6TH SEMI-ANNUAL MEDICAL DEVICE PACKAGING CONFERENCE

April 27 – April 28, 2017 | ARLINGTON, VA
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DAY TWO| FRIDAY, APRIL 28TH

7:30 REGISTRATION & MORNING COFFEE

7:50 CHAIRPERSON’S OPENING REMARKS

8:00 PANEL: CREATING AN INDUSTRY CONSENSUS ON CHANGE CONTROL PROTOCOL

Material changes in device packaging can be an arduous process for packaging departments, as extensive testing and validation is required for each material change. Many industry executives find the high frequency of testing and validation to be time consuming and a drain of resources. Packaging experts seek to develop an industry-wide consensus for scientific evidence and data that can be used to adequately demonstrate a new material in packaging is analytically equivalent to the original material, to ultimately exempt qualifying new material from costly validation testing. This panel discussion will feature packaging experts from across the industry that have come together to develop a unified approach for change control processes in medical device packaging.

  • Developing required testing according to projected risk
  • Data necessary to demonstrate material “non-inferiority”
  • Ensuring regulatory compliance in change controls

Moderator: Henk Bloom, Director of Technical Services, ROLLPRINT

Panelists:
Patrick Weixel, Deputy Division Director of Compliance, FDA

Nancy Smith, Senior Account Manager, DOW CHEMICAL COMPANY

Heather Killmeyer, Senior Packaging Engineer, CONVATEC

 

8:45 ACHIEVING WORLD CLASS CHANGEOVER TIME

An efficient changeover in a Packaging Line is critical for Lean Organizations. It provides the flexibility to match the product mix to actual demand. In turn, this prevents the accumulation of inventory that can add cost and substantial waste to a value stream.

This case study will discuss how ROCHE reduced changeover time in Glucose Measuring Strip packaging line while increasing the volume and therefore the amount of lots produced yearly. This journey that has allowed productivity to increase by 40% and the flexibility to manage the volume in a 2 shift operation.  This case study will address the following points:

  • SMED Methodology
  • Understanding regulations when working a Changeover Time Reduction Project
  • Creativity and Innovation as a vehicle for improvement
  • Machine and Information systems role in Changeover time reduction
  • Importance of having an engaged team during project lifecycle.

Jayson Diaz, Project Senior Engineer, ROCHE

 

9:30 BREAK

 

10:00 CASE STUDY: EFFECTIVELY REDUCING PACKAGING MATERIALS WHILE MAINTAINING SAFETY & EFFECTIVENESS

A constant hurdle for packaging engineers is the pressure to reduce the amount of packaging used in medical devices to satisfy end users and to reduce cost while simultaneously ensuring that packaging maintains sterility and efficiently protects a device. Minimizing the amount of materials used in packaging is beneficial from a cost effectiveness, storage, and sustainability perspective; however, reducing packaging can draw hesitations from sterilization and regulatory aspects. In this case study, lessons learned will be shared through a real world example of reviewing packaging materials and developing a new package design that reduced the amount of materials used without jeopardizing the sterility of a medical device.

  • Increased manufacturability with package minimization
  • Cost-effectiveness and reduction of material thickness
  • Reduced material effects on environmental hazards

Joseph LeBlanc, Sr. Packaging Engineer, FRESENIUS MEDICAL CARE NORTH AMERICA

 

10:45 GROUP DISCUSSION: EXPLORING VARYING AVENUES TO DECREASE PACKAGING

The manufacture of medical device packaging varies depending on multiple factors, including the type of device, the end user, internal manufacturing processes and more. Consequently, reduction in packaging material does not have a universal solution that can be applied to all medical devices. Following the case study example, small group discussions will cover multiple approaches for decreasing materials used in packaging while maintaining sterility standards

  • Impact of material reduction on supply chain
  • Encouraging sustainability through material reduction
  • Device-specific analysis of excess materials

Joseph LeBlanc, Sr. Packaging Engineer, FRESENIUS MEDICAL CARE NORTH AMERICA

Marty Anderson, Process Engineer, MERZ NORTH AMERICA

 

11:15 PACKAGE STERILIZATION: INSIGHT INTO MATERIALS THAT CAN INCREASE STERILIZATION EFFECTIVENESS

An essential consideration for packaging executives is utilizing materials in package designs that are conducive to the sterilization process. Through collaborative cross-departmental partnerships, packaging and sterilization teams can jointly decide what packaging materials are most appropriate for certain sterilization methods, ultimately streamlining the sterilization process while also ensuring ongoing sterility of the package and the medical device. A sterilization expert will bring clarity to how different materials are affected by various sterilization methods and offer guidance on optimal materials for preventing sterility failures.

  • Packaging materials that endure Ethylene Oxide sterilization
  • Accelerating product launches through sterility in package design
  • Enhancing communication between sterilization and packaging teams

Steven Douglas, WW Sterilization Services Sr. Manager, BECTON DICKINSON

Derek Eberwein, Research Specialist, BECTON DICKINSON

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

1:00 NURSES SIMULATION: UNCOVERING END USER FEEDBACK ON MEDICAL DEVICE PACKAGING 

Engineers have traditionally focused on manufacturability and overall functionality of packaging designs as the main criteria to incorporate into packaging blueprints. Trends in the industry have shifted towards focusing on voice of the customer and designing around end-user handling of devices. In this simulation, nurses will analyze and interact with a medical device and its packaging while providing initial impressions and feedback of usability within a hospital workplace.

 

2:30 CASE STUDY: ENHANCING PACKAGE DESIGN BASED ON USER FEEDBACK

Obtaining the customer perspective for improvements of packaging is essential to enhance design and increase user efficiency with a medical device. Packaging engineers need to create a robust strategy to incorporate customer feedback into a package layout and must consider cost efficiency of the updated package design, the need for re-qualification for material changes, and planning to proactively share prototypes with end  users to ensure the package changes are consistent with customer requests. Researching and incorporating end-user feedback into package design will set package engineers ahead of the curve and improve overall customer satisfaction.

  • Addressing areas of potential customer concern
  • Obtaining a firm grasp of customer needs
  • Design evolutions based on end-user feedback

Kati Coll, Packaging Sustaining Engineer II, Advanced Surgical Devices, SMITH & NEPHEW

Jason Ahleman, Senior Packaging Engineer, BAYER

 

3:30 END OF DAY 2 –CLOSING REMARKS & CONFERENCE CONCLUSION