Section 524B for MedTech Founders: A 2026 Cybersecurity Guide

Part of our Medical device vulnerability, threat, and attack-technique catalogue. For the full overview, start with The Top 50 Cybersecurity Issues with Medical Devices.

MedTech founders are usually focused on the device, the clinical story, and the next funding round. Cybersecurity tends to arrive late, as a line on the regulatory checklist a few months before submission. Since March 2023 that is a costly mistake: FDA Section 524B makes cybersecurity documentation a statutory part of the premarket submission for any cyber device, and a missing piece can stop the submission at acceptance review. For a startup, that means months of delay and a harder conversation with investors.

In a recent interview at the LSI USA 2025 - The Emerging MedTech Summit, Omar Khateeb, host of the State of MedTech Podcast, sat down with Christian Espinosa, CEO and Founder of Blue Goat Cyber, to uncover the often-overlooked cybersecurity threats facing the MedTech industry.

Why this matters

The stakes for overlooking MedTech cybersecurity are patient safety, market access, and runway. Devices with inadequate security can malfunction or expose patient data when attacked. On the regulatory side, Section 524B is binding statute, and the FDA's February 3, 2026 final guidance, Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, is the operative interpretation reviewers apply to it. Gaps lead to refuse-to-accept decisions, deficiency letters, and delays. Ignoring security during development often results in retrofitting, which is far more expensive and time-consuming than integrating it from inception. Early consideration of standards such as IEC 81001-5-1, ISO 14971, and AAMI TIR57 (now supplemented by ANSI/AAMI SW96:2023)/TIR97 is vital. Investors are increasingly scrutinizing cybersecurity posture, as it directly correlates with a device's market readiness and long-term success. A breach can erode trust, halt product rollout, and necessitate expensive remediation, making cybersecurity a non-negotiable component of modern MedTech innovation.

What does Section 524B require from founders?

Section 524B applies when your device meets the statutory definition of a cyber device in 524B(c): it includes software validated, installed, or authorized by the sponsor, it can connect to the internet, and it has technological characteristics that could be vulnerable to cybersecurity threats. The FDA reads "connect to the internet" broadly, so Bluetooth companion apps, USB update paths, and hospital network connections usually count.

If you are a cyber device, 524B(a) makes the requirements part of any 510(k), De Novo, PMA, PDP, or HDE submission. Section 524B(b) then lists what you must provide:

Investigational device exemptions sit outside 524B(a), but the February 2026 guidance still recommends the same cybersecurity content for IDE studies, so starting early helps there too. See our Section 524B requirements guide for the full statutory breakdown.

The Cybersecurity Blind Spot in MedTech Innovation

Espinosa explains that many MedTech founders simply don’t realize the gravity of their devices’ cybersecurity risks. “Most people don’t know what they don’t know about cybersecurity,” he says. “They don’t think about it until the very end, right before they’re trying to get their device cleared by the FDA or MDR (Medical Device Regulation), and then their regulatory affairs person’s like, ‘Oh, cybersecurity is on the checklist of documents we have to submit.'”

By that point, it’s often too late. Espinosa recounts a real-world example where his team discovered over 4,000 vulnerabilities in a client’s device just 60 days before their FDA submission. “They cannot fix it in two months,” he explains. “It delays their time to market, it causes frustration with the innovator, the investors, and everyone else, and it’s really costly.”

The Complexity of MedTech Cybersecurity

MedTech cybersecurity is a far more complex challenge than many founders realize. It’s not just about protecting against external attacks; it’s about understanding the unique vulnerabilities inherent in the various components of a medical device.

Firmware, Software, and Hardware Vulnerabilities

• Firmware: Espinosa cites the example of a client developing a bronchial decongestion system that used a microcontroller with firmware that didn’t support secure boot, a control the FDA expects to see addressed in the security architecture. “They had to basically make their device stand-alone because it was too risky to have it connected to anything,” he explains.
• Software: “Traditionally, we see vulnerabilities in software,” Espinosa says. “My team is very good at breaking things. We look at every angle an attacker would take to break into the device - every interface into the device.”
• Hardware: Hardware vulnerabilities can be just as dangerous. Espinosa emphasizes the importance of considering what interfaces are exposed on a device and whether they’re necessary for its operation. “If we don’t need access to these ports on the device, maybe we should create an enclosure to cover them up,” he suggests.

