Scarlet is an interesting notified body. It's the only notified body you might call a "startup", in the sense that 1) it's been founded recently, 2) it's actually trying to use fancy new technology (vs. using Excel spreadsheets) and 3) the average age of its employees is lower than a hundred years old. Just kidding for the last one. The others might be true. Chuckle.
Still, that makes it quite interesting. The knee-jerk reaction I had to Scarlet was that we, as OpenRegulatory, should instantly send all our current and future customers there. Because.. what a breath of fresh air! After 5+ years in this industry, I sometimes feel like I have some sort of PTSD from sitting in all those borderline useless audits, with auditors who last wrote code 50+ years ago, when programming mainframes in caves. So it would be really, really cool if some startup came along, went through the (probably very painful) process of becoming a notified body, and would actually service all those startups which want to bring cool medical devices to market.
That was my hope for Scarlet.
The reality is a bit more nuanced, and that's why I can't completely recommend Scarlet, at least for now. This mainly boils down to pricing.
Scarlet Pricing
Scarlet's pricing model is subscription-based and, last I checked, it starts at 5k€ / month. Personally, I don't like this (read on), but, objectively, it's complicated.
First off: 5k€ / month is actually very expensive for startups. Why? Because startups typically budget in a way in which they allocate a budget of X€ for their initial certification, after which.. the future is unclear, as they'll probably go and look for more investment after they've achieved that.
So startups typically plan in this way:
- Initial certification takes ~2 years (including creating documents, developing product, etc.).
- Typical cost of typical EU MDR notified bodies might be 50-80k€.
Okay, so you've got 2 years, and 50-80k€ for a typical notified body.
How does Scarlet compare?
If you take their subscription model of a minimum of 5k€ / month, you end up with a whopping 120k€ for those two years, which makes it ~2-3x more expensive than most other notified bodies out there.
But, look.. as always, it's even more nuanced than that. I regularly talk to one of the founders (Hi, Jamie!), and the points he makes are these:
- Startups usually don't pay for 2 years to get their initial certification - Scarlet tends to be "fast" (no hard numbers, but I'd guess 1-3 months), so you only pay for 1-3 months for your initial certification; but then, of course, the subscription continues. Still, the first certification is "cheap", and, in theory, you could abuse this system and move to another notified body immediately after your first certification at Scarlet (not recommended - moving NBs is a huge pain, by the way).
- The subscription fee includes unlimited updates and any sort of other work from Scarlet. So, you can literally submit an unlimited number of product (e.g. software) updates to Scarlet, and you don't pay extra. Contrast this with other notified bodies who charge you by the hour for this.
So yeah, those are valid points.
Still, personally, I do wonder why Scarlet doesn't offer some sort of hybrid pricing model, something like:
- 50k€ for the initial certification (fixed price)
- And then, once you start handing in the second version of your medical device for certification, "start" the subscription (at, say, 5k€ / month).
That would be an awesome pricing model, because you get 1) a fixed price for the initial certification (useful and easy to budget for startups, easier to compare, just undercut the expensive German competition, etc.) and 2) it aligns well with startups getting additional funding for their "v2" of their device which usually comes with a more relaxed budget which would allow spending on a "notified body subscription".
That would be cool. But not sure if they'll ship this. In the meantime, you're left with the "normal" subscription model.
Again, pros and cons. Your opinion might differ, and the value you get out of this subscription might be vastly bigger if your company ships a ton of product updates. But, in my experience with 100+ startups, most startups just tend to ship one version (at least for a long time). Anyway.
Scarlet Submission & Data Model
In the past, Scarlet had a custom submission "software". Roughly speaking, the procedure was that you manage your data (technical documentation etc.) within this Scarlet software, which would streamline the entire submission process, because the data model was rather, um, restrictive, so it was (probably) really easy for Scarlet to check the completeness of your submission.
I talked to a few startups who were considering this, and I thought it looked pretty terrible.
The good news is that Scarlet has since moved away from this! So, nowadays, you can submit in whatever file format you want, and Scarlet will sort it out on their end. This is a really cool change!
Final Thoughts
Sometimes I feel like Scarlet is the notified body of the future, but it's forcing the future on us while we're not ready yet.. chuckle. Like, I do think that medical device updates will become more frequent in the future, and the use of software / AI magic to audit and process these updates will become more commonplace. Also, a subscription model naturally aligns well with that. Scarlet is doing all of that.
But the problem is that human perception changes rather slowly: Right now, people still expect a mostly-fixed-price-offer from their notified body. This makes Scarlet a hard sell, because psychologically it hurts to see that your company is paying x,xxx€ / month while (potentially) not making any use of it (no product updates).
Sometimes, I wonder: If Scarlet would simply had set out to build not "the notified body of the future" but instead "the notified body of the present which doesn't suck", that would have been an awesome proposition. With things like:
- Lower initial certification costs (say, 30k€ instead of 50k€).
- More competent technical staff which actually have technical experience.
- Fast turnaround times.
That would have been awesome. But somehow, I feel, Scarlet is 1) a little too far in "the future" and 2) the pricing model just doesn't work particularly well for now.
Anyway, those are my thoughts, but do share your experiences in your notified body review form below!
