Emergence of digital technologies in various industries have been occurring at an astounding pace over the past decade. Healthcare is one of the key industries that can significantly benefit from this technological revolution. Application tools such as computational modeling and simulation (CM&S) as well as Data Analytics, could optimize drug and medical device development and regulatory research, with the capability to accelerate access to safe and effective products. Furthermore, manufacturing technologies continue to evolve as the internet of things, artificial intelligence, robotics, and advanced computing begin to challenge the traditional approaches, practices, and business models for the manufacture of pharmaceuticals and medical devices. The application of these technologies has the potential to dramatically increase the agility, efficiency, flexibility, and quality of the industrial production of both medicines and medical devices. How these technologies are deployed on the journey from data collection to the hallmark digital maturity of Industry 4.0 will define the next generation of pharmaceutical and medical device manufacturing. Achieving the benefits of this future requires a vision for it and an understanding of the extant regulatory, technical, and logistical barriers to realizing it.