Preventing Use Errors in Packaging and Device Design: Part 2

Use error. User error. They may sound similar, but the terms actually have different connotations in package and product design.Dr. Bryce Rutter, CEO and Founder of Metaphase Design Group, explains, “These errors are not due to the user screwing up, it is actually the product screwing up. The vocabulary that the FDA has brought to the table within the last few years is that we don't call them ‘user errors’ anymore. We call them ‘use errors.’”

In Part I, Dr. Rutter outlined six tips for preventing use errors in device and packaging design. Here he explains why global research is so critical and examples of “finding the simple” in device design.

Researching globally

Dr. Rutter notes that if you are selling into global markets, then it’s ideal to perform user research globally. “There’s a big difference between socialized medicine and pay-for-play medicine like we have here in the U.S. This impacts what is prescribed and how it's prescribed. In some cases, these healthcare systems will support higher capital equipment costs but they require low-cost disposables. Most of the healthcare systems in the U.S will give you a piece of hardware because they make all their money downstream on the disposables,” he says.

There also other factors that impact the clinical side such as different training or varying attitudes about healthcare that alter user needs for the same product depending on where it is sold.

“I think that is an area that is not being looked at as much as it should. A global brand says that they can't understand why they aren't doing well in France, but they haven’t taken into account any of the unique needs that are different than what's going on in Topeka, Kansas,” he says.

Q&A: Finding the simple

Q: You’ve served as a juror on many panels for judging design, including last year’s Medical Design Excellence Awards. Were you surprised by any “low-tech” solutions to complex problems?

A: I think one of the toughest things to do in design “find simple.” You may feel that it’s obvious once you see a design, but trying to find that simple solution can be very challenging.

• The Linked Visibility Inventory System from IntelliGuard is a cabinet using RFID technology that automatically tracks what is removed and an anesthetist can roll it where it is needed. I always loved taking technology that has been around for a while and applying it to solve a new problem because usually its cost structure has been brought down and the overall solution is more affordable. Its appearance also has a certain character versus looking like a standard cart. Why not have something that looks a little bit more interesting and beautiful?

• Obie is a mechanical product that essentially mimics an arm so that people with motor issues can feed themselves. It’s an elegant solution, because compared to a robot that's being used at a Chrysler plant, it’s significantly simpler. It solves a real need and restores dignity for someone who can now feed themselves as opposed to relying on others. When you look at it you say, “Wow, that is a simple solution because the robotic control that is buried in that design has been around for such a long period of time, but no one has really applied it for that problem.”

• Methofill SELF INJECT, a handheld device for subcutaneous injections, also caught my eye in terms of simplicity. When you look at the form factor (that employs West’s SelfDose injector), it's explicitly obvious how you use it. It doesn't remind the user how sick they are, but it doesn't look like a toy, so there's a wonderful balance between the functional aesthetics and the utility of the product.

Especially in medical products, the simpler the product is, the more approachable it is, the easier it is to learn, and especially for self-medication… there's a direct link back to compliance in that if I know how to use it, then I will.

There's research literature that shows that your positive emotional state of mind has a direct impact on human performance. If you feel good, if the product makes you feel good, then you'll actually perform better, so in healthcare that's a real benefit for us.