As delivery devices become more autonomous, regulatory bodies like the FDA (US) and EMA (EU) have had to rewrite their playbooks. In 2025, the focus is on "Human Factors Engineering" (HFE). Regulators now require extensive "Usability Testing" to prove that an 80-year-old with arthritis or a 10-year-old with asthma can use the device correctly and safely without supervision. The Drug Delivery...