The Threat of Interconnected Devices

MedTech devices don’t exist in a vacuum; they’re often interconnected with other systems, creating a complex web of potential vulnerabilities. “If I have a system that’s imaging and it connects to a PACS (Picture Archiving and Communication System) server, now we have to consider: Is the data we’re getting from that PACS server trustworthy?” Espinosa explains. “How do we know it hasn’t been altered? And then the data we’re sending back, how does that device know that the data hasn’t been altered?”

This interoperability challenge is a significant concern, as malicious actors can exploit vulnerabilities in one device to gain access to the broader ecosystem.

The Threat of Hostile Environments

Espinosa describes Medical devices often deployed in healthcare environments as “hostile.” He explains, “Hospitals are notorious for not securing their networks. I mean, how if you just look at the news, pretty much every hospital’s been compromised. Just when you think that can’t be a bigger data breach of a hospital, the next day you read in the news there’s been a bigger one.”

When a MedTech device is installed on a hospital’s network, it becomes vulnerable to the same threats that have plagued the healthcare industry. “That environment is not friendly,” Espinosa warns. “You can expect that device to be attacked over and over and over as soon as it’s plugged into the environment.”

The Consequences of Overlooking Cybersecurity

The consequences of overlooking cybersecurity in MedTech innovation can be severe, ranging from regulatory delays to patient safety risks.

Regulatory Delays and Investor Frustration

As Espinosa’s example illustrates, discovering critical vulnerabilities late in the development process can lead to significant delays in getting a device approved by the FDA or other regulatory bodies. “It delays their time to market, it causes frustration with the innovator, the investors, and everyone else, and it’s really costly,” he says.

These delays can be devastating for startups, eroding investor confidence and jeopardizing funding opportunities. Founders who fail to prioritize cybersecurity early on may find themselves struggling to secure the resources they need to bring their innovations to market.

Patient Safety Risks

Perhaps the most concerning consequence of overlooking cybersecurity is the potential impact on patient safety. Espinosa emphasizes that MedTech cybersecurity is not just about protecting data; it’s about safeguarding human lives.

See also: IVD Cybersecurity: Result Integrity Risk and FDA Evidence, QNX Vulnerabilities in Medical Devices, and Medical Device Interoperability: Cybersecurity Risks Explained.

“If I can affect the device in a manner that translates to affecting patient health or causing harm to a patient or a misdiagnosis or delayed diagnosis, then that needs to be fixed,” he says. “The bottom line is, if we can affect the device in a manner that translates to affecting patient health or causing harm to a patient, then that needs to be fixed.”

Cybersecurity as a Competitive Advantage

While many founders view cybersecurity as a necessary evil, Espinosa believes it can be a strategic advantage for MedTech startups. “If I can help in that regard as part of our cybersecurity service, if there’s a way for me to help with the entrepreneur journey because I’ve been doing entrepreneurship for a while, I like to do that too,” he says.

By proactively addressing cybersecurity concerns, founders can not only mitigate risks but also differentiate their offerings in a crowded market. Espinosa suggests that “if you can show that your device is more secure than your competitor’s, that’s a competitive advantage.”

Taking Action: Cybersecurity Strategies for MedTech Founders

So, what should MedTech founders do to address their cybersecurity challenges? Espinosa offers the following advice:

1. Integrate Cybersecurity into the Product Roadmap

Cybersecurity should be a core consideration from the very beginning of the product development process, not an afterthought. “At the requirements phase is where they should be looking at cybersecurity,” Espinosa says. “And then if it’s design, the requirements phase is done properly, then it enters the design phase, and the controls are designed into the device.”

2. Engage Specialized Cybersecurity Expertise

MedTech cybersecurity is a highly specialized field, and founders should not attempt to handle it in-house or as an add-on to their existing regulatory or quality management efforts. “You really need to hire someone that knows what they’re doing, not somebody that just, you know, took a cybersecurity course and is trying to help you with cybersecurity,” Espinosa advises.

