The Triple-PhD Problem
Disclaimer: Despite all the talk about PhD's, I'm a lowly BSc. Computer Science.
In 2021 I gave a lightning talk about why building software medical devices for consumers is really hard. It's been in the back of my mind for a long time, gnawing at me, because I had the feeling I didn't get it completely right.
In the talk I mentioned that bringing an innovate Medical Device into the market is a Triple-PhD problem. A couple months before, I was inspired by the Tech Crunch article "The dual PhD problem of today's startups". A super quick summary: to find really innovative solutions, you sometimes need breakthrough research from two different areas and combine them. I figured that in regulated industries, the Quality & Regulatory strategies were fundamentally a necessary "make or break" requirement, and a very rare skill. To build a great software medical device company you need people with incredible expertise on three aspects:
- The innovatie technology behind the solution (e.g. machine learning)
- Innovating within the medical field of application (e.g. eye care, you need to know what the start of the art is and what the shortcomings are, and what kind of solutions could work)
- The quality and regulatory strategy. You need to get it approved on time and within budget, do you go US first, then EU? Do you do things right from the start or patch it later? Do you start as a wellness product and then update your claims and go for a clinical study?
Of all of these, there might only be a couple of people in the world that could fit the bill for your medical field. So that's why I called it a Triple PhD problem. It sounded nice, and I still agree with the point I was trying to make, but I realized that the list isn't complete. You also need similarly rare expertise on:
- Product management / a viable business model: who pays for your product, how do you sell it and how do you make your customers happy? Are users convinced by a great UX, a high ROI, a solution to an unsolved medical need?
- Running a company in a phase of continuous change: hiring, day-to-day management, goal setting, accounting, etc
- Financing: in a rapidly changing investment climate it is difficult to manage your capital, investments and debts as a startup, and still stay in control despite the VC investments.
And you need to do this with handful of people, because you want to start a startup with 1 to 3 founders and can not afford anyone else. So these 1-3 people need to master a lot of skills. Not 3, as I said before, but 6! So do we now call it a 6-PhD problem, vs. a 5-PhD problem for non-regulated industries?Well I think I was wrong in calling it a PhD problem. A PhD is spending about 4 years of such detailed study on a hyper-specialized field that no else in the world has touched yet. Do you really need a PhD in financing to do the finance of a startup? The answer is of course no, unless your company needs a completely unique financial approach, which I do not recommend.
Then it clicked. Companies have a choice in where they want to be unique, and for that, they need the PhDs. For the other aspects you just need professionals whose skills are common and can be relatively easily exchanged. Some companies want a unique business model (Amazon selling online in the 90's). Others want a weird way of running the company (e.g. Gitlab when it started fully remote). Of course most innovative companies differentiate with their product, and be quite conservative with the rest.
By the time I was struggling with our regulatory approach, the knowledge on how to successfully navigate the medical device MDD to MDR transition in Europe was very rare. So maybe for a short time, we were unique and this was indeed a Triple PhD problem. But not anymore. By now plenty of companies have done it, and differentiating on your regulatory approach is not something most companies should choose to do.
So to re-iterate: companies can choose where they want to be unique.
With Comper.io we will be unique with the product and the business model, and that's about it. The rest will be boring.
The Good
I set up the corporate holding and LLC for exerta.io over the last month, so that's taken care of.
There were also a lot of blog posts about visual programming systems and the pro's and cons about them. I've linked to the HN discussions.
The Bad
It's vacation time so I will have both less and if lucky, a bit more time to work. The first goal is to get exerta.io up and running.
The Ugly
No progress (at least with the tech part of the product). Too busy with contracting work, friends and preparing for my family vacation.