Seattle-based Shift Labs now has three low-cost medical devices in the pipeline

They haven't gotten FDA clearance yet - and apparently infusion pumps require a 510k submission (heres the guidance document specifically for infusion pumps: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulation...).

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.

Edit: We changed the title to a more representative sentence from the article.

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.”