Biggest Mistake MedTech Founders Make… and How to Avoid It

If you’re an early-stage medtech founder and your first instinct is to jump straight into prototyping… you’re already on the same path that kills 90% of medtech startups.

The reality is that founders who win don’t start by building—they start by defining precisely what must be built.

Without this scaffolding, your company will collapse under scope creep, unclear requirements, and investor uncertainty.

I’m Vlad. I’ve spent the last half a decade working across medical device university spinouts, startups, and a Fortune 500 company. And along the way, I’ve noticed the same painful pattern:

Brilliant ideas die because teams did not spend sufficient time building their foundational documentation.

In this article, I will outline two essential documents you must establish before building a prototype, and I will explain how they protect your commercialization path.

My promise to you is that if you make the conscious decision to develop the documentation I outline, your development schedule will be much more robust, your task prioritization will become significantly clearer, and your investors will gain confidence in your vision – because it is grounded in truth, not guesswork.

Who and Where You Are

Right now, you are at the very beginning of the medical device lifecycle, inside the conceptualization phase.

• You are a physician who sees a clear opportunity to fix or optimize a process.

And that’s such a wonderful feeling! You’re at the dawn of a potentially revolutionary technology. Your mind starts to fantasize about :

• The MASSIVE impact you’re going to make
• The thousands of lives you will change
• The recognition and respect you will gain
• The opportunities that will open up

… as you become a thought leader in this wonderfully dynamic industry.

And, to no one’s surprise, all you want to do is start building this technology.
But that mentality is like Medusa: charming and enticing until the final moment – when ruin strikes.

Let me illustrate how this scenario plays out 9 out of 10 times.

Consequence of Building Aimlessly

You will start building – one feature after another, one improvement after the next – following no requirements and no constraints. You are simply relying on the project’s initial trajectory. And on paper, you are making tremendous progress.

Six months later, you snap out of the prototyping trance and decide to share your progress with the stakeholders, to get their feedback on your promising work. And, well, this is where Medusa strikes. Take a moment to analyze the burndown chart below. For those unfamiliar, a burndown chart is a graphical representation of the percentage of completed work over time.

As you overlay your work against your stakeholders’ expectations, you will notice a stark misalignment.

And this will become increasingly vivid as the stakeholders share their thoughts:

“This isn’t what we envisioned…”

“Why are there so many features?”

“This won’t fit in the laboratory we are currently working in…”

“The device does not automate the intended workflow…”

So, following this gutting conversation, you realize that 

And as if matters couldn’t get any worse,

• You need to break the news to your investors, and :
  • Justify the reason for missing their expected schedule
  • Request a schedule extension
  • Plea for additional funding to bring your project to fruition

A Successful Founder’s Approach

Compare that to the version of you who spent the first 2 months defining the project’s trajectory – alongside your stakeholders. All while developing the device in parallel and sprinkling critical design reviews along the way.

After six months, the final stakeholder review occurs, and what you can see is alignment – not perfect, but certainly more promising than the previous founder. Moreover, the slight delay is justifiable: there may have been sudden changes in the process that needed to be accounted for during development, or a high-risk item was identified, and the team and stakeholders reached consensus to mitigate it to improve the technology’s safety and efficacy. 

Now, the tone of the conversation is understanding, not judgmental; supportive, not damning; hopeful, not discouraging.

Stakeholders will back your decisions.

“It was a good idea incorporating that feature, maybe it’ll help us capture more of the market”

They will offer solutions to keep your project afloat.

“How can we help you make sure you can hit this next milestone? Do you need more engineers, consultants?”

Most importantly, their confidence and trust in you will increase as they begin to inquire about the future.

“ What does the next stage of development look like?”

“ Any ideas for a next gen device?”

So, which founder are you more interested in becoming? The one who strikes doubt in the hearts of your patients, coworkers, and investors? Or, the one who induces confidence, hope, and anticipation? Insert Figure 5

Critical Document #1

What exactly was the difference between the two founders? 

