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
Key terms
Modules
Covers how products reach patients, from science pipelines to FDA approval routes and proving value to payers.
Covers the key players, their power dynamics, and where value and margin are captured across the chain.
Covers the regulators, quality standards, data laws, and post-launch compliance shaping the sector.
Covers the market sizes, acronyms, benchmarks, and quick calculations professionals use daily.
Latest articles
Recent articles from the blog that apply to Biotech & MedTech.
- FinancePharma partnership terms that protect your pipeline when the science goes sidewaysMilestone-based deals are how most biotech companies survive long enough to see their drug approved, but poorly structured agreements can leave a CFO holding the downside while the partner captures the upside. This playbook shows how to build deal terms that align incentives across a decade-long development arc.
- DataOne HCP, six records: why identity resolution is pharma's most expensive data problemA single cardiologist can exist as six different entities across a pharma company's CRM, claims data, and prescriber analytics systems, and none of them match. Until identity resolution works in practice, every downstream decision, from sampling allocations to pharmacovigilance reporting, is built on a fractured foundation.
- FinanceRisk-adjusted NPV for pre-revenue biotech pipelines: how the math actually worksMost valuation frameworks break down when applied to a drug candidate that has never generated a dollar of revenue and may never reach patients. Risk-adjusted NPV fixes that problem, but only if you understand what the model is actually doing and where it quietly fails.
- DataGxP integrity, 21 CFR Part 11, and GDPR: what happens when three regulatory regimes collidePharma CDOs operate at the intersection of three distinct regulatory systems, each with its own logic, its own enforcement body, and its own definition of what a data record actually is. Understanding where those systems conflict, not just where they overlap, is the difference between audit readiness and a consent notice architecture that accidentally destroys your audit trail.