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Dr. Mary Schmidt is President of Schmidt & Libby Health Advisory Group. She is board-certified in infectious diseases and internal medicine. We're excited to share her thoughts as one of our nation’s leading experts on infectious disease! Bringing wearables and health innovation to developing countries is complex. Understanding the process of introducing innovation, including the inherent obstacles, is the first step. This is where Dr. Schmidt shares some great insights.
Eighty percent of the world’s population lives in developing countries. In these countries, limited public health budgets cover millions of lives, from neonates and pregnant mothers to the very old. The ministry of health budget must cover the cost of vaccines, health campaigns, infrastructure, materials, personnel, field healthcare workers, medications, storage, public hospitals and health centers, program monitoring, acquisition of and assessment of population health statistics and measures to contain outbreaks of infectious diseases, and any new technology that will incorporated into the system. Public health depends greatly on public-private partnerships to meet the needs of the population.
You can see why an innovative technology that can provide efficiency and value is an exciting proposition for these countries.
Even so, it’s a challenge for many countries to take full advantage of the opportunity. Innovative health technology is expanding faster than their ability to support and monitor the health benefit and ensure the quality of the technology. Challenges they face include:
Limited technological support after roll-out to monitor the accuracy of the device or repair a defective device
Barriers that need be overcome to ensure the device gets to the desired location, intact, working properly and then disseminated and used correctly
Sporadic availability of electricity and temperature control, which will affect the quality and utility of some devices
Poor port of entry controls resulting in lost or mishandled products, or product stolen for black market use
Additional resources are often needed to overcome language and cultural barriers. Packaging and instructions need to be in a language familiar to the users.
Communication and advertising efforts need to be created with cultural awareness so that the product will be accepted without fear or misunderstanding of its use and intent
Overcoming the Hurdles
Standardization of policies and guidelines in developing countries can be helpful for the industry, but often they are a hurdle in and of themselves.
This year the World Health Organization assembled a team of experts to create recommendations for pre-market, on the market and post market regulation of medical devices. The draft recommendations ensure any technology used to monitor the health, provide care, or test a human biofluid is safe and effective. Investigators of approved or unapproved devices will not only need IRB approval but most likely will need to register the study with the appropriate agency.
For companies, this means taking steps to find, review and comply with the regulations, including all associated laws and be knowledgeable of the penalties. Some items will include registering the item, the manufacturer, importers, authorized representative and distributor. Procedures will need to be in place monitor and report the quality of the device, provide performance and safety data of the device and follow record keeping guidelines.
Partnerships between government and nongovernment organizations and businesses will be essential to the success of any innovative technology in the developing majority of our world.
Knowledge shared about how to overcome barriers and comply with regulations will be important for moving the industry forward and creating value for these counties and communities.
What challenges to do you encounter––or anticipate––when bringing innovation to an developing country?