Controlling the 5Ms in Pursuit of Product Quality | Part 2 – Man

In the first part of our blog in this series, we made the observation that, despite the environment of change we see in the manufacturing industry today, some things always stay the same. Like the ba……

Controlling the 5Ms in Pursuit of Product Quality | Part 1 – Material

The more things change, the more they stay the same – translating a French proverb, “plus ça change, plus c’est la même chose.” Wiktionary interprets this, “Turbulent changes do not affect reality on……

Looking at Operational Excellence as a Value Stream

As we discussed in a previous blog, “From Point Solutions to Value Streams,” it’s time to look at the systems infrastructure of medical device manufacturers not as point solutions tackling particular……

Benefits of a Modern MES – 6 Key Requirements

Various manufacturing industries have different levels of MES adoption. For example, in the Semiconductor industry, almost every manufacturer has some type of MES deployed, and has for quite a while…….

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……

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……

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……

Why focusing on Quality rather than Compliance makes good business sense

In medical device manufacturing, as well as other regulated industries, we have served two masters. One is the end consumer, without whom we have no business. The other is the FDA (or other regulator……

Can you afford to aim for average? The cost of change in the med-tech industry

John F. Kennedy once said, “There are risks and costs to action. But they are far less than the long-range risks of comfortable inaction.” It is an appropriate concept for the state of the medical de……