Imagine you’re a small company developing software as a medical device. Your software is done (nice!), and you’ve created some documentation. But now you’re not confident whether that documentation is complete and fulfills all regulatory requirements. That’s understandable because you’ve never created that sort of documentation in your life, ever.

That’s where FBE GmbH stood.

FBE GmbH and BabyCare

Besides doing research-focused work around studies and statistical analysis, FBE GmbH also developed its own app, BabyCare. It’s a preventive care program for pregnant women, and it’s based on more than 20 years of experience and research.

The program is being reimbursed by more than 70 health insurance providers, and, best of all, it has already accompanied more than 250,000 women during their pregnancy! I think that’s really impressive. It shows that a small team can build a great app which delivers value to patients while bringing in enough revenue to sustain a company.

Personally, I liked that philosophy a lot. Instead of collecting millions in VC funding and announcing a grand mission to disrupt a questionable aspect of the Healthcare industry, they just got down to business and shipped an app. Nice.

But that’s not exactly what this case study is about! I actually wanted to talk about regulatory stuff. Still, it gives us context because a sustainable, profitable business like FBE has to be mindful about their expenses and optimize for efficient compliance.

The Situation

Nico from FBE contacted us. He had already taught himself a lot about quality management and compliance, and he had created a first draft of their regulatory documentation. But he wasn’t sure whether that documentation was complete and would pass an audit.

He was looking for someone to check their documentation for completeness with somewhat of a pragmatic approach - in the sense of “here’s what you’re missing for an audit and here’s a simple solution how to fix it”. In essence, a document review. They had worked with another consultant in the past who did an expensive workshop with them in which they explained what a medical device was and how to get there. Unfortunately, that wasn’t a document review, so that didn’t solve their problem.

We don’t like workshops very much. They are one of many tools which consultants use, but their use case is limited to situations in which many people want to work on a complex problem with many possible solutions. And, in any case, Nico only wanted a document review, so why are we talking about workshops in the first place?

Instead, we made a plan. Nico’s goal was to bring their software to market under the old legislation (MDD) before May 2021. And he needed someone to check their documentation before the deadline. So that’s what we did.

Our Procedure

First, we scheduled a 45-minute call in which Nico walked us through their existing Quality Management System (QMS) and Technical Documentation. This was important for us because we needed to get an overview of how he had organized things and what sort of thoughts he had when setting it up.

Next, Nico gave us access to their documentation system and Sven and I took some time to read their documents and cross-check them with the standards, like the ISO 13485. Our goal was to see whether anything was missing, and to give feedback on documents which could be simplified. Also, with our past audit experience, we knew what auditors would likely look at and how to make sure that FBE would not be exposed to any risks.

We set up a project in our project management software, Basecamp, and wrote up our reports there. We invited Nico to the project, and so he could see our progress while we were working on it.

Finally, we scheduled a call with Nico to discuss our results.

Price

As consultants, it sometimes feels a bit wrong to say “Hey, your documentation actually looks pretty good, there’s not much to do”. Just like auditors, we like to find stuff to justify our fee. But then again, isn’t it in the company’s best interest to tell them that they’re doing great, and we shouldn’t be creating unnecessary work? I think so.

How much did it cost, in this case?

We billed by the hour at our startup rate, €150/hr. Sven and I reviewed things in parallel and spent 10 hours, 45 minutes in total - that ends up being €1.612,50 before taxes, less than the workshop with the other consultant!

And that’s a pretty solid deal for an entire quality management system and technical documentation review. With many other startups, we’re even faster because they have less documents. But that’s not necessarily a good thing. FBE had more documents, but their documentation was also more complete. So, it took us longer, but it meant they had less work to do afterwards.

Conclusion

While this project may sound rather unexciting (and that may be a good thing), there are some good takeaways here:

• Manage your consultants. Consultants need to be managed well - probably even more so than employees. You need to be clear on what they should deliver, by when, for which price. Don’t settle for a generic workshop if you actually need a document review.
• Clear expectations and context enable successful projects. What was our goal here? To create the most detailed, over-engineered quality management system on the planet? Or to enable a small, agile company to ship their software as a medical device in a compliant way, minimizing regulatory overhead as far as possible while still ensuring the best level of patient safety. Our goal was the latter. But if this sort of context is not defined, consultants sometimes tend to get lost in regulatory details and create a ton of unnecessary work.

That’s it!

By the way, FBE is looking for investors. So if you’re an investor or know someone who’d be interested to help a solid Healthcare startup grow further, have a look at their website or contact Nico directly.

Also, FBE is one of our pilot customers for our regulatory software, Formwork, which enables companies to create and automate regulatory documentation much faster than using Word and Excel - let us know if you’re interested!