Project Management

April 25, 2018
REV.1 Engineering Medical Device Development Team

The Strategic Risk of Engineering Talent Turnover

Do You Have Contingencies in Place to Counter Disruption from the Coming Talent Wars? It’s a topic that’s been front and center since our recovery from the Great Recession: How will companies that depend on knowledge workers for value creation react to the inevitable talent wars? Due to the growing complexity and sophistication of our products, perhaps no other segment is more vulnerable to disruption than the medical device industry. And perhaps no place is […]
August 10, 2017

Speed Your Medical Device Development with In-House Machining

When in-house machining is not an option, medical device engineers are forced to use outside companies for quotes and machining. Typical turnaround times can run from 2 to 6 weeks, depending on the complexity of the piece. And then what happens if the outside machining company gets it wrong – or if it turns out your specifications were not exactly right? Then you are waiting several more weeks to get a part you needed at […]
July 27, 2017
REV.1 Engineering 3 Pillars of Medical Device Development

The Third Pillar of Medical Device Engineering: Compliance Certification

So far we’ve discussed two of the three key pillars of quality medical device engineering: Design Control and Quality System. The third, Compliance Certification, is the audit of the design controls and quality system, and is therefore heavily dependent on successful implementation of the first two pillars. Many medical device companies feel anxious when it comes to certification – and for good reason. While everyone is aware of the long check list the certification agencies […]
July 11, 2017
Medical Device Development - Quality Engineering

The Second Pillar of Medical Device Engineering: Creating an Effective Quality System

In our last blog, we explored Design Control – the first of three pillars that support quality medical device development. The second pillar is the creation of a Quality System. This pillar is instrumental in meeting regulatory requirements to FDA and CE Mark agencies requiring compliance to ISO 13485 – Medical Devices Quality Management System and ISO 9001 – Quality Management System. Regulatory entities require that the framework of a quality system be compliant to […]