There is a HUGE difference between how the FDA will support you through a 510K submission and what your notified body

Startups have different challenges along the road to market release than do the larger, established medical device

Monir El Azzouzi has a new podcast with a very catchy name - Medical Device Made Easy. He invited me to participate in

I have seen some VERY dysfunctional organizations in my day. No matter the size or how long the company has been in

Many startups make the mistake of viewing regulatory affairs - and regulators - as a necessary evil, or barrier to

Biotech is one of the riskiest sectors to invest in, so potential investors need to be able to discern signals that a

As an investor, when the company making the pitch says "We are a Class I, II and III device!" your ears should perk up

As an investor looking into the biotech and medtech industries, you need to know what questions to ask the company

The company has a great pitch, the financial projections look great, the device concept makes sense, and the presenter

Always begin with the end in mind. I say this over and over in my presentations to underscore the importance of knowing