Abstract
• Novel devices must meet rigorous thresholds for clinical efficacy and safety. Some innovations succeed more than others. • Variations in the success trajectory of innovations cannot be easily explained by device efficacy alone. • The key to successful device development lies in 2 concepts of business theory: disruptive innovation and co-opetition. • We propose that initial randomized clinical trials of newer devices be conducted on these 2 building blocks. • Our construct places interventions in a Venn diagram depicting disruptive innovation, co-opetition and randomized trials. • Our construct has significant implications for industry, regulatory bodies and clinical trialists.
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