Hold onto Your Ostomy Bags, I'm About to Blow Your Mind

This week in Pedersen's POV, our senior editor – a former ostomy patient – gets personal about what defines success and failure in innovation.

Amanda Pedersen

January 30, 2023

4 Min Read
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I was 21 when I first became an ileostomy patient.

An ileostomy is when the last part of the small intestine (ileum) is connected to a hole in the abdomen called a stoma, which allows stool to leave the body. It's like the more commonly known colostomy, which is where the colon is connected to the stoma. For me, my entire colon was removed, so I had an ileostomy.

Both ileostomy patients and colostomy patients wear a bag over their stoma to collect stool. Ileostomy patients tend to have looser stools than colostomy patients, requiring more frequent trips to the bathroom to empty the bag, and more frequent bag changes.

Most of the research and development work in the ostomy space has focused on improving the bags and related accessories, but it's been decades since the space has seen any true innovation. So, I was intrigued when I recently heard about OstomyCure, a small startup in Norway developing an implant that represents a giant leap forward for ileostomy patients.

The Ties implant is a titanium port designed to be implanted within a stoma. It is intended to be used with an attachable lid to effectively open and close the stoma. The idea is that patients can empty their stoma at their own convenience as opposed to it continuously emptying into a bag, causing discomfort, noise, smell, and inconvenience.

When I first learned about the Ties implant, I had flashbacks to my own experiences with an ileostomy. One particularly horrific experience occurred at an Applebee’s, where I was meeting a couple of friends. Something I was eating caused my ileostomy to kick into overdrive and my bag filled up within minutes until it burst open, right there at the table. I threw some cash onto the table to cover my portion of the bill, bolted out of the restaurant, and rushed home to deal with the mess.

But I'm one of the fortunate ones who only had to contend with a stoma for 15 months. Many patients have a stoma for the rest of their lives. And you can bet each of them have their own blowout stories.

Theoretically, if I'd had a Ties implant, I could have avoided such an embarrassing situation.

Granted, OstomyCure's executives were forthcoming with me in the fact that the device doesn't quite work as well as they had hoped. The first human clinical study was started about 12 years ago in a handful of patients. Although there were no adverse events, the study showed that the implant wasn't the leak-free system the company had envisioned.

"There were leakages, so the intestinal fluid was seeping out on the sides. From the company's standpoint it was a failure," said Mats Cardell, chief technology officer at OstomyCure.

And yet, three of the patients in that early study still have the Ties implant today.

"And they don't want it out – they're absolutely delighted with the situation," Graeme Smith, OstomyCure’s executive chair, chimed in.

As a former ileostomy patient, I can easily imagine why those patients are hellbent on keeping the implant, even if it isn't a totally leak-free system. Cardell said one of the patients can use the device as intended at least some of the time, meaning they can use the lid that OstomyCure designed and take a break from wearing an ostomy bag. The other two patients do experience leakage, but they find the Ties implant is still a major improvement over not having the implant.

"One is securing his bag over the implant and is super happy. His life is totally changed," Cardell said. "He thinks we're idiots to try to do something else."

The moral of the story, from an innovation perspective, is that, at the end of the day, the people using your device will be the ultimate judge of whether it's a successful product.

"The interesting thing is our goal or intention as a company was one thing and the patients have a totally different perspective and they were quite happy with it," Cardell said.

Even if the Ties implant isn't completely leak free, it would at least enable ileostomy patients to have some control over their stoma and avoid the ostomy bag blowouts that currently plague most ostomy patients.

If I'd had the Ties implant for those 15 months that I had a stoma, that trip to Applebee’s with friends might have ended on a more pleasant note. I might have felt some leaking around the implant and needed to excuse myself to visit the restroom, but I wouldn't have had to make a mad dash out of the restaurant with soiled clothing.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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