By Rachael Pasini, senior editor at Medical Design & Outsourcing sister publication Design World

Charlotte Böhning, creator of OriVa (formally called the Gutsy Port), sat down with one of Medical Design & Outsourcing‘s sister publications, Design World, last year to share how she used 3D printing to prototype the new medical device for ostomates.

After graduating from Pratt Institute, Böhning won a 2023 James Dyson Award and was named in the International Top 20 for her remarkable design. The funding program has had a lasting impact as she continues transitioning her idea from an academic incubator to worldwide commercialization.

Design World recently caught up with Böhning to see where she’s at in this exciting journey.

Design World: What have you been working on since we last talked?

Charlotte Böhning: The past year has been focused on setting the stage to move forward, get funding for trials, and develop prototypes at a higher fidelity. To do that, I’ve been working with a lawyer who specializes in patents and intellectual property. She’s been helping me file for a patent for the port, which is a key step in protecting the idea and making sure we can have the freedom to operate in the U.S. I used a majority of the prize money from Dyson to pay for the patent. We filed a few months ago, so we’ll hopefully have a better idea in the next six to eight months of what the next steps are. We also renamed the port. It’s now called OriVa instead of Gutsy, and we established an LLC. That’s all the business and legal background.

My other focus has been on applying to different accelerator programs. Now that I live in San Francisco, there’s a lot of access to amazing medical institutions, like UCSF and Stanford Hospital, and they all have their own accelerator programs. I’m applying and trying to get picked up by one of them because that’s a key next step in funding the progress.

The goal is to get the port into the hands of people and on people’s bodies at a commercial scale. Through the past year, I’ve learned that it’s a long runway with medical devices. When I feel a little discouraged at times, I think back to the process of designing the port — to the bodystorming and interviewing people — and it instantly reminds me that this is such a real problem and that a device like this could make a big difference in people’s daily lives. So, I’m still working towards this end point of getting it commercialized, and we made good steps so far.

DW: How are things different now than when you were in school with resources?

Böhning: It does feel like there’s a bit of a gap, especially in the medical device design space. For example, I was part of the semi-finals for a pitch competition at one of the hospitals here, where teams of 20-plus people had won last year, and they all had PhDs. There’s a heavier focus on medical expertise and not necessarily on design, engineering, and industrial design. So, I definitely had an imposter-syndrome moment and wondered if I’m qualified for this and if there’s a step in between for people like me, who are not medical experts but who are capable of speaking the language, are experts in the design side, and have these good ideas, but don’t necessarily have the backing of a major hospital. It has been feeling like there’s a bit of a gap between the two — PhDs and the new, first-time inventors or entrepreneurs — and that’s something that I’ve been trying to navigate.

When I mentioned roadblocks, I think the biggest one is how to make a case for myself and demonstrate that, although I might not have a PhD in this, I also know the limits of my expertise and can partner with someone like Dr. Pigazzi, who is an expert in his field, and acknowledge that he knows a lot more than I do, and take that knowledge and apply it with the skills that I have. That’s how the port got to where it was in applying for Dyson and now applying for the OriVa patent. I think that’s been the biggest challenge, but also an opportunity for me to take ownership of what I do offer and be confident in where I have gotten this port with a small team. It does feel like there’s a gap between these prestigious hospital-based accelerator programs and someone who is more heavy on the design and more technical engineering side.

In terms of going from a school environment, where you have access to all these tools and facilities, to being a post-grad, I have found a lot of maker spaces in San Francisco that are great for pushing the design forward and prototyping. It’s still a cost, and it’s different than in school, but they do exist. San Francisco has a strong maker culture, and people are really excited about new ideas here.

DW: Has anything changed with the OriVa port design?

Böhning: Originally, we had the wafer and the port as separate pieces so the port could be attached to the wafer. We recently started printing the wafer first with a flex material and then printing the port directly onto the wafer so it’s one continuous piece. That’s been an exciting development because I was always curious about it, and having fewer seams in the design helps reduce the chance of leakages. It’s a more seamless user experience where you have fewer parts to connect. That’s been the first biggest change.

Second, in the original design, the port opens away from the body and extends out. We have been exploring different configurations, whether it has to be a hinging lid or if it can be something like a squeeze pop lid. So, small little tests with users to see which interface is most comfortable and makes the most sense for cleaning.

It’s been taking small design interventions and steps and making really incremental, small changes. But I would say the biggest is connecting the two pieces. And it’s cool from a printing perspective because you’re doing two different materials in one print and having the flex material with the hard, durable port.

DW: Are you still 3D printing the prototypes yourself?

Böhning: Initially, I was operating myself and doing different tests of the more durable resins and the silicone, and trying to print on my own without a lot of success. Then, I started outsourcing to one of these maker spaces and collaborating or seeking the advice of their in-house 3D-printing experts. That was a big game changer for me, having people more well-versed in 3D printing. We were able to choose this very specific flex filament and then print on top.

DW: What software are you using?

Böhning: We’ve been modeling on Fusion 360 for the most part, and it’s been awesome because you can show the articulations before printing. You can show the animations of the different parts on the screen before printing them separately and putting them together, and then actually have it articulate in real life.

DW: Have your test groups tried the new OriVa prototypes?

Böhning: I’ve sent out the version that has the wafer combined with the port — the contiguous piece. So far, good feedback because it’s eliminating that seam between the wafer and the port. Not that we were having a lot of leaks, but it wasn’t ubiquitous, so it has made it a better experience so far. I’m currently working on the different lid variations and hope to send some of those out to Grace and the original interviewees once it’s done.

The development has been very relationship-based because you hear people’s stories and feel really connected to them. You want to provide updates when you can in a way that’s empathetic and realistic. There’s still a long runway for when this is actually going to be passing regulations and commercialized. But I’ve been amazed at how the core group and initial testers acknowledge that and are still excited about the prospect of having something new and wanting to try it. They know it’s part of the learning process, that some things might not work and some things may, and it’s all worth it if it’s moving towards a different product or experience down the road.