Saturday, 19 of May of 2012

Category » Medical Device Packaging

Join DDL Engineers Scott Levy, Robert Hoody and Al Gale at MD&M West 2012 this week in Anaheim

DDL will be participating as an exhibitor at this year’s MD&M West Expo & Conference, which is just 2 weeks away! MD&M West starts on February 13th, with the Expo opening the following day on the 14th at the Anaheim Convention Center. If you are attending the show, please make sure to stop by booth #1923 to speak with our engineers.

DDL Packaging Engineers, Scott Levy and Robert Hoody will be manning the booth along with our Product & Materials Engineer, Al Gale. If you have technical questions about any current or upcoming testing projects that you are working on, they will be available to answer those throughout all 3 days of the expo.

To learn more about how DDL can help you with your medical device package validation or product and materials testing, visit our website or contact us to see how we can help.

We look forward to seeing you at this year’s MD&M West Expo!

MD&M West 2012

About MD&M West
Medical Design & Manufacturing (MD&M) West is the most comprehensive resource for every aspect of medical device development. It gathers medtech professionals and leading medical OEM suppliers together to provide you with immediate hands-on access to the tools you need to accelerate your new device to market, all in one convenient location.

Register for MD&M West >>


DDL’s Upcoming Life Science/Medical Device Events

With the end of the year quickly upon us, we wanted to let you know where DDL will be venturing off to for upcoming industry events. There are two conferences that we are attending the first week of December; BIOMEDevice in San Jose and the LifeScience Alley Conference in Minneapolis.  We will also be hosting a networking happy hour event with a few of our MedTech industry partners, following the LifeScience Alley Conference on December 7th.

BIOMEDevice Expo & Conference | BOOTH #738
December 6-7 | San Jose, CA

Attend BIOMEDevice San Jose and gain immediate access to the newest technologies and innovative solutions, and the most up-to-date information for every aspect of medical device design and manufacturing

DDL Packaging Engineers, Scott Levy and Robert Hoody will be attending the BIOMEDevice show in San Jose. If you are in the area and would like to spend some time discussing any upcoming projects with Scott and Rob, please visit them at the show to say hello.

Register for BIOMEDevice >>

LifeScience Alley Conference & Expo | BOOTH #505
December 7 | Minneapolis, MN

Join medical technology professionals from around the globe at the 10th Annual LifeScience Alley Conference & Expo in Minnesota, the epicenter of medical device innovation. This year’s Conference will bring the medical technology community together to share vital resources, practices, and information on the shifting commercialization landscape.

We will have a couple of employees attending the conference and exhibiting in a booth at LifeScience Alley in Minneapolis. If you are attending the show, please stop by our booth and say hello.

Register for LifeScience Alley >>

Minneapolis MedTech Happy Hour – Hosted by DDL, following LifeScience Alley
December 7 | 5:00-7:00 pm | Porter & Frye in Downtown Minneapolis

DDL, along with several other leading MedTech industry partners, will be hosting a networking happy hour event for MedTech professionals at Porter & Frye in Minneapolis following the LifeScience Alley Conference on December 7th. Whether you are attending LifeScience Alley or not, please register and join us for a great opportunity to connect with other MedTech professionals. Light appetizers and drinks will be provided. To register, please use the link below.

Register to attend the Minneapolis MedTech Happy Hour >>


DDL Packaging Engineer Scott Levy is co-chairing the Medical Packaging Update at MD&M Minneapolis

DDL, Inc. will be exhibiting at the 2011 MD&M Minneapolis Expo & Conference next month in the Twin Cities. The show kicks off with the conference on November 1st at the Minneapolis Convention Center.

MD&M Minneapolis’ Expo hall maximizes your time by gathering the world’s best and most qualified suppliers under one roof. They know your industry, understand your objectives, and are ready to help you bring that new device to market and accelerate your project’s completion

DDL’s Lead Packaging Engineer Scott Levy is a co-chair of the Medical Device Packaging Update at the conference on Thursday, November 3rd. We invite you to join Scott, along with co-chair Kevin Zacharias of Oliver-Tolas Healthcare Packaging for an update on happenings in the medical device packaging industry.

