u/eucalyptusno

I was wondering if someone here has previous experience with Innofounder?
I recently got accepted with my startup, and I would love to hear from people who have been through the program, worked with the advisors, or know it well.
What would you recommend doing to start on the right foot?
Are there things you would suggest preparing before the program starts? For example, clarifying the value proposition, talking to more potential customers, mapping assumptions, preparing financials, refining the pitch, or setting specific goals for the first weeks.
I’m also curious about how to make the best use of the advisors.
Where do you think Innofounder advisors can provide the most value? Business model, customer discovery, fundraising, go-to-market, pitching, founder development, network, or something else?
And looking back, is there anything you wish you had done earlier or used more actively during the program?
Any recommendations, lessons learned, or things to avoid would be very appreciated.

Summative usability is not a pass or fail event, it is proof you understood and controlled your device’s real risks.

Summative testing in medical devices often gets treated like an exam. Teams line up for that one big moment, hoping to count up the use errors and see if they “pass.” That thinking often backfires. You are not supposed to end up with a perfect, error-free study. In fact, if every user breezes through without a single hiccup, it usually means you missed something, because real users make real mistakes, even with good design.

The focus should be on what you do with those findings. If someone makes an error, what exactly happened? Was the interface unclear? Did the instructions create confusion? Did users rely on habits from a different device? Each event gives you a chance to look at the root cause and ask whether the risk is already handled, or if you need to rethink the design, instructions, or training. The total number alone means almost nothing.

I have seen cases where just a couple of use errors led to a red flag and others with more errors still moved forward. The difference comes down to how well the team understood the risks, how clearly they addressed them through design and iteration, and how convincingly they could show that the issues left were truly controlled for their actual user group.

Good summative studies are just the wrap-up to a much longer process. You should have identified your critical tasks and high-risk steps up front, tested and learned with real users through formative studies, and used all that feedback as early as possible. By the time you reach summative, you should be confirming a story that is already built, not searching for last-minute fixes.

Regulators do not just want a set of numbers. They want a clear path from identifying risks to making design decisions, supported by actual evidence. Summative usability is not about getting a perfect score, it is about showing that you understand how your device will really be used and that you have put in the work to make that as safe as possible for the intended setting.

Anyone else run into projects that get stuck at the summative stage because they skipped the early work?

Defining critical tasks early sharpens your usability focus and protects against risk control surprises later.

Critical tasks are often misunderstood in device development. Teams sometimes assume complexity makes a task critical, but that is not the real driver. The real question is what happens if a user messes up that action. If a single slip could cause injury, deliver a double dose, or interrupt treatment, that step is critical, even if it looks simple.

Risk management standards like ISO 14971 give structure for identifying hazards, but they do not highlight which user interactions need usability evidence. That is where the concept of critical tasks helps. These tasks become the backbone for your human factors work by telling you which actions to focus on in design and testing.

FDA groups take slightly different stances here. CDRH typically defines a critical task as anything that could cause serious harm. DMEPA which deals more with drug-device combination products, widens the lens to include any harm, delays, or disruptions to therapy, so things that might not seem severe at first glance can still make the list. The EU and other bodies have their own nuances, sometimes casting a wider net than FDA.

In practice, you do not need to be paralyzed by these differences, but you should be clear which expectations apply to your device. The best way to use critical tasks is not as a checklist for regulators but as a tool for your own development.

If you leave this work until the end, you are likely to end up relying on IFU tweaks or last-minute training as your main protection. That is almost always weaker and harder to defend. Teams that define their critical tasks early can build actual design controls and collect evidence before the big summative study.

Not every task is equal, and not every user step needs the same level of scrutiny. Critical tasks let you put focus where it counts. In my experience, making them part of your day-to-day language pays off when it is time to justify your approach to both regulators and users. Anyone else have stories of teams that realized too late which tasks were truly critical?

Does anyone else run into teams that think Human Factors only matters for high-risk or Class II/III devices?

I keep seeing this myth come up, where people assume HF is just a regulatory checkbox for higher-risk products. But I’ve seen plenty of cases where even lower-class devices and drug products get regulatory questions about use-related risks. The class doesn’t really decide whether HF matters. If your product can be misused or misunderstood by real people, regulators may still ask how you addressed it.

In my experience, treating HF like a late-stage compliance exercise puts you behind from the start. The real benefit is avoiding problems in actual use and making something people want to use. Sure, high-risk devices need more depth, but every product benefits from basic usability work. I’m curious if others have faced pushback on this, and how you help teams understand HF is about safe and effective use, not just regulatory class.

How do you handle the tension between creative interface design and the need for consistency in medical devices?

I’ve seen a lot of enthusiasm for “fresh” or “innovative” design choices, pulled from consumer tech, but in medical devices I’ve found inconsistency creates real risk. When you introduce novel symbols or change familiar color codes, even intentionally, users can get confused and it can slow their response to critical situations. For me, the safest approach has always been to really understand what users already know and expect from similar devices before trying anything new. That said, sometimes the established patterns are pretty limited or outdated, so sticking to the status quo forever isn’t ideal either.

Curious how others navigate this. Where do you draw the line between following conventions and trying to improve the user experience with new ideas? Have you ever made a design change that seemed like an upgrade but caused unexpected confusion for users?

This community is for people who care about designing medical technology that real people can use safely and effectively.

We will discuss Human Factors and usability engineering across MedTech, including traditional medical devices, combination products, SaMD, and AI-enabled medical devices.

The goal is simple: share practical knowledge, ask better questions, challenge weak assumptions, and help raise the standard of Human Factors work in medical technology.

Topics may include user research, use-related risk, formative and validation studies, IFUs and training, regulatory expectations, design controls, submission strategy, and the many grey areas where real projects usually struggle.

Whether you are a designer, engineer, researcher, regulatory professional, quality specialist, founder, clinician, or Human Factors practitioner, you are welcome here.

Let’s build a community focused on better devices, better evidence, and safer use.

https://preview.redd.it/vn9vwbxanb0h1.jpg?width=2172&format=pjpg&auto=webp&s=c14f0ebd2d4432dbb5636c96c7ae88bb39fef397