What does it mean when we say we make medical grade flex arms?
You’ve probably seen us use the term “medical grade” in some of our posts over the last year and might be wondering what that exactly means. Have we changed the way we make flex arms? Well, the answer, as always – is complex. Here’s the short answer:
No. We haven’t changed the way we make flex arms because since the beginning, Moffatt has established ourselves as a premium component provider for dozens of companies over the decades. We create flexible, premium components with custom engineered mounting parts that are made in the USA.
The longer answer? Well, let’s get into it.
What is a medical grade flex arm?
A medical grade flex arm is a flex arm specifically designed to work in a hospital environment. That could be in an OR room, bed-side, or any sort of patient/doctor interface. When a client comes to us and we know that it will be used in contact with a patient, we’ll have a longer design checklist that we’ll walk through.
In short, a high quality flex arm is the same in an industrial and medical environment, but the way in which they’re used may cause them to have different thresholds for cleanliness, aesthetics like color matching, and other medical-specific design needs.
How long have we been manufacturing medical grade flex arms?
We’ve been creating flex arms for medical device manufacturers for well over a decade. We started working with a few different companies around the same time. In 2009, we helped Midmarkcreate their LED exam light for the Ritter 253 exam light. When Midmark’s product requirements pushed us to find an absolutely quiet arm, and another company contacted us at exactly that same time, the quiet brass arm Construction really got the attention of the medical customers and gave us a lot more confidence approaching that group.
We were finally able to talk about guaranteeing silent Flex arms, which had only been a wish for us up to that point. While we had been creating these processes before the Midmark project, that one caused us to really ramp up our capacity for that long arm.
One reason we started working with medical companies might surprise you: the 2008 recession, which caused us to think much further outside the box and our comfort zone.
Dave Moffatt, had this to say about that time “I think the medical community took notice of what we were doing and began to bring more projects our way and the new capabilities allowed us to design at a higher level than we’ve been able to do before.”
This was a big moment for us, as it was also the first time we did a multi-sectioned flex arm. It was a great first project, but it was far from being the last one. Over the ensuing decade, we’ve worked with dozens of medical device manufacturers to help bring their devices to market.
Is there more testing on a medical grade flex arm?
Well, as you know as a device manufacturer, the ultimate responsibility for a tier 1 company’s testing and validation falls on the company itself. That said, we’re extremely familiar and used to adhering to those quality standards and validation process. We will work with you to comply to your quality program and we’ve standardized our quality program to deliver to our customer’s specifications. That includes whatever they need to make it through testing and validation.
Where are medical grade flex arm devices used in a hospital?
This is one of the areas we’re most excited about in terms of future use. In the last ten years we’ve seen flex arms move away from simple exam light devices to be an integral part of many devices. We have flex arms used as monitor holders in the patient’s room, we’ve had flex arms used in the OR, and we’re even getting into patient-doctor hand held interfaces (more on that soon!).
In short, flex arms have become ubiquitous in hospital settings. That’s because they hold up with repeated use, are easy to manipulate, and are able to support most wiring and electrical needs for medical devices. That’s a big deal.
What’s the difference between an industrial flex arm client and a medical grade flex arm client?
Most industrial device manufacturers care about one thing: function. They aren’t too concerned with how a flex arm looks or if it’s going to cause problems with an end user. Medical device manufacturers HAVE to care about safety and the end user. They’ll need to know exactly the settings a flex arm can be used in, what’s going to make it break, and how it’ll respond to strenuous cleaning.
Our design checklist is typically longer with a medical device manufacturer. They’ll also be more concerned with validation because when a device is used in contact with a patient, there may be biocompatibility concerns. We’re not necessarily experts on that, but we want to know everything about where your product will be used and how it will be used.
Do you have more questions? We’d love to answer them. Give us a call!