Q&A: Judi O’Malley, CEO of Spiorad Medical

 

Judi O’Malley is the co-founder and CEO of Spiorad Medical, an Irish MedTech company developing a device that simplifies and improves femoral artery access closure — the critical step after many minimally invasive cardiac and vascular procedures.

From growing up over a Dublin pub to building early prototypes on a kitchen counter, her journey blends vascular science, IP, business, and a stubborn determination to fix a medical problem.

 

Where did you grow up and what are your earliest memories?
I actually grew up over a pub in Dublin. I think it’s called the Berkeley Inn now. My parents were publicans at the time and those are my first memories. I had three older brothers, and we were effectively living over a pub in the city. I think I entered the workforce at a very young age. I remember counting the change from the public pay phone at the time, which gives away my age a bit, as this was before mobile phones. I can remember that being my job even as a toddler— stacking up the 2, 5 and 10ps!

 

How do you think that upbringing influenced you later on?
I give a lot of credit to my mum and dad. They didn’t have the opportunity to go on to third-level education themselves, and they really wanted all of us to have that. It was something they valued and respected very much.

I got a strong work ethic from my mother. She’s still very active now in her seventies. She doesn’t stop. She’s always minding grandkids, volunteering, doing housework, or doing something. From my dad, I probably got my sense of humour and maybe a bit of laid-backness. They’re absolute opposites if you meet them. I think I sit somewhere in the middle between the two.

I started my career as a vascular physiologist and did my degree in clinical measurement science in DIT (now Technological University, Dublin). I never really thought I would end up as a founder, or CEO.

 

Where did your career begin, and what drew you to vascular?
I worked for the Health Service Executive in Ireland as a vascular tech in what’s now called a Clinical Vascular Scientist role. I just really loved vascular. My first boss, Dr. Anne O’Shaughnessy, now head of education for the Royal College of Physicians in Ireland, was phenomenal and I was very lucky to have her. She really inspired my love of vascular. I was fascinated by it and really enjoyed working with vascular surgeons. What’s nice about vascular is that you learn a little bit about everything. Veins and arteries go everywhere in the body, so you get a good understanding of medicine across the board, which I loved.

 

What pushed you beyond the clinical world into IP, business, and industry?
I wanted to learn more outside the clinical setting, about the IP side, the business side, and the industry side. I did my diploma in IP with the Law Society in Ireland and gained some work experience with a patent firm in Dublin. I realised the nine-to-five office job wasn’t for me, although I did enjoy it. It was great for understanding how technology comes about, what’s patentable, what isn’t, and how different countries operate. You also learn that just because you don’t find something on Google doesn’t mean it doesn’t exist.

I then did my master’s in project management with the UCD Smurfit Business School. From there, I moved into industry, and sales and marketing, and I first worked with a distributor managing the peripheral vascular portfolio for Medtronic.

I was later approached by Abbott after they acquired St. Jude Medical, to manage their structural heart business in Ireland.

 

You’re now the CEO of Spiorad Medical, the company you co-founded. What does it do?
Spiorad Medical simplifies the closure of femoral artery access. For people outside the field, that means we close the hole made in the groin after certain cardiac or vascular procedures. Rather than opening someone up to repair the heart or an aneurysm, doctors can now go endovascularly—through an artery or vein—to fix the problem, but the issue is that after the procedure, there’s a hole left in the groin that must be closed, or the patient risks massive blood loss. We’ve developed a technology that closes that access point very safely and very quickly.

 

What made you move into this side of the medical world?
I saw a real gap in the market for a good closure device. The company I was working for was the market leader, and I sold that product, but unfortunately, we saw a significant failure rate, and it was also very difficult to train physicians to use it. Customers complained to me about it regularly. It was myself and one of my customers, Dr. Samer Arnous, who said one day after another failure, ‘There has to be a better way to do this.’ He pointed out my background in vascular physiology, and my commercial experience, and asked whether we could come up with something better. That’s really where it started.

 

What did the earliest R&D look like in practice?
We literally just started developing it ourselves. We began with drawings, then moved to CAD drawings, and then printed parts to see if they would work. This was very early on and entirely kitchen based. My kitchen counter became a small lab space. I was going to local abattoirs to get sheep and pig arteries to practice on. We bought a simple pump online, got placement boards from Ikea, cable ties, tubing, and built a basic rig to test on.

