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. 

In this op/ed, consultant and former FDA official Steve Silverman reveals how medical device firms can best interact with the US Food and Drug Administration's Center for Devices and Radiological Health as the COVID-19 pandemic recedes.

In this op/ed, consultant and former FDA official Steve Silverman looks at what he got right – and wrong – in  his predictions for 2022 and walks us through his expectations for the new year.

In this op/ed, former US FDA device compliance chief Steve Silverman argues that while the agency's digital health precertification (Pre-Cert) pilot program failed to make much of a splash, the concept deserves a second look -- and more Congressional support.

In this op/ed, former US FDA device compliance chief Steve Silverman argues that savvy manufacturers understand the organizational and operational differences between agency centers and offices. Here, he offers five questions firms should answer before engaging the agency.

In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?