User Needs (UNs) are the foundational component of your Design History File (DHF). This single document should be the one that feeds design requirements, risk management, and the V&V process....

Minimum viable product (MVP) is a strategy that has gained rapid and widespread acceptance among the startup community. Used effectively, it can be a compelling strategy to...

When you are developing a new medical device, it is tempting to start by brainstorming, developing prototypes, and running demos for investors and others. But this approach will often lead you to a...

You have probably been told that you need the $1B market to attract investment in medtech. Yes, market size matters, but pursuing the monster market is not always the right move in medtech.

And...

Early stage medical device innovators and entrepreneurs often feel that the first critical step in their new venture is to build a prototype. Without a prototype, these visionaries rely on verbal...

Bringing a novel technology to the market in the form of a new medical product introduces several challenges:  Will the technology work the way that it is intended?  Will it meet clinical...

Many new companies have a business model based on transitioning their product to high-volume manufacturing and distribution. Unfortunately, this is more complex than breaking out the parts from a...

During the COVID-19 crisis, Archimedic collaborated with hospital-clients and fabrication partners to rapidly develop the Origami Mask.  This mask can be made from a variety of materials...