i DIFFUSION AS A VALIDATION PROCESS: LEARNING FROM PATIENT INNOVATORS

ii Randomized, controlled clinical trials, although important for ensuring safety and efficacy, are criticized for being an inadequate validation process for certain medical innovation modalities and conditions. The main limitations and causes for critique are high costs, long duration, low patient recruitment, design rigidity and ethical issues. At the same time, there is growing evidence that patients and their family members innovate in treatments, therapies, and medical devices. These patient innovators are increasingly recognized as an important source of innovation. Although there is a fairly complex structure developed to formally validate healthcare products, little is known about the paths patient innovators take to validate their solutions before involving health regulators. In this context, we attempt to answer the following research questions: What are the patterns of the validation processes undertaken by patient innovators for their innovations? How can current practices of patient innovation validation be improved from its comparison with observational studies and clinical trials