McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, 101 College Street Suite 406, Toronto ON, M5G 1L7, Canada.
BMC Int Health Hum Rights. 2010 Dec 13;10 Suppl 1(Suppl 1):S10. doi: 10.1186/1472-698X-10-S1-S10.
A traditional pathway for developing new health products begins with public research institutes generating new knowledge, and ends with the private sector translating this knowledge into new ventures. But while public research institutes are key drivers of basic research in sub-Saharan Africa, the private sector is inadequately prepared to commercialize ideas that emerge from these institutes, resulting in these institutes taking on the role of product development themselves to alleviate the local disease burden. In this article, the case study method is used to analyze the experience of one such public research institute: the Kenya Medical Research Institute (KEMRI).
Our analysis indicates that KEMRI's product development efforts began modestly, and a manufacturing facility was constructed with a strategy for the facility's product output which was not very successful. The intended products, HIV and Hepatitis B diagnostic kits, had a short product life cycle, and an abrupt change in regulatory requirements left KEMRI with an inactive facility. These problems were the result of poor innovation management capacity, variability in domestic markets, lack of capital to scale up technologies, and an institutional culture that lacked innovation as a priority.However, KEMRI appears to have adapted by diversifying its product line to mitigate risk and ensure continued use of its manufacturing facility. It adopted an open innovation business model which linked it with investors, research partnerships, licensing opportunities, and revenue from contract manufacturing. Other activities that KEMRI has put in place over several years to enhance product development include the establishment of a marketing division, development of an institutional IP policy, and training of its scientists on innovation management.
KEMRI faced many challenges in its attempt at health product development, including shifting markets, lack of infrastructure, inadequate financing, and weak human capital with respect to innovation. However, it overcame them through diversification, partnerships and changes in culture. The findings could have implications for other research institutes in Sub-Saharan Africa seeking to develop health products. Such institutes must analyze potential demand and uptake, yet be prepared to face the unexpected and develop appropriate risk-mitigating strategies.
开发新的健康产品的传统途径始于公共研究机构生成新知识,止于私营部门将这些知识转化为新的企业。但是,尽管公共研究机构是撒哈拉以南非洲基础研究的主要驱动力,但私营部门尚未做好充分准备将这些机构提出的创意商业化,从而导致这些机构自身承担产品开发的角色,以减轻当地的疾病负担。本文采用案例研究方法分析了一家此类公共研究机构的经验:肯尼亚医学研究所(KEMRI)。
我们的分析表明,KEMRI 的产品开发工作起点较低,并且构建了一个生产设施,该设施的产品输出策略并不是很成功。预期产品 HIV 和乙型肝炎诊断试剂盒的产品生命周期很短,并且监管要求的突然变化使 KEMRI 的生产设施处于闲置状态。这些问题是由于创新管理能力差、国内市场的变化、缺乏扩大技术规模的资金以及缺乏创新作为优先事项的机构文化所致。但是,KEMRI 似乎已经通过多样化其产品线来分散风险并确保其生产设施的持续使用来适应这种情况。它采用了开放式创新商业模式,将其与投资者、研究合作伙伴、许可机会以及合同制造收入联系起来。KEMRI 多年来为增强产品开发而采取的其他措施包括建立营销部门、制定机构知识产权政策以及对其科学家进行创新管理培训。
KEMRI 在尝试进行健康产品开发时面临许多挑战,包括市场变化、基础设施不足、资金不足以及创新方面的人力资本薄弱。但是,它通过多元化、合作关系和文化变革克服了这些挑战。这些发现可能对其他寻求开发健康产品的撒哈拉以南非洲研究机构具有启示意义。这些机构必须分析潜在的需求和采用情况,但也要做好应对意外情况的准备,并制定适当的风险缓解策略。