Michael J. Free

Achieving appropriate design and widespread use of health care technologies in the developing world.: Overcoming obstacles that impede the adaptation and diffusion of priority technologies for primary health care

Objectives: To identify and describe constraints facing the development and dissemination of technologies appropriate for public health care challenges and solutions in the developing world. Methods: Review of lessons learned in development and introduction of numerous health technologies as experienced by a non‐profit organization working on technologies for 25 years. Results: Many obstacles prevent appropriate technologies from reaching widespread use and acceptance. These include low profit margins in developing world markets, regulatory constraints, and the need for systems changes. Strong public/private‐sector partnerships and realistic approaches to working in these environments make a difference. Conclusions: There is a growing awareness of the need for new technologies and experience with strategies that can make them happen. Some technologies with documented value for maternal care in developing world settings appear to be stuck short of widespread acceptance and use. Understanding the factors impeding their progress can enable the public sector and its collaborators to organize and facilitate their progress more effectively.

An assessment of burst strength distribution data for monitoring quality of condom stocks in developing countries

Laboratory tests were conducted on condoms to examine the changes that occur over time in indicators of condom burst strength, and to determine the relationship between laboratory-assessed condom burst strength and breakage during use in a developing country setting. Three groups of unaged condoms purchased directly from the manufacturer were used: one group exposed to UV light for 10 hours; one group exposed for five hours; and one group unexposed. A sample of each of these groups was tested according to ISO condom air burst test protocols. The remaining condoms were individually packaged in coded polyethylene bags for shipment to the developing country study site. Also used in the study was a group of condoms that had been aged for over 40 months under field conditions in a tropical climate; a sample from this group was tested by the ISO air burst test protocol and the remainder distributed to the study site. One-hundred-thirty Indonesian urban males participated in the double-blind study. Volunteers were not relying on the condom for contraceptive purposes. Each volunteer was given one individually packaged untreated condom, one condom from each treatment group, and four condoms aged in the field. Study participants were instructed to return all used condoms. Each condom that was returned after use was examined for breakage, and the unbroken condoms were subjected to an air inflation test to determine volume and pressure at burst. A comparison of the air burst volume data for a sample of unused and used condoms from the same treatment group indicates that most of the condoms that broke during use had air burst volumes below 11 liters. Therefore, a significant downward shift in the burst strength distribution as measured in the laboratory is likely to result in an increased breakage rate during use. A Condom Deterioration Index calculated from regular periodic testing of stored condom stocks is a convenient and sensitive means of monitoring trends in the distribution and deterioration of condom strength.

Relationship between condom strength and failure during use.

The relationship between condom strength and failure during use was examined in six volunteers using artificially deteriorated condoms. Samples of each condom set exposed to ultraviolet light for three to eleven hours were tested for strength by air burst procedures. The remaining condoms were used by volunteers protected from pregnancy by other means. Burst pressure fell to 35% and burst volume to 17% of untreated levels after six hours of ultraviolet exposure. A maximum mean breakage rate during use of 30% was obtained at this time, although individuals experienced breakage rates up to 70% at this stage of deterioration. No failures occurred during use until condoms had deteriorated by more than 25%. Conclusions were: 1) that burst test parameters can effectively and sensitively measure changes in condom strength, 2) that condoms produced to western industrial standards carry a wide margin of strength over and above the minimum required for effective use, 3) that stored condoms should not necessarily be thrown out if they are uniform in strength but fall below original acceptance standards.

Latex rubber condoms: Predicting and extending shelf life

Condoms from five manufacturers were subjected to controlled exposures of heat, humidity, and air and to different natural environments in five countries. Under aerobic conditions (condoms in permeable packages or unpackaged), stress properties declined. The relationship between rate of decline as a function of temperature was quadratic. Under oxygen-restricted conditions (foil-wrapped packages) at average storage temperatures of 30 degrees C and lower, strain properties declined with little or no significant change in stress properties. The effect is to cause condoms to become stiffer; high-breakage rates in use have been correlated with product stiffening. A new rationale for accelerated-aging tests to predict condom shelf stability is suggested, including a test to control the trend of condoms to stiffen. Silicone lubricant, impermeable packaging, and inclusion of antioxidants in the condom formulation can prevent or minimize aerobic breakdown of latex condoms. Specifying low-modulus condoms can prevent excessive stiffening.

Health technologies for the developing world. Addressing the unmet needs.

