As an entrepreneur I have dedicated most of the last 25 years to doing hardware (read: manufacturing) ventures. Manufacturing in the US is hard, if not impossible, save cases where the ecosystem or nature of the market can support it. Problems one could face include: ip (patents) mine field, government regulations, liability issues, lack of localized supply chains, high labor costs, high insurance costs, high taxes and more.
Then, to boot, if you are lucky enough to have to deal with the government or in an industry where government has decided they know better, well, this can be described with two words: Pain and Frustration.
The mechanisms described in the article kept me from even considering making an effort to do some good in the medical field. It's just too painful.
Finally, about two years ago, I had enough and decided to be done with making stuff and pivot into software-only products. This was not a huge pivot in that most of the products we manufactured during the last 20 years had significant software elements (embedded, FPGA and related workstation applications). The transition just meant making a very conscious effort to not go after hardware ideas. This was hard in that I personally like making physical products. But, no more.
My point in relating this personal story is that I have the scars to understand what this little syringe company must have been through.
The article in question highlights something that we should all understand very well at this point: Government rule-making is, more often than not, fraught with unintended consequences that, ultimately, end-up costing us in terms of money, freedom and choice. And, when it comes to the medical field, might even result in people dying.
Part of the problem is that we continue to give the keys to the shop to bureaucrats who have zero real-world, business or employed-by-a-non-government-business experience. You really can't expect much from anyone who has lived their entire life within the confines of an ecosystem where personal decisions carry almost no risk. That is vastly different from the real world, where, if you are a bad programmer or lousy barista you get fired and, no, you don't get to enjoy 80% of your salary for the rest of your life.
Programmers, for example, know and live this issue of making the wrong decision. In the course of solving a problem we choose an approach and go with it. Sometimes it works and often-times there are unintended consequences that need attention. Other times the approach is entirely wrong and has to be scrapped in favor of a different idea. The solution is evolved rapidly until the right approach surfaces. This ultimately leads to better solutions, particularly if peer reviewed.
The trouble with government decision making is that you have the equivalent of managers who don't know how to code --at all-- telling you what algorithm and database to use to solve a problem. Furthermore, it is equivalent to these non-technical managers making their decision the law for the company. And, yes, regardless of what the overwhelming reality of the matter might indicate, changing their laws is either impossible or you need 2/3 of said morons (non-technical managers) to agree to the change. In other words, you should expect the beatings to continue until the morale improves. Of course, reality in the technology world is closer to the idea that those who actually understand the subject should make the decisions. Wouldn't it be cool if every single politician had to have a real job 3/4 of the year? Work three months for government and then go back to the private sector. Now that could be interesting.