The Touchproof Advantage

The Touchproof Advantage

As anyone who has spent any time around young children, connectors—specifically to power—can be a catastrophic safety hazard. And due to a number of incidents that lead to young children losing their lives, the practice of touch-proofing connector systems was originally designed to provide protection from accidental power main insertions.

It’s important to remember that with something like eyewear—there is a big difference between protective eyewear and standard eyewear. Connectors are no different. There are many ways for a connector to be engineered to ensure greater safety for those that come in contact with it. Touchproofing is one of those.

What does it mean to ‘touchproof’ a connector?

Similar to ‘water-proofing,’—making a device’s electrical components untouchable by water—touch-proofed connectors are designed so the conductive surface of a connector is unable to be touched. A touch-proof connector is a connector that has been designed to provide additional safety to the product and the human interacting with it.

What is “touchproofing”?

When creating a connector that requires “touchproofing,” you need a design that prevents electrically conductive surfaces from being touched. To test how touchproof a connector is, a standard IEC 60601 test finger is used. This testing mechanism replicates human interaction with your connector and verifies that a human will not be able to cause themselves, anyone else or the product unintentional harm while handling the device.

Are there requirements, if so, what are they?

As mentioned above, one of the standards or requirements for a touch-proof connector is IEC 60601.

IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, published by the International Electrotechnical Commission. First published in 1977 and regularly updated and restructured, as of 2011 it consists of a general standard—about 60 particular standards and about 10 collateral standards.

Medical devices, specifically, incorporate one or more Means of Protection (MOPs) within IEC 60601. A few examples of MOP can be a protective earth ground, a pre-defined creepage distance, an air gap, safely insulation or other barriers of protection. Any of the MOPs can be used in numerous combinations.

There are Means of Operator Protection standards and Means of Patient Protections standards that help to isolate patients and operators from risks of electrocution.

MOPP-2 provides two means of patient protection by defining separation between circuits with different characteristics (i.e. power circuits and data circuits) and between direct patient connections and other circuits.  There is also a MOPP-1 which only provides one mode of patient protection.  MOPP-1 is adequate for many applications but devices with high life danger (direct cardiac access for example) are typically required to be MOPP-2.

 

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ATL Technology in an interconnect solutions company specializing 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.

ATL Acquires Leading Medical Device and Catheter Manufacturer

ATL Acquires Leading Medical Device and Catheter Manufacturer

SALT LAKE CITY, UT and INDIANAPOLIS, IN — April 30, 2018 — Biomerics and ATL Technology, in a joint venture (Biomerics ATL, LLC), announced that they have entered into an agreement under which together they will acquire Catheter Research Inc. (CRI)‘s assets in the Indianapolis and Costa Rica divisions.

catheter manufacturing

 

CRI is a manufacturer of interventional catheters, tube sets, and other assemblies for medical devices with expertise in tube extrusion, catheter assembly and final FDA product packaging for sterilization. CRI services OEM customers as well as sell their own catheter line under the brand Thomas Medical.

“Through the addition of CRI, we are in a position to serve the medical device industry at an even higher level,” stated Brad Brown, CEO at ATL. “This expansion of our global network offers numerous benefits to both national and international OEMs. Now, combining ATLs connector know-how with CRI’s catheter capabilities, we will make optimal use of our expertise and specialties relating to catheters and custom engineering in delivering a best-in-class product.”

“This acquisition is consistent with Biomerics’ overall strategy to expand and invest in additional production and engineering capabilities to develop a global competitive advantage,” said Travis Sessions, CEO, Biomerics. “CRI’s productsCatheters, Catheter manufacturing and technology complement our current portfolio in the medical space and will broaden our product offering for suppliers around the world.”

CRI has manufacturing both domestically (Indianapolis, IN) and internationally (Costa Rica). The employees at these locations will be working closely with teams from ATL and Biomerics throughout the integration process and as they work to expand the Costa Rica operation.

About ATL Technology
Based in Utah’s “Silicon Slopes” and founded in 1993, ATL Technology combines the industry’s best engineering experts and technology to deliver connectivity solutions for market-leading devices. With a domestic development center and offices around the world, ATL uses local teams and wholly owned global execution resources to take devices from concept to prototype and into scalable production. Turnkey interconnect solutions from ATL include connectors, wire design, overmolding, wire harness automation, surface mount technology (SMT), and injection molding.

 

The True Cost of Interconnect Solutions

The True Cost of Interconnect Solutions

Cost, Cost, Cost. What does it cost?!?

