title: Steps required to inclusion in commercial ECG analysis systems--the new ECG indices for quantitating extent, acuteness and severity of acute myocardial ischemia for facilitating emergency triage decisions.
abstract: Clinically useful diagnostic methods for chest pain triage often fail to reach everyday practice where they can improve patient outcomes. One means to bridge the gap is through adoption of ECG interpretive algorithms with enhanced accuracy or expanded features into established commercial products. The transition from innovation to industry can be facilitated if researchers consider three factors aiding a successful handoff to companies. First, they should assess their algorithm to assure that it meets a real market need and can be easily assimilated by commercial partners. Second, their design documentation and databases should support the regulated development processes required of manufacturers. Finally, they should hold appropriate expectations for the structure of commercial partnerships that lead to release of a marketed product.
authors.affiliation: Stone Bridge Biomedical BV, Maastricht, the Netherlands. Electronic address: dave.hampton@stonebridgebiomed.com.
authors.forename: David R
authors.initials: DR
authors.lastname: Hampton
mesh_terms: D000208:Acute Disease; D003936:Diagnosis, Computer-Assisted / Q000295:instrumentation / Q000379:methods*; D004562:Electrocardiography / Q000295:instrumentation* / Q000379:methods*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D007221:Industry / Q000295:instrumentation / Q000379:methods; D017202:Myocardial Ischemia / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index
keywords: Commercialization; Decision support; Innovation; Interpretive algorithm; Medical device development; Technology transfer