The 3 Biggest Mistakes Startups Make When Getting Their Medical Device Certified

And how you can avoid them and bring your product to market before your competitors.

Working in a startup is hard. Bringing a medical device to market is even harder.

I've worked with over 40 companies by now and, unfortunately, I always see the same problems re-occuring over and over again.

That's frustrating because many of them are easy to avoid and startups could be on the market much earlier, saving enormous amounts of time and money!

So let's talk about them here and see how we can fix them.

Mistake #1

Not Knowing What To Do

It's easy to learn programming online - there are lots of free online courses with great content. Additionally, there are many of helpful communities in which people answer other people's questions and share their knowledge for free!

Unfortunately, this is not the case for regulatory compliance. This leads to many startups not knowing what to do exactly, getting stuck in endless discussions or, even worse, creating the wrong documentation which requires tedious rework.

Doing stuff the wrong way is dangerous: Rework takes much longer, is hugely expensive and exposes you to regulatory risks when you get audited.

Mistake #2

Hiring the Wrong Consultants

Hiring a consultant generally makes sense so that you actually know what to do. But hiring the wrong consultant may destroy your company.

Startups operate in a different environment: You're under enormous pressure to develop your product with limited resources. At the same time, you're juggling a bunch of other tasks: Getting investors, hiring employees, writing code.

This requires a regulatory consultant who is pragmatic and used to working with startups.

Unfortunately, those are rare. Many have lots of corporate experience. But corporate experience doesn't translate well to startups. You don't have time for multi-day workshops on "regulatory training".

Also, you need a clear roadmap and project plan. What happens when you don't have that and your consultant bills by the hour? You lose cost control. I have seen startups spend anywhere between 10.000€ and 150.000€ for the same outcome.

Startups need consultants with a very specific skill set: Pragmatic people who provide a clear project plan while re-using as much existing documentation and testing as possible.

Mistake #3

Using the Wrong Tools

Regulatory compliance needs a specific set of tools - mostly for reviewing and signing documents, but also for writing your product specification.

Now you need to right software tools for that. Ironically, this is less about choosing the right tool and more about not choosing the wrong tool. There's lots of crappy enterprise software out there which you must avoid at all costs.

Most regulatory work can be done in simple tools like Google Docs, SharePoint or Jira/Confluence.

Choosing the wrong set of tools will cost you endless pain once your whole documentation is in there. Better choose the right tools from the start.

Okay. But Why Is Regulatory Compliance So Hard?

Good Question! Maybe Because of These 12 Reasons:

Consultants are incentivised wrongly.

They bill by the hour. This incentivises them heavily to make the project unnecessarily long and complex so that they can earn more money.

There's no clear project plan.

Consultants are wary of creating a project plan because that would imply that there are deadlines until when work has to be done.

There's no sharing of knowledge.

The regulatory community (which consists mostly of consultants) doesn't openly share knowledge and templates (we are probably the first website ever to publish a complete set of free templates). This leads to everyone coming up with their own set of templates which are usually pretty crappy. Also, everyone starts interpreting the regulations on their own terms which is often wrong.

Hardly anyone understands software.

There are lots of consultants out there who've brought various hardware devices to market. But very few consultants actually understand software or have written code themselves. This is bad because you'll lose lots of time when you have to explain GitHub and Continuous Integration to them (spoiler: I don't think they'll understand it).

A startup requires hands-on working.

Lots of consultants are happy to give you high-level advice and do 8-hour, multi-day workshops with you. But they won't help you write the actual documents. That might work in large enterprise companies where productivity is often optional, but not in startups, where real results have to be delivered.

Pragmatic solutions are rare.

Many regulatory requirements can already be met with very simple solutions! There's no need to create documents which span 30 pages - sometimes, one page is enough.

Regulatory software is pretty crappy.

For some reason, enterprise software almost always is crappy. This includes regulatory software. This is unfortunate because regulatory requirements can already be fulfilled by using simple software, like using Google Docs and GitHub.

Standards are not freely available.

All Medical Device manufacturers have to adhere to certain regulatory standards, like the ISO 13485. But those aren't freely available - depending on where you buy them, they can cost up to 500€. Seriously? 500€ for a PDF? This sort of pricing deters people from public sharing those regulations and discussing them openly.

Requirements are very ambiguous.

