Here's what happens when I introduce myself to people at Healthcare conferences:
"Hello, my name is Oliver, I run a medical device consulting company"
At this point, I already see their attention drift off, their thoughts akin to something like "ugh, another one of those consultants who wants to sell me their services". But I persist:
"... and the company is called OpenRegulatory and we've published all our MDR templates for free."
Now, at this point, I've literally seen people choke on their coffee and blurt out "You have WHAT?", because it seems so unexpected.
"Hello, my name is Oliver, I run a medical device consulting company"
At this point, I already see their attention drift off, their thoughts akin to something like "ugh, another one of those consultants who wants to sell me their services". But I persist:
"... and the company is called OpenRegulatory and we've published all our MDR templates for free."
Now, at this point, I've literally seen people choke on their coffee and blurt out "You have WHAT?", because it seems so unexpected.
You Have WHAT?
So why did we publish our templates for free?
When I entered the regulatory consulting industry in the stone age (2020), I thought the industry was incredibly, incredibly shady. Like, next-level shady. People within the industry often disagree with me, either because they're too deep within the rabbit hole, or because their financial interest is somehow tied up in it, or both. But, here goes:
When I entered the regulatory consulting industry in the stone age (2020), I thought the industry was incredibly, incredibly shady. Like, next-level shady. People within the industry often disagree with me, either because they're too deep within the rabbit hole, or because their financial interest is somehow tied up in it, or both. But, here goes:
- Notified Bodies, the companies which audit you, also offer paid trainings. They say this is completely separate from their auditing activities, but.. I mean, come on, what would common sense reasoning tell you?
- Consultants would very commonly show us documents from their other customers "as examples". To this day, I've hardly met a consultant who doesn't do this.
Many of these things continue to exist, but the thing with the templates irked me the most. Like, wait, I'll pay x,xxx € just to receive a few Word documents which I then have to fill out myself? That just didn't feel right.
I think, sometimes, it's important to ask ourselves what's not necessarily the best for us personally in a short time frame, but what could be the best for everyone in a longer time frame.
Selling templates would be the best for me, personally, in a short time frame, because I could make some solid money. But it wouldn't be the best for everyone, because templates would continue to not be available publicly.
Thinking about this another way: I think, for many things, there's some sort of "global optimum" price. Like, assuming perfect infrastructure and perfect incentives, what would the price of information be? In my opinion, it would be free. We already see this happening: Sci-Hub did amazing things to research, because, who would've thought, selling PDFs of scientific publications is actually a terrible business model.
The notion that every manufacturer has to come up with their own documentation structure is already borderline absurd. Let's take a step back for a moment and remember how we file our taxes in developed countries. You go to the tax authority website, download a form, fill it out, submit it and you're done.
Imagine how this process would work if the tax authorities wouldn't provide you with the forms. Instead, they would just make vague statements like "the tax payer SHALL declare their taxes by doing X", and every tax payer would have to interpret in his or her own way and draft up their own forms. Then, as a next step, you'd designate a bunch of auditors, call them "Notified Bodies", and their only job would be to review each form which has been drafted by an individual company. And, as a side effect, you'd create an entire side industry of "tax consultants" whose only job would be interpreting the tax regulations and drafting up forms for tax payers (wait, we actually have something like that already.. ugh. but they don't draft forms).
I think, sometimes, it's important to ask ourselves what's not necessarily the best for us personally in a short time frame, but what could be the best for everyone in a longer time frame.
Selling templates would be the best for me, personally, in a short time frame, because I could make some solid money. But it wouldn't be the best for everyone, because templates would continue to not be available publicly.
Thinking about this another way: I think, for many things, there's some sort of "global optimum" price. Like, assuming perfect infrastructure and perfect incentives, what would the price of information be? In my opinion, it would be free. We already see this happening: Sci-Hub did amazing things to research, because, who would've thought, selling PDFs of scientific publications is actually a terrible business model.
The notion that every manufacturer has to come up with their own documentation structure is already borderline absurd. Let's take a step back for a moment and remember how we file our taxes in developed countries. You go to the tax authority website, download a form, fill it out, submit it and you're done.
Imagine how this process would work if the tax authorities wouldn't provide you with the forms. Instead, they would just make vague statements like "the tax payer SHALL declare their taxes by doing X", and every tax payer would have to interpret in his or her own way and draft up their own forms. Then, as a next step, you'd designate a bunch of auditors, call them "Notified Bodies", and their only job would be to review each form which has been drafted by an individual company. And, as a side effect, you'd create an entire side industry of "tax consultants" whose only job would be interpreting the tax regulations and drafting up forms for tax payers (wait, we actually have something like that already.. ugh. but they don't draft forms).
