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Successfully run medical device companies are cross-functional. From product development, manufacturing, quality, and regulatory compliance, to marketing and sales, every business operation works together to produce and sell medical devices that improve the lives of end users. Still, many medical…
Suppose you would like to know mortality rates for women during childbirth, by country, around the world. Where would you look? One option is the WomanStats Project, the website of an academic research effort investigating the links between the security and activities of nation-states, and the…
The internet of things, or IoT, is a phenomenon that merges real-life devices with online control. Think smart home systems or maybe the FordPass Connect app. The manufacturing industry has already begun to leverage this idea to monitor heavy industrial equipment and analyze data from multiple…
The toughest part of being in a relationship is finding a perfect gift for your loved one. Gifting is an essential part of any relationship. You gift your better half for every reason and every season. Gift as a form of bribery in love is a time-tried tool.
Being a system believer, I use the…
ISO 9001 lead-auditor training should enable auditors to focus on the requirements when auditing and to stay away from the pitfall of guidelines.
Take the case of ISO 9001 or, for that matter, any management system standard. The standard has notes to explain the clauses. ISO 9001’s clause 4.1, for…
When educational and public sectors consider applying a proven method like lean Six Sigma, the perception persists that this “manufacturing program” will not work in a nonmanufacturing environment. Along with that limiting assumption, there is an underlying expectation within the service industry…
Imagine a manufacturing facility prioritizing cleanliness and organization—aisles are kept clear, equipment is well maintained, the plant floor is regularly cleaned, operators can easily locate tools, and materials are always stored in the right place. All employees contribute to managing work…
Effective and efficient supplier management is possible, but not when we’re still using old tools and expecting different outcomes.
Emailing suppliers to communicate product specs, corrective action requests, or audit reports may be “the way it’s always been done,” but that doesn’t mean it isn’t…
(Greenlight Guru: Indianapolis) -- Greenlight Guru, creator of the only quality management software designed specifically for the medical device industry, announces new software platform updates to align with the recently updated ISO 14971:2019 standard, as well as further enhancements to the change…
The Covid-19 coronavirus has developed into a widespread pandemic. With growing outbreaks of diagnosed cases in all 50 states, and vastly larger numbers of undiagnosed cases, there’s serious cause for concern. Yet quality professionals who follow the official advice on Covid-19 coronavirus prep…
With Covid-19 continuing to impact many businesses, lead time as well as sourcing new suppliers is increasingly difficult. If you currently outsource manufacturing overseas, it is likely you have encountered some turbulence to your supply chain.
Rapid prototypes and large-quantity production of…
This is supposed to be trade-show season. The time when companies send their employees to industry tech shows and user-group meetings to see and experience the latest offerings in their field. A time when companies expend a good portion of their budget on booth space, shipping costs, and hotel and…
‘That escalated quickly!” is a common trope used in popular culture to describe when a situation gets out of hand before you’ve even had a chance to think about it. We don’t often use this trope in medicine, but I can think of nothing better to describe what has been going on in the United States…
For most of us, the word “robot” conjures something like C-3PO—a humanoid creature programmed to interact with flesh-and-blood people in a more or less human way. But the roster of real-world robots is considerably more varied. The list includes Boston Dynamics’ dog-inspired robots, Dalek-like…
For most of us, the word “robot” conjures something like C-3PO—a humanoid creature programmed to interact with flesh-and-blood people in a more or less human way. But the roster of real-world robots is considerably more varied. The list includes Boston Dynamics’ dog-inspired robots, Dalek-like…
Companies and societies are at the precipice of rebuilding their foundations to compete in an age of advanced analytics, artificial intelligence (AI), and machine learning (ML). Yet, in the real economy—or in the world outside the tech companies—I see more struggle than success in making advanced…
As the skills gap widens and more employees retire, decades of experience and company investment is predicted to walk out the door. With nearly 10,000 people turning retirement age daily, manufacturers will need to look to proactive solutions to capture tribal knowledge and transfer it to the…
The outbreak of the Covid-19 virus in China and the railway disruptions across Canada represent two different yet similar classic case studies. They remind us that nations and global economies are becoming increasingly interconnected. Incidents thousands of kilometers away are being felt locally.…
The Manufacturing Institute estimated that 2.4 million job openings in manufacturing—accounting for half of all open positions—will go unfilled between 2018 and 2028 as a direct consequence of the skills gap. This isn’t a future problem.
The challenges of the skills gap and a shifting workforce…
In a recent article I discussed the traditional 5S audit, shared a set of reservations, and offered some remedies—“The Five Tweaks,” as I called them. Remedies are important because most of you have a vested interest in continuing regular audits but want them to be successful and more valued. The…
Shop floor scheduling is a huge headache for many manufacturers. You can’t operate without it, but operating with it presents a host of challenges. In particular, scheduling systems struggle to account for the many variables present in a typical high-mix, low-volume shop.
Each of the following…
A couple weeks ago a consultant friend of mine, who coincidentally focuses his practice on lean in healthcare, was complaining about issues with his healthcare providers. It’s a story we hear often: doctors running late, very short and often superficial consultations, a rush to diagnosis, and a…
(The L.S. Starrett Company: Athol, MA) -- The L.S. Starrett Company, a global manufacturer of precision hand tools and gages, metrology systems and more, has recently expanded the horizontal X-axis travel on its HB400 Benchtop Optical Comparator from 12 in. to 16 in. (300 mm to 400 mm), providing…
Have you ever wondered why the sales and marketing departments walk out of the boardroom with a bag full of money after they made their pitch, but board members only see you and your quality unit presentation as the bearer of bad news?
I have seen it too many times to count. The quality unit has a…
The Chinese character for “crisis” means danger and opportunity. The coronavirus, aka Covid-19, outbreak has already wreaked havoc in the global economy, curtailed international and even domestic travel, and caused roughly 7,146 fatalities to date around the world.1 The reaction to this outbreak,…
