Ellis J R
Jeffrey R. Ellis, Inc., Technical & Economic Services, Newtown, PA 18940.
J Biomater Appl. 1988 Jan;2(3):328-40. doi: 10.1177/088532828700200302.
Entrepreneurial companies in biomaterials serve a valuable function in lowering the risk of developing new products and devices. In many cases liability considerations and a pragmatic conservatism make it difficult for established health-care products suppliers to develop new products directly. Biomaterials entrepreneurs encounter more difficulties in achieving commercial success than do entrepreneurs in other fields. For any reasonable profit to be made, the entrepreneur must be able to convert the biomaterial into a useful device. Safety and toxicity test data collection take a minimum of three years to collect, and it is often five or more years before a positive cash flow can be obtained. Start-up funding can be obtained from government agencies, charitable foundations, and private investment capital. A major health-care company can often be attracted once initial successes have been achieved. Biomaterials usage and device design is specific for each function or need. Specific devices that are currently needed are small (c. 4 mm) diameter artificial blood vessels, synthetic skin, and internal prosthetic devices which have better tissue compatibility, abrasion, corrosion, and wear resistance especially for flexing devices such as artificial joints, ligaments and tendons.
生物材料领域的创业公司在降低新产品和新设备研发风险方面发挥着重要作用。在许多情况下,责任考量和务实的保守态度使得成熟的医疗保健产品供应商难以直接开发新产品。与其他领域的创业者相比,生物材料领域的创业者在实现商业成功方面面临更多困难。为了获得任何合理的利润,创业者必须能够将生物材料转化为有用的设备。安全和毒性测试数据收集至少需要三年时间,通常要五年或更长时间才能实现正现金流。启动资金可以从政府机构、慈善基金会和私人投资资本获得。一旦取得初步成功,往往就能吸引一家大型医疗保健公司。生物材料的使用和设备设计针对每种功能或需求都是特定的。当前所需的特定设备包括小(约4毫米)直径的人造血管、合成皮肤以及具有更好组织相容性、耐磨性、抗腐蚀性和耐磨损性的内部假体设备,尤其是对于诸如人工关节、韧带和肌腱等可弯曲设备。