Pharmaceutical Cybersecurity Challenges
Pharmaceutical, medical device and healthcare manufacturers are migrating from traditional manufacturing to advanced manufacturing – spanning a range of processes, from chemical or biological API (active pharmaceutical ingredients) production to formulation and packaging. This migration is part of the Industrial Internet of Things (IIoT)/Industrie 4.0 revolution, and it introduces new connectivity technologies into pharmaceutical industrial networks. While connectivity is beneficial for controlling the efficiency and quality of production environments, it exposes the industrial (ICS/SCADA) networks to new cyber risks that pose a threat to the company’s operational and business continuity.
The production environments contain the company’s most sensitive information and intellectual property, such as recipes, formulas and manufacturing information – which were the targets of the highly-publicized Dragonfly/Havex campaign. This information must be protected from cyber theft activities that risk the company’s competitive edge. Once these industrial networks are connected to external environments, cybercriminals can target code labeling or track-and-trace systems as part of a counterfeiting operation. In addition, other cyber risks such as process sabotage or potentially-deadly product manipulation threaten manufacturers with severe loss of revenue, damaged reputation, or an FDA intervention.