The COVID-19 pandemic has disrupted global supply chains on a monumental scale, rushing all MD&D manufacturers to quickly readapt and respond to new challenging market conditions. Moreover, today’s increasingly sophisticated personalized medicine, value-based care, real-world evidence models, demographic differences across regional economies and the new FDA and EU Regulatory implications have led to a point that even the most seasoned professional has difficulty navigate them. Important investments from US and China on their national supply chain and manufacturing processes have been actioned to provide high-quality and ready-to-use products for future crisis. This caused new market conditions in the MD&D. Medical manufactures, can access a specially tailored digital infrastructure from Siemens for the MD&D industry called “Operational Excellence through Smart Manufacturing”. This means to develop a digital infrastructure by using production digital twins to design and simulate manufacturing scenarios, schedule and execute production, enforcing routes, quality inspections to deliver high quality devices. This is also an approach for the small- to medium-sized businesses (SMB), the new emerging market leaders, aiming at creating the same digital infrastructure of their larger competitors to get their own innovation to market, rapidly, cost-efficiently and in compliance with high quality standards international regulatory authorities require.