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ATL Blog

Developments and items of interest to the custom label and medical device markets.

Live from MD&M East!

ATL highlights medical device converting capabilities at MD&M East

We're here at Booth 958 at MD&M East in the Jacob K. Javits Convention Center through June 15. If you're interested in learning more about how our converting and printing capabilities can benefit your next disposable medical device or labeling project, make sure to stop and talk to Scott, Mike or me. Can't make it to the show? Just contact us, and we'll be glad to discuss your needs.

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Learn about ATL’s Medical Device Labeling & Converting Expertise at MD&M East

Once again, we’ll be exhibiting at MD&M East, running June 13-June 15 this year at the Jacob K. Javits Convention Center.

Scott Pedersen, Mike O’Connell and I will staff Booth 958, and we’ll be showcasing our die cutting and printing capabilities for medical tapes and foams as well as custom label products.

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Medical Device Packaging & Labeling Summit

The 6th Semi-Annual Medical Device Packaging and Labeling Summit will be held in Alexandria, VA, on April 27-28.  As a sponsor of the event, we will be displaying our extended content labeling and medical device packaging capabilities as well as attending seminars on new labeling requirements and regulations in the medical industry. 

Knowledgeable presenters from companies such as Stryker, Baxter, Abbott Diagnostics, Roche, and Becton Dickinson will share their experiences on medical labeling and packaging challenges.  The conference includes panel discussions on feedback from end users working in hospitals and clinics as well as FDA guidance and case studies. 

If planning to attend, please stop by our table to discuss your labeling and packaging needs. 

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Custom Labels, Die Cutting and Converting Medical Tapes at ADM Cleveland Show

ATL looks forward to meeting new and existing customers in the Cleveland area at the Advanced Design & Manufacturing Cleveland show March 29th - 30th at the Cleveland Convention Center. 

This new show gives us the opportunity to introduce our custom printing, die cutting and converting capabilities to a variety of manufacturing industries. 

Stop by Booth 1236 to discuss your new and existing label or product development project with our friendly and knowledgeable representatives. 

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Medical Tape Conversion, Security Labels Top the List at MD&M West

We’re back from MD&M West and still impressed with the variety and depth of the questions posed by show attendees.

Topics included:

  • Security labels for protecting branded products and tamper proofing their packaging
  • Converting medical tapes for various skin adhesion disposable products
  • Wearable devices
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Shining a Spotlight on Medical Device Labeling, Converting at MD&M Minneapolis

Once again, we’ll be exhibiting at MD&D Minneapolis, meeting up with the region’s leading medical designers and other key decision makers.

This year’s event runs September 21 through September 22 at the Minneapolis Convention Center, and we’re particularly looking forward to highlighting our medical device labeling capabilities.

MD&M is always a great opportunity to educate members of the medical device community about the benefits of partnering with ATL. Our designation as one of a handful of 3M Medical Preferred Converters often plays a featured role in those conversations.

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Medical tapes, disposable devices at heart of new engineer’s job

ATL is pleased to introduce Scott Pedersen to our New Business Development team. Scott joins ATL today, July 18th, as our Business Development Engineer.

Scott comes to ATL with over 17 years of senior sales account experience in the Microfluidics, OEM and Medical Device businesses. Previously, he worked for a brokerage company that contracted with 3M, specifying medical tapes for wearable medical device applications.  Scott has extensive knowledge of medical tapes, foams, and adhesives and how they are used in various applications.

Scott, who has a bachelor of science degree in business management from the University of Phoenix, served in the U.S. Military for four years as a corpsman for both the Navy and Marine Corps. 

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Live from MD&M East

 

We're pleased to be exhibiting this week at MD&M East in New York City. If you're at the Javits Convention Center, stop by and see us at Booth 1852. We're looking forward to talking to new and potential customers about ATL's areas of expertise, including custom disposable medical devices, medical tapes and foams, and product design.

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Helping a Client Launch a New Disposable Medical Device

ATL has long been known for our ability to help customers take their designs from concept to completion.

That process for Nistaa, Inc. reaches an exciting milestone this week with the debut of its new disposable medical device, NistaaTM Waterproof Transparent Barriers, latex-free hypoallergenic protective covers that patients can use while bathing or showering.

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Trade Show Focus on Medical Device Labeling & Converting

Our capabilities centered on the medical industry will once again be in the spotlight as ATL gears up for three trade shows this spring.

First up on our list is the Medical Device & Diagnostic Labeling Conference, for which ATL is one of 11 sponsors. We’re particularly focusing on our medical device labeling capabilities this year, so the conference topic is of special interest to ATL.

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The Benefits of Working with a 3M Preferred Converter

As a disposable medical device converter and label printer, we value our relationship with our suppliers, knowing that it only benefits our customers in the long run.  One of our long-standing suppliers in the medical and label industry is globally recognized 3M.

