Validate, Validate, Validate

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 · 
27th May 2024
 · 
5 min read

Validate even before you have anything to validate.

Photo by David Travis on Unsplash

I've been listening to the audio book of Noah Kagan's Million Dollar Weekend while flying last week.

I'm not usually one for audio books. I stopped listening to them about the time I stopped driving to work. I'm usually not one for non-fiction books either. I find most of them a struggle.

I'm especially not one for "how to get rich" books.

While the principals are often sound, these kinds of books usually stink of he-with-the-most-money-wins, which turns me off. Maybe it's a cultural or personality thing.

I listened to this particular book because it was recommended on the very same Ali Abdaal video I linked last week. I've also seen the book pop up quite a bit as I use TidyCal for calander bookings, Sendfox for newsletters, and planning to give BreezeDoc a go for document signing (NDAs particularly). All are AppSumo-owned platforms, and of course Kagan owns AppSumo.

And it was right there on Spotify for the listening. So I thought, fine, I'll give it a listen.

One key theme from the book is validate, validate, validate.

In the book, Kagan talks about how to come up with business ideas (identify problems and determine demand for solutions) and then test your solution with potential customers. Even before you have something to sell them.

He goes so far as to say that getting customers to prepay for your solution is the only way to truly validate that your business idea has legs. Customers will say they would buy your product or service, but putting money down is the real test.

This is the foundation of the Million Dollar Weekend. Create your business idea, and get someone to prepay for your product or service, before you've even built anything. Do it in one weekend.

This isn't going to be an article on how to start a business. There is, however, some real crossover between building a startup from a business perspective and building a startup from a medical device perspective (any physical product actually).

Validate (x3)

I spend a lot of time engaged with medtech startup founders. It's always fascinating to hear about the inception of their ideas, and sometimes watch how those ideas evolve in time.

But the failure rate is huge. Failure maybe isn't even the right word. Perhaps misfire.

Even if we ignore the difficulty and expense of developing a product, if the foundational idea is misdirected, the business is doomed from the beginning.

Validate The Idea

It's so easy to become a victim of 'tunnel vision'. I'll admit it happens to me often too. We get so focused on could we develop the idea, we lose sight of should we develop the idea.

This is where the overlap with Kagan's Million Dollar Weekend is strongest. Before you invest any time and money into the device, you need to make sure people will buy it.

The best way to do this is to start by talking to the people who matter most; the users and, if not the same person, the buyers. Validate your idea against your potential user base. Even before you put pen to paper, or spend a cent on design or prototyping. Insinuating yourself into the groups of people with the problem your trying to solve will help you ensure your solution is most meaningful to them.

Better still, building relationships with these user groups will help you build a network of champions you can call on for testing. If you're genuinely solving their problems, they'll want to help you to solve it. More on that later.

Even if users want it, you also need to be sure that whoever holds the purse strings will also pay for it. In medical devices especially, this can be an opaque and bureaucratic process of procurement. It's hard to do, but think about it from their perspective. Does it save or make them money? Money can look like all kinds of things; time, waste, lost opportunity, and of course actual money.

If you can't sell your device, you don't have a business.

Before you've spent a dollar is the best time to validate any idea. It costs you nothing to pivot if you identify a different need, or a better solution.

Oh, and one other thing. Don't be afraid they're going to steal your idea. They're not.

Validate The Concept

So you have an idea that people love. And you've created a design.

Validate it ASAP.

The very earliest prototype you can begin validating is your proof of concept (POC). I've already written at length about creating and testing a POC (Pt 1, Pt 2), so I won't go over it again here. What I will reiterate is how critical it is to continue to develop and test throughout the entire design process.

A successful design process includes validating your design at every iteration, and folding that into the next. It is continuous.

Regardless of the state of your prototype, you can always get valuable feedback by getting it in user's hands. Block models are good for testing form and ergonomics. Dummy user interfaces (UIs) set up on breadboards, good for testing workflow. It doesn't have to 'work like' and 'look like'. It can be one or the other, or even parts of either.

Even if they hate it, that means you need to go back a step and re-evaluate the need you're addressing and how you're addressing it.

Don't sleep on this. The sooner you find issues with your business model or device design, the quicker and cheaper you can fix them.

Validate The Device

"Validation" as we know it in medical device design and development parlance should really just be tying the bow on all the validation you've already done.

Don't wait for "validation" to do validation.

By the time you're ready to do formal validation, there should be very few questions you don't know the answer to. Both from the business side, and the device side. The objective here is just to put a fence around the work you've done and say "this is ready for market".

That's not to say there won't be changes. There's almost always something.

As your pool of 'testers' grows, and the spectrum of tests increases, so too does the chance of some rare occurrence happening. If you have a failure mode or a user error that happens 1 time in every 1000. You might need a 1000 people and hundreds of devices to find it.

But it's still cheaper than a recall.

ⓒ Lincoln Black 2024

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