DDL will be exhibiting at booth #830 during the expo, where you will have an opportunity to talk to Scott Levy about any current and upcoming package testing projects.

We look forward to seeing you at this year’s show. If you have any questions regarding your package testing needs, please contact us, we are happy to help answer your questions.


DDL will be exhibiting at MD&M East 2011 and participating in the Medical Device Packaging Update

DDL will be exhibiting at the 2011 MD&M East Expo & Conference next month in New York City. The show kicks off with the conference on June 6th at the Jacob K. Javits Convention Center.

MD&M East, New York, Medical Device, Tradeshow, Conference, DDL, Inc.

MD&M East’s Expo hall maximizes your time by gathering the world’s best and most qualified suppliers under one roof. They know your industry, understand your objectives, and are ready to help you bring that new device to market and accelerate your project’s completion

DDL’s Lead Packaging Engineer Scott Levy is a co-chair of the Medical Device Packaging Update at the conference on Wednesday, June 8th. We invite you to join Scott, along with co-chair Kevin Zacharias of Oliver-Tolas Healthcare Packaging for an update on happenings in the medical device packaging industry.

DDL will be exhibiting at booth #1969 during the expo, where you will have an opportunity to talk to Scott Levy about any current and upcoming medical packaging projects.

MD&M East, DDL Inc., medical device packaging, package testing

We look forward to seeing you at this year’s show. If you have any questions regarding your package testing needs, please contact us, we are happy to help answer your questions.


DDL West is hosting a Spring Medical Device Packaging Seminar in Fountain Valley, CA

DDL will be hosting its 3rd Medical Device Packaging Seminar on Thursday, May 5th at its Fountain Valley, California location.

“This will be our first seminar in California and we’re really excited about the opportunity of opening up our facility to attendees,” John Koch, Lab Manager at DDL West, said.

The seminar will take place from 9:30 am – 3:00 pm and will include both seminar presentations and an interactive learning workshop on test methods.


“The program will cover similar topics to what was discussed at our fall seminar held in Minneapolis, MN. The seminar and interactive workshops are intended for medical device packaging engineers, supply chain managers, product engineers, and quality professionals. Scott Levy, Packaging Engineer said. “The material for our May seminar has been revised in response to what our fall attendees indicated as well as to reflect what the industry is doing today.”

The one day program will focus on topics ranging from distribution simulation for the medical device industry to regulatory compliance and ISO 17025. The program will be presented by, DDL Packaging Engineer, Scott Levy, DDL’s Quality Assurance Manager, Kim Pratt and DDL’s Operations Director, Corey Hensel.

“A major addition, which we also added to our fall seminar, were the interactive workshops lead by DDL’s project managers,” Hensel said. We love the opportunity to give our guests firsthand experience on the integrity testing processes that take place during test method validation.”

The workshops will include demonstrations of;

  • ASTM F88 – Peel Seal Testing
  • ASTM F2096 – Bubble Leak Testing
  • ASTM F1929 – Dye Leak Testing
  • ASTM F1886 – Visual Inspection Testing

The most beneficial part of DDL’s seminar, however, is the opportunity for clients and prospective customers to sit down and talk with DDL’s lead packaging engineer Scott Levy. Levy has been in the packaging industry for over 15 years. He specializes in helping medical device manufacturers comply with ISO 11607 and other industry standards. He is also able to consult with clients on package failures when needed.

