# Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access
## 3 Overview of Medical Devices
### Medical Devices Market  
The global medical device market is primarily driven by increased investment in the sector and favorable regulatory environments for device approval and testing [25]. Regional support for device demand, along with the gradual recovery of the global economy from the pandemic, have also contributed to market growth. Wearable medical devices are gaining popularity among consumers, further increasing market expansion. Key factors, such as advanced product models, innovative features, competitive pricing and intensified marketing efforts by market leaders are expected to expand market growth in the future [25; 26].  
Consumer lifestyles, an increase in chronic diseases and fewer clinic visits for regular checkups are expanding the market for home monitoring medical devices. Patients are looking for more convenient ways to manage their health, increasing the demand for devices that allow remote monitoring and early detection of health issues [27; 28; 29]. Additionally, the prevalence of chronic diseases such as hypertension, diabetes and cardiovascular disorders increases the demand for medical devices. Population reliance on ophthalmic and orthopedic devices due to vision and mobility issues also creates new growth opportunities. Increased healthcare facilities and awareness initiatives can also help market growth. However, the high initial costs of medical devices may pose a challenge to market expansion [30; 31].  
The USA is currently the largest medical device market globally, followed by the EU, with Japan ranking fourth [32]. The Japanese market is poised for further expansion, particularly with the aging population projected to increase from 28% in 2020 to 38% by 2065 [33]. Additionally, North America is expected to lead the global medical device market in terms of revenue until 2026, holding approximately 35% of the market share. This dominance is driven by factors such as the presence of key players, expanding healthcare infrastructure, rapid adoption of advanced medical technologies and a favorable regulatory framework. Meanwhile, in 2026, Europe is forecasted to experience the highest compound annual growth rate, supported by its well-established healthcare system and increasing adoption of advanced diagnostic and treatment devices [26].  
As the medical devices market expands, two segments have emerged as particularly noteworthy due to the advances they represent in the healthcare field. These segments are referred to as wearable technology and prosthetic innovation. The wearable technology segment initially included simple equipment such as fitness trackers. However, to meet the increasing demand for preventive health solutions and through the incorporation of advanced technologies like artificial intelligence (AI) and big data, more sophisticated devices are now available, such as continuous glucose monitors that provide real-time data for diabetes management. These new devices enable remote patient monitoring and improve the management of chronic diseases. On the other hand, the prosthetics innovation segment emphasizes the development of highly personalized medical devices, taking advantage of advances in materials science, biomechanics and robotics to produce realistic artificial limbs. An example of a device included in this segment is the 3D-printed prosthesis, which offers personalized adjustments for individual patients [30; 31]. Both segments not only exemplify the rapid growth of the medical devices sector, but also emphasize the unique challenges and opportunities they present in meeting the diverse needs of patients.