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Clinical use is a significant milestone for most medical device companies. Investors often see this milestone as a significant de-risking activity – one that can come with valuation...
Written by Eric Sugalski
It’s a critical decision that defines your commercial strategy – but it’s one that is often taken without carefully weighing the pros and cons of each...
New technology is one of the primary drivers of growth in the medical device industry. Developing new tech can be long, iterative, and expensive -- so it is understandable that...
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...
Written by Eric Sugalski
Many medtech leaders are pressured by investors and others to rapidly achieve regulatory clearance with a product design that is not intended for the market. This...
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...