Last month, I was happy to represent DDL at ISTA’s first annual International Transport Packaging Forum. While I was presenting” Laboratory Practices for Optimal Thermal Gel Design and Specification” DDL’s own Mike Woletz, Packaging Engineer and Project Manager, was attending multiple presentations, networking, and since the event was held at Disney’s Coronado Springs Resort, most likely having a little bit of fun.
It is my pleasure to introduce below a guest post from Mike Woletz sharing his thoughts on the first annual International Transport Packaging Forum:

This week, I will be out at MD&M Minneapolis, both meeting with you at DDL’s booth, and presenting later this morning.

My presentation, “The Compliance Sweet Spot” Employing the TIR 22 for Effective ISO 1160 Compliance” will highlight the key activities that provide the necessary competitive advantage for sterile medical device packagers as they engage in the competitive race to market.

Geared towards those relatively unfamiliar with the details of compliance to ISO 11607, or how best to follow its “how to” guide the TIR 22, my presentation will serve as an introduction to both, and frame them within a “12 Steps to Market” for easy compliance.

Medical device companies must work through a number of challenges facing their corporate packaging engineers. In my article, “Six Benefits of Outsourcing Your Packaging Engineering Activities - A Case for Virtual Package Engineering for the Medical Device Industries“, I discuss the benefit of outsourcing and other important issues challenging today’s packaging professional.

These six benefits can significantly reduce the time needed to get a product to market. In addition, outsourcing your package engineering can allow for more effective problem solving and innovative design. By outsourcing, your company focuses on what it does best, while getting the crucial packaging completed through the use of a virtual package engineering support team.

If you believe package engineering is not a science, a technology or a multi-billion dollar global business force, then you need to attend Dimensions.08.  Dimensions is a broad scope packaging forum covering all aspects of the technology and management of transport packaging.

Dimensions.07 covered issues of packaging sustainability as presented by Sams Club, IBM Corporation, Rochester Institute of Technology, Herman Miller and Lansmont Corporation.  These companies are setting the new standards for the total packaging lifecycle and challenged packaging professionals with their original research, corporate metrics programs and their forecasts for continuous improvement on preserving and conserving our world’s resources towards the development of packaging materials and systems.

DDL understands that time to market is critical for manufacturers.  This is why DDL has developed the 12 Steps to Market, a step-by-step guide to help manufacturers deliver their product to market on-time and intact.

1.  Packaging Design Requirements
2.  Packaging System Hazard Analysis
3.  Labeling Requirements
4.  Evaluation of Similar or Competing Devices
5.  Understanding the Clinical Application of a Medical Device
6.  Distribution, Storage & Handling of the Product
7.  Prototyping the Packaging System
8.  Stability Testing, Accelerated & Real Time Aging of Sterile Barrier System
9.  Sterilization Effects on Biocompatibility & Sterilization Validation, Device & Package
10. Integrity of the Sterile Barrier System & Packaging System Performance Testing
11. Packaging Equipment Qualification, IQ and OQ
12. Packaging Process Development & Performance Qualification (PQ)

I am also pleased to announce that I will be speaking at HealthPack 2007 on “Offshore Packaging - An Insider’s View”. Join me on March 9 at 2.15 pm.

Don’t forget to stop by the DDL Table #21 to find out how you can reduce time to market for your medical device or product.

Another interesting session that I was able to attend at the Biocom Drug/Device Summit was about regulatory issues for new in vitro diagnostics and combination products.

Here is a summary of the session’s highlights:

• Combination products can be drug-device, device-biologic, drug-biologic, drug-device-biologic, but not drug-drug.
• Also defined that if a manufacturer co-packages any of the above in a kit then the package is defined as a combination product.
• The FDA has 3 medical products centers:
• CBER (center for biologics evaluation and research)
• CDER (center for drug evaluation and research)
• CDRH (center for devices and radiological health)

While I was at the Biocom Drug/Device Summit in December 2006, I attended a session that addressed the key players and issues at the intersection of Nanotech, Microelectronics and Regenerative Medicine.

Here’s a summary of the session’s highlights:

I recently attended the Biocom Drug/Device Summit in La Jolla, California. This summit brought together several players concentrating on developing next generation medical products and key investors interested in funding their growth and development.

Participating companies were small, start-up companies and larger, more established companies. Plenary sessions focused on defining the drug/device opportunity, combination products, key players and issues at the intersection of nanotech, microelectronics and regenerative medicine and how the FDA is addressing the new regulatory issues for in vitro diagnostics and combination products.

Over the next week or so, I will be posting the highlights of the plenary sessions I attended while at the summit.

2006 has been a great year for DDL West. Thank you to all of our customers, employees and partners for contributing to our company’s success.

DDL West Welcomes Karen Greene who is a tenured packaging professional has already secured a speaking slot at next year’s HealthPack and was quoted in Medical Product Outsourcing on process validation.

This year, important revisions were made to ISO 11607, the foremost guidance document for validating packaging for terminally sterilized medical devices. More industry standard revisions lie ahead in 2007. DDL is helping industry professionals stay on-top of changes to standards with its new “Industry Standards Alert” service.