Medical Devices and Pharmaceutical Manufacturing

Making medical products is manufacturing under a licence. A device plant or a drug plant can only ship what its regulator has approved, made by a process it has validated, in a facility that passes inspection; a quality failure does not just cost scrap and warranty, it can stop a product line for years and leave patients without supply. In the US the rules are the FDA's device quality system — the Quality Management System Regulation (QMSR), which aligned 21 CFR Part 820 with ISO 13485:2016 and took effect on 2 Feb 2026, when the FDA also retired its old QSIT inspection technique — and the drug current good manufacturing practice (CGMP) rules. The industry's recent history is a run of plant-level shocks with national consequences: Abbott's Sturgis, Michigan infant-formula recall (17 Feb 2022), Philips Respironics' ventilator and sleep-apnoea device recall (2021) and consent decree (2024), BD's Alaris infusion-pump recalls, and Hurricane Helene's flooding of Baxter's North Cove, North Carolina IV-solutions plant in late Sep 2024, which caused a national IV-fluid shortage until Baxter restored inventory in May 2025 and the FDA declared the sodium chloride 0.9% shortage over on 8 Aug 2025 (reported). On the drug side, contract manufacturers (CDMOs) and sterile fill-finish capacity became strategic assets: Novo Holdings bought Catalent for ~$16.5bn (closed 18 Dec 2024), GLP-1 demand drove the largest pharmaceutical plant-building programme in US history — Eli Lilly said its US capital commitments since 2020 exceeded $50bn (company claim) — and Section 232 tariffs of up to 100% on patented pharmaceuticals (proclaimed 2 Apr 2026) pushed companies to pledge US plants. This section takes the manufacturing and process angle: how devices and drugs are made, validated and inspected, why supply is fragile, and what the 2024–26 shocks and build-outs show. The device and drug businesses, their pricing and their recalls as commercial events are covered in Healthcare 07 Medical Devices and Healthcare 05 Pharmaceuticals.