Overcoming challenges: Insights from a MedTech start-up

June 20, 2024

by The CergenX team

MedTech insights

“You basically all need to become inventors and acrobats. Everything you are used to having doesn't exist yet. All of your previous experience needs to be flexed, and shaped, and applied in a different way. It’s not about reinventing the wheel. It’s about inventing a new wheel-shaped object from raw materials.”

Like most start-ups, we face obstacles that can make our day-to-day work tricky at the best of times (demoralising at the worst!) While the lows can be tough, the highs are incredibly sweet. We regularly document our successes on internal Slack channels, social media, and in our newsletter, but we rarely talk about the niggles and the "oh no" moments. So, we've decided to take you behind the scenes. We asked some of our team members to share the difficulties or challenges they face in their roles. 

John - AI Research

Clinical adoption: Building trust and confidence in our new product is a significant challenge. Medicine is understandably—and rightly—conservative when it comes to new technologies. This is not an exact science; opinions vary widely, and clinical practices differ greatly among different centres, even within the same country. For instance, small regional hospitals in Ireland operate differently compared to large third-level centres Meeting this challenge requires a multifaceted approach, including providing robust evidence, engaging key opinion leaders, continuous improvement of our technology, and proactive integration of the latest advancements in AI and clinical research.

Implementing a Quality Management System (QMS): The QMS can feel like the antithesis of innovation. It introduces supercharged bureaucracy, sometimes to the point of absurdity. For example, we have documents on how to write documents. That said, it’s important and necessary—it enables us to develop the technology in a structured and regulatory-compliant manner while always putting patient safety first.  

Dan - UX Design

Diverse responsibilities: As the lead designer, my responsibilities are incredibly diverse, which means my day-to-day work can vary a lot. One day, I might work on user research, gathering feedback to understand how our users interact with our technology. The next day, I might design and add a new page to the company website. This variety keeps things interesting but also requires a broad skill set and the ability to switch gears quickly.

Product design: One specific challenge in product design is creating a tool for very busy users who operate in intense, complicated, and sensitive environments. Our end-users, often clinicians and medical staff, need a product that is intuitive and efficient, as they cannot afford to spend extra time figuring out a complex interface. The design must be streamlined to enhance their workflow without adding to their cognitive load, all while maintaining the high standards necessary for medical technology.

Finola - Product Management 

Building from first principles: Our product is novel, pending regulatory approval, and pre-market. This challenges our product management approach as we must develop our strategy and market understanding without the benefit of traditional inputs like direct customer feedback, established market data, or insights from competitors. For me, this is really about how inventive you need to become to gain true opportunity understanding and product feedback and how closely you can simulate “experimentation” in different ways while also focusing on the regulatory journey.

Learning mindset required: Generally, I'd say this type of work suits certain qualities perfectly—we need drivers who'll roll up their sleeves and dive in. Discomfort needs to become your companion because so much of what we do is new territory; you'll often find yourself clueless and making mistakes—and you need to be okay with that. It's immensely helpful if you're naturally curious, thrive on learning, and are driven to build something meaningful with a fantastic group of people. Egos are left at the door—everyone does what needs to be done, even if it's well outside your comfort zone!

Rob - AI 

Moving outside comfort zone: Recently, I had the opportunity to present on behalf of CergenX at the International Newborn Brain Conference. As someone relatively new to the medical field, addressing a room full of global expert clinicians was a new challenge. The goal was to make some of the technicalities of AI accessible and interesting to a non-specialist audience and convey their importance to the field of neonatal brain injury—no small feat!

Paul - Software Development

SOP struggles: For me, the most challenging aspect is compliance. Unlike other industries where processes are developed over time, here in MedTech, we need our Standard Operating Procedures (SOPs) upfront. It's like trying to build a plane while you're flying it! What's surprising is the sheer number of processes required—development processes, complaint processes, post-market surveillance processes, requirements processes… Developing them all is quite the task, but we are getting there!

Jason - Co-Founder & CEO

Keeping all the plates spinning: With limited resources, what do you prioritise? I could have twenty different things going on at once, each vying for my attention. As with any start-up, you have to muck in wherever needed. I find myself doing tasks I haven't tackled in years, like management accounts!

Adapting to a new area: Being new to the medical world adds another layer of challenge. Confidence is key, especially when engaging with globally renowned medical experts, primarily neurologists. It's about projecting a level of assurance and expertise despite the learning curve. 

The workload is significant at times. However, the CergenX team is highly dedicated to our goal: identifying newborn infants most at risk of brain injury so that appropriate treatments and interventions can be initiated. It's this shared vision that makes every late night and every challenge worth it.