In the beginning of 2020, I left my job at Vara, where I worked as a Software Engineer, Soccer Mom and Regulatory Affairs Person. I didn’t really know what to do next. While I enjoyed the Coding and Soccer Mom Duties, one thing was for sure: No more regulatory work, ever.
Fast-forward one year. I spent the year doing regulatory work. What the hell?
I worked as a regulatory consultant at Ada, MindPeak, imvaria and countless of other, lesser-known startups.
But.. why? And what the hell is regulatory consulting?
If you develop medical software, lots of regulations suddenly apply to you. Historically, they were created to prevent you from killing patients with your software. A sensible goal. Unfortunately, those regulatory requirements are written in a very generic, unhelpful way. It’s not really their fault, either: They simply have to handle all sorts of edge cases. Like, the same rule may have to cover breast implants and machine learning software.
That’s where regulatory consultants come in. And that’s where I came in when I joined my first few clients in February 2020.
I was very transparent about my knowledge. Like, Hey, listen, I appreciate that you want to hire me, but I accomplished this goal exactly once (at Vara) and I have no clue how much knowledge I’m lacking.
Surprisingly, all of them continued to hire me. And even more surprisingly, I saw the work which other consultants had done before me and noticed.. it was bad. Wait, does that mean I was better? That doesn’t sound right.
I certainly didn’t know the regulations very well. So I couldn’t be better.
But then I learnt: Knowing regulations very well doesn’t mean you’ll be a great regulatory consultant. Just like knowing medical textbooks well won’t make you a great doctor, and perfect programming skills won’t make you a great developer. Developing software is not about writing code, it’s about solving problems.
Certainly, those hard skills don’t hurt, but unless they’re coupled with sufficient soft skills, they’re useless. Also, the hard-skill-soft-skill classification doesn’t work very well here, as essentially, we’re talking about multiple hard skills.
For regulatory consulting, those are:
- Project management: How the hell can we accomplish a huge task which needs input from almost everyone in the company?
- Pragmatism: We’re only a three-person startup. How can we become compliant with minimal effort?
- Concreteness: Don’t give us a talk about how things work. Show us how to fill out those documents!
If you don’t have project management skills, you’ll never get done. The idea of the magical consultant who comes in, sits in a corner, creates a pile of documents and leaves again (after charging a huge sum of money) is just that, magical. It doesn’t work. Compliance is an all-team effort.
If you don’t have pragmatism, you’ll get caught up in regulatory overengineering. Like working on a document for more than a day. Does that mean you should be sloppy? No – meticulous work is important. But look, you might have to fill out 80 documents, and if you spend two days on one, you can do the maths and see when you’ll be done with the remaining 79. You can always go back and improve stuff when you’re done. But if you’re never done, you’ll never go to market and your company will run out of money.
And finally, if you don’t have concreteness, you end up being something like an in-house lecturer. Always happy to give workshops and answer theoretical questions, but when it comes to actually doing stuff, like filling out documents, then things get tricky.
Many consultants are lacking in those areas.
Please note: I’m not ranting or bashing consultants here! I think that this combination of skills is very rare, regardless of industry. And startups are a part of the problem – because, if those skills are so important, why are they not selecting consultants with exactly those skills?
That’s the thing. Startups who hire consultants don’t really know what they need. It’s a misunderstanding of the job to be done: Startups don’t need someone with perfect regulatory knowledge. They need someone to make them compliant. Sounds like the same, but it is not.
Making a company compliant includes all of the above and more. It’s a huge problem, and nobody has solved it well. In the meantime, Healthcare startups are struggling.
I think it can be solved well. That’s why I choose regulatory consulting.
So – how can we solve regulatory compliance for startups? The problem is complex, but we can roughly decompose it into two sub-problems:
From the startups perspective:
- What the hell do we need to do?
- How the hell do we do it?
Before I dive into how we currently “solve” these problems, it’s worth mentioning that Germany has recently launched a program for apps to become reimbursable by public insurances. Of course, it’s highly regulated. But in this case, there’s a comprehensive, modern website which even includes a 128-page pdf guide in easily-understandable language with lots of examples. Awesome! Things are moving in the right direction for sure.
But, before we get too optimistic, let’s turn our attention back to medical device compliance. There’s no shiny website and no readable pdf. So how do we solve the two problems above?
The state-of-the-art answer of regulatory consultants is billable hours: Let’s do a 8-hour workshop and we’ll explain it to you. Unfortunately, that often only answers question 1), what needs to be done. It still remains unclear how to actually do it.
That’s where templates come in. Templates are a custom set of pre-written documents which consultants “sell” to their clients by implicitly sharing them only when a longer-term contract (billable hours) is signed. That answers question 2), how to achieve regulatory compliance. By filling out the templates.
Now, I’m trying not to sound negative here, I’m simply stating the facts. I think workshops are a viable way of sharing this sort of highly-customized, it-depends-on-your-company knowledge. And sharing templates only with your clients makes sense, because you always need to heavily customize them. Because every company is a unique snowflake. Right?
Right?
Or maybe not. Maybe every company isn’t a unique snowflake.
Maybe there is a common denominator of regulatory things which apply to every company. Maybe there is a common set of knowledge, and a common set of minimalistic templates which can be re-used.
And if something can be re-used – shouldn’t it be shared?
Consultants like to think that openly sharing knowledge and templates is a zero-sum game: The more you share, the more people can do by themselves, the less billable hours you have.
That may be true. Maybe not. In any case, I think it’s a huge misalignment of incentives. Why are we here in the first place? To bill hours? Or to bring medical innovation to patients? What if we have the choice between bringing one device to market while getting paid, or bringing ten devices to market, for free?
I’d choose the ten devices, any time, as long as I have enough money to pay my bills. And right now I do.
I think that sharing knowledge (and technology) for free is not a zero-sum game. If I publish my knowledge, will that cost me money every time someone reads it? Of course not. Will it reduce my billable hours? Maybe. But then again, I’m tired of regulatory consulting because a large chunk of it is repetitive and mind-numbing.
So, today, I’m launching OpenRegulatory. It’s a place where I’ve started brain-dumping all my consultant knowledge and templates, for free. And it’s my new company.
It’s not complete, but it’s a start. The templates are mostly done, and there’s a step-by-step guide on how to certify software as a medical device.
If you want to talk to other Healthcare startup people, there’s a friendly Slack Community full of people willing to share their experiences.
If you need even more concreteness, there are videos in which you can watch me create documentation from scratch.
And finally, most obviously, being a software developer at heart, there’s a software which automates many of the most tedious tasks.
If we want medical device innovation to scale, sharing knowledge openly is the only way forward. Let’s see if we’re up to the challenge.
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