, and I've certainly learned a lot along the way. I would share with all my colleagues that if you do see gaps in the space, don't be afraid to start questioning it. Don't think that the way that we've always done things has to be the way that we're always going to do things. And re-questioning and asking those questions and taking the next steps should be something that, again, as clinical scientists, we're always thinking about doing so. If you even have that that thing in mind, think about it and present it to colleagues and other individuals that you think may be able to take this to fruition.