Assuming you managed to purchase on of the standards for less than 500€, now you're faced with weridly ambiguous requirements like "The manufacturer shall document software requirements". What the hell? Does that mean to create issues in GitHub? Or write a document? The standard doesn't tell you.

There are a million different solutions to the same problems.

Depending on who you ask, they have a great solution to your regulatory problem, like "just document tickets in Jira". The problem is that someone else may recommend something completely different. So what's the right solution now?

Startups have other important problems to solve.

At a startup, you have to work on essential things like getting funding, hiring the right people and developing a product which will be loved by users and generate revenue. Now regulatory compliance is added into the mix. If it consumes too much time and distracts everyone from the essential tasks, it's doomed to fail.

Software developers don't have the time or patience to learn regulatory requirements.

Who would be the perfect person to write your technical regulatory documentation? Your software developer. And who has the least time in your company? Also your software developer. So someone else gets tasked with writing it. Sounds like a bad idea? Yup.

We can do so much better.

Introducing Headstart.

A predictable, fixed-price program
for startups becoming compliant.

I'm super hyped to leave this review for OpenRegulatory. They've been hands down the best choice of supplier/consultants I've made in a very long time. They understand how startups work, and speak their language, which feels extremely rare in the QMS/regulatory world.

We worked with Sven, Sören, and Oliver to set up our quality management system from scratch, and write the full technical documentation of a simple device that we now have clearance for to market in the US. The whole process took between 3 and 4 weeks, excluding a Christmas break. It would have been even quicker if more people from our team worked on it, or if we internally got to spend more of our time on the project. It cost significantly less than 10.000€, which for the level of service - and in general - feels unreasonably low. (I think you should raise prices!)

The templates are amazing, OpenRegulatory already did most of the work they could, and from now on it is really up to your company to implement and finish things. The whole QMS/regulatory infrastructure you need to build feels very complicated though at first, so you will want someone who guides you through the process, reviews and discusses with you everything you write, provides the required context to speed up your work. OpenRegulatory does this basically in real time, you're never held up by them.

Marton Meszaros, MD

COO at Novoic

40+ Successful Companies Have Chosen Us.

What Is Headstart?

OpenRegulatory Headstart is a proven system to get software approved as a Medical Device under MDR (classes I, IIa and IIb) for a fixed price. It's heavily optimized for startups which need to get things done fast.

Features

Pricing

Do It Yourself

7.900 EUR

(+ VAT)

Get access to our videos and software and self-learn how to create your own documentation. Best for startups on a limited budget.

  • Learn how to fill out our free templates by getting unlimited user access to our video screencasts which cover the ISO 13485, IEC 62304, ISO 14971 and IEC 62366

  • Make your compliance work even more efficient by getting access to our compliance software (Formwork) with unlimited user accounts for 12 months and 1 medical device

  • 2 hours of consulting in case you have questions

Guided by Us

59.000 EUR

(+ VAT)

We'll guide you through the process of creating your documentation by helping you with project management and document reviews.

  • Learn how to fill out our free templates by getting unlimited user access to our video screencasts which cover the ISO 13485, IEC 62304, ISO 14971 and IEC 62366

  • Make your compliance work even more efficient by getting access to our compliance software (Formwork) with unlimited user accounts for 12 months and 1 medical device

  • To make your project even more clear and predictable, we set up a project plan with step-by-step todos in our project management software, Basecamp

  • Unlimited weekly status meetings to clarify questions until you're done

  • Send us your document drafts for review and we give you feedback on what's missing.

Currently booked out.
Accepting new customers for April / May 2022.

All Inclusive

89.000 EUR

(+ VAT)

Save lots of time by letting us write the first drafts of your documents for you. Saves you time, but you'll have to understand them later.

  • Learn how to fill out our free templates by getting unlimited user access to our video screencasts which cover the ISO 13485, IEC 62304, ISO 14971 and IEC 62366

  • Make your compliance work even more efficient by getting access to our compliance software (Formwork) with unlimited user accounts for 12 months and 1 medical device

  • To make your project even more clear and predictable, we set up a project plan with step-by-step todos in our project management software, Basecamp

  • Unlimited weekly status meetings to clarify questions until you're done

  • We write the first drafts of your document so that you can save time

  • You only need to review the documents we've created (but will need to understand them going forward)

Currently booked out.
Accepting new customers for April / May 2022.

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