This paper provides a critical overview of several strategies and mechanisms that have been employed by the Program for Appropriate Technology in Health over the past decade to address the unmet needs for health technologies in the developing world. Partnerships between public and private-sector organizations are emphasized in order to share risks, encourage efficiency, and ensure the availability of priority products for health care in resource-poor settings. Incentives for the involvement of the commercial sector, the means to protect the interest of the public sector, and the role of bridging organizations are discussed in the light of the shifting goals of the public sector.

Prioritizing investments in innovations to protect women from the leading causes of maternal death

PATH, an international nonprofit organization, assessed nearly 40 technologies for their potential to reduce maternal mortality from postpartum hemorrhage and preeclampsia and eclampsia in low-resource settings. The evaluation used a new Excel-based prioritization tool covering 22 criteria developed by PATH, the Maternal and Neonatal Directed Assessment of Technology (MANDATE) model, and consultations with experts. It identified five innovations with especially high potential: technologies to improve use of oxytocin, a uterine balloon tamponade, simplified dosing of magnesium sulfate, an improved proteinuria test, and better blood pressure measurement devices. Investments are needed to realize the potential of these technologies to reduce mortality.

Health Technologies for the Developing World: Promoting Self-reliance through Improving Local Procurement and Manufacturing Capabilities

To reduce their dependency on donors or the international currency costs of essential health care products, developing countries are building or improving capability for local manufacturing or competitive international procurement. Through long-term strategic planning, public/private partnerships, collaboration with firms in industrialized nations, and farsighted donor policies, the capacity for alternative supply can be increased in stages from importation through local processing and packaging to full production and multiproduct enterprises.

Transfer of contraceptive production technology to developing countries.

Explores the value of local production as a supply option for contraceptives. The views of donor agencies service organizations multinational firms and developing countries are frequently divergent on this issue. At present 20 developing countries have contraceptive use rates above the level required for full scale production of orals IUDs or condoms. 14 of these countries already have some production capacity or have conducted feasibility or preinvestment studies in preparation for technology transfer. In most cases current local production capacity is not sufficient to meet local public sector demand. Often the local products are competing with donor supplied imported contraceptives which are distributed free of charge or at a subsidized price. The problems of technology transfer to developing countries for contraceptive production are common to the establishement of any industrial technology requiring high standards of quality rigorous manufacturing practices and precision equipment. These problems can be overcome but the process requires more time than is usual for the developed world and project costs can escalate rapidly. Costs of the finished product may not be lower than those in the developed country in spite of lower costs for land buildings labor raw materials or other inputs. However savings in foreign exchange currencies can be expected when compared with purchase of imported products. Careful planning on the part of developing countries and donor agencies can ensure the optimum outcome for local production decisions. These decisions will not always be made solely on the basis of technical and economic feasibility. Strategies for effective decision making are detailed for donors and developing countries as well as critical decision paths for choosing supply options. (authors modified)

Local production of contraceptives in developing countries.

The local production of contraceptives is considered in this paper. Focus is on the following: perceptions of contraceptive supply and production issues (international and local viewpoints); the decision making practice (the limits of production purpose and nature of feasibility studies options for implementation special problems and considerations in assessing feasibility of industrial projects in developing countries specific product considerations and quality control); current status (existing facilities models for local production of contraceptives and project and production costs); and strategies (donors and the developing countries). In the face of increasing uncertainty regarding the nature and extent of donor assistance many governments are exploring in greater detail the options available to them for self-support in family planning. Except for those countries that already have a substantial contraceptive manufacturing industry the options for self-support in contraceptive supplies involve either procurement using international currencies or development of the means to manufacture locally. Very few developing countries presently have use rates sufficient to justify full-scale local production but packaging and testing operations may be scaled to the needs of many countries. Feasibility studies are necessary for developing country governments to make a decision whether to participate directly or through the private sector in the manufacturing of contraceptives. The donor agencies can play a vital role in these decisions. From the local perspective several benefits arise from local production of contraceptives providing contraceptive use is sufficient to justify a reasonable scale of production technology. Full-scale production of contraceptives can only be carried out efficiently at production volumes above a minimum scale of operation. The technologies associated with different contraceptive products are sufficiently different that each presents a unique set of problems and calls for special consideration at a very early stage of the study. Condom IUD and oral contraceptive production are reviewed. The current cost of setting up complete contraceptive production capabilities at the minimum economic scale in a developing country is likely to be in the range of U.S.

Single use disposable syringe

5-8 million for condom production