Engineering topics
Publications and source records attributed to Grimes, Howard.
Biopharmaceutical production systems and processes are vulnerable to cyberattacks from sophisticated adversaries. Consequently, it is imperative to start building biopharmaceutical manufacturing systems that offer verifiable formalism and transform the current state of security across all production stages.
U.S. national security, prosperity, economy, and well-being require secure, flexible, and resilient Biopharmaceutical Manufacturing. The COVID-19 pandemic reaffirmed that the biomedical production value-chain is vulnerable to disruption and has been under attack from sophisticated nation-state adversaries. Current cyber defenses are inadequate, and the integrity of critical production systems and processes are inherently vulnerable to cyber-attacks, human error, and supply chain disruptions. The following chapter explores how a BioSecure Digital Twin will improve U.S. manufacturing resilience and preparedness to respond to these hazards by significantly improving monitoring, integrity, security, and agility of our manufacturing infrastructure and systems. The BioSecure Digital Twin combines a scalable manufacturing framework with a robust platform for monitoring and control to increase U.S. biopharma manufacturing resilience. Then, the chapter discusses some of the inherent vulnerabilities and challenges at the nexus of health and advanced manufacturing. Next, the chapter highlights that as the Pandemic evolves, we need agility and resilience to overcome significant obstacles. This section highlights an innovative application of Cyber Informed Engineering to developing and deploying a BioSecure Digital Twin to improve the resilience and security of the biopharma industrial supply chain and production processes. Finally, the chapter concludes with a process framework to complement the Digital Twin platform, called the Biopharma (Observe, Orient, Decide, Act) OODA Loop Framework (BOLF), a four-step approach to decision-making outputs from the Digital Twin. The BOLF will help end users leverage twin technology by distilling the available information, focusing the data on context, and rapidly making the best decision while remaining cognizant of changes that can be made as more data becomes available.
The manufacturing sector is dramatically evolving with recent technical and digital advances. Among these, the digital thread is revolutionizing manufacturing operations well beyond the historic downloading of programs to computer numerically controlled (CNC) machine tools and the uploading of edited programs from CNC controllers. The digital thread is “the communication framework that enables a connected data flow and integrated view of the asset’s data throughout its lifecycle across traditionally siloed functional perspectives” (Leiva 2016). It is pervasive around the world and has changed the way society operates; for example, map apps are used to provide time-optimal directions to destinations using real-time traffic feedback. The digital thread makes it possible to digitally verify products, ensure that the latest technologies are deployed across the entire manufacturing ecosystem, and strengthen the workforce by making each individual more efficient and effective. These three foundational advanced manufacturing concepts will ensure a next-generation secure, resilient, and adaptable manufacturing ecosystem and sustainably support current and future needs of society (Lynn et al. 2020).