Everyone, no matter the industry, deals with this reality buzzkill. And the world of interconnects is no different. As a device engineer, sourcing personnel consistently knead the thought of cost into your head to ensure cost is always being considered during the development phase of a device.

Unfortunately, in the world of custom connectors, knowing the cost of the interconnect is not as simple as presenting a pricing chart.

So, what does a Connector cost? Let’s dive into it.

Let’s hypothetically start with the development of a connector needed to produce the best results and functionality for the device.

For this device, we have to consider the requirements of the FDA’s 21 CFR, part 820. [We won’t bore you in this post to exhaustively correlate the requirements established by the FDA and the standard requirements for a medical device connector as this is a hypothetical situation] As you read and continue to develop your reasoning to go one direction or another, remembering the need to uphold FDA 21 standards, consider the value-add of working with a company who keeps it top-of-mind throughout design, development and production.

Figuring out the cost to develop a device connector—whether for medical, consumer or industrial use—are as follows:

Design Phase

Before we get too far along in this process, start by asking, “what are the quality department requirements for the Design Input Summary (including the human factors, risk and hazard assessment and applicable standards or requirements), the Design Validation Protocol, and the Design Validation Report?” Then ask, “are these tasks we are going to do in-house, or are we going to ask our design partner to complete these tasks?” The answer to these initial questions is the first line in the quoted price. Depending on the requirements for the design verification and validation and establishing who completes said requirements, the design phase could range in cost from $25k – $50k.

Development Phase

It’s this stage of the game is where the system will determine if what you have designed is going to be able to survive the tests it will be put through. Here are a few items to consider that commonly occur in this phase:

  • Validation Master Plan
  • Process Risk Assessment
  • Environmental Health and Safety Assessment
  • Installation Qualification (IQ)
  • Operational Qualification (OQ) (and all the requirements that are included in this step)
  • Performance Qualification (PQ) (and all the requirements that are included in this step)

Each company, each device category and even down to the specific device could have its own unique requirements for the IQ, OQ and PQ phases. The costs associated and required will dictate the price of the development phase.

During the development phase, identifying and establishing the regulatory strategy is a must. After deciding on the level of tooling utilized in the phase, it is then necessary to decide how many parts are needed to produce and complete the phase.

Taking the fluid nature of the components mentioned above into consideration, it’s easy to see the complexity of quoting a price for the development phase at the onset of a project. But, since we’re talking about cost, let’s not dance around it. The cost of the development phase is the largest expense as it can grow in scope as the project grows and changes—requiring an investment of $50k – $200k, depending on who does what and how much is required.

Let’s not forget the expense of manufacturing. Manufacturing is, for all intents and purposes, the cherry on top of the development phase. A big decision to be made for each product is whether to produce domestically or globally. Where manufacturing is done, plus the number of units being produced and materials being used, the build price can vary drastically.

Launch Phase

And now for the payoff. This is where all the efforts from the last 3 to 18 months, or—heaven forbid—longer, come together. Your design has been beaten up, refined and optimized, you’ve moved from concept to completion and are ready to unleash your wonderful creation on the world—making the medical community a better place to operate, to make consumers lives so much easier they won’t even realize it and kickstart a whole new industrial revolution.

During the launch phase, departments outside of engineering become much more involved providing the voice of the customer and discussing anything from color schemes, aesthetics, customer price point, etc. These same groups are going to tell us how many products we are going to build for a Pilot run, how many parts they want in stock prior to the official launch and how many parts they want in the first quarter, the first six months, etc.

Also during the launch phase, the NRE diminishes and the price per part expense begins. There are a couple of remaining items to think about enlisting NRE for:

  • Ongoing measurement and testing during the initial product runs and across a certain number of lots
  • Documentation – a company’s documentation requirements may be different than the company engaged to design, develop and produce the device. There may be additional documentation required during the Launch Phase. This is not documentation tied to regulatory though, as all regulatory documentation must be completed prior to launch.
  • It might also be beneficial to engage engineers during this phase to capture initial findings to—when it’s time to begin looking for opportunities to generate cost down—judge the initial line functionality against production efficiency later.

There could be other areas to engage engineers and pay an NRE. Generally, the NRE at launch decreases and accounts for the smallest portion of the NRE expense. In this phase, the cost could also be between $10k – $25k.

The costs associated with taking a concept converting it into a design, transitioning it into a manufacturable device and then launching the device requires everything we have discussed above and much, much more depending on the device. We did not discuss any of the other ancillary aspects of bringing a device to the market, items such as the Business Review, Sterilization Validation, Packaging Requirements, submission for a Premarket Notification (510K / CE Mark) or Premarket Approval (PMA), nor did we discuss Post Launch Review.

