To encourage device innovation for medical conditions that impact small populations, including pediatric populations, the Federal Food, Drug, and Cosmetic Act (FD&C Act) includes the Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE) pathway. The program provides a marketing pathway for devices intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the US per year. Since 2008, the year Congress began requiring annual Pediatric Medical Device Reports, 29 devices have been approved through the HUD/HDE pathway. Seven of those have a pediatric indication, and 4 are indicated only in pediatric populations.
Growing the Prevalence of Infectious Diseases among the Pediatric Population
is also expected to contribute significantly to the Pediatric Medical Device market. Overall, Hospitals
applications of Pediatric Medical Device, and the growing awareness of them, is what makes this segment of the industry important to its overall growth.
AMAs Analyst on the Global Pediatric Medical Device market identified that the demand is rising in many different parts of the world as "Government Initiatives for Incentivizing Manufacturers". Furthermore, some recent industry insights like "On 6 March 6, 2018, Abbott announced the United States Food and Drug Administration (FDA) approved the Masters HP 15mm rotatable mechanical heart valve, the world's smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement. Until today, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, and larger valves are often not suitable given the smaller size of children's hearts. This dime-sized new valve is the first and only pediatric mechanical heart valve developed for newborns and infants and offers hope for pediatric patients in urgent need of treatment who have no other approved options." is constantly making the industry dynamic.
The report provides an in-depth analysis and forecast about the industry covering the following key features: o Industry outlook including current and future market trends, drivers, restraints, and emerging technologies o Analyses the Global Pediatric Medical Device market according to Type, Application, and regions o Analyzes the top 10 players in terms of market reach, business strategy, and business focus o Provides stakeholders insights and key drivers & trends of the market
Market Size Estimation In market engineering method, both top-down and bottom-up approaches have been used, along with various data triangulation process, to predict and validate the market size of the Pediatric Medical Device market and other related sub-markets covered in the study.
o Key & emerging players in the market have been observed through secondary research. o The industrys supply chain and overall market size, in terms of value, have been derived through primary and secondary research processes. o All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
Data Triangulation The overall market size is calculated using market estimation process, the market was further split into various segments and sub-segments. To complete the overall market engineering and arriving at the exact statistics for all segments and sub-segments, the market breakdown and data triangulation procedures have been utilized, wherever applicable. The data have been triangulated by studying various influencing factors and trends identified from both demand and supply sides of various applications involved in the study. Along with this, the market size has been validated using both top-down and bottom-up approaches.