Opinion: Smart Device Firms (and Investors) Unwind Regulatory Risk

Investments in medtech firms have been drying up, with some speculating the reason lies in the degree of regulatory uncertainty inherent to the field. In this opinion piece, consultant and former FDAer Steve Silverman describes how device companies can help investors clarify the risk. 

Businessman riding paper boat in sea of money
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Investment and acquisition is a key strategy for new medtech firms (and some that have been around a while). This means getting funding from outside parties and even selling whole operations to investors like venture capital funds.

But there’s been a decline in medtech investment. One explanation is the murkiness of regulatory risk – this risk is often opaque and hard to calculate. By “regulatory risk,” I mean the regulatory requirements and costs to market a medical device (more on this later)

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