2024 MedTech Regulatory Updates: 4 Areas Of Interest

By Tina Caruana, Director of eClinical Solutions

In 2024, McKinsey's projections foresee a promising year for the MedTech industry, driven by innovation but shadowed by regulatory uncertainty. Regulatory bodies are honing in on four crucial areas: holistic evidence, AI and ML, cybersecurity, and participant diversity.

Holistic evidence collection, emphasizing efficacy, safety, and cost-effectiveness, is becoming imperative, with advancements in real-world data (RWD) and evidence (RWE) enhancing postmarket safety monitoring. Regulators are adapting oversight to the rapid pace of AI and ML innovation, evidenced by the FDA's draft guidance and the European Medicines Agency's reflection paper. Cybersecurity is also paramount, with the FDA and European authorities issuing guidelines to fortify data security in medical devices against cyber threats.

Addressing historical biases, efforts to enhance participant diversity in clinical trials are underway, supported by regulatory initiatives like the FDA's draft guidance and the Food and Drug Omnibus Reform Act. MedTech companies must prioritize regulatory compliance, seeking ISO certifications and partnering with vendors compliant with industry standards like SOC 2 Type II, ISO/IEC 27001, GDPR, and more, ensuring both therapeutic and data assets are safeguarded.