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Disposable Medical Devices in 3 Trade Shows and 6,800+ Miles

We’ve just wrapped up a mega trade-show extravaganza, traveling from one end of the U.S. to the other, hitting major medical device shows and finding a lot of great people with a lot of great ideas for new products.

No matter where we went, we were impressed with the show attendees’ enthusiasm and interest in bringing some fascinating and innovative applications to market. Here’s a quick wrap-up of where we were and what we saw:

MD&M Minneapolis

Highlights: Visiting with our Minnesota and Wisconsin customers at the Minnesota MedTech show … Discovering exciting opportunities to prospect for new label and disposable medical device business as MD&M Minneapolis combined with Life Science Alley for the first time and attracted even more design and engineering, manufacturing, and R&D professionals

Hot Topics: 3D printing … product design innovation … new healthcare technologies

Bonus: Beautiful, unseasonably warm weather

MD&M Florida/SouthPack

Highlights: Marketing in a new region … Meeting exhibitors and attendees from central Florida as well as a number of Southeastern states

Hot Topics: label capabilities… industrial applications for double-sided and conductive tapes … packaging design for today’s world

Bonus: Orlando. In November. Enough said.

BIOMEDevice San Jose

Highlights: Meeting attendees in product development and engineering from companies all over the Bay area

Hot Topics:  Wearable technology … which led to discussions about some very unique and interesting products with prospective customers

Bonus: Getting out and playing bocce ball with fellow exhibitors, which allowed us to learn more about their businesses – and have a little fun away from the show floor

If you’d like to learn more about what we saw or how ATL can meet your disposable medical device or label needs, make sure to contact us. Even after five weeks of trade shows, we’re always glad to talk with somebody new and share our expertise.

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Visit ATL at a Trade Show Near You

Trade show season is in full swing, and we’ll be exhibiting at several of the major medical device events this fall, including:

MD&M Minneapolis 2015
Minneapolis Convention Center
Minneapolis, MN
Nov 4-5, 2015
Booth 1461

MD&M Florida 2015
Orange County Convention Center
Orlando, FL
Nov 18-19, 2015
Booth 134

BIOMEDevice San Jose
San Jose Convention Center
San Jose, CA
Dec 2-3, 2015
Booth 1030

A major focus at all three shows will be our die cutting and printing capabilities for disposable medical devices. As a leading medical industry supplier and contract manufacturer for three decades, ATL has a great understanding of the industry’s needs and how to meet specific client goals.

Stop by our booth any day to speak with our knowledgeable staff about your disposable medical device applications. If you’d like to schedule a certain meeting time, give us a call at 262.255.6150 or submit a contact form, listing what times would best suit your schedule.

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Systems Validation Protocol Methods for Disposable Medical Devices

If your product must meet the requirements of FDA cGMP 21 CFR 210, 211, 820, ISO-9000, ISO-13485, or MDD/93/42/EEC (for the CE Mark), there are three very critical elements you must have to be in regulatory compliance.   They are the following:

  1. You must have a sound and strong Quality Management System (QMS).  This is an expression of WHAT you do (your quality policies and structure).
  2. You must have reliable Standard Operating Procedures (SOP’s).  These are expressions of HOW you do things.  SOP’s must be very detailed and employees must be trained for suitable proficiency for the task they perform.
  3. Missing in the above two items is an expression of HOW WELL you do what you do.  This is where you must establish your “Systems Validation Protocol” (SVP).  Your SVP is an expression of how well your system is working (for example, this can be expressed in overall product conformance percentage or in defects per million for your various products.)

The SVP is a living and continuous document based on your quality records.  The ATL White Paper “What is Systems Validation Protocol?” is our attempt to share with you a sound approach to Systems Validation and the various protocols that you can use.  Click here to learn more.

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Control Plans for Disposable Medical Devices

The customers of many disposable medical device manufacturers require that their vendors adhere to a quality management system that is demonstrably planned and complete.

To do so, manufacturers often find they must:

  • Complete quality assurance functions and inspections for critical characteristics on their disposable medical devices
  • Detail, in chronological order, all phases of their production processes
  • Provide proof of cGMP compliance (Current Good Manufacturing Practices) for FDA products, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Our article entitled “What is a Control Plan or FDA Performance Qualification (PQ)” strives to help you understand the methods and control points the FDA and/or customer auditors will be looking for.  An actual Control Plan/ Performance Qualification is included for your review.  Please click here to read the article.

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Process FMEA for Disposable Medical Devices

Are you responsible for process and quality assurance functions (risk analysis) for critical characteristics on disposable medical devices?

Must you detail, in chronological order, all manufacturing risks associated with your production processes (so your customers can see your risk management is planned and complete)? 

Are you manufacturing an FDA product (or a product that requires the CE Mark) that requires proof of cGMP (current Good Manufacturing Practices) or ISO-14791 (risk analysis) compliance? 

