John Linehan

John Linehan is a Clinical Professor of Biomedical Engineering at the McCormick School of Engineering, Northwestern University. His research focuses on medical device innovation processes, health technology assessment, and FDA regulation of medical devices. He has authored numerous influential publications on regulatory frameworks, medical device development methodologies, and interdisciplinary collaboration between academia and industry.

His work emphasizes improving the efficiency and safety of medical device approval processes, particularly through analyses of the FDA’s 510(k) pathway. He has also contributed to global initiatives like BioInnovate Ireland, which trains innovators in healthcare technology commercialization.

• Key contributions include stage-gate process optimization for medical devices and economic analyses of obstructive sleep apnea therapies.
• His research bridges engineering, policy, and clinical practice to address challenges in translating medical innovations into clinical solutions.

While no formal awards are listed, his extensive publications and academic roles highlight his leadership in biomedical engineering and regulatory science.