天津哈娜好医材有限公司成立于1986年,是中国较早生产一次性使用医用高分子制品的中外合资企业之一。公司于2020年4月进行了新一轮股权变更,现由天津天时泽投资管理中心全资控股。现公司总占地面积143677.63平方米。
多年来对品质的坚持为企业积累了良好的口碑,使企业保持着良好的市场占有率和竞争实力。目前,是天津医疗器械行业协会会员、天津国际交流协会会员、输液器标委会委员、高分子行业协会会员、天津生物医学工程学会成员,国家高新技术企业、天津市科技小巨人领军培育企业。
以“HANACO”、“哈娜好”品牌生产的一次性使用输液器、注射器、输血器、头皮针、血液透析管路、动静脉穿刺针、造影导管、采血针等系列产品,均达到国际标准,通过了ISO13485和CE认证。在医疗器械GMP推行初期,作为试点企业首批通过认证,同时,公司历经多次美国FDA工厂审核并通过。产品覆盖全中国并远销南北美洲、欧洲、亚洲等,在国内有天津、北京、上海、沈阳、哈尔滨、武汉、西安、杭州、南京等十余个办事处及数十家分销商,产品外销美国、日本、韩国、沙特阿拉伯、菲律宾、斯里兰卡以及南非地区国家等近20个国家。
企业目前占地面积58794平方米,其中天逸工厂40010.3平方米,建筑面积10227.57平方米,泰达工厂18783.6平方米,建筑面积合计13644.13平米,净化厂房总计9202平方米。企业年均销售额3亿左右,拥有世界先进的生产设备、检测仪器和先进的生产工艺的企业。优秀的产品品质和经营诚信在市场树立了良好的品牌形象和产品知名度。企业共有固定员工800人左右,由一支优秀的忠于企业的管理队伍和一支诚实、忠厚、吃苦耐劳的职工队伍组成,是一个和谐、快乐、极富竞争力的团队。企业股份变更后,新的领导团队加大管理力度,引入OA、ERP、5S、合理化建议、精细化管理等新型管理模式,管理效率得到进一步改善。
企业以科技为未来发展战略,积极承担科技项目,提升自身科技水平,先后获得天津市企业技术中心、天津市企业重点实验室认定。企业重大改进产品“新型血液净化装置体外循环血液管路(血液回路)”获得“天津市杀手锏产品”和“天津市专精特新产品”认定,该产品已形成一定规模的经济效益,且在天津市场占有率持续排名第一位,且产品销售覆盖全国二十多个省市,出口日本的产品达到8600万元,在日本血液回路市场占有率30%。企业新产品“多功能输液器”获得“天津市重点新产品”认定,该产品在企业主打输液器产品的基础上设计开发,迎合临床使用要求,具有革命性意义。未来企业将逐渐向内销转化,进一步降低销售成本,为国内市场提供更高标准的医疗耗材产品,创造更大市场价值。
新产品“多功能输液器”获得“天津市重点新产品”认定,此外企业还承担市科委科技支撑重点项目、科技小巨人了领军企业培育项目、滨海新区科技小巨人项目等多项科技项目。拥有有效专利44项,其中发明专利5项,实用新型专利20项,外观设计专利14项,另有专利申请十余件。
企业秉承“做全球品牌的医用管路专业生产基地,做大做强国内市场,适机拓展国际市场”的战略。未来企业将通过厂房扩建,破除向行业高端化发展的瓶径,达到集中生产、节省管理和人工成本的目的,为全面向自动化智能化生产转型打好基础。企业下一步计划研发新产品包括:血栓切除术系统、山诺士®随行宝消毒喷剂、胰岛素针、静脉治疗类等高附加值项目。随着企业自身产能的大幅度提高,未来将减少对外加工式生产模式的依赖,特别是随着具有国内独家知识产权的血栓切除术系统、山诺士®随行宝消毒喷剂等一批新品的投产和上市,企业在行业高端市场的竞争力也将得到进一步增强。我们有充分地理由相信,在未来的5年内,依靠本企业自身的品牌、技术、质量的优势,完全有能力占领全国医用高分子材料高端市场的半壁江山。
尽管近年来公司不断地在品牌影响力与渠道建立上加大投资力度,但仍存在产品线不够丰富、产能以及配套人员和生产设备一定程度上不能满足市场需求等问题。因此近年来企业一直实行自主生产为主,外加工生产为辅的策略,有七家外加工厂配合公司进行产品的生产。为了节约成本,实现统一管理,更好地控制产品质量,开发更丰富的高附加值产品,为市场和患者提供更高标准的一次性使用医疗器械,哈娜好将扩建厂房,不仅将外加工厂业务收回改为自主生产,提高公司生产效率;并且紧跟行业发展趋势,为公司生产血栓切除术系统、胰岛素针、静脉治疗类等高附加值产品提供生产空间和条件,为公司全面向自动化、智能化生产转型打好基础。
新厂房包括研发中心、实验室、办公用房及生活配套用房;生产区包括净化车间、原料库、产成品仓库、危险品库、动力用房等,总建筑面积约为58150平方米。购置生产设备866台、实验仪器设备40台、公用工程系统及环保设施设备14台。项目达产后,各产品生产规模为:血液回路3500 万套,安全采血针8000 万套,采血针、头皮针120 万套,导管、导丝100 万条,麻醉针1200 万套,血管血栓去除平台12 万套,山诺士®随行保消毒120 万套,胰岛素针5000 万套,留置针4000 万套,中心静脉导管60 万套。
TianJin Hanaco Medical Co.,Ltd, established in1986, is one pioneer of Sino foreign joint ventures of producing disposable medical high polymer product.The company carried on the updated change of equity in April.2019 and is wholly owned by TianJin TianShiZe investment & management center. With occupation of 143,677.63 square meters space。
