Not to appeal to my authority, but as a Boarded Doctor of Internal Medicine that spent half of his time in the ICU during residency:
1. I would say that I have seen Masimo products used extensively there.
2. Medical-grade means (hopefully) independently verified reliability with clinical studies to back that assertion. Usually when devices are medical grade in the US, they have to be prescribed by a physician. (They do this so they can charge higher prices because your insurance company will pay the brunt of the cost). The ideal test would be correlating the oxygenation level on the pulse oximeter with more invasive monitoring (arterial line, etc). This type of testing is not insignificant and would significantly increase the cost of going to market.
3. Just because Apple Watch is not medical grade does not necessarily mean that it is unreliable. (triple negative ahh!) Additionally as stated before Masimo's commercial MightyStat line also has similar language to the Apple Watch legalese.
4. Masimo's complaint of their employees being poached has no merit. Employees are free to go to a competitor. If trade secrets, etc were passed then the courts will take care of that process. Pretty sure SCOTUS ruled against the tech companies (and all other companies from placing in anti-poaching clauses).
5. On the topic of reverse engineering, IANAL obviously so I will defer to the experts.
Technological innovation doesn’t take place in a vacuum. Innovators routinely draw upon the insights of others as they develop new ideas. Studying an existing technology to figure out how it
peillaw.com
6. There is no hard rule that SpO2 for a normal person is > 98%. I normally run around 96-97% on a pulse ox and I have no lung problems and I am not a smoker. People can exist on various O2 levels depending on altitude, genetics, etc.
7. Finally ANY product that encourages patients to be more mindful of their health and encourages them to speak with their doctor if it is detecting problems is a plus in my book. (I would say that not all products are equal, e.g. my mom bought a wrist blood pressure detector that said her BP was super high. I told her to make an appointment to see her GP--even though I knew that this type of monitor have been historically very inaccurate--and as expected it turned out that her BP was fine and she returned that product back to the store).