the reason medical devices are so expensive is a lot more complicated than what this article suggests.
1) upfront costs. you have to complete the development of the product before you can conduct clinical trials. this is a huge risk: if you say the device is ready, but the fda or eu says it's not, then all that work is gone or has to be redone and you have to foot the bill.
2) clinical trials and animal testing are insanely expensive. I'm talking 50k+ for 1 dog to test your device on. don't even get me started on human centric trials.
3) risk of litigation. look at the current mess with vaginal meshes: boston scientific, medtronic, and others are paying out huge sums of money over faulty tech that was approved by the fda.
4) regulatory overhead. navigation of the fda and ce mark beaurocracies is complicated enough that it is an entire industry in itself. we have a full team working on our project full time just to make sure we stay within the law, to meet with the fda and eu, and to do all our governmental paperwork.
5) ip law. medical companies sue eachother for patent infringement all. the. time. if you aren't checking to make sure you aren't violating patents, you are exposing yourself to huge amounts of risk. hundreds of millions of dollars of risk.
sigh.
plus all the overhead to navigate each hospital's unique purchasing process, dealing with different regulatory requirements in different countries, different radio spectrum requirements (if your tech uses any type of emitors) in different countries, traceability requirements in manufacturing, certified manufacturing sites, and all the rest.
sigh.
but the good news is that I'm an expert at navigating these treacherous waters and am looking for a new job. if anyone at shift labs (or other medical device manufacturer) is interested in a chat, feel free to reach out.