Product Development

July 29, 2019

REV•1 Engineering® Named As Exclusive Development Partner For Valvublator

Leonhardt Ventures taps REV•1 Engineering to design and develop Valvublator’s heart valve regeneration technology platform. MURRIETA, Calif. – July 26, 2019 – REV•1 Engineering has been selected as the exclusive design and development partner for the commercialization of Valvublator’s advanced, combination drug/device/biologics technology for regenerating human heart valves.  Valvublator’s platform integrates mechanical, electrical, therapeutical, and biological elements in a single, minimally invasive catheter to decalcify, cell sod and regenerate a patient’s heart valve leaflets.  It is intended […]
July 29, 2019

How Design For Manufacturing Can Effect Company Valuation At Exit

Throughout a medical device’s Life Cycle, few opportunities ever afford themselves to the organization to initiate a strategic approach to Design for Manufacturing in order to optimize product profitability.  This is especially true for companies navigating the transition from clinical stage to commercial stage operations.  The pressure to get to market and begin generating revenue is fierce.  A device that has successfully cleared FDA/secured CE mark, and demonstrated its merits in clinical studies, is going […]
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 […]
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