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The Natural
Bruce Hamilton
In 1985, about the time I was discovering there was a better way to produce products, The Natural, a film about an aging baseball player with extraordinary talent, was garnering multiple Academy Awards. This archetype concerning natural “God-given” abilities is common in Western culture—in sports…
Ultraviolet Light Can Clean N95 Masks for Reuse Without Hindering Performance
NIST
To combat Covid-19 amid supply shortages in 2020, healthcare facilities across the United States resorted to disinfecting personal protective equipment (PPE), such as N95 masks, for reuse with methods such as ultraviolet (UV) light. But questions lingered about the safety and efficacy of these…
Editorial Quality Assurance the Old-Time Way
Mark Hembree
As a late Boomer, I can say my particular age group is better positioned than any to marvel at and bemoan what’s become of journalism and publishing in the last 40 years. Not that I’m a Luddite. The advent of word processors was a boon to ham-fisted typists like me. A word processor that actually…
Stanford Engineers Enable Simple Cameras to See in 3D
Andrew Myers
Standard image sensors, like the billion or so already installed in practically every smartphone in use today, capture light intensity and color. Relying on common, off-the-shelf sensor technology—known as CMOS—these cameras have grown smaller and more powerful by the year and now offer tens-of-…
Upskilling Remote and Hybrid Employees
Gleb Tsipursky
The future of work—of hybrid and fully remote workers—will require upskilling of employees for organizations that wish to succeed in the post-Covid world. Leaders who want to seize a competitive advantage in that future will need to benchmark their training initiatives for best practices on…
Everything You Need to Know About Root Cause Analysis
Brittney McIver
At some point, every medical device company will encounter an issue that requires an internal investigation. Whether it’s due to a nonconformance, complaint, CAPA, or an audit issue, you’ll have to conduct a failure or root cause investigation to pinpoint why the issue occurred in order to resolve…
How to Have More Successful Conversations
Knowledge at Wharton
Negotiating a salary increase or a job promotion ranks high on the list of hard conversations to have at work, and it doesn’t get any easier without a plan. “People think, ‘I’m just going to knock on their door, sit down with them, and noodle around and see where this goes.’ That’s not a plan,”…
How to Prepare a Maintenance Budget
Bryan Christiansen
Top management often struggles to approve large sums required for annual maintenance because the expense is seen as a necessary evil. As a result, if a business encounters short-term financial constraints, the first place it looks for savings is maintenance. This is why your maintenance budget can…
Using Smart Technologies to Improve Quality and Reliability
Anthony Tarantino
In 2007, Nassim Taleb described black swans as highly improbable events that had dramatic or even catastrophic effects on markets and economies. Until recently, it seemed that such events were indeed rare.1 There’s now a major rethinking with the world entering the third year of the Covid-19…
Managing Product Development Risk With DFM and Quality Partnerships
Del Williams
From design to prototyping to manufacturing and scaling up, manufacturing is fraught with risk. Machining of critical parts may not be on the front burner until well into a product’s development. This isn’t in stakeholders’ best interests. Take products with semiconductors as a component, for…
Senior Leaders As Chief Reframing Officers
Ben Bensaou
Not every CEO can be the next Steve Jobs, constantly conjuring up game-changing new ideas and revolutionary products. But what all CEOs and senior leaders can be are champions for innovation within their own organizations. They are the ones who can help give their employees the freedom and space to…
The Staggering Costs of Health Insurance ‘Sludge’
Edmund Andrews
Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.” Reimbursements that take months to process. It’s no secret that healthcare in the United States is…
Study Examines How Machine Learning Boosts Manufacturing
Kara Baskin
Which companies deploy machine intelligence (MI) and data analytics successfully for manufacturing and operations? Why are those leading adopters so far ahead—and what can others learn from them? MIT Machine Intelligence for Manufacturing and Operations (MIMO) and McKinsey & Company have the…
The Present and Future of Automation in Maintenance
Bryan Christiansen
Even though it is notoriously resistant to change, the maintenance industry is not immune to the advances in maintenance automation. Things like data collection and analysis, inventory management, resource scheduling, and work order management have been automated for years, thanks to computerized…
‘Tech for Good’ Needs a ‘Good Tech’ Approach
Theodoros Evgeniou, Ludo Van der Heyden
Technology has always been a double-edged sword. While it’s been a major force for progress, it has also been abused and caused harm. From water power to Fordism, history shows that technology is neither good nor bad by itself. It can, of course, be both, depending on how it’s used.…
Software Bill of Materials for Medical Devices
Wade Schroeder
On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill of materials (SBOM) with their product. Given that…
Too Happy Too Soon
Bruce Hamilton
The level of excitement was high in our machine shop as we drew closer to our goal of less than 9-minute changeovers on the BNC lathe. (See Part One of this story for how we got there.) Setup improvements had so far reduced changeover time to 20 minutes, cutting the economic order quantity from…
Why Sometimes You Need to Source Locally
Jonathan Gilpin
The world of procurement is often tricky. It involves choosing one appropriate candidate, ultimately benefiting them while rejecting and disadvantaging others. That said, it isn’t just the businesses picked that will profit from winning the contracts; it’s also their supply chain, their local…
There’s More to AI Bias Than Biased Data, NIST Reports
NIST
As a step toward improving our ability to identify and manage the harmful effects of bias in artificial intelligence (AI) systems, researchers at the National Institute of Standards and Technology (NIST) recommend widening the scope of where we look for the source of these biases—beyond the machine…
Managing Medical Device Vulnerabilities With Compensating Controls
Dennis Fridrich
As the number of networked medical devices grows, so too will online threats and vulnerabilities. In this era of interconnectivity, healthcare systems must prioritize medical device security and patient safety. The heightened risk is drawing the attention of federal regulators, who warn that “it…
What FDA QSR and ISO 13485 Harmonization Means for Medical Device Companies
Etienne Nichols
On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international…
Do Your Job
Bruce Hamilton
We had been working with the Toyota Production System Support Center (TSSC) for two years to build a model line in our assembly department. As we moved from small batch production to one-by-one, the results had been astounding: Customer lead time reduced from two weeks to one day, crew size cut in…
Realistic Expectations of Artificial Intelligence
Susanne Tedrick
Although we’re still a few decades out from seeing most businesses and industries use artificial intelligence (AI) in their operations, there is certainly greater adoption than there has been in years past. It behooves business leaders to learn all they can about AI. According to a top IT training…
Safely Studying Dangerous Infections Just Got a Lot Easier
Aliyah Kovner
To combat a pandemic, science needs to move quickly. With safe and effective vaccines now widely available, and a handful of promising Covid-19 treatments coming soon, there’s no doubt that many aspects of biological research have been successfully accelerated during the past two years. Now,…
Manage Hybrid and Remote Teams Through Revised Performance Evaluations
Gleb Tsipursky
The pandemic forced leaders to reconcile with the need for effective hybrid and remote team management strategies, including in performance evaluations. Research has shown the benefits of moving away from large-scale quarterly or annual performance reviews. Instead, systematic, frequent, and brief…

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