How a Quality Management System Reduces Cost

Quality management systems help companies better understand how to structure their organization in order to operate more cohesively. They provide a means of measuring how effectively a company produc…

The Impetus for Paperless Manufacturing

Manufacturers in virtually all industry sectors have been made less efficient by paper-based processes. The problem with paper is manifold:

From a documentation perspective,the opportunity f…

Why MES for emerging Medical Device manufacturers

There’s a common belief that manufacturers need to have attained a certain scale before considering investing in technology like MES, but an increasing trend among emerging medical-device companies i…

Manufacturers have more to scrutinize to maximize resources

As manufacturers consider how to overcome rapidly increasing demand, shortened product life cycles, and reduced margins, they would do well to take a good look in their own backyard.
A McKinsey Ins…

Driving Transparency – How Quality Management Systems Prevent Catastrophe

We have all heard about public disasters around potential systematic disregard for quality problems in companies – from the automotive industry (think emissions tests, brake failures) to the oil &amp…

Digitization vs. Digital Transformation in MedTech

We hear a lot of buzzwords – Industry 4.0, Internet of Things, Industrial Internet of Things, Digital Enterprise, Digital Twin, Virtual Factory, and so many more. We are going to focus on two here: D…

Quality Management – A Holistic Approach

Strategic quality management professionals envision a holistic solution across the entire product life cycle and supply chain that is able to

Support compliance
Detect risks and failures
Mit…

Global trends for Medical Device companies – An executive view from Terumo

In a series of interviews conducted by Dan Matlis, President of analyst firm Axendia, Terumo Cardiovascular Group executives Mark Lincoln, VP Global Operations, and Chris Zarecki, Director of Manufac…

Using Quality Systems to Gain Efficiency – Is that even possible?

Cost and Quality. They are often thought of as two sides in a game of “tug of war.” When one side gains traction the other loses. However, that is a very non-strategic view of how well-architected ma…