While working at Western Sydney University's clinic at Camden Hospital, gastrointestinal researcher Dr Jerry Zhou saw firsthand how many patients couldn’t access effective treatment for their gut disorders.

“One lady who was in a wheelchair could not commit to the full treatment because it was such an ordeal for her to come into the clinic,” the Senior Lecturer in the WSU School of Medicine says. “She needed to organise two carers and specialised transport for every appointment…she said, ‘I know it’s a great treatment but it’s so much work just to get into the clinic’.”

One in four people live with bowel disorders such as chronic constipation, faecal incontinence, and rectal pain/spasms. But they rarely complete effective treatment in a clinic.

Western Sydney University gastrointestinal researcher Dr Jerry Zhou. Credit: Supplied

Dr Zhou knew that biofeedback therapy – treatment that retrains the bowel muscles by using real-time visual feedback to show how the muscles are functioning – is almost 90% effective in providing long-term relief to defecation disorders.

“Normally, when you go to the toilet, it involves quite a lot of specific sets of muscle coordination and movements,” he says.

“For these patients, the coordination of the muscles isn’t working properly: they’re either too weak or not coordinating…that’s where the (biofeedback) treatment comes in.”

Inspired by patients who faced barriers to accessing care for these disorders, the researcher set out to develop a more accessible version of gastrointestinal therapy—one that could be used in the comfort of their home.

Five years later, the relatively affordable Ins&Outs device has been commercialised and has been approved as a TGA Class I medical device.

“Ins&Outs is a probe with sensors which monitors muscle activity in the rectum and anal sphincter, displaying real-time hospital grade biofeedback through an app to help patients identify and correct dysfunction,” Dr Zhou says. “It acts like physiotherapy for the bowel—guiding users through targeted exercises to rebuild strength and coordination.”

A 2024 clinical trial found biofeedback while using Ins&Outs showed improvements in bowel function and symptoms within six weeks and provided long-term relief in up to 87 percent of cases.

A key advantage of the device is that the data saved on the app can be remotely shared with a clinician, removing the need for further in person appointments.

The design of the device has come a long way from “a few drawings on a piece of paper” and an initial presentation of the concept at the NSW Smart Sensing Network meeting in 2019.

Ins&Outs took out the 2024 Good Design Award for Medical Product Design.

But the journey to commercialisation wasn’t smooth sailing.

It helped that Dr Zhou worked in a public clinic - the WSU’s GI Motility Disorders Clinic –based at Camden Hospital.

He also had access to a research centre at the WSU School of Medicine and the ability to run clinical trials in the Macarthur Clinical School.

“We can identify problems in the clinic, bring them back into the lab and create some sort of solution for it and then test them out through various clinical trials,” Dr Zhou says.

The first hurdle to commercialisation came “because I knew it was going to be a medical device, and I knew there was going to be some link to an app, but I’ve got no engineering background, I’ve got no software programming background. My background is in clinical research.”

Dr Zhou began by researching the device requirements, such as the length and dimensions of the probe, and the training activities required on the app.

He interviewed patients and clinicians about these requirements before handing the design to an engineer for further development and starting an intense commercialisation course at deep tech incubator Cicada Innovations.

“They take you through all the different obstacles you would encounter in that commercialisation journey with IP and reimbursement and stuff like that,” Dr Zhou says.

“It was quite a journey because then I spoke to the Uni about creating a patent around the device. That was my first serious pitch …My plan was to create a spin out company and then licence that into a company. Western Sydney University were actually pretty keen on that.”

From there it was a whirlwind of grant applications – he eventually received $350,000 – and creating different prototypes.

An early concept drawing of *Ins&Outs*. Credit: Jerry Zhou

“We had a benchtop prototype, and it was a very crude device,” he said.

“It’s a probe with a long wire and it had a circuit board, which was all exposed. Sounds scary and it looked terrifying: it had two nine-volt batteries attached to it. But at the time we were just trying to prove that the technology worked.”

Once the researcher knew the sensors were able to measure what was required, and the app could record in real time, he moved onto a human test to prove the safety of the device.

“We discussed “what’s the minimum amount of people we need to test it on to make sure it’s safe and see how much variability you get in terms of the anorectal muscles?” he said.

“We concluded – because a healthy person would probably use the same number of muscles - that one was probably good enough.”

Dr Zhou became his own first test subject, conducting a single-person trial under full ethics approval.

“It's always hard to recruit someone to test out your new experimental device. So the one to step forward and test it is always the inventor because it's the easiest way to recruit.”

The early study not only confirmed the device’s function but also led to key design improvements and a published safety paper that laid the groundwork for further trials.

The first *Ins&Outs* prototype was a very crude device. Credit: Supplied

Then he ran a controlled trial to assess usability—finding strong patient engagement and clinician confidence thanks to its simplicity, visual feedback, and cloud-based monitoring.

“For class one devices, we don't need clinical trial data, but we wanted to run a trial, regardless. The main reason for that is we knew later when we began selling this device, the thing the clinicians are going to ask for is the clinical trial data. So essentially, we were doing it as part of our sales and marketing.”

After receiving TGA approval last year, Dr Zhou licensed the IP from the university and launched a spin-out company Amazing Gut earlier this year.

The $400 device is now being trialled at Royal Prince Alfred Hospital, with plans to expand into his own clinic and several private physiotherapy practices—marking the start of real-world use.

“One of the things I’m really proud of is just how far we took it because initially I didn’t think I’d get this far,” he says.

“I’ve got some advisors and collaborators who we work with to get things off the ground…But essentially it just been me pushing this project along in my spare time.”

Dr Zhou says it took more than five years to turn his idea into an approved medical device—all while working full-time, teaching, getting married, and starting a family.

He says his commercialisation journey is a good case study for other researchers or clinicians who are interested in entrepreneurship.

“You can do it, even if it’s just one person. For us to get so much done with so little speaks volumes. I hope my story can inspire more people to try commercialisation.”

But he recommends having a team of supporters and advisers along the way.

“Some of the advisers were there to help motivate me…hear me complain about stuff. But when things aren’t working, when things are horrible and you want to quit, you need someone to just say ‘no, just go a little bit further’. I think those people are important as well.”

From frustration to innovation: one researcher’s journey to a bowel therapy breakthrough