Posts by Kendall Groelsma
What Manufacturing Tasks Shouldn’t Be Automated?
Automation is one of the most powerful tools available to manufacturers today, so much so that if you’re not at least thinking about where to automate, you’re probably falling behind. Automation reduces waste, speeds up production, and takes repetitive, physically demanding work off the plates of your people. But the part that doesn’t get talked about enough is that automation isn’t the right answer for everything. In our experience working…
Read MoreThe Best (and Worst) Materials for Food Processing Equipment
Choosing the wrong material for your food processing equipment is one of those decisions that probably won’t hurt you right away. It shows up later in a failed inspection, a contamination event, or a line shutdown that you weren’t prepared for. If you’re designing or upgrading food processing equipment, material selection isn’t just a mechanical checklist item. It affects sanitation, regulatory compliance, product…
Read MoreDesign Verification vs. Validation for Medical Devices
If you work in medical device development, you have probably heard these two terms in the same sentence more than once: verification and validation. And if you’re honest, you might admit that the line between them still feels a little blurry. You’re not alone. Even highly experienced engineers use them interchangeably or treat them as the same regulatory checkbox. They are not. The FDA and ISO 13485 treat them…
Read MoreHow to Build a Continuous Improvement Culture
Building a continuous improvement (CI) culture — one where people look for problems, suggest better ways, and follow through — takes more than a methodology like Lean or Six Sigma. It takes intentional leadership, putting the right structures in place, and a team that believes their voices are heard and their input matters. If your team isn’t there yet, that’s okay. Honestly, most aren’t. Continuous improvement is a journey that never ends, but it does have a beginning. Let’s look at what…
Read MoreHow Many Prototypes Should I Make? How Do I Know When to Stop?
Every prototype costs time and money. And at some point, you’ll look at the most recent one shoved to the back of a workbench and think, “What test was this one for again?” Many engineering and product teams spend days and dollars on habitual prototyping routines that stretch away from the critical path, burning runway quickly but building design confidence slowly. At DISHER Engineering, we’ve helped teams work through this exact scenario. In this article I’ll explain how many prototypes are typically needed,…
Read MoreWhat Is Cold Chain Packaging? Plus 3 Use Cases
You’ve spent months, maybe years, developing a product. And then the product lands at its destination compromised, out of range, or completely ruined because the packaging couldn’t hold temperature during transit. It’s a frustrating and costly problem. And it’s more common than most teams expect. If you’re developing a temperature-sensitive product in the food and…
Read MoreWhat Happens If My Contract Engineer Quits Mid-project?
It’s a fair question, and one that more engineering leaders are asking before they sign on with a contract engineering firm like us. You’re about to hand off a critical piece of work to someone outside of your organization. Project timelines are tight, institutional knowledge is hard to transfer, and finding qualified engineers is never easy. If something goes sideways…
Read MoreLean vs. Six Sigma: What’s the Difference and Which Is Right for My Manufacturing Team?
Continuous improvement isn’t optional in manufacturing, but missed takt times, rising scrap, and overloaded engineers make how you improve just as if you improve. Lean and Six Sigma are two of the most trusted continuous improvement strategies in the world. Both have helped manufacturing teams reduce waste, improve quality, and increase profitability, but they’re each designed to solve different types of problems. In this article, I’ll explain: …
Read More10 Common Reasons Medical Devices Fail FDA Review (and How to Avoid Them)
The FDA review process can be one of the most intimidating parts of developing and manufacturing a new medical device. You’ve invested time, money, and momentum into your product. You may even have strong early data or a working prototype. But then you hear stories of devices getting stuck, delayed, or outright rejected during FDA review, and suddenly…
Read MoreA Guide to IQ, OQ, PQ in Medical Device Manufacturing
In the medical device field, you must demonstrate, test, and document via a protocol supported by your quality management system (QMS) meeting ISO 13485 requirements. You do so by creating protocols (IQ, OQ, PQ), which are methods to demonstrate that the equipment being installed or used gives you a high degree of assurance that production processes will consistently manufacture products that meet quality…
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