Surgical Instrument Tracking System Market Size, Share, Trends Analysis with Forecast forecast 2021 – 2031 | Fortive Corporation , Becton, Dickinson and Company , Haldor Advanced Technologies

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.

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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.

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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COVID-19 Impact

A worldwide emergency has been caused by the COVID-19 pandemic. The impact of COVID-19 on the surgical instrument tracking systems market is lower than other medical devices, timely development and the implementation of contingency plans are extremely critical for business operations. Depending on the impact on economic conditions, there will most likely be threats to vulnerable business models and growing opportunities for development. The factors may play a key role in shaping the growth of the global market including the number of cases of COVID-19 has increased exponentially in the US. This adds to the risk for healthcare workers and patients and has reduced the number of surgeries performed in hospitals. According to the US National Library of Medicine National Institutes of Health, in 2020, all plastic surgeries were postponed. There has been a decline in regular patient visits to hospitals and clinics, which has led to a decline in the number of surgeries conducted. Moreover, shortages in medical supplies and equipment due to the temporary lockdown of manufacturing sites in affected areas or travel restrictions impacting shipments have created hurdles for the market. Beyond transportation-related delays arising from travel restrictions and the shortage of drivers, COVID-19 has not significantly impacted surgical supplies across geographies. Furthermore, players operating in the market are altering their long-term and short-term growth strategies by tapping the consumables market and developing innovative products to combat the pandemic.

Global Surgical Instrument Tracking System Market Segmentation

Product

  • Hardware
  • Software
  • Services

Technology

  • Barcodes
  • Radiofrequency Identification (RFID)

End-use

  • Hospitals
  • Research and Academic Institutes

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