Biotech & MedTech: how the sector works
how biotech and medtech work: the science-to-market path, the difference between drugs and devices, regulatory approval (FDA/CE, 510(k)/PMA), and the role of evidence.
This block builds foundational fluency in the biotech and medtech sector, covering how value is created from discovery through clinical development, manufacturing, and commercialization. You will map the end-to-end value chain, identify the players who shape it (pharma incumbents, biotech challengers, CROs, CMOs, payers, and regulators), and understand where margin concentrates. You will learn the regulatory architecture governing drugs and devices in the US and Europe, what approval and compliance actually require, and the market sizes, growth rates, and benchmarks that frame decisions. The block closes with the routine calculations and due-diligence checks professionals run when evaluating assets, companies, and opportunities in this capital-intensive, highly regulated sector.
What you'll master
- Map the biotech and medtech value chain and locate where margin and power concentrate
- Identify major player types and analyze competitive and power dynamics across the chain
- Apply the key US and EU regulatory requirements (FDA, EMA, MDR) to real compliance situations
- Run standard sector calculations and due-diligence checks on assets, pipelines, and companies