The article “How to do a Process FMEA for Medical Devices after ISO-17791 Risk Analysis” (which includes an example of a Process FMEA form) attempts to help you understand the methods and control points in the contract review and risk analysis phases of your product development.  These are items that the FDA and/or customer auditors will be looking for.

To view an FMEA flowchart, please click here.

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Risk Analysis for Disposable Medical Devices

Are you or your company responsible for high level risk analysis, which includes critical characteristics on disposable medical devices?

For complex medical devices, risk analysis is sometimes required to be in compliance with ISO-14971:2012 and MDD/93/42EEC.  These are two medical device risk analysis knowledge bases.  ISO-14971 is an international standard and MDD/93/42/EEC is the law.  

Does your company have to detail all phases of your risk and hazard considerations prior to your production processes to be compliant?  The purpose of ISO-14791:2012 risk analysis is very similar to that of an FMEA (Failure Modes & Effects Analysis); only this time you must consider risk and hazards as they would potentially harm the end user. 

The ATL White Paper “What is ISO-14971 & MDD/93/42/EEC Risk Analysis for Medical Devices (CE Mark)” attempts to explain some of the risks and hazards you must consider so the people using the medical device are protected from potential hazards. 

Click here to view the white paper on Risk Analysis for disposable medical devices.  

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Process Capability for Disposable Medical Devices

Do you design, order, or have responsibility for quality assurance functions (inspections) for critical characteristics of disposable medical devices

Quality actually starts when the first concept of the product idea is postulated by the design engineering team.  The manufacturing of medical devices (made of medical foam or tape) is much different than manufacturing “rigid” items such as plastic components for a car.  This is because most medical materials have an elongation factor, so accurate and precise measurements usually demonstrate more variability. 

The article entitled “Process Capability/Medical Devices” strives to help you understand the common pitfalls in the main aspects of disposable medical device manufacturing (converting) from:

  1. The physical properties in the selection of materials
  2. Process inspection/controls
  3. The expression of critical characteristics into Cpk terms (capability)
  4. Accurately estimating your possible production failures and expressing this figure in defects per million.

 Click here to learn more about Process Capability for disposable medical devices.  

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When Quality Counts

Whether your application requires a pressure-sensitive label or an FDA-compliant disposable medical device, one thing in every project is true: a commitment to quality makes a difference in the end product.

It’s an easy sentence to type but a difficult concept to achieve. Here at ATL, we live that commitment every single day by consistently taking a Six Sigma approach in accordance with a number of standards and regulations, including ISO-13485, MDD 93/42/EEC and FDA cGMP.

These protocols, which involve a variety of elements, always begin with the same steps:

  1. Formulate product development by identifying customer needs from a variety of perspectives, including:
    • Stated customer requirements (the intended use of the product)
    • The Six-Sigma approach of DMAIC - Define, Measure, Analyze, Improve, Control
    • APQP (Advanced Product Quality Planning)
  2. Define and Implement process development from the customer's design goals by determining:
    • Necessary materials
    • Process flow
    • Timeline for completion
    • ATL roles and responsibilities
    • Feasibilities of the proposed product as ranked by manufacturability (cost effectiveness)
    • Feasibilities of the proposed product as ranked by potential product hazards to the end user (FMEA or ISO-14971 Risk Analysis)
  3. Measure, Analyze, Improve, and Controlthe manufacturing process by:
    • Understanding the critical to quality characteristics (CTQ’s) required by the client
    • Determining process stability
    • Determining process capability
    • Determining packaging standards
  4. Develop the client's product control plan or FDA cGMP Performance Qualification (PQ), which covers:
    • Product
    • Process
    • Operations
    • Machines
    • Characteristics class
    • Specification tolerances
    • Measurement technique
    • Cpk determination
    • Sample size
    • Sample frequency
    • Control method
    • Reaction plan

The process is time consuming and detail oriented but always attempts to achieve this final goal: the best product for the client made the best way with the best materials.

Click here to view a PowerPoint providing more details on our system validation protocolsand, when quality is paramount, make sure to contact ATL for assistance with your disposable medical device or pressure-sensitive label.

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Recap of BIOMEDevice/ Design and Manufacturing Show in Boston

My coworker, Mike O’Connell, and I worked our booth at the BIOMEDevice/ Design & Manufacturing show in Boston last week.  The show highlighted new and innovative medical technologies, prototyping, engineering, manufacturing, assembly, and packaging. 

At the show, we had the opportunity to meet many new people and learn more about their projects and current challenges they are facing.  We had many inquiries on custom product labels as well as medical tape die cutting and packaging.  Other discussions we had were on unique hydrogel applications and other disposable medical device applications.

We were blessed with beautiful weather while visiting Boston, and during our down time we enjoyed dining alfresco on fresh seafood the region has to offer at restaurants on the harbor and at Faneuil Hall. These locations and historical sites of Boston are all within walking distance of the Boston Convention & Exhibition Center.

To learn more about what we offered attendees at the show, please contact us.

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