Ensuring Your Medical Device is Government-Ready in 2024: The Ultimate Guide

Get Your Medical Device Approved By Meeting Three Crucial Requirements

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 aiming to enter the competitive landscape of government contracting—particularly with influential agencies like the Veterans Health Administration (VHA)—must navigate a series of vital requirements. In today's article, we delve into three crucial prerequisites that can significantly enhance your chances of securing that coveted government contract. By thoughtfully completing these steps, you’ll pave the way for your medical device to stand out in an essential market.

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 holds paramount importance for the federal government, which handles an extensive array of personal information, from Social Security numbers to detailed residential histories and sensitive tax returns. Agencies and departments scrutinizing medical devices will rigorously assess their security features to ensure that this critical information remains safeguarded against malicious attacks and unauthorized access. Protecting such sensitive data from the prying eyes of bad actors is not just a priority; it's an essential duty to uphold trust and integrity in the systems that serve the public.

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

The Basic Input/Output System, or BIOS, is a crucial piece of firmware intricately woven into the fabric of a computer's motherboard. This foundational layer acts as the bridge between the hardware and the operating system, enabling the kernel to rise from the depths of the BIOS to orchestrate the complex dance of programs interacting seamlessly with various components like the CPU and memory. With BIOS setting the stage, the computer can efficiently manage and communicate with its essential hardware, ensuring that everything operates in perfect harmony.

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 system designed to indicate the energy efficiency of various products. It was created by the U.S. Environmental Protection Agency (EPA) and is managed in collaboration with the Department of Energy (DOE). For those seeking government contracts in the medical device sector, obtaining ENERGY STAR certification with a minimum rating of ES8.0 is essential to enhance competitiveness and capture attention.

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 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.