Surgical Instrument Tracking System Market

Need to meet FDA Unique Device Identification mandates to boost market growth

The FDA's Unique Device Identification (UDI) mandate requires medical device manufacturers to uniquely identify and track their products throughout their distribution and use. This mandate has created a need for surgical instrument tracking systems that can comply with the UDI requirements and help hospitals and other healthcare facilities manage their inventory of medical devices. Surgical instrument tracking systems are designed to track the usage and location of surgical instruments in real-time, providing visibility into the inventory of medical devices and facilitating better inventory management.

These systems can also help to reduce the risk of medical errors by ensuring that the right instruments are used for the right procedures. With the FDA's UDI mandate driving the need for more robust tracking systems, the demand for surgical instrument tracking systems is expected to grow. The market CAGR is likely to be driven by healthcare providers seeking to comply with the UDI regulations, as well as by the potential benefits of improved inventory management and patient safety.

Surgical equipment classified as Class I devices had to fully adhere to these FDA regulations until September 24, 2020. The time was then changed to September 24, 2022, though. Also, labelers must report data to the FDA's GUDID regarding each device ( Unique Device Identification Database). For all devices, this database acts as a reference catalogue. This drives the surgical instrument monitoring systems market revenue.

Additionally, developing nations like China and India as well as the Middle East, Central America, and Southeast Asia are projected to offer significant growth prospects for companies that make surgical instrument tracking systems. Healthcare market businesses in these economies may have opportunities for expansion due to rising healthcare spending and infrastructure. In order to comply with the new Unique Device Identification (UDI) tracking regulations set forth by the U.S. FDA, surgical instrument monitoring systems enable automatic identification of medical equipment, including instruments.

The need for compliance-enabling solutions, like surgical instrument tracking systems, is anticipated to increase as the number of devices subject to UDI continues to rise. The regulatory standards for traceability from manufacturer to patient have also been established by a number of other governmental agencies.

The Global Surgical Instrument Tracking Systems Market Industry is significantly influenced by the need for regulatory compliance and adherence to industry standards. Governments and health organizations are implementing stringent regulations to ensure the safety and efficacy of surgical procedures. Tracking systems play a vital role in helping healthcare providers meet these compliance requirements by providing accurate documentation and traceability of surgical instruments. This regulatory pressure is likely to drive the adoption of tracking systems, contributing to a projected CAGR of 8.73% from 2025 to 2035. As compliance becomes increasingly critical, the market is expected to expand, reflecting the growing importance of accountability in surgical practices.

The Global Surgical Instrument Tracking Systems Market Industry is experiencing a notable surge in demand driven by the increasing emphasis on patient safety. Hospitals and surgical centers are increasingly adopting tracking systems to minimize the risk of retained surgical instruments, which can lead to severe complications. The implementation of these systems enhances accountability and traceability, thereby improving overall surgical outcomes. As of 2024, the market is valued at approximately 0.4 USD Billion, indicating a robust growth trajectory. This focus on patient safety is likely to propel the market further, as healthcare providers seek to comply with stringent regulations and enhance their operational efficiency.

The Global Surgical Instrument Tracking Systems Market Industry is poised for growth due to the rising number of surgical procedures globally. As the demand for surgical interventions increases, so does the need for efficient management of surgical instruments. Tracking systems are essential in ensuring that instruments are accounted for, sterilized, and available when needed, thereby enhancing operational efficiency in surgical settings. The market's valuation of 0.4 USD Billion in 2024 is indicative of this trend, with projections suggesting a significant increase as surgical volumes continue to rise. This growth is likely to be fueled by advancements in surgical techniques and an aging population requiring more surgical care.

Cost efficiency is a critical driver in the Global Surgical Instrument Tracking Systems Market Industry. Healthcare facilities are under constant pressure to optimize their resources and reduce operational costs. Implementing tracking systems can lead to significant savings by minimizing instrument loss, reducing sterilization costs, and improving inventory management. As hospitals seek to enhance their financial performance while maintaining high standards of patient care, the adoption of tracking systems is expected to increase. This trend aligns with the projected market growth, with an anticipated CAGR of 8.73% from 2025 to 2035, reflecting the potential for cost savings and improved resource allocation in surgical environments.

