Sara Adams’s picture

By: Sara Adams

At Greenlight Guru, we collectively have hundreds of years of experience in medical device quality management. We’ve all seen some great successes during our time in the industry—high-quality medical devices that improved the quality of life for countless people around the world. But we’ve also seen plenty of mistakes, especially when it comes to quality.

Not only have we seen actions (or inactions) that contravene industry standards, but we’ve also encountered issues that have the potential to undermine a company’s success entirely.

Quality management is the cornerstone of medical device manufacturing. There is simply no way to overstate how essential quality is to bring a medical device to market and keep it there long term.

So, let’s take a look at the five biggest quality mistakes we see medical device manufacturers making and how you can avoid them.

1. Conducting infrequent management reviews

How close is your management team to the inner workings of your quality management system (QMS)?

Stavros Karamperidis’s picture

By: Stavros Karamperidis

Ningbo-Zhousan may not exactly be a household name, but find something in your house made in China, and it’s quite likely it was delivered from there. Ningbo-Zhousan, which overlooks the East China Sea some 200 km south of Shanghai, is China’s second-busiest port, handling the equivalent of some 29 million 20-foot containers every year.

At the time of writing, the port has more than 50 ships waiting to dock. This is because the Ningbo-Meishan terminal, which handles about one-fifth of the port’s total volumes, has been closed for a week after a member of staff tested positive for Covid. With still no word of a reopening, many more ships have diverted to alternative ports.

Torsten Schimanski’s picture

By: Torsten Schimanski

The manufacturing skills gap has been a topic of discussion for several years. According to a 2021 Deloitte study, it is estimated that by 2030, there will be 2.1 million manufacturing jobs that will need to be filled. Finding employees who are trained, skilled workers is becoming more critical in a post-pandemic world, and meeting this demand is requiring manufacturers to begin thinking outside the box when it comes to future labor force planning.

As technology in the manufacturing industry continues to move forward, and career manufacturers begin to retire out, it is also becoming apparent that the skills required for success are growing more complex. Manufacturers that have participated in apprenticeship programs are taking control of the skills gap and labor deficit while also setting themselves up for success in the future.

Eliot Dratch’s picture

By: Eliot Dratch

The International Organization for Standardization (ISO) is an independent, nongovernmental, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. As technology continues to rapidly develop, new standards are drafted and implemented by people at all levels within global industries.

The ISO 9000 family of standards pertains to quality management systems in any industry; read on to learn more about ISO 9004 and how it can benefit your manufacturing organization.

What is the ISO 9004 standard?

ISO 9004:2018 gives guidelines for enhancing an organization’s ability to achieve sustained success, which is consistent with the quality management principles given in the standards included in ISO 9000:2015. ISO 9004 provides a self-assessment tool to review the extent to which the organization has adopted the concepts within the ISO 9000 group. Also, ISO 9004:2018 is applicable to any organization, regardless of its size, type, and activity.

Andrew Maynard’s picture

By: Andrew Maynard

Elon Musk announced a humanoid robot designed to help with those repetitive, boring tasks people hate doing. Musk suggested it could run to the grocery store for you, but presumably it would handle any number of tasks involving manual labor.

Predictably, social media immediately filled with references to a string of dystopian sci-fi movies about robots where everything goes horribly wrong.

As troubling as the robot futures in movies like I, Robot, The Terminator, and others are, it’s the underlying technologies of real humanoid robots—and the intent behind them—that should be cause for concern.

Musk’s robot is being developed by Tesla. It’s a seeming departure from the company’s car-making business, until you consider that Tesla isn’t a typical automotive manufacturer. The so-called “Tesla Bot” is a concept for a sleek, 125-pound humanlike robot that will incorporate Tesla’s automotive artificial intelligence and autopilot technologies to plan and follow routes, navigate traffic—in this case, pedestrians—and avoid obstacles.

Lauren Dunford’s picture

By: Lauren Dunford

Manufacturing is stepping up investment as the U.S. economy recovers from the challenges of 2020. Nearly 40 percent of manufacturers have increased CapEx spending, with less than 7 percent planning to spend less, the National Association of Manufacturers reports.

