Abstract
A new product has completed clinical trials in a distant, resource poor hospital using a few dozen prototypes. The data looks great. The novel medical device solves a widely felt problem. The next goal is to integrate the device into the country’s healthcare system and spread the device to other countries. But how? In order to be widely used, the device must be manufactured and distributed. One option is to license the intellectual property (IP) to an interested third party, if one can be found. However, it is possible to manage the manufacturing and distribution without licensing. There are at least two common means for manufacturing a novel medical device targeted to resource poor settings: (a) formal (contract) manufacturing and (b) informal (local) manufacturing. There are three primary routes to diffusion of novel medical devices in the developing world: (1) local distributors (2) direct international sales and (3) international donations. Perhaps surprisingly, the least effective mechanism is direct importation through donation. The most successful mechanism, the method used by nearly all working medical devices in resource-poor settings, is the use of contract manufacturing and a local distributor. This article is written for the biomedical innovator and entrepreneur who wishes to make a novel healthcare technology or product available and accessible to healthcare providers and patients in the developing world. There are very few documented cases and little formal research in this area. To this end, this article describes and explores the manufacturing and distribution options in order to provide insights into when and how each can be applied to scale up a novel technology to make a difference in a resource poor setting.
Similar content being viewed by others
References
Basant, R., and P. Chandra. How universities promote economic growth. In: Chapter 13: University–Industry Links and Enterprise Creation in India: Some Strategic and Policy Issues, edited by S. Yusuf and K. Nabeshima. Washington, DC: World Bank, 2007.
Branson, B. R. Rapid tests for HIV antibody. MD AIDS Rev. 2:76–83, 2000.
Case Studies on Social Entrepreneurship. Project Impact. The Affordable Hearing Aid Project: Navarra University, 2004.
Compton, B. Let’s Make Donations More Effective: Don’t Waste These Important Efforts. St. Louis: Health Progress, 2012.
Crawford, M. Medical Product Outsourcing. Asia’s continued manufacturing evolution, May 2012.
Donaldson, K. M. Product design in less industrialized economies: constraints and opportunities in Kenya. Res. Eng. Des. 17(3):135–155, 2006.
Free, M. 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. Int. J. Gynaecol. Obstet. 85(Suppl 1):S3–S13, 2004.
Henderson, J. Electronics Industries and the Developing World: Uneven Contributions and Uncertain Prospects. Manchester: Manchester Business School, 1993.
Howitt, P., A. Darzi, G. Z. Yang, H. Ashrafian, R. Atun, J. Barlow, A. Blakemore, A. M. Bull, J. Car, L. Conteh, G. S. Cooke, N. Ford, S. A. Gregson, K. Kerr, D. King, M. Kulendran, R. A. Malkin, A. Majeed, S. Matlin, R. Merrifield, H. A. Penfold, S. D. Reid, P. C. Smith, M. M. Stevens, M. R. Templeton, C. Vincent, and E. Wilson. Technologies for Global Health. Lancet 380(9840):507–535, 2012.
Kwansah, J., M. Dzodzomenyo, M. Mutumba, K. Asabir, E. Koomson, M. Gyakobo, P. Agyei-Baffour, M. E. Kruk, and R. C. Snow. Policy talk: incentives for rural service among nurses in Ghana. Health Policy Plan. 27(8):669–676, 2012.
Malkin, R. A. Design of health care technologies for the developing world. Annu. Rev. Biomed. Eng. 9:567–587, 2007.
Marek, T., C. O’Farrell, C. Yamamoto, and I. Zable. Trends and opportunities in public–private partnerships to improve health service delivery in Africa. Washington, DC: The World Bank, 2005.
Medical Devices: An Area of Great Promise. Dr. Margaret Chan, Director General of WHO, Opening address at the Global Forum on Medical Devices, Bangkok, Thailand, September 9, 2010.
Medical Device Contract Manufacturing: World Market Prospects 2011–2021. Vision Gain, 2011, London, England.
Ministry of Health (MOH) [Zambia], Central Statistical Office [Zambia], and ORC Macro. Zambia HIV/AIDS Service Provision Assessment Survey 2005. Calverton, MD: Ministry of Health, Central Statistical Office, and ORC Macro, 2006.
Obalum, D. C., and F. Fiberesima. Nigerian National Health Insurance Scheme (NHIS): an overview. Niger Postgrad. Med. J. 19(3):167–174, 2012.
Perry, L., and R. Malkin. Effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? Med. Biol. Eng. Comput. 49(7):719–722, 2011.
Pupo, R. Why contract manufacturing in the U.S. makes sense, ReliablePlant, http://www.reliableplant.com/Read/19689/contract-manufacturing.
Riley, M., and A. Vance. Inside the Chinese Boom in Corporate Espionage. Bloomberg Business Week, March 15, 2012.
The U.S. Commercial Service is the trade promotion arm of the U.S. Department of Commerce’s International Trade Administration. U.S. Commercial Service trade professionals in over 100 US cities and in more than 75 countries help US companies get started in exporting or increase sales to new global markets. http://trade.gov/cs/.
The World Bank Group. International Finance Corporation. The business of health in Africa: partnering with the private sector to improve people’s lives. Washington, DC: IFC, 2007.
World Health Organization. Managing the Mismatch, 2010.
Zhuang, L. The Changing Landscape for Chinese Small Business: The Case of “Bags of Luck”: Emerging Markets Case Studies Collection. Bingley: Emerald Group Publishing Limited, 2011.
Author information
Authors and Affiliations
Corresponding author
Additional information
Associate Editor Andrew DiMeo oversaw the review of this article.
Rights and permissions
About this article
Cite this article
Malkin, R., von Oldenburg Beer, K. Diffusion of Novel Healthcare Technologies to Resource Poor Settings. Ann Biomed Eng 41, 1841–1850 (2013). https://doi.org/10.1007/s10439-013-0750-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10439-013-0750-5