Two types which are common to all devices would be validations for efficacy (is it effective in meeting the claims the manufacturer makes) and is it usable (can the user use it to support his / her needs).

These claims are the cornerstone for the device.

What does the manufacturer say it will do and does it do it effectively for the entire user population?

Band-Aid

Take, for example, a simple band-aid.

Maybe the manufacturer wants to say that the band-aid can stay adhered for 36 hours.

Sounds reasonable, right?

• But what about if it gets wet?
• What about if it is adhered to oily skin?
• What about if it’s used in 100o heat and 95% humidity?

You can see that there are many aspects to consider.

Usability is Key

Usability is the cornerstone for the market.

Can it be used by everyone for whom it’s intended?

Again, consider the humble band-aid.

• Will users with arthritis be able to open the package and peel off the backings?
• Will children try to put one on a dirty cut?
• Will it work for athletes who are profusely sweating?

So again, many aspects to consider.