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Written by Eric Sugalski and Ulrich Herken
“You need to show clinical evidence that your medical device provides a benefit.”
It's a common request that early medical...
The phrase “proof-of-concept” (POC) is widely used and engrained in the accepted formula of innovation. Engineers, scientists, researchers, and instructors operate under this mantra...
It’s a critical decision that defines your commercial strategy – one that affects your market time horizon, pricing, marketing claims, distribution strategy, and more. Who pays and why?...
Whether you are an established OEM or a medtech startup, clearly understanding and articulating your healthcare economic story is a vital part of your go-to-market strategy. With healthcare...
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...
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...