Bringing a new medical device to market is always a daunting proposition. Every aspect of the device must be considered, from its target audience to the need for medical-grade certification. On average, it costs $54 million to develop a new medical device and 3 to 7 years for the U.S. Food and Drug Administration (FDA) to approve it for sale.
Medical device manufacturers planning to market to government agencies like the Veterans Health Administration (VHA) will have additional requirements to complete. Today's article covers three major ones. Completing these will bring your medical device closer to getting that coveted government contract.
Government Contracts: A Massive Market
Contracting with the federal government can be lucrative for any company. The federal government spends hundreds of billions each year on contracts in the private sector. The VHA has the largest integrated healthcare system in the country, with 1,321 medical facilities, 9.1 million enrolled veterans, and a budget of over 121 billion for 2024 alone.
To maximize their chances of getting contracts, medical device manufacturers should make sure their products:
- Meet governmental cybersecurity requirements
- Are TAA-compliant
- Are ENERGY STAR-certified
Meeting Government Security Standards On Your Medical Device
Unsurprisingly, data security is critical to the federal government, as it has access to personal information ranging from Social Security numbers to residential history and tax returns. The agencies and departments looking at your medical devices will check to make sure they possess the following security features to ensure such information is protected from bad actors.
Personal Identity Verification card reader
A personal identity verification card, or PIV, is a form of identification used in federally controlled facilities. It is a smart card with a chip containing relevant information about the holder: name, position, fingerprints, pictures, security clearance, etc. Your medical device and its medical computer should have a smart card reader built-in for easy yet secure access to all private information.
Self-encrypting drives
Self-encrypting drives (SED) are data storage units that encrypt any data written on them thanks to built-in encryption circuits. Any solid-state (SSD) or hard-disc drive (HDD) used by your medical device and computer should be SED.
National Information Security (NIST) - compliant BIOS and kernel
A computer's Basic Input/Output System, or BIOS, is firmware embedded in the motherboard. The kernel of the computer's OS builds on the BIOS to run programs that interact with the rest of the hardware, such as the CPU, memory, etc.
Since the BIOS and kernel perform essential functions such as system start-up, they're potential targets of hackers looking for high-level access to the computer, its data, and networks. Getting rid of malware in them is also extremely difficult and may require replacing the hardware (in cases of infected BIOS).
Medical device manufacturers should ensure the BIOS and kernels of any computers used by their devices comply and are up to date with the standards set by the National Information Security and Technology (NIST), namely SP 800-53 and SP 800-37.
"Keep your hard drive" service
Cybersecurity breaches can also occur when bad actors remove disc drives from computers, such as when they are being repaired, replaced, or recycled. To protect the data, the federal government mandates it keep the drives during those times. Ensure your company offers such "keep your hard drive service" for any of your medical devices' computers.
Be U.S.-friendly with TAA-compliance
The Trade Agreements Act, or TAA, requires that your product be made either entirely in the U.S. (domestic end products) or in a country with which the U.S. has a trade agreement (designated country end products). At least 50 percent of your device's production must meet these conditions. If you need more clarification, contact a TAA specialist, as the government is known to prosecute companies making false claims about their TAA compliance status.
ENERGY STAR certification meets EPA and DOE Green Goals
ENERGY STAR is a rating system that shows how energy-efficient a product is. It was developed by the U.S. Environmental Protection Agency (EPA) and run jointly with the Department of Energy (DOE). To maximize catching the government's attention (and that contract), you'll want your medical device to be ENERGY STAR-certified with at least an ES8.0 rating.
Getting That Government Contract Made Easier with Cybernet
The U.S. government, with its departments and agencies like the VA, is a huge market for medical device manufacturers. However, companies must proceed cautiously, as the government has many requirements stemming from its position and unique duties.
Contact the team at Cybernet Manufacturing if you're a medical device manufacturer looking to market your products with the government. We're an Original Equipment and Design Manufacturer, and we make sure our All-in-One medical computers, tablets, and medical-grade monitors comply with all the above governmental requirements and mandates. We'll work closely with you to ensure your medical device has the best chance of securing that government contract.
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