Many of these deaths are preventable through high quality hospital care. But even routines, such as syringe pumps and phototherapy lights vital to achieving this level of care- and standards in most US hospitals- are often inaccessible or difficult to use in low and medium-income countries.
The development of medical devices that are suitable for these areas is not a small feat – the transaction of the devices must be affordable, easy to use and functional in environments that may have extreme temperatures, high levels of dust or frequent power outages.
To meet this need, a team led by Kellogg Sustainability and Social Impact Teachers Caravan and Rebecca Kirby It was converted to an approach often used by health organizations. Through research and inputs by clinical doctors, NGOs, manufacturers and researchers, they developed 15 “target product profile“-Guidelines that analyze the ideal specifications and cost requirements for the production of newborn medical devices that are adapted for low-resource settings.
As the researchers published the product profiles in 2020, many companies and NGOs have been based on them to create new devices or customize existing low -resource settings. To date, thousands of these devices have been purchased and installed in hospitals across Africa.
“We have seen product developers adopt these profiles and others have told us that they have been reported and making changes to ensure that their products meet the requirements,” Palamountain says. “He has shown governments how they can invest in newborn health and save lives.”
In general, leaders can use these product profiles and the process that researchers have used to create them as a plan to address shortages in many other markets. By completing experts both from the supply and the sides of the demand for a given market, “we were able to facilitate a healthy dialogue and bridge the gap where there may have been a high cost of trading or information gaps,” says Kirby.
By defining the needs
For their research, Kirby and Palamountain have worked with UNICEF and Nest360, an international alliance working to reduce deaths that can be prevented by Sub-Sachara.
The collective goal of the group was to support the United Nations plan to reduce newborn mortality rates to less than 12 deaths per 1,000 live births by 2030 – which would prevent millions of deaths potentially.
They began with the revision of his guidelines which to determine which medical devices were more critical to small and sick newborns. Overall, they identified 15 broad categories for devices that could help manage nutrition and tradition of drugs, treat jaundice, monitoring and diagnosing conditions, provide respiratory support and control and control newborns.
“We were not worried about whether the product already existed or not,” says Palamountain. “For many of these categories, there was an adult version – such as an adult diabetic sweet – but they didn’t have the right specifications for newborns.”
The researchers then spoke with experts and carried out field observations to determine the minimum and optimal features for the effective performance of the devices in each of the 15 categories. They took into account both environmental factors and human factors that may not exist in richer or more urbanized countries.
For example, they noted that oxygen concentrators should be able to operate in areas exposed to high dust levels. And that a newborn unit may not have enough nurses to get the temperature of each baby during each shift. “You can then draw a thermometer that constantly measures the baby’s temperature and alerts the nurse through a visual symbol that the baby is very cold,” says Palamountain.
They used this information to design 15 target product profiles, every detail features and technical requirements for the desired device type. They then had more than 100 main interested parties in newborn care in low and medium-income areas-including clinical doctors, defense organizations, manufacturers and technical organizations-retrieve the plans online and discussed in a personal meeting.
By the end of this process, the reviewers resulted in consensus in 97 % of the 668 performance characteristics highlighted in the 15 product profiles, from the critical features of a device to its price. In other words, most of the interested parties eventually agreed on the vast majority of the features that these newborn medical devices had to have.
“In many of these arrangements, there is a great need and some demand,” says Palamountain. “And buying healthcare devices is not so profitable in these countries, so you need such a process to bridge supply and demand, to show manufacturers what they need and where to price it should be.”
Indeed, Kirby says that “it was difficult, at times, to reach the price consensus because different geographical areas accept more of different price points”.
Price points can be difficult to install, as they include not only the cost of manufacturing, shipping and maintenance for medical devices, but also difficult compromises. For example, in areas where the holidays are common, hospitals could ask manufacturers to add battery use as a feature to devices that require continuous power, but this can significantly increase their price. Alternatively, a hospital could invest in a backup for the hospital that would allow him to buy several more cost -effective devices without the additional battery mode.
“These are the kind of compromises made by different countries,” says Palamountain.
Impact research
Researchers’ goal product profiles were published on the UNICEF website in April 2020 and have been screened more than 7,000 times since 2023. Their work has also recently received the “Academic Research Research Award” from Financial times.
Now, more than five years later, manufacturers and buyers continue to report profiles when developing or examining new devices. The Neopenda device manufacturer, for example, referred to many of the researchers’ target profiles for new vital monitoring. Palladium International, who works on behalf of the Integrated USAID Health Program, incorporated many profiles in its offer to buy educational material for the care of small and sick newborns.
Overall, researchers have identified 38 newborn medical devices – both new and up -to -date – in 13 different product categories where manufacturers used team recommendations.
Palamountain and Kirby continue to monitor devices to evaluate their life and ensure that hospitals and biomedics have the necessary training to maintain and repair.
“We don’t stop alone and say,” here’s the devices, “says Kirby.” We want to ensure that the devices are really useful and that staff are educated properly. We want to ensure that we really have an impact. “
The final measure of success will be if devices help reduce newborn deaths in these countries.
“But a real health-system approach is necessary to hit the target,” says Palamountain. “We cannot hit the goal whether hospitals do not have infrastructure support and human resources to use and support the devices where other parts of Nest360 and government cooperation are set.”
Facing gaps beyond health care
The early success of the project shows how the principles of strategic planning can be implemented that can be intuitive in a business environment to solve public health challenges.
The extensive and community approach of researchers – in which they combine the insights of experts from many countries on both the demand and supply of medical devices – could help to deal with gaps in markets beyond healthcare, teachers say.
One of the keys to this approach is to get buy-in from stakeholders on both sides of a given product market-from manufacturers to users. In order to attract these groups well and translate what each side needs into a cohesive product, you must be curious and humble, according to the researchers.
“You have to be a good listener and ask what may sound like ‘stupid’ questions,” says Palamountain. “You have to have good translators to understand the issues on each side and the Mbas are generally good translators who can coordinate in all branches, newborn lives ”.