In the end, you can start to see the complexity of building what the lay-person sees as “just a cord” and attaching a cost to said “cord.” Let ATL work with you and your team to build your cable, to the exact specifications you need, and help you find the best price point possible—without compromising industry-leading technology and quality.

 

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

ATL Technology is a leader in interconnect solutions. Specializing in design, development and production of connector-based devices, ATL’s success is built through its dedication to building strong, successful partnerships—facilitating their engineering team working side-by-side with its partners’ engineering teams, their project managers working alongside their partners’ and so on. Utilizing their experience and expertise to benefit their partners, ATL creates success by commercializing innovative connector based devices with cutting-edge technology.

Why ESD Could Be Your Worst Enemy (and Why You Need to Consider It)

Why ESD Could Be Your Worst Enemy (and Why You Need to Consider It)

Growing up in the southern United States, I often found myself walking home in the midst of a torrential downpour. And if being soaking wet wasn’t enough, to add to the despair in my shivering body, this rain was accompanied by a copious amount of bone-rattling thunder and sky-illuminating thunder. To be honest, I really love the sights and sounds of lightning and thunder. But ever since those experiences as a kid, I’ve always been nervous near power lines during a storm having witnessed—from a distance mind you—the electrifying scene of the colliding charges of the lightning and power lines. The remnants of those two separate electrical currents, naturally, renders all component of the power lines severely damaged.

Electrostatic Discharge (ESD)—in short—is the sudden flow of electricity between two electrically charged objects caused by contact, an electrical short, or dielectric breakdown. Similar to a bolt of lightning striking and frying a power line, ESDs can cause permanent—yet sometimes unseen—damages within the interconnect structures. For this discussion, a medical device can be one “electrically charged object,” and the patient can be the other “electrically charged object.”

Where in the device is ESD protection incorporated?

For simplicity, we are going to break a medical device into two components; 1. The Capital Equipment, 2. The Disposable Device.

  1. The Capital Equipment: This piece of the medical device typically has more room and ability to incorporate ESD protection. Also, more people are going to be interacting with the capital equipment, as opposed to the disposable portion of the medical device.

We suggest an extensive investigation into incorporating ESD protection into your capital equipment.

The Disposable Equipment: This is where ATL’s expertise in interconnect solutions and experience comes into play. For this discussion let’s break the disposable into three components: the Interconnect Solution (or Connector), the Wire; the Device:

  • The Connector – The connector is typically either metal or plastic, metal connectors can intercept ESD arcs, but are too expensive for more disposable medical devices. A correctly designed plastic connector can meet pricing constraints and provide the required ESD protection. There are many ways to incorporate ESD protection into a plastic connector. A connector can be designed and produced to incorporate: Mylar, metal mesh, conductive filled materials, as well as a number of other possible materials to support and benefit your product, based on the products specific requirements.
  • The Wire – The wire is the easiest component of the disposable to incorporate ESD shielding, with the use of wire shielding.
  • The Device – The device will share many similarities to the connector. The design of the device should be discussed with experts in electronics, such as ATL Technology.

Is ESD testing required in a Medical Device Connector?

From the FDA’s Design Considerations for Devices Intended for Home Use Guidance for Industry and

Food and Drug Administration Staff; “Although not a requirement, the Agency generally finds testing to the following immunity tests levels acceptable for the home environment based on FDA’s experience with home use devices: Electrostatic Discharge (ESD): ± 8 kV contact discharge, ± 15 kV air discharge;”

From the FDA’s document on Electromagnetic Compatibility (EMC); “The different forms of EM energy that can cause EMI are conducted, radiated, and electrostatic discharge (ESD). EMI problems with medical devices can be very complex, not only from the technical standpoint but also from the view of public health issues and solutions.”

The FDA’s document Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems states, “Immunity – FDA recommends EMC testing also demonstrate the device will perform as expected in the presence of other electrical and electronic devices or other sources of electromagnetic disturbance in the intended environment of use (immunity). The device should operate in an acceptable manner during and after exposure to various forms of electromagnetic disturbance. FDA recommends testing include exposure to electrostatic discharge (ESD) … [and other possible electrical disturbances and discharges]”

There are a myriad of other products and suggestions from the FDA that we could reference, but we try and keep our blogs short. From what the above represents, we would suggest you confirm with the FDA or an independent auditor the ESD requirements for your project, know what ESD testing the FDA will require for your specific product and, most of all, make sure that your product provides the safest possible outcome to the patient.

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.