Founders can explore resources like Blue Goat Cyber to find specialized MedTech cybersecurity expertise that can guide them through the process.

3. Raise Awareness and Educate the Team

One of the key initiatives at Blue Goat Cyber is to “raise the awareness about the importance of cybersecurity early on in a product’s life cycle,” Espinosa says. Founders should ensure that their entire team, from engineering to regulatory affairs, understands the gravity of cybersecurity risks and the importance of addressing them proactively.

4. Incorporate Cybersecurity into the Funding Roadmap

Securing the necessary resources to address cybersecurity concerns should be a critical part of a MedTech startup’s funding strategy. Founders should allocate budget and resources for cybersecurity assessments, penetration testing, and ongoing monitoring and maintenance.

Conclusion: Embracing Cybersecurity for MedTech Innovation

In the world of medical technology, cybersecurity is no longer an optional consideration - it’s a critical component of successful innovation. By proactively addressing cybersecurity risks, MedTech founders can protect their patients and their businesses and position their companies for long-term success.

As Espinosa eloquently states, “If it wasn’t for a medical device, I wouldn’t be here.” The stakes are simply too high to overlook the cybersecurity threats facing the MedTech industry. By embracing cybersecurity as a strategic priority, founders can unlock new opportunities, drive innovation, and ultimately, save lives.

To learn more about the importance of cybersecurity in MedTech innovation, be sure to check out the State of MedTech Podcast and explore the resources available at Blue Goat Cyber. Together, we can build a future where medical technology is not only groundbreaking but also secure.

How Blue Goat approaches this

Blue Goat Cyber assists MedTech founders in working through the intricate cybersecurity environment, transforming potential liabilities into market strengths. Our approach focuses on embedding security throughout the product lifecycle, from concept to post-market surveillance. We offer specialized services including threat modeling, penetration testing, and premarket cybersecurity services tailored to meet regulatory requirements. Our team brings deep expertise, holding certifications like CISSP and, and using insights from ex-military red team personnel. We work alongside your team to identify and mitigate risks proactively, ensuring your devices meet the stringent requirements of the FDA's February 3, 2026, guidance. Should the FDA raise cybersecurity deficiencies after our submission, we resolve them at no additional cost. We emphasize practical, effective security solutions that align with innovation, avoiding last-minute, budget-consuming fixes. Learn more about our thorough support at Blue Goat Cyber FDA Premarket Cybersecurity Services.

If you want one team to own the whole cybersecurity package, see our full-service FDA premarket cybersecurity submission support.

Related reading: MedTech Cyber Standards Every Device Team Must Know.

FAQ

Why is cybersecurity often overlooked in MedTech development?

Founders frequently prioritize innovation and regulatory navigation, postponing cybersecurity considerations until late in the development process. This often stems from a lack of awareness regarding the complexity and criticality of medical device security.

What are the consequences of neglecting MedTech cybersecurity?

Neglecting cybersecurity can lead to severe issues, including significant regulatory delays, increased development costs, investor frustration, and serious patient safety risks from compromised devices. It can also harm market reputation.

How does the FDA view cybersecurity in medical devices?

The FDA considers cybersecurity a critical element of medical device safety and effectiveness. Their February 3, 2026, final guidance outlines stringent expectations for cybersecurity throughout the total product lifecycle, requiring strong security measures for all submissions.

When should cybersecurity be integrated into MedTech product development?

Cybersecurity should be integrated at the earliest stages of product development, ideally during the requirements phase. This ensures that security controls are designed into the device rather than being retrofitted, which is more effective and less costly.

Can strong cybersecurity be a competitive advantage for MedTech companies?

Yes, demonstrating a commitment to strong cybersecurity can be a significant competitive advantage. It builds trust with healthcare providers and patients, reduces market entry barriers, and differentiates a company's products from less secure alternatives.

What specific vulnerabilities are common in MedTech devices?

MedTech devices commonly exhibit vulnerabilities in firmware, software, and hardware. Interconnectedness with other systems and deployment in potentially 'hostile' hospital network environments further amplify these risks, creating multiple points of attack.