Luckily, this distinction can be outlined in two critical documents.

Firstly: the User Requirements Specification (URS). This document captures your end users and customers. It outlines their pain. It broadly defines the end user’s expectations for the technology’s functionality, performance, features, and dimensions.

An example user requirement looks something like this.

“The scientist must be able to automatically transfer a solution from a bag to a culture vessel.”

“The scientist must be able to efficienctly and accurately transfer the solution from a bag to a culture vessel.”

At this stage, the document structure should be simple, leveraging three categories:

1. Unique identifier for each requirement
2. Description of each requirement
3. Method for categorizing each requirement’s criticality

In other words, you must be able to distinguish among the requirements; the importance of this will become more apparent in future discussions. You must include a description of the need; the rationale for this is evident. And, very importantly, you must identify whether each need is a “must have” or a “nice to have”? Since you are in the early concept phases of your medical technology, understanding what needs are a “must-have” and which ones are a “nice to have” is absolutely critical. It’ll save you months of development, significant capital, and help you stay focused on the aspects of your design that provide the most value to your stakeholders.

To get you started, I compiled a few questions that should ease the uncertainty of brainstorming your user needs:

• Who does the device touch?
  • Every person who comes into contact with your technology will have their own level of understanding, expectations, desires, and drawbacks. You should get to the bottom of those, understand, and document every nuance.
• Who consumes the information the device generates?
  • If your device outputs data, this question will help you clarify the formatting and sharing of that information. A doctor may be okay with technical information being displayed, but a parent may only need very simple instructions for how to deliver the medication to their child.
• Who pays for it?
  • Is it a lab manager, a hospital manager? What information and features will they need to integrate this technology into their system? 
• Who handles the device when it’s reached its end-of-life?
  • How does the device get thrown away? Will it be recyclable?
  • Will it have components that should go into a sharps container?
  • Does the device have batteries? If so, how should those be disposed of

So, I urge you to start developing this document as early as you can. I urge you to spend the necessary time outlining every detail, truly understanding your users and customers, their pain, and their expectations. It’ll guide your every decision from this moment on.

Critical Document #2

Now, I have good news and bad news. The good news is that you now have a comprehensive list of needs. The bad news is that they are useless for the actual development of the technology until translated into the following document – the Product Requirements Document (PRD). This is where the real engineering work begins.

So where do you start?

To begin populating the PRD, you will convert each of the requirements in your URS into engineering specifications. These engineering specifications will, from this point on, be known as your design inputs. The term “design inputs” will be a recurring theme throughout your career in med device, as they will drive the majority of your downstream verification, validation, FDA Clearance, and commercialization path. However, at this stage,  all you need to know is the following

• User needs are translated into engineering specifications > engineering specifications are known as your design inputs > your design inputs are stored in your PRD.

What does this conversion actually look like in practice? 

Take the above example,

“The scientist must be able to efficienctly and accurately transfer the solution from a bag to a culture vessel.”

A direct translation of this into a PRD format will look something like this :

“The device SHALL dispense a solution at a maximum rate of 2000ml/minute +/- 10ml”.

As you can see, the high-level efficiency need is paired with a design input of “2000ml/min” and the accuracy requirement is linked to a “+/- 10 ml” tolerance.

Efficiency and Intentionality

It’s important to note that med device development is not entirely sequential. In other words, if you want to be efficient, you can not afford to wait three months to complete your user requirements, then start your product requirement document.

A more realistic approach is to start outlining your user needs and concurrently outline the design inputs for those needs. Also, in parallel, you will want to start developing your prototype to meet your outlined criteria and make adjustments as needed.

So, we’ve explained the major contributor to medtech startup failure, the build-first mentality, and identified two critical documents that will save your startup from ruin. Those are the User Requirement Specification and the Product Requirement Document. Remember, start documenting early, be detailed, and be patient. Your effort and thoroughness will pay off later on.