The global surgical instrument tracking system market was valued at USD 195.0 million in 2021 and it is anticipated to grow up to USD 764.1 million by 2031, at a CAGR of 14.6% during the forecast period.
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Surgical instrument tracking systems is a combination of latest scanning technology and application software for inventory management. It provides a solution which allows users to maintain Quality, Compliance and Traceability of Instruments in work place. Starting in 2014, different classes of medical devices are included in UDI program to provide more accurate tracking of medical devices. Moreover, EU acted to adopt UDI in 2017, under the EU MDR.
Market Trends and Drivers
Need to meet FDA Unique Device Identification mandates will augment the overall market growth. Manufacturers are required to track surgical instruments—from manufacturing through the distribution chain. The purpose of device tracking is to ensure that manufacturers of instruments establish tracking systems that will enable them to promptly locate devices in commercial distribution. The UDI (Unique Device Identification) regulations proposed by the US FDA (Food and Drug Administration) are expected to drive growth in the surgical instrument tracking systems market. According to the UDI rules, labellers (manufacturers, reprocessors, specification developers, re-packagers, and relabelers) of surgical instruments are expected to implement direct marking at the individual instrument level. Until September 24, 2020, surgical instruments categorized as Class I devices had to comply fully with these FDA requirements. However, the date was then shifted to September 24, 2022. Additionally, labellers need to submit information about each device to the FDA’s GUDID (Global Unique Device Identification Database). This database serves as a reference catalog for all devices. These mandates are expected to be the key factor driving the adoption of surgical instrument tracking systems among end users.
Market Restraints and Challenges
High system costs, long investment cycles, and low ROIs may hampers the market growth. Surgical instrument tracking systems require heavy upfront investments that encompass the costs of application software, hardware, tags, and middleware and the cost of integrating the barcode/RFID framework along with the legacy system, maintenance services, consultancy fees, and staff training. Although the cost of tags and readers has reduced considerably, the implementation cost of automated tracking systems, such as RFID, that require additional servers, databases, and middleware, has been increasing steadily. The overall cost of implementing automated surgical instrument tracking systems using RFID is very high compared to traditional systems such as barcode-based systems. Apart from high implementation costs, most automated surgical instrument tracking systems have very long investment lifecycles.
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Major Players in the Global Surgical Instrument Tracking System Market
The key players in the surgical instrument tracking system market are Fortive Corporation (US) , Becton, Dickinson and Company (BD) (US), Haldor Advanced Technologies (US), Getinge AB (Sweden), STERIS (US), STANLEY Healthcare (US), Mobile Aspects (US), Integra LifeSciences Holdings Corporation (US), and B. Braun Melsungen AG (Germany) among others
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