Cybersecurity Is Now a Product Problem. Is Your Organization Treating It Like One?

What recent FDA actions, device recalls, and enterprise breaches are telling medtech executives about the state of product security governance.

On June 8, 2026, iRhythm discovered that a threat actor had gained unauthorized access to data maintained on third-party-hosted business applications. The following day, the company received a ransom demand threatening to release stolen proprietary data, protected health information (PHI), and other personal information unless payment was made. iRhythm disclosed the incident to the SEC within 48 hours and activated its cybersecurity response plan.

It made headlines. And for the R&D leaders and engineering teams reading those headlines, the instinct was probably familiar: that is an IT problem. A network problem. A security operations problem. Not ours.

That instinct is understandable. It is also becoming dangerous.

While enterprise IT breaches dominate the news, the more consequential cybersecurity story for medtech R&D is unfolding at the product level. FDA recalls, Class I alerts, and evolving regulatory expectations all point to the same conclusion: cybersecurity is no longer an IT responsibility alone. It is a product development responsibility that begins with architecture, extends through commercialization, and continues throughout the product lifecycle.

Download the full white paper to explore:

• What recent FDA recalls reveal about product security risks
• Why cybersecurity must be engineered into Class II and III medical devices from the start
• How legacy products create ongoing business and regulatory exposure
• The role of governance, PSIRTs, SBOMs, and postmarket security programs
• Practical considerations for R&D, Quality, Regulatory, and executive leadership

Download the complete white paper to learn how leading medtech organizations are treating cybersecurity as an engineering discipline rather than a compliance exercise.