Dec 10, 2019

The Critical Elements That Drive Efficiency Of Development

The Critical Elements That Drive Efficiency Of Development

I recently had the opportunity to read Greenlight Guru’s “State of Medical Device Product Development and Quality Management - 2020 Report”. I highly recommend giving it a look. The comprehensive report, which emerged from surveying more than 500 medical device companies, illustrates many of the lessons I've learned over my thirty year career in the industry. Lessons that, in my experience working with medical device startups in particular, are far too often discounted or entirely ignored.What jumped off the pages of the report for me was the intrinsic, inter-dependences of Quality, Risk Management and the Efficiency of Development. In my experience, enlightened managers realize that fully embracing Quality and Risk Management, as mission critical elements of the business, actually drives developmental efficiencies. Unfortunately, all too often, the opposite position is held…where Quality and Risk Management are seen as a cumbersome burdens, and as a result, Efficiency of Development evaporates.Some key takeaways from the report include:

Prior to joining REV.1 Engineering®, I worked with investor-driven, medical device startups. I’d like to share a couple of real world examples of how failing to fully embrace and manage Quality and Risk Management, as mission critical essentials to the core business strategy, can effect performance. (Of note, REV.1 follows a highly disciplined approach to Design for Risk Management Along the Critical Path…a key accelerant to Efficiency of Development).

Is there a cost to fully integrating Quality and Risk Management into one’s design & development activities…of course. Nothing of value in this industry is free. Conversely, the cost of not fully embracing a meticulous and disciplined approach can be the company itself.Copyright 2019, REV.1 Engineering®.

All the best,
Terry Murray

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