We thought it would certainly be nice to introduce you to the team here at HidraWear. So over the coming weeks, we’ll feature a member of our team to talk a bit about what they do. First up is Laura!
Hello, I’m Laura.
In short, I am the Quality & Regulatory Engineer at HidraWear. I worked alongside the team that got HidraWear on the market. My job is to ensure we do everything in a safe and ethical manner for you wonderful HS warriors.
Recently we were asked why we’re only selling in America, Europe and the UK right now.
The thing is, HidraWear is a classified as a Medical Device. And for this, there are lots of rules & regulatory requirements that must be met in different countries. Sometimes these rules make getting HidraWear out to you a lengthy process. But this is actually a good thing. Your safety is of our utmost importance and every country also wants their own set of regulatory rules adhered too. Because we are a small team, we have to do these regulatory submissions one at a time.
But HidraWear is just clothing right?
Not really in the quality and engineering world. Because HidraWear is used to help manage a medical condition, it’s highly regulated. For example, every step from the design, material selection to the manufacturing has a strict process to follow. There are lots of rules to adhere to, and these change depending on the country. So, here’s the difference between consumer products (sports tops) and medical devices (HidraWear garments). And how their development challenges differ:
Developing consumer products is all about urgency.
Firstly, the window of opportunity is open only briefly. So speed to market is vital. Minor design or development problems can be tolerated because the product life cycle is short. And also because consumers hungry for the latest tech, fashion or gadget prioritize innovation over perfection.
Importantly, that’s definitely not the case for medical devices.
Because medical devices are healthcare products, there is no room for error. Manufacturers can’t put out a device knowing it has a few problems to be subsequently fixed. Therefore perfection is the goal. Therefore speed to market takes a back seat to testing, testing and finally more testing. This is in addition to complying with a slew of strict regulatory requirements. Above all, risk management and safety takes on far greater importance in the medical device realm.
To sum up, the team that developed HidraWear are working hard with the regulatory associations to get our device to you worldwide.