Is Your Medtech Idea Worth Pursuing?

Is Your Medtech Idea Startup Worthy?

“When founders ask me about starting a company, I tell them: Is this something you’re willing to eat, sleep, and breathe for the next 10 years? Because that’s what it takes.” Caitlin says. For her, the sacrifice a startup demands is only worth it for problems that truly matter — something a generic consumer widget just can’t justify.

Medtech is full of opportunities, but not all problems are worth pursuing. Caitlin explains, noting that a good medtech company will essentially be life changing for customers, which includes patients as well as clinicians and others in the healthcare ecosystem. 

A simple, user-friendly product might look effortless, but behind the scenes, it’s anything but that. ”Think about a tapestry. The front side may be a single image, but if you look at it on the back, there's all the threads crisscrossing all over the place, getting the colors where they need to be. It's fairly chaotic,” says Caitlin. In other words, running a medtech company means you assume all that complexity, so clinicians and patients can enjoy the simplicity. That’s why it’s crucial to carefully assess your ideas before diving into product development.

It’s important to keep in mind that not every problem is suited for venture funding. Some issues might have real-world impact, but don't promise the kind of returns that venture capitalists expect. These are better tackled through bootstrapping or alternative funding models.

Beyond that, it’s important to consider how vulnerable your idea is to disruption. Could a strategic release an update and wipe out your business? If a competitor can solve the problem with a simple software update, it’s probably not a strong business idea. While medtech works differently than the tech industry, you still need to think about how defensible your product really is.

On that note, it’s beneficial to ask yourself, does solving this problem solve other problems? Clinicians expect new solutions to meet the baseline of existing technology while also solving additional problems. Adding one great feature might sound useful, but remember, you also need to meet the existing standard, which can be a massive effort in the first place. In environments like the ICU, for example, the stakes are even higher as nurses need a solution that works across all patients, such as traumatic brain injury, stroke, and pediatric hydrocephalus. That means your product must be comprehensive and practical at scale.

This is where Caitlin suggests taking flywheel effects into consideration — small, consistent efforts build momentum over time, leading to exponential growth. For instance, BrainSpace’s precision drainage system provides immediate value for the patient and the hospital while paving the way for biomarker-driven pipeline products advancing neuroscience and dementia research.

Rich datasets can enable scientific discoveries — all without adding to the workload of frontline workers. “We're going from one data point an hour to thousands of data points a second. And so we are super excited to start to see some of that in a human context and really understand what's possible and what we can really learn from that to make a difference for patients,” Caitlin shares.

Balancing Development, Regulatory Milestones, and Clinical Evidence

Caitlin had seen startups take 20 years to bring a product to market, and she knew she didn’t want to take that path. With BrainSpace, she aimed to make a real impact within five years.

Before shutting down her thriving consultancy, she started by talking to nurses to better understand the problem. She saw that the existing process for cerebrospinal fluid drainage was incredibly labor-intensive and high-risk. Caitlin reached out to researchers who had published papers or hosted webinars, and many of them supported her idea.

With that initial validation in hand, Caitlin converted her bathroom into a makeshift wet lab to test early concepts during the COVID lockdown. Ultimately, she and her soon-to-be co-founder came up with a solution that made sense for the market, the clinical workflows, and the gross margins. Furthermore, the problem had reimbursement, a clear clinical workflow, and a realistic path forward.

The gap between an early prototype and a fully regulated, market-ready device is bigger than many realize. Caitlin highlights the difference between technology innovation — establishing the science and engineering that compose the initial concept — and product innovation — getting through regulatory approvals with a sellable device that fits seamlessly into clinical workflows and is manufacturable at scale.

A faster path to regulatory clearance, like a 510(k) clearance, lets you start with a lean version of a product. This approach provides more flexibility — it allows you to begin post-market studies, collect real-world data, and refine your product while building momentum with early customers. However, it’s essential to ensure that even a lean version delivers real value. “From the FDA's perspective, from all the published standards perspective, once your device is cleared, it is considered safe and effective,” Caitlin explains. “But if you don't have a single doctor, who a new customer can call up and say, ‘what's your experience been?’ good luck getting it through the Value Analysis Committee (VAC) or hospital purchasing.”

A device must integrate seamlessly into hospital workflows, meeting the baseline functionality of existing solutions while adding meaningful value. This is especially critical in ICUs, where tools must work across different patient types, not just a single condition like traumatic brain injury.

Early usability testing can reveal how well a device fits into real-world settings. “I had interviewed more than 200 people,” Caitlin recalls. At a critical care nursing conference, she and her team let nurses try their system with no prior training. “I basically gave them no training whatsoever and just said, ‘Try this,’ and watched what they would do correctly or incorrectly and how we could make it more intuitive.” The response was telling: more than 50 healthcare systems asked for information on the device, wanting to learn more about how they could use it in their hospitals.

To drive adoption, you also need to show hospitals proof of value. A strong post-market strategy should focus on collecting data on hospital workflows and ROI. Studies showing reduced ICU stays or improved patient mobility can be key to convincing clinicians and administrators. That’s why rather than jumping straight into full-scale commercialization after FDA clearance, Caitlin is planning to introduce the device in a few hospitals first, testing it over a few months to gather real-world feedback and ensure it meets clinical needs before scaling.

Staying resilient through the long development cycles is important, during which you need to balance ambition with realism. Remember, promising too much too soon can harm credibility with investors and partners. Instead, focus on building a solid foundation: a clear regulatory path, a well-thought-out clinical evidence plan, and a product that genuinely meets users' needs. When you feel stuck, reach out to your peers. Networking with other CEOs and sharing insights can give you valuable guidance.