Connected, Wireless Medical Device Product Development
The product development cycle is not simple – or straightforward – and adding wireless connectivity to a device involves much more than adding a WiFi adapter and enabling Bluetooth.
There are thirteen primary development milestones to be met along the way to full commercialization.
There are the obvious ones – preparing the project plan, creating the prototype, developing and testing the product, determining the final design, preparing the documentation, and defining the regulatory strategy.
And there are the not-so-obvious milestones, such as outlining the full system architecture, performing biocompatibility testing, aligning your packaging and shipping processes with regulatory requirements, and verifying your cellular connectivity plan with the FCC.
At Bold Type, we’re not intimidated by this long and specific list of requirements – we’re inspired.
We specialize in developing connected, wireless medical devices, moving them quickly and competently through each of these milestones.
We can translate your conceptual sketch into a fully developed product ready for commercialization. We’ll even prepare your regulatory submissions for you, and help you establish your quality management system.
Connected, wireless, product development – it’s what we do.