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Design Verification vs. Validation for Medical Devices

Kendall Groelsma — Wed, 20 May 2026 13:14:42 +0000

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…

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How to Build a Continuous Improvement Culture

Kendall Groelsma — Mon, 04 May 2026 13:14:02 +0000

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…

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How Many Prototypes Should I Make? How Do I Know When to Stop?

Kendall Groelsma — Tue, 28 Apr 2026 13:16:29 +0000

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 91�Թ� Engineering, we’ve helped teams work through this exact scenario. In this article I’ll explain how many prototypes are typically needed,…

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What Is Cold Chain Packaging? Plus 3 Use Cases

Kendall Groelsma — Fri, 17 Apr 2026 14:56:50 +0000

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…

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What Happens If My Contract Engineer Quits Mid-project?

Kendall Groelsma — Mon, 06 Apr 2026 14:18:49 +0000

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…

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Lean vs. Six Sigma: What’s the Difference and Which Is Right for My Manufacturing Team?

Kendall Groelsma — Mon, 06 Apr 2026 14:06:37 +0000

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: …

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10 Common Reasons Medical Devices Fail FDA Review (and How to Avoid Them)

Kendall Groelsma — Thu, 02 Apr 2026 15:37:35 +0000

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…

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A Guide to IQ, OQ, PQ in Medical Device Manufacturing

Kendall Groelsma — Thu, 02 Apr 2026 15:25:48 +0000

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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5 Ways to Recruit Participants for User Interviews and Testing

Kendall Groelsma — Mon, 23 Mar 2026 19:55:02 +0000

Great innovation and product development start with understanding your users and their needs. One of our top recommended first steps for any company developing new products is to talk to their users. But finding the right people to talk to is often the hardest part—and one of the biggest reasons teams skip research altogether. At 91�Թ� Engineering, we partner with our customers to…

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The Medical Device Product Development Process: From Concept to Launch

Kendall Groelsma — Fri, 20 Mar 2026 12:54:33 +0000

Launching a medical device is not a simple product release. It is a structured engineering and regulatory process that ensures the device is safe, effective, manufacturable, and compliant with global regulations. At 91�Թ� Engineering, we guide companies through the full medical device product development roadmap, from early concept work through engineering, validation, regulatory approval, and production launch.…

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