Innovation for medical devices for low resource settings- how limiting the scope of work to creating low cost attention grabbing designs is not enough

摘要

A growing number of manufacturers, universities, social enterprises, and entrepreneurs are devoting substantial effort to designing innovative and interesting medical devices for low resource settings. These devices usually, because of their “cool factor” and low cost, easily draw the interest and elicit the excitement of investors and donors as well as of the general public. These devices are often presented as having the potential to improve health outcomes and the quality of life, or to offer a solution to an unmet medical need. However, these efforts very often do not succeed due to a failure to address some very essential realities concerning production, regulations, marketing, cultural acceptance, distribution, supply chain, after sales support, maintenance, and the overall practicality of the product to the users. The methods traditionally used for many years by the established medical device industry in high income countries seem to be ignored with the attempts to proliferate these new devices in low income countries: knowing the customer's needs, understanding their context, understanding their ability to pay, understanding the regulatory requirements, and others, before designing and manufacturing products. The scope for innovation needs to go beyond transposing our obsession for the latest contraption onto poor hospitals. A life cycle or value-chain approach can help innovators think beyond technology and help develop a business model that can generate a sustainable impact. Additionally there is a need to provide equal attention and associated resources to the application side of the technology transfer process. Grants and investments for innovation should bind financing to sustainable social impact.