In April 2017, Cortex journeyed to Hollywood, California for the Qualcomm Tricorder XPRIZE Awards, a global competition designed to stimulate new diagnostic technologies that will improve access to healthcare in the U.S. and beyond — technologies that are drastically needed both at home and abroad. Our client and partner Cloud DX entered the race in 2012 with the VITALITI Tricorder, a portable device that can be used to self-diagnose medical conditions.
“It creates a discipline and an internal corporate culture that can help you grow. -Robert Kaul
Medical products are entering the consumer space at a growing rate, providing safer and more effective health outcomes for the public. For prospective device manufacturers, it’s important to understand the impact that quality certifications like ISO-13485 have on the design process.
A primer from Cortex Design.
All medical devices marketed in the U.S. are regulated by the Food and Drug Administration (FDA). The FDA classifies any new medical device as either Class I, Class II, or Class III, depending on the device’s risk, invasiveness, and a number of other factors. If you want to market a new medical device, the first steps are to find out:
- whether your device even qualifies as a medical device, and if so
- whether it’s a Class I, Class II, or Class III device, and
- the likely path to market for the device.
The classification system — as well as the FDA’s explanations of it — can be confusing to the uninitiated, so we at Cortex wrote this guide as a jumping off point for anyone who wants to understand the difference between these three classifications.
Awesome products deserve to be appreciated, so as an exercise we put together a quick list of some of our favourite product designs — both past and present — to try to get at what makes a product great.
It’s something we think about a lot at Cortex: why do some products fail to resonate, while some succeed? What is it about certain special products that allows them to vault themselves into the pantheon of pop culture and seep into the fabric of our lives?
The best product designs have a few things in common. They look contemporary no matter how long they’ve been on the market. They’re made of honest, durable materials. Their meaning increases the longer you have them, and the very best products achieve something greater than the sum of their function and aesthetics to say something about who you are as the person who owns them.
Here are 5 product designs — some classic, some contemporary — that inspire us at Cortex to try and create work that will stand the test of time.
Any business leader (along with the venture capitalist who invests in them) knows that there’s no defined skill-set to success — no formula. That said, over course of my career, I’ve noticed shared habits of successful leaders designing incredibly innovative hardware solutions. Cortex spoke with some of those leaders, both on the entrepreneurial side and on the venture capitalist team, to chart some of these golden characteristics.
Cortex Design uses 3D printing to rapidly prototype hardware ideas in a physical form. Our in-house Objet polyjet 3D printer allows us to quickly print parts that could cost hundreds or thousands of dollars with subtractive CNC prototyping methods. It’s exciting technology, and it’s easy to understand why startups and Fortune 500 companies alike think about how 3D printing can augment their product design process, making it faster, cheaper, and leaner. In the future, 3D printing might completely replace other prototyping methods used in product design. It might even make advanced manufacturing in North America affordable again, and it might deliver a personal replicator to every home.
But we’re not there yet. Not even close.
Cortex Design is integrating Fusion 360 into our existing design process. In order to work with our vendors, we need Custom Drawing Templates in Fusion 360. This is not a feature that the Fusion team has implemented yet, so here’s how we made it work:
You know those little frustrations that happen over the course of the day? Many of them are actually moments of design failure — the gap between the promise a brand makes to you, and the product you actually get.
If the tech world was a baseball game, the rules of it would change every time a new player stepped onto the field, a seasoned pitcher unveiled a new pitch, or a spectator entered the stadium. That’s basically how we won $100,000 + $5.4 million in R&D for a prize we’d already been disqualified for. Here’s how it happened.
There is a lot of work needed before an idea can be presented to the world for crowdfunding. New product ideas need to be seen and touched first before their value can be appreciated. That’s what a prototype will achieve.