We live in a global marketplace, and because of this, medical device manufacturers have a lot of power supply companies to choose from. When shopping around for PC-based power supplies for your medical device, you may wonder why working with one based in the United States would matter. We’ll cover the benefits you can get from working with a US-based power supply manufacturer and other factors you may want to consider when choosing a supplier.
The U.S. Medical Device Market
The U.S. medical device market is the largest in the world, making up 43.5% of the total global medical technology landscape. Business is booming for medical devices, and the FDA has made it easier than ever to gain approval in the market. The chances are good that if you are currently manufacturing and selling a medical device, you’re building it and trying to get it approved in the United States.
U.S. Manufacturers of Power Supplies and FDA Compliance
If you work with a U.S. manufacturer of power supplies that caters to medical devices, you won’t have to worry as much about being FDA-compliant.
For medical device manufacturers that want to sell in the United States, their equipment needs to be compliant with the latest version of IEC 60601-1. You can run into roadblocks in two ways. First, working with a power supply manufacturer that doesn’t cater to medical devices based in the U.S. might mean you have to take extra steps to ensure compliance. Harmonized standards can mean that meeting the standard in one country will qualify you in another. However, depending on the country manufacturing the power supply, they may or may not be compliant with US-based standards, or they may be behind.
RAM Technologies’ medical PSUs are compliant and certified to meet the standards set by IEC 60601-1 3. Choosing a power supply shouldn’t mean taking a step back in getting your product to market.
Working With Outsourced Suppliers Can Be More Difficult
Working with power supply manufacturers outside the U.S. can be a cost-effective option. Still, the cost savings may only be an upfront benefit.
First, there’s the time you may have to wait to receive your power supplies. If you’re working with a country outside of the US, chances are it’ll take longer for items to arrive if they have to pass through customs. Say something isn’t quite right, and you need to make a revision – the back-and-forth time to get your power supply customized the way you need it will slow down the time it takes to get to market.
This is assuming that you can get your power supply customized at all. When you work with manufacturers that are more affordable, it’s likely that you won’t have as many options to customize your power supplies to meet your exact specifications, either. The process may be more cookie-cutter with these suppliers, leaving you with the burden to alter the PSUs yourself or work with another company to make alterations once you receive them from an international manufacturer.
RAM Technologies offers customizations for power supplies and cables that comply with all applicable regulations and meet the specifications of your project. You don’t have to back into what you’re looking for. We can get it right the first time.
U.S. Manufacturers of Power Supplies Can Be More Reliable
When it comes to medical devices, reliability matters. Medical devices must be safe, predictable, and have little to no downtime. All components a manufacturer uses also need to be available for the lifetime of the product.
Lower-priced power supplies may be budget-friendly initially, but they may also have shorter warranties and lifetimes. RAM’s long-life, reliable power supplies are backed with a 3-year warranty. Our products also have a demonstrated mean time between failures (MTBF) of 500,000 hours.
You also want reliability when it comes to knowing that the power supply you need will still be on the market for the life of your product. If the power supply you use in your medical devices changes, you’ll have to select a new one and repeat the certification process.
RAM guarantees that our power supplies will be available throughout your product lifecycle. In fact, we’re still producing the first PSUs we’ve been making since 1996.
Have Questions About Medical Power Supply Manufacturers? We’re Here to Help
Sometimes, you need questions answered quickly. We don’t just pride ourselves on having the most reliable and powerful PC medical power supplies since 1996.
We’re also happy to be able to answer questions and offer support for anyone who is looking for the right power supply for their medical device. Help is an email or phone call away.
RAM Technologies’ power supplies are 60601-1 3.2 certified and meet 60601-1-2 EMC standards. When you’re designing your medical device and need help with a PSU, contact us for details.
More Resources:
What the FDA Moving to IEC 60601-1 3.2 Means for Manufacturers
Downloadable Guide to IEC 60601-1
Differences Between 3.1 and 3.2 Certification for IEC 60601-1
Understanding IEC 60601-1-2
