May 30, 2019
REV.1 Engineering catheter device development.

Developing Medical Devices in an Age of Reimbursement Uncertainty

Developing advanced medical devices is challenging enough even during the most predictable of times.  Today, we’re still in mid-migration, from the traditional, fee-for-service system to a value-based reimbursement system.  Simultaneously, a noteworthy percentage of our nation’s electorate and presidential candidates are debating various versions of a single payer system.  Our industry cousins in the pharmaceutical trades are also finding their pricing coming under greater scrutiny.  Yet, with change comes opportunity. I believe it can be […]
April 24, 2019
Innovation at REV.1 Engineering

The High Cost of Trying to Develop Medical Devices on the Cheap

Having worked with investor-driven, medical device startups over the past two decades, I’ve learned, often the hard way, what works and what doesn’t work, in attempting to bring a new device into the marketplace.  If you’ve been following this blog, you’re familiar with the concept of Strategic Dollars in device development (the ≈ 25% of your development project that occurs during discovery & feasibility).  How these dollars are invested have a disproportionate impact on success […]
March 26, 2019
Innovation at REV.1 Engineering

Identifying and Managing Strategic Dollars in Device Development

Developing a medical device to commercialization is a complex, multi-faceted endeavor.  It’s also an expensive undertaking fraught with risk factors at each stage of development. While maintaining a meticulous attention to detail is paramount throughout the entire process, the fact of the matter is, some of the dollars you’ll be spending will inevitably be more strategic than others. Strategic dollars drive two areas of value creation.  First, strategic dollars intermediate critical risk factors from metastasizing […]
February 27, 2019

Strategic Engineering and Speed to Revenue

A REV•1 Engineering® White Paper Strategic Engineering is a comprehensive approach to medical device development that drives speed to revenue while simultaneously scrubbing away risk along the critical, developmental path.  This White Paper sets forth to examine the value of Strategic Engineering and how to go about adopting and implementing the approach. Strategic Engineering hinges on two key factors; highly coordinated resourcing combined with the rigorous execution of Design for Risk Management.  Perhaps a good […]
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