Medical manufacturing is embracing a new wave of digital innovation. Production lines now integrate connected devices, data-driven automation, and analytics platforms designed to improve speed and precision. These advances bring clear operational benefits, but they also raise security questions that many organizations are not yet prepared to answer.
At the center of this shift are operational technologies. These systems were engineered for uptime and throughput, not security. As manufacturers begin connecting these assets to enterprise networks and cloud tools, many new vulnerabilities emerge. On one hand, these integrations bring efficiency, but they also increase exposure to cyber threats.
Without adequate protections, these technologies can result in critical gaps in visibility and control. Worse, the very systems designed to improve production can unintentionally create paths for attackers. For medical product manufacturers, those weaknesses carry real risks for both the business and public health.
Why the FDA Is Sounding the Alarm
The FDA recently published a white paper as a response to this evolving threat landscape. It focuses on the cybersecurity of operational technology within medical manufacturing, urging companies to rethink how these systems are developed, deployed, and maintained.
A core issue is that OT systems continue to prioritize uptime over security. Many rely on aging software and insecure configurations that were never designed to operate in today’s interconnected environments. When reliability becomes the only benchmark, cyber risks are more likely to be ignored or postponed.
“Hardware devices in general are tricky to embed security controls,” said Nivedita Murthy, Senior Staff Consultant at Black Duck. “With medical devices the biggest challenge has been that the underlying devices and components included still use legacy ports and protocols to establish connections. These connections are usually unencrypted or allow users access to manipulate information.”
The FDA also calls attention to the lack of visibility within many production networks. Malicious activity can often move undetected through systems that traditionally have limited monitoring capabilities. When these networks span multiple vendors or include internet-facing components, the risk only grows.
A Call for Security by Design
Adding to the challenge is the fact that manufacturing tools often ship with default settings that do not meet today’s cybersecurity standards. While these configurations may simplify deployment, they leave systems exposed. Fixing these issues after implementation is not only costly but also fails to address deeper structural weaknesses.
The FDA is urging companies to rethink the way they evaluate and implement OT systems. For example, cybersecurity must be factored into architectural decisions from the beginning. This includes how systems communicate, authenticate users, and recover from failure.
Analysts agree with this position. “OT security is strongest when supported by robust IT security, requiring coordination between IT and OT teams to defend the entire network,” said Nathaniel Jones, Vice President of Threat Research at Darktrace. “By adopting good cyber hygiene, proactively securing digital estate, and addressing any vulnerabilities before they can be exploited, organizations will be much better equipped to defend their networks against increasingly opportunistic threat actors.”
The first notable FDA guidance related to cybersecurity in medical devices was released in January, 2005, and this regulation has evolved over time and has rightfully focused on building cybersecurity, considering that the number of attacks continues to rise,” said Agnidipta Sarkar, Chief Evangelist at ColorTokens. “However, years later, not many have clearly understood that the regulation requires cybersecurity-by-design, and not just an expensive machine.”
The agency also recommends pushing security into procurement. Vendors should be selected based on how well their products support resilience. Procurement teams should ask more pointed questions about access control, logging, and threat detection. These decisions set the tone for how secure a manufacturing environment will be over time.
Three Pillars of the FDA’s Cybersecurity Guidance
The FDA organizes its guidance around three core principles: secure collaboration, compliance with recognized standards, and proactive security engineering. Each plays a distinct role in building resilience across manufacturing systems that are becoming more complex and more connected.
The first principle calls for improved information exchange between manufacturers, vendors, and regulators. This includes open communication about system architecture, vulnerability management, and threat modeling. When stakeholders share insights early, it becomes easier to detect systemic flaws before they impact operations or safety.
Next is the need for better alignment with security frameworks. Standards like NIST and FIPS are already in place, but many OT systems fall short of full compliance. The FDA is pushing for more than just meeting the minimum. It wants organizations to go further by designing for flexibility, monitoring, and adaptability from the start.
Finally, the FDA is reinforcing the value of building security directly into the design phase. Security should not be an afterthought. It should be part of every technical decision, from software integration to user permissions. Achieving that balance requires a mindset shift, but it also makes resilience easier to scale.
The Broader Stakes: Supply Chain and Patient Safety
Cyberattacks on medical manufacturing don’t just disrupt operations. They can delay the production of essential drugs, interfere with quality control, and impact distribution timelines. In a tightly regulated industry, even a short disruption can lead to shortages that affect hospitals, pharmacies, and patients.
These risks extend far beyond a single manufacturer. When operational technology is compromised, it can affect suppliers, logistics partners, and connected healthcare systems. One vulnerable system can trigger a chain reaction across the entire medical supply network.
Given these stakes, cybersecurity is no longer a siloed concern. It requires shared accountability. Manufacturers, technology vendors, and regulators must coordinate efforts to reduce risk across the ecosystem. Protecting patient safety in a digital age depends on strong partnerships, clear standards, and sustained vigilance at every stage of the production and delivery pipeline.
Rethinking Risk in an Interconnected Era
The FDA is calling for more than improved technology. It is advocating for a culture change across medical manufacturing, one that places cybersecurity on equal footing with safety, quality, and efficiency. This shift requires teams to think differently about risk, seeing security not as an afterthought, but as a critical part of system design and operational integrity.
“Clearly the shift by malicious hackers to target IoT/OT devices has brought new requirements to the lines of business, such as manufacturing, healthcare, physical security, and facilities,” said John Gallagher, Vice President of Viakoo. “As threats become more cyber-physical in their impact, faster incident response and forensics will drive employers to recruit security professionals who can operate outside of the traditional IT space.”
There is growing urgency to act before small gaps lead to large-scale failures. In a connected environment, a single vulnerability can escalate quickly, affecting supply chains, treatment availability, and patient care. Building stronger defenses now means fewer emergencies later. It also signals to regulators and the public that the industry is prepared to take cybersecurity as seriously as every other aspect of healthcare delivery.