Technological innovations are significantly shaping the Global Surgical Instrument Tracking Systems Market Industry. The integration of RFID technology, barcoding, and IoT solutions is revolutionizing how surgical instruments are tracked and managed. These advancements facilitate real-time monitoring, inventory management, and data analytics, which are crucial for optimizing surgical workflows. As hospitals increasingly recognize the benefits of these technologies, the market is projected to grow, with an expected valuation of 1.0 USD Billion by 2035. The continuous evolution of tracking solutions suggests a promising future, as healthcare facilities strive to enhance their operational capabilities and improve patient care.

By Region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. North America Surgical Instrument Tracking Systems market accounted for USD 0.11 billion in 2022 and is expected to exhibit a significant CAGR growth during the study period. One of the main causes of this region's dominance is the U.S. FDA's establishment of the UDI system for the efficient identification of medical devices and instruments.

Additionally, it is projected that the region's market would increase due to the presence of a highly established healthcare infrastructure and the quick uptake of cutting-edge products and technology.

Further, the major countries studied in the market report are The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2 SURGICAL INSTRUMENT TRACKING SYSTEMS MARKET SHARE BY REGION 2022 (%)

Source Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe surgical instrument tracking systems market accounts for the second-largest market share due to the rising investment in healthcare sector, growing investment in surgical instrument products and rising technological advancement and development. Further, the Germany market of surgical instrument tracking systems held the largest market share, and the UK market of surgical instrument tracking systems was the fastest growing market in the European region

The Asia-Pacific Surgical Instrument Tracking Systems Market is expected to grow at the fastest CAGR from 2022 to 2030. This is due to untapped potential in this region. Additionally, it is anticipated that throughout the course of the forecast period, the number of surgical procedures will rise along with the fast-evolving healthcare infrastructure in Asian nations like China, Indonesia, and India. In the coming years, it is also projected that the development of technologically enhanced hardware and software solutions would increase the use of surgical instrument tracking devices.

Moreover, China market of surgical instrument tracking systems held the largest market share, and the India market of surgical instrument tracking systems was the fastest growing market in the Asia-Pacific region

Major market players are spending a lot of money on R&D to increase their product lines, which will help the market of surgical instrument tracking systems grow even more. Market participants are also taking a range of strategic initiatives to grow their worldwide footprint, with key market developments such as new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the surgical instrument tracking systems industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.

One of the primary business strategies adopted by manufacturers in the  surgical instrument tracking systems industry to benefit clients and expand the market sector is to manufacture locally to reduce operating costs. In recent years, surgical instrument tracking systems industry has provided solution with some of the most significant benefits. The surgical instrument tracking systems market major player such as Steris PLC (Ireland), Fortive Corporation (US), Getinge AB (Sweden) and others are working to expand the market demand by investing in research and development activities.

Steris PLC was established in 1985 and its headquarters is in Basingstoke, United Kingdom. An Irish-based manufacturer of medical equipment named Steris Corporation is focused on providing the US healthcare system with surgical and sterilizing products.

The company provides its customers with a distinctive combination of innovative capital equipment products, such as sterilisers and washers, surgical tables, lights, and equipment management systems and connectivity solutions, such as operating room integration; consumable products, such as detergents and gastrointestinal endoscopy accessories, dental instruments, and other products; and services, such as equipment installation and maintenance, microbial reduced of medical devices, instrument and sanitization services, and instrument and sanitization services. The employee size of the company is 10,001+ employees ly. In Nov. 2020 STERIS plc. acquired Key Surgical.

With this acquisition, STERIS's product portfolio and  reach are strengthened, complemented, and extended.

Also, Fortive Corporation was established in 2016 and its headquarters is in Everett, Washington, United States. The company is an American industrial technology conglomerate. In July 2016, the company was separated from Danaher. The founders of Danaher, Mitchell Rales and Steven M. Rales, continued to serve on the board of Fortive long after the company split. The company provides wide range of solution and services such as advanced healthcare solution, intelligent operating solution, precision technology and more. The employee size of the company is 10,001+ employees.

In Nov. 2019, Fortive Corporation annouced the acquisioton of Censis Technologies to increase its SaaS-based surgical instrument tracking and processes solutions for sterile processing department (SPDs) of hospital services and ambulatory surgical centres.