“We are very excited to open our doors at our Fountain Valley facility and give attendees an opportunity to expand their knowledge on distribution testing, validation and quality,” Pat Nolan, President of DDL said

The seminar, which is scheduled for May 5, 2011, will be held at DDL’s West coast location in Fountain Valley, CA. For more information please visit our Packaging Seminar Website by clicking on the link below or contact DDL’s marketing department 952-941-9226 ext. 157 or 159. You can also reach us via email at lyndsey.danberry(at)testedandproven(dot)com

DDL Spring Packaging Seminar Website


DDL’s Scott Levy Talking Distribution Simulation Testing Standards and Test Methodologies

DDL Packaging Engineer Scott Levy, discusses some of the current standards in relation to distribution simulation testing. Scott explains the importance of understanding the standards, as well as how future changes may affect medical device manufacturers bringing new products to market.


DDL’s Fall Medical Device Packaging Seminar/Interactive Workshop

DDL will be hosting its 2nd Medical Device Packaging Seminar of 2010 on Wednesday, November 17th at our headquarters in Eden Prairie, MN.

The seminar will take place in our brand new space from 9:30 am – 3:00 pm and will include both seminar presentations and an interactive learning workshop on test methods.

Here is the schedule for the day, as well as the topics that will be presented:

9:30 am -10:00 am - Coffee/Networking

10:00 am -10:10 am - Welcome
DDL President – Patrick Nolan

10:10 am -11:10 am - Distribution Simulation – What is the Industry Doing?
Packaging Engineer – Scott Levy

11:15 am – 12:15 pm - 17025 Quality Systems/Test Method Validation
Director of Quality – Kim Pratt and Director of Operations – Corey Hensel

12:15 pm – 1:00 pm - Lunch

1:00 pm – 3:00 pmTest Method Interactive Workshop, Presentations/Q&A
Lab Manager – Eric Borchardt, Packaging Lab Supervisor – Jason Simon
Sr. Project Manager – Luke Munroe and Project Manager – Mike Woletz

*Attendees will break into small groups for the test method workshop and rotate stations every 30 minutes.

The cost for the workshop is $155/per person, however, if you register before Friday, November 5th you will receive an early bird discount of $50 on your registration.

Register for DDL's Fall 2010 Packaging Seminar/Interactive Lunch and Learn in Eden Prairie, MN  on Eventbrite

We look forward to seeing all of you that are able to attend on the 17th!

If you have any questions about the workshop, please contact Lyndsey Danberry, Marketing Manager at DDL.


Packaging Sustainability for the Life Sciences Industry

Here is an excerpt from an article that I wrote recently for PMP News, outlining some of the challenges that many companies in the medical industry face when redesigning packaging to meet sustainability goals, by reducing or minimizing the materials used in their packaging. Visit PMPNews.com if you would like to read the full article on Packaging Sustainability for the Life Sciences Industry.

Sustainability has become mainstream, and European standards may influence the development of global standards. But there could be some unintended consequences to sustainability that medical device manufacturers should be wary of when redesigning packaging.

For packaging professionals, designing the optimal package has always been the objective. For years the packaging industry has been obligated to provide “sustainable” packaging through state and local legislation (Green Laws, Packaging Waste Directives, ‘Reduce/Reuse/Recycle initiatives); economics (increased margins on products and lower product costs to the consumer); reduced damage claims (engineering, design, testing); and new technologies. Packaging engineers have been designing packaging with these criteria in mind since the first packaging engineer graduated from Michigan State University. The first Earth Day heightened the challenge for packaging engineers. More recently, the rapid industrial growth of countries such as India and China has heightened the awareness of the environmental impact of industrialization.

And so, for many corporations, sustainability is one of their goals. Designing sustainable packaging and minimizing packaging’s impact on the environment fall into that scope. They view (packaging) sustainability as just as important as what is produced, how it is produced, and where it is delivered. These initiatives are spreading among corporations, organizations, regulatory bodies, and governments.

However, in the medical industry, there are many challenges to implementing truly sustainable packaging initiatives. Considerations include the regulatory requirements; preserving the efficacy of the product at end use; ensuring material compatibility with manufacturing processes, sterilization processes, and transportation; and guaranteeing that package designs do not cause unintended consequences within the sustainability continuum that impacts economic, environmental, or social responsibilities.

