Written by Dr Michael Challenor
When should a medtech founder start thinking seriously about usability?
According to Carla Zampaglione, the answer is simple: much earlier than most people think.
In a conversation recorded at the 2026 Innovate Medtech Masterclasses, Innovate Medtech's Dr Michael Challenor sat down with Carla, Managing Director of specialist usability engineering consultancy Sento Solutions, to discuss what happens when founders begin with the problem, listen closely to users and make design decisions from evidence rather than assumption.
The full conversation explores the realities of medtech product development, the risks of taking a do-it-yourself approach to usability and why even experienced teams should expect to be surprised by their users. Here are a few of the ideas that stayed with us.
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YOU CAN START TOO LATE, BUT NEVER TOO EARLY
Usability is sometimes treated as a validation activity to be addressed once a device has already taken shape. Carla sees it differently.
Early usability work can help a team establish whether it has identified a genuine clinical need before it becomes committed to a particular solution. Starting without the solution firmly fixed allows founders to examine the problem objectively and hear perspectives beyond the founding team.
As Carla put it, “You can never come to us too early, but you can definitely come to us too late.”
When usability begins late, the work can become retrospective: rescuing decisions that have already been made, redesigning features that are difficult to change or assembling evidence after the fact. Starting early creates room to learn while change is still comparatively easy.
CREATE A SOURCE OF TRUTH BEYOND THE FOUNDING TEAM
Founders naturally arrive with conviction. That conviction is essential, but it can also make an untested assumption feel like evidence.
Carla described the importance of creating an objective source of truth through conversations with clinicians, patients and other intended users. Those insights can then inform product requirements, risks and design priorities.
This changes the answer to a crucial question: Why did we design this feature?
The answer should not be that someone on the team thought it would be useful. It should be that research showed users need it, want it and can use it safely.
That distinction helps teams separate must-have features from attractive distractions. It also gives founders a stronger foundation when product, commercial, reimbursement and regulatory priorities begin competing for attention.
QUALITATIVE RESEARCH REVEALS WHAT SURVEYS CAN MISS
Early in development, neat yes-or-no answers can create a misleading sense of certainty.
Sento's approach places particular value on qualitative research: speaking with people individually, understanding the context around their needs and exploring how willing they are to solve the problem being presented.
The aim is not simply to collect opinions. It is to understand behaviour, motivation and risk deeply enough to make better product decisions and build a more objective picture of product-market fit.
Carla described usability as both logical and “deeply human.” That human dimension is precisely why teams cannot reliably predict every interaction from inside a design meeting.
DIY USABILITY CAN BECOME EXPENSIVE LATER
For resource-constrained startups, doing usability work internally can appear efficient. Carla understands the attraction, but cautions founders to be clear about the risks they are accepting.
The cost of an early shortcut may not become visible until much later, when a team encounters avoidable design changes, safety concerns or missing evidence. At that point, the product may be harder and more expensive to change.
This does not mean founders must outsource every activity. It means usability decisions should be deliberate, appropriately supported and accompanied by an honest understanding of the risk.
FEELING OVERWHELMED IS NORMAL. START ANYWAY.
The conversation closed with advice for anyone trying to enter the medical-device sector.
Medtech is complex. Founders must navigate clinical needs, engineering, users, regulation, commercialisation and reimbursement, often at the same time. Feeling unsure about where to begin is not a sign that you do not belong in the industry.
Carla's advice was candid: start, fall over, learn and get back up. Just as importantly, remember that specialists across the ecosystem exist to help founders improve outcomes, not to stand in their way.
That spirit was evident throughout the 2026 Innovate Medtech Masterclasses. The people in the room were curious, purposeful and willing to ask difficult questions. For Carla, that calibre of engagement was one of the qualities that made the event and the Perth medtech ecosystem stand out.
HEAR THE FULL CONVERSATION
This article captures only part of Michael and Carla's discussion. In the complete podcast, they explore how usability supports startups at different stages, how founders can approach competing product needs and why being surprised by users is one of the most valuable parts of the process.
Watch the full podcast on YouTube
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