Examining the importance of management and development of medical equipment, the challenges and obstacles it faces, and providing solutions to overcome these barriers
Abstract
Maintaining and improving the health of society requires key activities in the areas of prevention, treatment, and rehabilitation. Medicines and medical equipment are among the essential tools for carrying out these activities. To enhance the health level of the population, the healthcare system must not only ensure equitable access to pharmaceutical products and medical technologies but also guarantee their safety and quality. Human resources and financial guarantee systems are among the factors that influence the proper implementation of these activities. Skilled human resources play a role in the use of medical equipment, and an appropriate financing system is necessary to cover the high costs of medicines and medical equipment within the healthcare system.
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Economic Importance of the Health Sector
The medical equipment industry plays a vital role in both healthcare and the overall economy. In the U.S., it has been a growing source of jobs and economic growth, with employment rising significantly between 2005 and 2007. In Iran, although exact data is limited, around 17,000 people worked in this sector in 2008-2009, and workforce numbers have surged recently due to COVID-19-related production increases.
Management and Development of Medical Equipment in Countries
Countries such as the UK and the US employ an integrated process for identifying technological needs, managing innovation, and disseminating new technologies, which fosters extensive collaboration between suppliers and healthcare institutions. Key strengths of this system include high transparency, regular collection of new ideas, and the creation of a market for innovation. However, a potential weakness is the unclear relationship between innovation centers and public procurement agencies.
Regulation of Medical Equipment and Supplies in Iran
Iran has a long-standing legal foundation for regulating medical equipment, but the sector faces challenges due to a lack of specialists and academic focus on regulatory affairs. Although the Food and Drug Administration was formed in 2011 through a merger of relevant bodies, its structure was approved without sufficient expert input, weakening effective regulation and oversight.
Scientific, Academic, and Expert Gaps
Ensuring public health through safe and effective medical devices requires a strong regulatory system and skilled experts. However, there is a scientific and academic gap in this area. Ineffective regulation can threaten public safety. Globally, Good Regulatory Practices (GRP) are being developed to create enforceable laws and guidelines aligned with national and international standards, aiming to ensure safety and foster global cooperation in medical device oversight.
Providing recommendations for the regulation and development of medical devices
Key proposals for improving medical device oversight and development include:
- Restoring licenses for individual consultants and production advisors,
- Revising emergency import regulations with clear criteria,
- Labeling producer and consumer prices on retail medical items,
- Implementing tiered pricing based on product quality,
- Eliminating conflicts of interest among government-linked suppliers,
- Removing unqualified companies from urgent import activities.
This study was conducted at Economic Corruption Confrontation Think Tank in collaboration with Mehdi Rafsanjani, Alireza Rahimi Aghdam, Hamid Izadbakhsh, and Mehdi Mokhtari Payam in 2022.
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