NUA Surgical is an award-winning startup developing innovative surgical medtech for obstetrics and gynaecology.
The company is a product of the BioInnovate Ireland Fellowship: a medical device innovation programme aimed at identifying unmet clinical needs and aligning them with new market opportunities.
NUA Surgical’s inaugural device, the SteriCISION C-Section Retractor, has been designed to reduce surgical complications, improving outcomes for both mother and baby.
Health Tech World talks to the founding team about the challenges of C-section surgery and advancing innovation in women’s health.
Hi Marie Therese. Could you tell us about the context surrounding the development of the SteriCISION C-Section Retractor and what appealed to you about the project?
COO and co-founder, Marie Therese Maher (MM): I know from experience that childbirth can be the most vulnerable time in a woman’s life.
I care about all things mother & baby, and especially anything around infant delivery.
When Barry approached Padraig and I in early 2018 with this project and presented the clear unmet clinical need, I realised straight away that this was a fantastic opportunity to do something really meaningful with huge scope to make a real difference.
Ultimately, you’re trying to improve outcomes from a procedure that has seen very little innovation for decades.
At a time when complication rates are increasing, the existing surgical instruments have significant limitations and are not designed for the current patient demographic.
Why is that?
MM: Today’s C-Section demographic is different than it was 20 or 30 years ago. But nothing has come along to cater for those changing patient needs.
Infants and mothers, along with their obstetricians, deserve better. They deserve more novel technology than is on the market today.
An obstetrician who had moved from gynecology told us that it felt like she had gone from a very novel, high-tech discipline to a role where she was basically handed a knife and fork.
There was no innovation – nothing to cater to the specific surgical needs during a caesarean delivery.
CEO and founder, Barry McCann (BM): C-Section has evolved from being a last-resort surgery used in emergency cases to save a life, into the most common major surgery in the world.
The procedure is performed over thirty million times each year around the world, representing over twenty percent of all births.
There are many reasons for the increased number of C-Sections, but a primary cause is that more patients are arriving into pregnancy with existing complications and comorbidities.
Women with diabetes, obesity, or those with higher maternal age, are all at higher risk of being indicated to have a caesarean section as their safest form of delivery.
However, innovation has lagged behind.
What retracting tools are used today?
BM: The most common tool for retracting an incision during surgery is a metal handheld retractor.
The device has been around for not just decades, but probably centuries, with very little innovation.
When you look at the innovation in this space, a couple of single-use disposable devices have been adopted and rebranded as C-Section tools, but because they were never specifically designed for C-Sections, they have certain shortcomings, particularly when youve got very different patient demographics.
Today, over half of European and probably two-thirds of US C-Sections are being performed on either overweight or obese mothers.
That creates a really challenging surgical field for the whole clinical team which unfortunately results in higher complication rates.
To address this, we’ve developed the first C-Section retractor that’s specifically designed for this procedure and also addresses challenges presented by high-BMI patients.
What makes this surgery so challenging for medtech innovators?
MM: There are two significant patients involved in the surgery: the mother and the infant. And it is the most dynamic surgery so the ergonomics are difficult for the obstetric team.
You can’t leave metal retractors in place. They need to be removed before an infant can be delivered.
And given the dynamics of the surgery, you’re trying to design a device that will cater for all different body types and a changing patient demographic.
We’re trying to design a single device that will suit all patients and all the various infant sizes, that is safe and non-traumatic to both the infant and the mother.
It’s a significant design challenge and it’s taken us a number of years.
Also, there is no developed test model to challenge our device iterations as we have progressed. It’s like we’ve had to develop a test model as we’ve developed our design.
It has been challenging, but it’s really exciting,
How do you get the medical community to actually adopt new technologies when they’ve been working in the same way for decades or more?
CTO and co-founder, Padraig Maher (PM): I’ve designed products in many different areas.
Normally, you try to put yourself in a person’s shoes to understand the problem.
But I’m not a surgeon. I can’t don the gloves and put my hand in the wound space. I can’t feel what it’s like to perform surgery.
That’s why we work closely with clinicians so we can really understand the challenges that they face.
At the end of the day, they’ll manage with whatever tools they have, because they have to.
But when you understand their challenges more, you can develop a concept for them, give them a prototype and then adapt that prototype based on constant feedback.
You have to demonstrate that the device works and is going to benefit them. These people will tell you very quickly if something is rubbish.
But once you do get the buy-in, they’ll come to you with suggestions and ask you is this or that possible.
I wanted to show them that there is another way of working. [I can create a tool that] holds back the incision and frees up a pair of hands.
Now your assistant can get in there and do something that could be life-saving.
Once you start to tell that story, they are more interested in the opportunities it may bring to them and ultimately to their patients.
What particular criteria are clinicians looking for?
MM: At the entry level, it has to be quick and simple to use in a very time-critical surgery.
At the next level, it needs to be very effective at what it’s supposed to do. [In our case], that’s holding back incisional tissue.
After that, you have to demonstrate value proposition to the various obstetric departments around the world.
The burden of proof is on us to gather clinical data that is meaningful for hospital value analysis committees.
They need to be able to look at the data and say, yes, this device will save time within the OR and that time equates to money and better safety outcomes for patients.
For other hospitals, it might be about staffing.
In a teaching hospital, this isn’t an issue. They can call in extra assistants to hold back tissue if they need to.
But in rural hospitals or late at night in some hospitals, that extra assistance isn’t going to be available.
They also want to prevent bacteria from transferring into the wounds, which increases the risk of complications and surgical time.
So we need to gather the data that demonstrates the value proposition for each stakeholder and clinical setting.
Where do you plan on marketing the device initially?
BM: We’re initially going to be targeting the US for clinical adoption.
Over the past number of years, we have engaged closely with key decision makers within large hospital networks throughout the US and we received huge support from them throughout our R&D phase.
They are excited about the potential our solution brings to this procedure and have become early advocates for the SteriCISION device.
Unfortunately, the rates of maternal mortality and morbidity continue to rise in the US and there is a spotlight on trying to correct this.
We certainly hope that NUA Surgical We certainly hope that NUA Surgical can play its role in making childbirth a safer procedure through our novel technology.
So where are you now? What’s next?
MM: We’re at a very exciting point where we’re now close to the point where we can freeze our design..
We’ve kept iterating until there are no more signals about possible design changes.
We’ve selected our final materials and our manufacturing process will soon be up and running, too, and we hope to be FDA cleared and on the market in the US in 2025.
BM: On the commercial side, we’re engaging closely with hospitals and healthcare systems in the US.
At the start of 2023, we were the only non-US company on the Texas Medical Center Healthcare accelerator and we’re working with women’s health and obstetrics departments at various hospitals there.
Again, it’s de-risking and looking at gaining more clinical champions for when we do get to market.
