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Updated September 16, 2021

Exakt Health: MDD Class I Compliant in 3 Months

Dr. Oliver Eidel

If you’re a Healthcare startup developing software as a medical device, you’re probably wondering: How long does it take to do all this regulatory stuff and become compliant?

If you’re Exakt Health, the answer is: 13 hours and 15 minutes.

Well, not quite - those were the hours we billed as their consultants. Still, compare that with what other consultants bill: I’ve routinely seen offers in excess of 100.000€! At our startup rate of 150€ per hour, that’s equivalent to 666 hours (surely that number is not a coincidence). What do you do in all that time?

Don’t ask me, I don’t know. What I do know is this: Exakt Health got it done in less than three months. Of course the actual effort was more than 13 hours as they did most of the work themselves. But still: It’s a real-world example of a small, agile tech startup becoming compliant - and shipping their product to customers on schedule.

Exakt Health

First off, let’s talk about Exakt Health. Exakt Health’s product is a free physiotherapy app that provides customised treatment plans for sports injuries. They are a Berlin-based Healthcare startup, founded by former N26 employees Philip Billaudelle and Lucia Payo in January 2021. They’re still a rather small team of six people with 500k$ of pre-seed funding.

Now, I’d like to say that the kick-off event of our consulting project was hugely spectacular, with a two-day regulatory workshop and fancy finger-food buffet, but (unfortunately?) that wasn’t the case.

It was rather down-to-business: We worked with Philip, the CEO of Exakt Health. We scheduled a weekly catch-up call. I invited him to our Basecamp (our project management tool) and video platform. Philip invited us to their Notion workspace - their internal documentation tool of choice. That was it.

How Did We Work Together?

We think that compliance work has to be done from within a company - in contrast to your tax return, you can’t outsource compliance work. That being said, setting up a Quality Management System (QMS) and Technical Documentation is not some magical, unique activity which needs to be re-done for each company. We’ve taken the common parts and prepared them in the most efficient way possible.

That includes using our video course instead of endless, hard-to-schedule calls. And providing solid project management with a complete todo list of all required activities and documents.

Concretely:

  1. Philip got access to our video platform to self-train himself on regulatory compliance and technical documentation.
  2. We set up a Basecamp project with a todo list of all things we need to do - this enabled everyone to keep an overview over the project’s progress.
  3. Philip created documents based on our free templates and sent them to us to review.
  4. Philip pinged us on Basecamp when he had questions.
  5. We scheduled a weekly call in which we discussed the trickier questions which were not easy to resolve via text communication.

That’s it? If you were expecting yet another funny or surprising article, sorry to disappoint. I suppose the hallmark of well-executed projects is that there aren’t crazy stories to tell.

Takeaways

If you’re a Healthcare startup and want an efficient, pragmatic approach to becoming compliant, our model works well. But there’s a caveat: You must be willing to put in the work. You’ll have to write the documentation yourself, and (possibly) read the standards. Then again, that’ll always be the case, regardless of your consultants, we’re just transparent about it.

Besides that, there are some important lessons to be learned.

Lessons Learned

  1. Do it yourself. Philip had the clear expectation that he’d be doing the work. There’s no way around that. We tell that to all of our clients. Good consultants will help you to get stuff done faster by answering questions and sharing their experiences, but in the end, it’s your company, with your QMS and technical documentation.
  2. Dedication of time and structured thinking. We had weekly calls with Philip, and we’d go over all documents he created in the past week. Then, we’d discuss what he’d be doing next. He dedicated significant chunks of his time to compliance work. He didn’t “just do it on the side”, because that never works.
  3. Manage your consultants. At his prior jobs, Philip had gained a fair share of experiences working with consultants. While consultants are often happy to help you, they are also often happy to bill lots of hours. Philip knew exactly what he needed from us: A project plan, document reviews, and answers to tricky questions - like how to set up a QMS in Notion.
  4. Regulatory Experience. Prior to founding Exakt Health, Philip worked at N26 where he learned about compliance work in the financial sector and was one of the driving forces behind acquiring their banking license. While financial compliance is quite different from Medical Device compliance, the concepts of a QMS and requirements management weren’t entirely foreign to him.

Done!

That’s it! Everything was done in less than 3 months with 13 hours and 15 minutes of consulting hours.

If you’re looking to join a well-run Healthcare startup with an exciting product, check out Exakt Health! I’m sure they’ll be hiring again in the mid-term future.

And if you like how this project was organized and could imagine implementing something similar at your company, have a look at our consulting page.

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I work as a regulatory consultant for Healthcare software startups. I try to publish all my knowledge here so that startups can certify their medical devices themselves in the future.

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