I only gave it a quick skim, and it doesn't seem overly difficult to fulfill (I work at a company that makes an FDA cleared diagnostic device). I'm guessing that they received more funding than the article stated - the regulatory process + setting up all the quality systems required is an easy way to burn cash, even if you are a smart lean savvy startup. Trying to fulfill the 510k submission could easily burn ~1 million even if they were lucky and smart.
For another thing, marketing costs in medical devices tend to by high because you need a lot of face time and networking. You often have to work through a lot of little different fiefdoms at every hospital/hospital network you want to sell at. It's rare that you have a product whose technical advantages are so overwhelming that it 'just sells itself', as the majority of the medical field is in general pretty conservative. Incremental improvements to existing products are in many ways a much easier sell than any attempt to break a mold.
Since Shift does not have FDA clearance yet, then they are in fact legally not allowed to market in the US for human use. If that's the case, then their marketing costs will naturally be lower.
That said, I have no idea how their veterinary sales/marketing work out.
Sure there are politics and products are mostly the same, but doesn't selling something much much cheaper via direct channel, attractive to purchasers? Aren't they measured by cost?
There are very few people who don't like the way everything use to go. They find shortcoming in some of these very complex things and find ways to improve them. But then naysayers try to discourage them by giving some facts and figure. But these people, with their indomitable will, don't stop and find a way of their own. This story of Kolko and her DripAssist device is one hell of an inspiring story. Her company has potential to revolutionize the medical device industry.
A IV drip regulator "changes how medical devices are made?" Hardly an example to compete with pacemakers, stimulators, orthopedic implants, biologics, endovascular devices, laproscopic surgery, electromagnetic navigation, CT and MRI scanners, etc. Bit of an oversimplification (not uncommon for "Fortune") I might suggest.
The claim isn't that the drip regulator changes how medical devices are made, but that the company wants to change how medical devices are made -- that is, it wants to make them affordable and accessible for countries that don't have access to them.
Even the original headline ("Startup Shift Labs wants to change how medical devices are made") doesn't make the claim that the drip regulator is revolutionary or will change how devices are made.
Also, a relevant quote, italics mine:
> The primary market for DripAssist, however, isn’t U.S. hospitals, where nearly every bed has its own IV infusion pump. “If you think worldwide about the number of infusions that are done every day,” says Kolko, “The vast majority of them are done without a pump and that’s the market we’re targeting.”
Ok, but that doesn't make what they are doing insignificant, and it seems a bit unfair to only react to the excesses of yet another euphoric headline when maybe there's a real incremental advance here to talk about.
Edit: We changed the title to a more representative sentence from the article.
