Product Development

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 […]
January 4, 2019

Identifying Meaningful Metrics For Strategic Engineering & Development

It’s often, and rightly said, if you can measure it, you can manage it.  Yet, performance metrics are applied in a somewhat uneven manner throughout most businesses.  Commonly used in manufacturing (yield rates, COGS, assembly times) and sales (the simplest of metrics…hit the number!), metrics are not as common with marketing (marketers are notoriously metric-averse) or in new device development. Granted, there’s a modicum of discovery that is necessary at the outset of new medical […]
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