By David Shaywitz

Biopharma – especially big pharma – gets all sorts of grief for being large, stodgy, and unable to innovate (or evolve);this Corey Goodman interview represents the perspective well.

Before writing off these companies entirely, however (an ignorant reaction in any case), it’s important to consider how much experience they have in doing two very difficult, very important things: (a) documenting the medical value of their products through a rigorous series of clinical studies conducted in a highly regulated environment; and (b) navigating their way through a complex maze of stakeholders in order to successfully market their products.

Much of the difficulties facing the industry these days stem not from their lack of regulatory experience or marketing skill, but rather from the intrinsic value proposition of the products they offer; simply put, making an impactful new drug is extremely hard and quite expensive, as Matt Herper’s recent piece makes clear.

My sense is that the view from the digital health/start-up side is in many ways the mirror-image of this: the space seems to be brimming with promising nascent ideas; yet, as I’ve discussed before, the measurable health impact of these technologies is usually unclear (at best).

Some emerging digital health companies don’t worry about this – they are deliberately seeking to circumvent the regulatory process by aiming directly at consumers, and avoiding explicit health claims.  Others seem to be leaning pretty heavily on the concept of being so disruptive that, in effect, the world will change for them.

I’d suggest that there still is a huge opportunity for digital companies that are keen to robustly demonstrate health benefits, at the high level of rigor that is standard in the medical products industry.Continue reading…