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    Date submitted
  • 27-Mar-2017

Surgical Implant ID System

Abstract

In September 2017, international and US government agencies will begin requiring hospitals and manufacturers to track all surgical implants using Unique Device Identifiers (UDls) marked onto sterilized packages or the devices themselves.

If industry does not comply, they could be subject to criminal and civil penalties, seizure, and injunction by the FDA and non-reimbursement by CMS.

Matrix IT's Tractus is the only practical means to electronically track all surgical implants with UDls during surgery, as mandated by law.

Matrix lT holds comprehensive patents on the collection of implant information in the sterile field, safeguarding the company against competitors, and ensuring that Tractus' patented technology will be the standard of UDI collection in all hospital surgical suites, beginning in September 2017, with a 3 year phase in period.

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Original YouTube URL: Open

Introduction Video

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Additional Questions

Who is your customer?

Medical device manufacturers will purchase scanners. Hospitals will purchase scanners, software and drapes. Payers will purchase data derived from surgical cases..

What problem does this idea/product solve or what market need does it serve?

Three government agencies require the collection of UDI data in the operating room; and identify and track implants through their lifecycle. Implants sterilized in the hospital must bear a UDI mark on the device and must be traced through the product’s lifecycle. Every device must be accessible by patients, be placed into the hospital's electronic health record and monitored to ensure that patients with recalled devices can be quickly identified. The only practical method to collect implant information during surgery is to quickly scan the unique identifer that is etched onto each implant. Because these devices are sterile, they may not be scanned by traditional scanners. Tractus is covered with a sterile drape and placed into the sterile field, next to the implants. As the surgeon calls out for an implant, the O.R. personnel pass the device over the scanner, which identifies all implant attributes and matches it to the patient. This process is the only method that satisfies all aspects of the UDI laws, and can save the healthcare industry billions of dollars per year.

What attributes will make this idea/product successful? Why do you believe that those features will create success?

As the only effective UDI tracking solution for hospital sterilized implants, Tractus is an optical scanning system that is covered with a disposable sterile barrier drape, and placed in the operating room’s sterile field. During surgery, Tractus captures all surgical implant and supply information by passing devices over the scanners during surgery. Upon completion, all case data is transferred to the hospital EHR system, including anatomical placement. In the event of a recalled medical device, Tractus automatically identifies all affected patients. In addition, manufacturers and hospitals may use Tractus to identify recalled products in the field or on shelves.

Explain how you (your team) will execute to make this idea/product successful? What gives you (your team) an advantage over others already in the market or new to this market?

As a completely new market, Tractus is uniquely positioned to capture all surgical UDI data. In order to achieve that, Tractus will initiate: (1) B2B sales to hospitals, payers, medical device companies and distributors. (2) Distributor agreements with connected industries such as hospital and medical device distributors, software vendors, and laser manufacturers. (3) Steerage from industry leaders such as GS1, Pew Charitable Trusts, HIMSS, AdvaMed, FDA, AIM, ONC and others.