The Insistence for quality control over years accumulates perfect reputation for the enterprise and make it keep good market shares and competitive strength. So far, TianJin Hanaco Medical Co.,Ltd has been the member of Tianjin Medical Device Industry Association and Tianjin International communication Association, the member of the Standard Committee on Infusion set and of the high polymer industry association and of Tianjin Biomedical Engineering Society, the enterprise of national high-technology and the leading and cultivated small giant enterprise of Tianjin science and technology.
The series of products produced with the brand of“HANACO”or“哈娜好”including disposable infusion sets,disposable sterile hypodermic syringe,disposable blood transfusion sets,disposable scalp vein sets, disposable dialysis bloodlines, disposable Arterial Venous fistula sets,disposable angiographic catheter and disposable blood collection sets and so on, reached up to the international standard and got approval of ISO13485&CE。In the initial stage of promoting GMP, the company got the first approval as the trial enterprise, and experienced and passed through many FDA plant audits.The scope of product covers all China and North and South America,Europe and Asia. Hanaco has nearly a dozen of offices and dozens of distributors in TianJin, BeiJing, ShangHai, ShenYang, HaErBin, WuHan, XiAn, HangZhou and NanJing, and the product is exported to nearly 20 countries like US, Japan, Korea, Saudi Arabia, Philippine, Srilanka and countries in South Africa.
TianJin Hanaco Medical Co.,Ltd has occupation space of 40,010.3 square meters in TianYi factory and 18,783.6 square meters in TEDA factory and 9202 square meters for purified workshop.The total structural area of production and development base project which has got the approval to be in construction stage in Airport economic zone is 84,883.63 square meters and the total structural area of purified workshop is 50,300 square meter. The annual sales amount of enterprise is around RMB300,000,000 and we are the enterprise with global advanced production equipment, inspection apparatus and up-to-date production arts and crafts. Excellent quality and business sincerity establish very good brand image and reputation of product. The enterprise with 800 permanent employeesconsisting of an outstanding and faithful management team and an honest, sincere and hard-working worker team is a harmonized, happy and very competitive team. After the change of equity, the new teamleaders of enterprise engage in strengthening the management, introducing updated management mode like OA、ERP、5S、rational proposal、fine management and further improving the management efficiency.
