Medical Device Counterfeiting and How to Avoid It

Medical Device Counterfeiting and How to Avoid It

Last year, MPO magazine addressed the growing global problem of medical device counterfeiting. The article stated, “Counterfeit medical devices pose a serious and escalating threat to U.S. patients. While the FDA has taken some action to remedy the situation through its Unique Device Identification (UDI) legislation, the move falls well short of what could and what is being done in other industries.”

Figures representing the percentage of counterfeit products in the market, some research show the number as high as eight percent internationally. How much money is this growing epidemic costing your company, and what can be done to protect your device? ATL Technology has three solutions that can limit the use of your interconnected device.

How can I protect my device from counterfeiters and pre-processors?

ATL has created three means of limiting the number of times a device can be used, disabling the devices ability to function if it isn’t mated into a corresponding piece of equipment, along with other advancements and technologies. We refer to these benefits as Use Limiting Technologies, and refer to each as:

  1. Mechanical Use Limiting
  2. Radio Frequency Identification Limiting
  3. Single Wire/Electronic Limiting

What is Mechanical Use Limiting (MULS)?

The characteristics of MULS is as follows:

  • Preset number of uses
  • Compatible with all common sterilization methods
  • Inexpensive
  • Use limitation only (no counterfeit) detection/prevention

What is Radio Frequency Identification Limiting (RFID)?

The characteristics of RFID are as follows:

  • Wireless communication
  • Cable authenticity
  • Previous use validation
  • Counterfeiting made difficult (not impossible)
  • Does not consume any connector pins
  • Requires capital equipment alignment

What is Single Wire / Electric Limiting?

The characteristics of Single Wire Limiting are as follows:

  • Fuse across two pins in the connector
  • Capital Equipment checks for circuit
  • Requires capital equipment alignment
  • Power “blows” the fuse
  • Compatible with all common sterilization methods
  • Inexpensive
  • Use limitation only (no counterfeit detection/prevention)

With the ever-increasing problem of device counterfeiting, the need for security across the entirety of the device is of paramount importance. If you are in need of, have questions about or see how your application could benefit added security from something like ATL’s use-limiting technology, please contact us. We’d love to hear from you.

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How can ATL Technology help with your next connector or interconnect project?

ATL Technology in an interconnect solutions company, we specialize in design, development, and production of devices that are connector based. We succeed by incorporating our partners engineering teams with our engineering teams, their project management with ours, and so on.  We use our experience and expertise to benefit our partners by commercializing innovative devices that are accessing and treating previously untreated conditions in the human body.

Becoming a Best-in-Class Global Manufacturing Company

Becoming a Best-in-Class Global Manufacturing Company

As a global manufacturing company in the medical industry, ATL is focused on adhering to governmental regulations while maintaining compliance with additional industry requirements. The cost of quality for any global manufacturer in the medical industry is significantly higher than manufacturers of similar products in other industries.

Given ATL’s costs associated with producing at the highest level of quality come at a price, ATL goes above and beyond to maintain Best-in-Class practices through implementing company-wide objectives like Focus on Quality, Global Training, and Innovation to achieve the best possible performance and outcomes for our partners.

How’s ATL continually improving its Focus on Quality, Global Training and Innovation?

Focus on Quality

A quality product doesn’t happen by chance. ATL’s holistic perspective on quality starts at the origins of each project and is carried through until the customer is satisfied and the device functions perfectly during the procedure.

Everyone who has managed and maintained a Quality Management System (QMS) that generates results within one facility knows it is an extremely tasking undertaking. Maintaining a QMS in three manufacturing facilities, on three separate continents is magnified at least three times.

ATL is very proud of our Quality team, the excellence with which our Quality team is managed, and the global team perspective that; “Quality Begins with ME”. A message that is reiterated on a constant basis throughout all departments in the company.

Training

John Holloway during training session at ATL’s Dongguan, China facility

There are several innovative practices performed within ATL to maintain or pursue Best-in-Class practices, one of these practices that ATL’s performs on a consistent basis is global training.

A recent example of ATL’s ongoing effort to support best-in-class operations was exemplified when in the first quarter of 2017 ATL’s Chief Technology Officer, John Holloway, and ATL’s Director of Medical Sales, Mike Anderson, performed multiple training sessions over the course of two weeks at our facility in Dongguan, China.

Through the training sessions, the goal is not only to help everyone involved in the manufacturing process understand why the device is constructed the way that it is, but also help each person understand how the device is used and how each team member’s efforts ultimately benefit another human being.

Recent training session at ATL’s Dongguan, China facility.

Innovation

ATL is dependent on our partners incorporating our interconnect solutions, connectors and other manufacturing innovations. In previous post’s we’ve shared ATL’s innovations in our MP1 and MP2 connectors and the innovations, we’ve generated in the use limiting category of interconnect systems.

ATL’s MP1 interconnect system with RFID use-limiting technology

Additional innovations that are currently being worked on and we look forward to sharing as they become disclosable include touch-proof connectors, modular connectors, high-pin/high-density connectors.

We operate in an evolving market, the requirement for continuous improvement is more important today than ever before. ATL is committed to a balanced approach of working on the current design requirements, as well as dedicating time to future innovations, conceptualization, and result oriented designs.

ATL’s global approach to Quality, Training, and Innovation along with the incorporation of our core values and multiple other characteristics