The client
HelloCath is an early stage bladder care venture founded by Antionette, backed by Innovate UK. She came to us with a strong idea and first-hand insight into the problem, but no engineering or regulatory support behind her.
The brief
Take the idea from a concept in her head to something physical that could be tested, shown to funders, and eventually put through a regulatory submission. That meant concept development, prototyping and the regulatory groundwork, all under one roof.
What we did
We started with concept work, sketching and reviewing different ways the device could function before committing to a direction. The design that came out of this was a silicone device with a semi-rigid, spring-like core, which is a genuinely awkward combination to get right (soft materials and springy cores don’t naturally want to work together, and manufacturability has to be thought about from the very first sketch).
From there we ran several rounds of prototypes, testing and refining the design each time in our workshop near Bristol. Alongside the physical work we produced full technical drawings, so the design isn’t just a prototype in a box, it’s properly captured and ready to hand to a manufacturer.
We also mapped out the regulatory pathway, so HelloCath knows exactly what route the device will take to market and what evidence will be needed along the way, rather than finding out the hard way later.
Where it stands
HelloCath now has a tested concept, manufacturable drawings and a clear regulatory route, which is exactly the pack an early stage device company needs for its next funding round.
“I want to say how much I’ve valued the collaboration over the past few weeks. You’ve been incredibly responsive, engaged, and clearly invested in the process.”
Antionette, Founder, HelloCath