Regarding technology as future development strategy, actively undertaking science and technology project and promoting its scientific and technological level, the enterprise successively got the approval from Tianjin Enterprise Technology Center, Tianjin Enterprise Key Laboratory. The product“new blood purified device -- bloodline set”on critical changes by the enterprise obtained the approval from “Tianjin master-card product” & “Tianjin specialized and new product”. The product has formed a certain scale of economic benefits, continuously ranked the first in market shares in Tianjin and been sold over 20 provinces and cities in China, the sales amount reaches up to RMB86,000,000 on Japan direction and the product takes 30% market shares in Japan bloodline market. The new product“multifunctional infusion set” which obtained the approval from“Tianjin key & new product” is designed and explored on the base of focus on IV set to meet clinical-use requirement and to be revolutionary significance.The enterprise will gradually shift the sales focus to the domestic to reduce the cost of sales, to provide disposable medical product with higher standard for the domestic market and to create greater market value.
The new product“multifunctional infusion set”obtained the approval from“Tianjin key & new product” and the enterprise which undertook many scientific and technological projects like the key project supported by Municipal Science and Technology Commission, and the project of little giant in TEDA owns 5 patents for invention and 20 patents for practical and new patent and 14 patents for exterior design of total 44 effective patents and about a dozen patent applications.
The enterprise is always following the strategy of “Being the professional production base for global medical blood tubing set, being bigger and stronger in China domestic market and seeking the chance to explore the global market”. The enterprise will get the goal of centralizing production and saving the cost of management and labor through plant expansion and break of bottleneck in the process of industrial advanced development, and lay the foundation for transformation toward total automatic and intelligent production. The new products to be planned for the next step are: thrombectomy system, Sanosil sustainable shield disinfectant spray, insulin needle, products for treatment by venous and some high added value projects. Relying on the mode of OEM process will be reduced in the future as the significant increase on the capacity of the enterprise itself and the competitiveness of enterprise in advanced market of this industry will be further enhanced especially as the production and going public of thrombectomy system, Sanosil sustainable shield disinfectant spray and some new products with exclusive domestic intellectual property rights. We’re in deep trust for that we totally have capability to conquer half of advanced market of medical high-polymer material in China.
To some extent, the problem of insufficient production line and the problem of lacking productivity, correspondent staff and production equipment are still hardly to meet market requirement although our company is always increasing investments on brand promotion and establishment of distribution channel. Therefore, the enterprise is always implementing the strategy of independent production as main and OEM production as supplementary in recent years, and 7 outsourcing plants for cooperation on production. In order to save the cost, to realize unified management, to be better to control the product quality, to develop more abundant and high added value product and to provide disposable medical equipment with higher standard for the market and patient, Hanaco selected industrial area of 76,000 square meters in Tianjin airport economic and developed zone in 2019 to construct the new production and development base(total area of structure 84,883.63 square meters). Hanaco not only retracted the business from outsourcing plants and returned into independent production for promoting productive efficiency and following the trend of industry development, but also supplied production space and condition for thrombectomy system, insulin needle,high added value products of venous treatment and laid on the foundation for the complete automatic and intelligent production transformation.
The new factory in total area of structure 58150 square meters includes research center, lab, office and living area; the working area includes purified workshop, raw material storehouse, storehouse for finished products, storage for dangerous goods and power room. We purchased production equipment 866pcs,inspection equipment 40pcs、public engineering system and environmental equipment 14pcs. When the production is ready, the production scale of these products is : BL set 350,000pcs,safety blood collection needle 80,000,000pcs,blood collection needle and scalp vein sets 1,200,000pcs, guide wire and catheter 1,000,000pcs,spinal needle 12,000,000pcs,thrombectomy 120,000pcs,Sanosil sustainable shield disinfectant spray 1,200,000pcs,insulin needle 50,000,000pcs,IV catheter 40,000,000pcs,central venous catheter 600,000pcs.