With that investment, factories have substantial room to reduce waste and improve profitability. In many plants the key efficiency metric, overall equipment effectiveness (OEE), stands at just 60 percent—meaning 40 percent of potential production capability is lost. In contrast, state-of-the-art factories regularly achieve 85 percent OEE.

Getting to real-time insight

Digital tools can be an important lever to help factories and entire manufacturing ecosystems dramatically reduce waste. As a foundation, most digital technologies start by providing real-time insight into what’s going on, what’s going wrong, and why. With that information, operators can act more quickly to fix issues as they occur and even prevent problems.

Christopher Allan Smith’s picture

By: Christopher Allan Smith

This final article in the series is about dealing with the aftermath of catastrophe. When it was originally written, not so long ago, it was a look back to the Camp Fire of 2018, and what those of us who survived learned that could help those in the future deal with their own disasters.

But the summer of 2021 has reminded us, again, that we are always living in an aftermath. As I write this new introduction, communities across Butte and Plumas counties, like Greenville, pick through the ashes of homes that still stood when I began writing this series. And flames curve around the rim of the communities of Lake Tahoe.

In the media stories about disasters, there is often a kind of curve that emerges.

Peace gives way to catastrophe. Unexpected heroes emerge, displaying service and courage. First responders, governmental, and private groups rush in to nurse the wounded and restore peace—or at least lessen the destruction that chaos leaves behind.

Teary survivors survey the wreckage that was once their anonymous corner of the world and look to the future with resolution to build it all back. Wreckage is cleared, hammers start driving into two-by-fours, and pretty soon after that, the story is “over.”

Matt Mong’s picture

By: Matt Mong

During a recent interview with Dirk Dusharme, host of Quality Digest’s QDL, we discussed project-based manufacturing, the umbrella term that covers the types of manufacturing done on a project-driven schedule. Some refer to this as “engineer to order” (ETO), a niche in engineering-focused manufacturing.

As repetitive high-volume manufacturing has been offshored to China, Vietnam, and other locations, many U.S. manufacturers have moved toward mass customization (sometimes called “made to order”) for the consumer market. These typically involve a base product to which the customer can add variations. Project-based products, on the other hand, are unique to each customer from the ground up and have grown significantly now that the technology is able to support it.

Project-based products are largely targeted at the B2B customer. The types of industries that are project-based include those that manufacture equipment for wind turbines, aerospace and defense, and biotech, as well as contract pharmaceutical developers. These projects tend to be long-term and complex.

Christa Martin’s picture

By: Christa Martin

Unless you are a supervillain, or hiding from the authorities, a cloak of invisibility is not necessarily a good thing. When you’re in business, and you are looking to use your digital presence to drive customers and revenue, invisibility, most definitely, is not a good thing. But if you can’t remember the last time you updated your website—or if the pictures and text look super-teeny-tiny on your mobile device—you may, very well, be invisible.

Google’s new mobile first indexing for the whole web

That’s because in March 2020, Google—the search engine, internet-of-everything behemoth—announced it was changing the way that websites are indexed into its search engine. Though we’ll get deeper into the weeds in a moment, the key distinction is this: If your website isn’t built with a mobile-first posture, it now—and likely, into the future—will be overlooked by Google’s indexing algorithm.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest

In any lab setting, bench space is limited. Between samples, notebooks, laptops, and other various supplies, it can be hard to find a place to put your test or measurement equipment.

If you use microscopes in your daily inspection work, the need to use two systems to look at one sample compounds the problem. Inspectors often observe a sample on a low-magnification microscope to identify an area of interest, then move the sample to a high-magnification and high-resolution microscope to take measurements and capture images. The process of moving samples and reacquiring the area of interest on another microscope is inefficient and means you have two systems taking up valuable space.

The solution to this challenge is surprisingly simple: use one system that provides low magnification for the initial review and high magnification with high resolution for the detailed inspection. One example is the Olympus DSX1000 digital microscope.

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