An engineered 3D-printed realistic patient simulator: market assessment

在加拿大、美国和大多数西方国家，心血管疾病是导致死亡的首要原因。准确的诊断和治疗需要高性能的医疗设备和持续高质量的医疗培训。使用“标准”医学教育模式很难实现这一点。最近医学界发生了一些重大变化：1)医生的教学时间大幅减少；2)患者作为教育资源的可用性较低；3)更严格的医学法律制度；4)认证和监管机构更加重视能力的持续维护。因此，对于住院医师培训和医生能力的维持来说，依靠真实的病人正在成为一个不太理想的选择，导致对高保真模拟器的需求显著增加。另一方面，新开发的植入式医疗设备需要经过一系列广泛的台架测试。这不仅包括设备本身的性能测试，还包括其输送系统的性能测试。然而，目前现有的心脏模拟器并没有针对高级医疗培训和接近真实的医疗设备台架测试进行优化。我们已经开发出了第一个真实完整的心脏模拟器，能够再现正常和病理状态。该模拟器能够在解剖正确的心脏腔内再现正常和异常的生理压力和流量条件，为植入式医疗器械和医疗实习生在植入过程中所经历的复杂环境提供更真实的画面。我们的技术最重要的市场是不断增长的医疗模拟器和植入式心血管医疗设备市场。这项市场评估拨款申请的目的是在重新提交我们不成功的第I阶段申请之前，确定最适合我们技术的市场并确定其规模

Cardiovascular disease is the first cause of death in Canada, in the United States and most occidental countries.Accurate diagnosis and treatment require high performance medical devices and continuous high-qualitymedical training. This is becoming hardly achievable using the "standard" medical education model.Significant changes have been recently affecting the world of medicine: 1) an important reduction in physicianteaching time; 2) a lower availability of patients as educational resources, 3) more strict medicolegal systems;4) accreditation and regulatory bodies putting more emphasis on continuous maintenance of competence. As aconsequence, relying on real patients is becoming a less desirable option for resident training and maintenanceof physician competence, leading to a significant increase in the demand for high-fidelity simulators. Fromanother side, newly developed implantable medical devices are required to undergo an extensive series ofbench testing. This includes not only performance testing of the device itself but also of its delivery system.Currently existing cardiac simulators are, however, not optimized for advanced medical training and forclose-to-real bench testing of medical devices. We have developed the first realistic complete heart simulatorcapable of reproducing normal and pathological conditions. The simulator is capable of reproducing normaland abnormal physiological pressure and flow conditions in anatomically correct heart cavities, providing amore realistic picture of the complex environment that will be experienced by the implantable medical deviceand by the medical trainee during the implantation procedure. The most important markets for our technologyare the growing markets for medical simulators and for implantable cardiovascular medical devices. Theobjective of this market assessment grant application is to define and size the most suitable market for ourtechnology before re-submitting our unsuccessful I2I phase I application