5 Minutes with Mark Leaning

Transforming Real-Time Care Through Intelligent HealthTech

I recently sat down with Dr. Mark Leaning, Founder and CEO of Directed Systems, to talk about his journey through multiple HealthTech ventures, the lessons he’s learned bringing innovation into clinical settings, and how his team is shaping the future of real-time, intelligent care. From building purpose-driven cultures to navigating the challenges of scaling in healthcare, Mark shared some great insights for anyone operating in this space.

Chris: What inspired you to start Directed Systems, and what problem in healthcare were you determined to solve?

Mark: After years working across physiology, data science, and medical software, I became increasingly frustrated by how much valuable cardiovascular data is ignored or underused during real-time care. Intraoperative hypotension (IOH) was a case in point: it’s common – affecting around 1 in 3 surgical patients – yet often goes unaddressed until it’s too late, leading to kidney injury, heart complications, and longer stays.

I realised that by applying intelligent software grounded in physiological understanding, we could equip clinicians with the tools to detect and respond to instability before it causes harm. Directed Systems was founded to turn this vision into reality. We’re building a new category of software that acts as an intelligent co-pilot – giving clinicians real-time insights and guidance to keep patients stable. We started in the operating room, but the vision always extended further: intensive care, emergency medicine, and eventually even chronic cardiovascular care.

Chris: Looking back at your career across multiple HealthTech ventures, what’s the biggest lesson you’ve learned about bringing new technology to market in healthcare?

Mark: The biggest lesson is that clinical need – not technology – drives adoption. It’s not enough to be clever. Hospitals adopt solutions that solve pressing problems, especially those that improve safety, outcomes, or cost-effectiveness.

In our case, we’ve zeroed in on real-time decision-making during acute cardiovascular instability. That’s where clinicians need the most support – and where software can have the biggest impact. We’ve developed DS Aware™, our first product, to help anaesthetists navigate blood pressure control during surgery. It’s already in clinical use in US and European hospitals and has shown it can reduce IOH exposure. That traction has only come because we focused first on a real clinical pain point- and worked hand-in-hand with the clinicians using it.

Chris: From your perspective, what is the most exciting trend in digital health or MedTech right now?

Mark: For me, it’s the convergence of intelligent algorithms with real-time clinical workflows – moving from retrospective analysis to bedside action. AI and automation are beginning to assist in the moment, not just analyse afterwards.

What excites me most is how this intersects with physiology. At Directed Systems, we’ve built real-time software that interprets cardiovascular signals live – providing clinicians with immediate insight and guidance. We’re now taking this further with directive treatment advice, and in future, closed-loop control systems. That progression, from insight, to suggestion to action, is where innovation becomes transformation.

Chris: What do you see as the biggest barriers for SMEs trying to bring innovative solutions into hospitals or clinical settings?

Mark: Three stand out: evidence, access, and inertia.

Clinicians want innovation, but they also want to know it works. Generating high-level evidence like RCTs is hard for SMEs early on, so real-world evidence becomes essential. At Directed Systems, we’ve partnered with leading hospitals to generate early clinical and operational data, while also securing grants to support further research.

Access is the next hurdle, navigating complex procurement systems and IT gatekeeping. And even with access, there’s inertia: hospitals are busy, overstretched environments, and changing practice takes trust and persistence. You need champions inside the system who believe in your mission. We’ve been fortunate to find those – and they’ve made all the difference.

Chris: As a founder and CEO, how do you create a culture that attracts and keeps top talent in a competitive HealthTech market?

Mark: Purpose is magnetic. We’re not just building software – we’re helping clinicians save lives by managing cardiovascular instability more safely. That mission resonates with talented people who want their work to matter.

But purpose alone isn’t enough. We’ve worked hard to create a culture where bright people can build, question, grow – and feel they’re part of something bigger. We keep our team small but dynamic, and give them real responsibility from day one. Everyone is close to the product, close to the clinicians, and close to the impact. That’s a powerful motivator – and it keeps people engaged.

Chris: If you could give one piece of advice to an SME HealthTech leader trying to scale their company in the next 12 months, what would it be?

Mark: Stay close to your users. In our case, that means being in the OR, watching how anaesthetists work under pressure and listening, really listening, to what they need.

Our biggest breakthroughs have come from these moments. For example, we redesigned key elements of our UI and analytics platform based on direct surgeon and anaesthetist feedback during early hospital trials. That not only improved the product, it built trust. And those clinicians became our strongest advocates. In healthcare, the best ideas come from the frontline. Everything else, investment, growth, partnerships – follows from getting that right.