 

What were you trying to improve compared to existing devices?
We knew these procedures were only going to increase as doctors moved away from open surgery toward endovascular approaches because they’re safer and quicker for patients. We wanted to create a product that was first and foremost safer for patients and eliminated catastrophic failures. The other key goal was ease of use. Doctors shouldn’t need 50 or 100 cases to become confident. We evaluated the tactility of the end user, how physicians naturally use their hands, and tried to mirror that using familiar design cues from devices they already use.

 

When did you feel confident this could work?  The first time we felt we were onto something was probably the fifth or sixth device design. The first few failed completely, but we learned what not to do. When we tested it on the bench and pushed the pump up to about 240 millimeters of mercury and the plug stayed in place, we thought, ‘Okay, this might work.’ Then we then ran an acute animal study in Paris on a sheep, and it worked successfully. I didn’t have real confidence until about 12 months in. At that point, we had good materials, the device stopped blood effectively, and it held at high pressures. There are still other factors to evaluate, risk of infection, tissue damage, and so on, so that process is ongoing.

 

A bit about the entrepreneurial journey. When did you formally set up the company and go full-time?
We set up toward the end of 2021 after securing Enterprise Ireland High Potential Startup support. They made it clear that one of us had to go full-time. Samer continued as a consultant cardiologist, and I left my role in industry to pursue this full-time.

 

What assumptions did you have going in that proved wrong?
That you can have all the degrees and qualifications you want, but they don’t always stack up. On paper, I looked ready, but psychologically I probably wasn’t. In multinationals, you’re very supported. When you’re the CEO, you’re responsible for everything, even when you’re paying experts.

Solicitors, accountants, engineers, they can all still get things wrong. Ultimately, it’s on you to check everything and take responsibility. I was probably a bit naïve in how much I trusted specialist skill sets.

 

What keeps you awake at night—and what helps you sleep?
What keeps me awake is funding. Do we have enough money to reach the next milestone? Where is the next raise coming from? Am I going to have enough to get to first-in-human? Enough to go to market? Enough to build a sales team?

What puts me to sleep is reading regulatory documentation. If you want to fall asleep, read the EU MDO directive for a Class III device—it works better than most sleep aids!

What does it take to start from scratch, and did you ever think about walking away?
I wouldn’t say I nearly gave up. I’ve never been willing to walk away. There have been major letdowns of course. Angel investors promise money; you spend months or even a year meeting their requirements, and then they pull out at the last minute. That’s frustrating, but you learn to manage that. The biggest thing people don’t understand is the risk to your personal life. When you start a business, you don’t know where your next salary is coming from. You have to raise your own salary. There were times with no cash flow when I went back to doing sales one day a week just to cover myself, but for me, the fear of regretting not trying was stronger than the comfort of staying in a secure, well-paid job.

 

How has building Spiorad changed you personally, and what do you think your CEO superpower is?
It’s made me much more self-aware and more empathetic. I used to project my own personality and assume everyone thought the same way. They don’t, and that’s a good thing. I learned that people who seem ‘slow’ are often methodical, and that’s incredibly valuable. Going from a six-figure salary to nothing made me far less materialistic. I’ve had the cars, but you’re still sitting in traffic. I’ve learned I can live very simply and be content.

I find it hard to answer what my superpower is, but I think it’s probably my ability to speak across disciplines. I have enough understanding to talk to engineers, lawyers, accountants, clinicians, and then connect those conversations into a coherent plan. Communication and persistence are probably my strengths. I follow things through. I will keep pushing until things get done.

 

What does success look like for Spiorad?

Success is seeing our product used in patients. It’s being in the operating room when another device fails and ours works, stopping the bleeding, giving the physician confidence, and allowing the patient to go home the next day.

 

If you weren’t doing this, what would you be doing and what advice would you give to someone thinking of taking the leap?

If time and money were no obstacle, I’d probably still do this, and I’d reinvest in other startups I believe in, and help them where I can. It’s part of who I am now.

I’m not great at protecting my time. Work-life balance doesn’t really exist when you’re building a company, but I don’t mind lab work on weekends or calls at 2 a.m. with Japan or Australia. I get energy from what I’m doing. It doesn’t drain me. So, my advice would be to go for it. What’s the worst that can happen? If it doesn’t work, the job you left will still be there. This isn’t a dress rehearsal. You might as well pursue your dream. And the best advice I’ve received is to keep your integrity. If you say you’ll do something, do it. Your business brand is your personal brand. Be honest, even when it’s uncomfortable. You’ll get to where you need to go faster.