What is Sustainability?
One of the major dilemmas facing the industry is determining just what sustainability means. “Sustainable development” is a term that grew out of the conservation/environmental movement of the 1970s. While the conservation/environmental movement asked questions about preserving the Earth’s resources, sustainable development includes questions about how human decisions affect the Earth’s environment.

Sustainable development is a process of developing (land, cities, business, communities, etc.) that “meets the needs of the present without compromising the ability of future generations to meet their own needs,” according to the Brundtland Report, a 1987 report from the United Nations. The precise meaning of sustainable development has been widely debated. For example, two years after the Brundtland Commission’s term, more than 140 definitions of sustainable development had been catalogued,” according to ENO Online.

There have been many more definitions for sustainability cataloged since then. The table below illustrates how three other organizations define sustainability.

Read more »


510(k) Approval and Aspects for Medical Packaging Design

In an ever changing regulatory environment for medical device manufacturers and vendors to the medical device industry, it is extremely important to know how changes are affecting packaging design considerations. Medical device packaging has come under more scrutiny from the FDA in the past few years and is causing MDMs to look closer at the requirements before designing, testing and manufacturing packaging for their medical device products. As a vendor to many medical device companies, it is our priority to monitor and educate ourselves on how the premarket notification process or 510 (k) works.

This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.

Package integrity is specifically mentioned in the FDA guidance documents for 510 (k) approval relating to Submissions for Medical Sterilization Packaging Systems. It is important that manufacturers understand these guidance documents before starting packaging testing, to ensure that time lines will be met and that any failed package validation doesn’t hold up the entire product development process.

Vendors also need to know how the FDA looks at packaging for terminally sterilized medical devices, so that they can have the proper expectations for working with medical device manufacturers.

Here are some of the aspects to consider when designing medical device packaging, in addition to a more strict regulatory environment.

  • Meet the needs of all health care practitioners and distributors
  • Easy to manufacture
  • Comply with increasingly rigorous regulatory requirements
  • Protect the sterile integrity of the medical device
  • Minimize the impact on the environment

Packaging for medical devices will continue to play an important role in the development of new medical devices. As technology continues to evolve, process for both MDMs and their vendors will need to be clearly defined so that they can maintain positive working relationships. In addition to issues with the regulatory bodies; sustainability, safety, ease of production and meeting the needs of a health care environment that is rapidly changing will be at the forefront of packaging design for medical device products.

What other aspects of medical device packaging need to be addressed in today’s health care environment?


Top 10 Common Mistakes Companies Make When Developing and Validating Packaging Systems: Part 1 of 2

Packaging for medical devices plays a key role in safely delivering specialized treatment to patients. Most single-use, sterilized medical devices can be opened with a high degree of confidence that it has remained sterile throughout storage, handling, and transportation.

What makes packaging doubly important is that regulatory authorities recognize the critical nature of sterile barrier or primary package by considering them components or accessories to the medical device. This implies that packaging is almost as important as the device itself. And it is. If a package does not keep, for instance, a pacemaker sterile, patients will be put at risk.

The design and development of packaging has rightfully come under closer scrutiny by international and domestic regulatory agencies. This scrutiny has placed a great deal of emphasis on standardizing package development. Some standardization comes in the form of the international standard ISO 11607: Packaging for terminally sterilized medical devices.

Package validation is useful for testing medical packaging for defects that may come from handling (or mishandling), vibrations during transportation, storage, and impacts caused by dropping.

As critical as packaging is, some companies occasionally don’t take it seriously. They’ll consider it late in the design cycle, cut corners, or use inappropriate materials.

In part 1 of 2 posts on the ten common mistakes companies make when developing and validating packaging systems for terminally sterilized (inside a closed package) medical devices, here are the first five.

1. Loss of sterile integrity
This is the most common defect in medical packaging and can happen from fractured thermoforms along with pinholes, slits, cuts, and tears in pouch packages. These defects come from handling (or mishandling), vibrations during transportation, storage, and impacts caused by dropping.

Read more »