What Market does SurgiTrace plan to serve?

While SurgiTrace plans to serve various entities through the healthcare network the Company’s initial focus will be on the ever-growing needs of the medical device manufacturer.

 

What type of coverage area does the TRAXMD system have?

The TRAXMD system has the ability to transmit globally. Anytime. Anywhere.

 

How can I order the TRAXMD system for use with my company?

Currently our products are not available for sale, but we are building a list of medical device manufacturers who are requesting to participate in our initial launch. If you would like to be added to the list please send us an email and we will consider your application.

 

How large is the medical devices industry?

U.S. Medical Device Companies: 5,394

Value of Shipments: $85,441,622,000

(AdvaMed 2004’)

 

 

What is Unique Device Identification Bill H.R.3580?

The Senate unanimously passed a bill (9/21/07) that includes a provision requiring the Food and Drug Administration (FDA) to put into place a unique medical device identification system. The House approved the same bill earlier (9/19/07) which would reauthorize user fee programs under the FDA and expand FDA's authority to monitor medical devices and prescription drugs.

 

What are Common Problems the Healthcare Supply Chain Faces?

 

Medical Devices that become Misplaced

Medical Devices that become Lost

Medical Devices that become Stolen

Courier Inadequacy

Drop-Ship Delinquencies

Products that are Late for Surgery

Hand-offs in the field that are not monitored

 

What are the challenges the Healthcare Industry is confronted with by using
RFID, Barcode Scanning, and Manual Quality Control for an inventory management solution?

 

Lack of Real-Time inventory tracking

Human-Factor (barcode, manual tracking)

Inventory Loss (point-to-point, field transfers, theft, shipper/courier error)

Dark Zones (In-flight, buildings, basements, sterilizers, etc.)

Need for Excessive Inventory Levels to accommodate sub-optimal tracking methods resulting in loss of profits for medical device manufacturers.

 

What makes the SurgiTrace TRAXMD™ System more valuable than other monitoring technologies?

 

SurgiTrace plans to deliver a true hybrid positioning system that jointly maximizes location data from different sources.

The system will have the ability to interface and enhance current RFID and Barcode scanning systems.

TRAXMD does not require a stationary reader to send or receive data.

The system will work where others will not (Long Range = Cross Country).

In deep urban settings, IPS uses GPS signals and WPS to acquire a location 100% of the time.

TRAXMD uses a Combination of GPS signals and WPS facilitate stationary detection techniques which reduce jitter and power consumption.

 

Why does the Healthcare Industry need TRAXMD™?

 

Building excessive inventory to accommodate the current available tracking systems greatly reduces a hospital and manufacturer’s profit margins.

Current RFID and Barcode systems only track assets over short ranges (<50 ft.). TRAXMD incorporates both short and long range tracking capabilities which provide “Real-Time” data both worldwide and room to room.

Bill H.R. 3580 - Recently Congress passed a bill, which will require by law medical device manufacturers and hospitals to define and use a universal system to uniquely identify products by the year 2012.

 

FDA Web site on unique device identification

The FDA maintains a special Web site on unique device identification at:
http://www.fda.gov/cdrh/ocd/udi/

 

 

Floor Statement

The Honorable Darlene Hooley

Wednesday, September 19, 2007

H.R. 3580 – Food and Drug Administration Amendments Act of 2007

Thank you Mr. Speaker.

I rise today in strong support of H.R. 3580.

Patients and consumers are the clear winners in this legislation today.

This legislation will save lives by promoting the safe and quick approval of life-saving medications and providing the FDA with vital new authority to protect consumers after a drug is on the market.

This bill collects an additional $225 million over five years to enhance drug safety reviews and also promotes testing of pharmaceuticals and medical devices to ensure they are safe for children.

Moreover, provisions I crafted with my colleague Mr. Doyle, the FDA and others require the creation of a unique device identification (UDI) system for medical devices that will help take important strides to improve the public health. Medical devices cannot easily be tracked or identified in any systemic fashion with current tools. A UDI system will enable the FDA to detect warning signs of a defective device earlier and quickly respond to recalls. Every person with an artificial knee or hip, pacemaker, or one of the thousands of other medical devices will benefit once this UDI system is in place.

I urge my colleagues to support this bipartisan and comprehensive drug and device safety bill.

Thank you Mr. Speaker.