JLU: 1. Workforce Shortages
As demand for services explodes, there is a growing shortage of nuclear medicine physicians, technologists, radiopharmacists, medical physicists, and radiochemists. Training new specialists takes time, and there is a lag between the rapid expansion of the field and the capacity of the educational pipeline. New models such as fast-track fellowships, theranostics certification programs, and cross-specialty training (bridging radiology, oncology, and nuclear medicine) are being actively considered and created to address this gap.

2. Supply Chain Fragility
Isotope production and supply chains—for critical isotopes like Tc-99m, Lu-177, and Ac-225—are fragile, aging, and vulnerable to geopolitical risks. Manufacturing capacity for radiopharmaceuticals, particularly therapeutic agents, remains limited. Fortunately, substantial public and private investments are now underway to build new cyclotrons, enable accelerator-based production, and expand U.S. isotope capacity, reducing reliance on imports.
3. Infrastructure Limitations
Many hospitals and clinics still lack essential facilities such as hot labs, shielded infusion rooms, and storage for radiotherapeutics needed to offer full theranostics services. Expanding access, especially to rural and underserved areas, remains challenging without major investment. However, innovations in mobile imaging/therapy units and the development of regional radiopharmacy hubs are beginning to make broader access feasible.

4. Regulatory and Reimbursement Hurdles
FDA approval processes and CMS reimbursement policies often cannot realistically keep pace with the exponential scientific advancements occurring annually. Uncertainty around reimbursement for newer diagnostics and therapies is a known deterrent for investment. Strong advocacy efforts are helping to drive consideration for new reimbursement pathways and more streamlined regulatory mechanisms for theranostics radiopharmaceuticals.

5. Integration of Artificial Intelligence
AI holds great promise for nuclear medicine, but challenges remain around validation, regulation, and education. There is still hesitation and a lack of clarity about integrating AI safely into clinical workflows. With appropriate implementation, AI can significantly assist in image interpretation, patient selection, dosimetry calculations, and therapy response prediction, ultimately boosting efficiency and patient outcomes.

Molecular Imaging Homepage