8:00 BALANCING REGULATORY COMPLIANCE AND INNOVATIVE PACKAGING DESIGN
To remain competitive within the medical device industry, engineers focus greatly on developing innovative designs for product packaging to ensure sterilization and safeguard a medical device, augment the value of a product through dual-use packaging and minimize carbon footprint while maximizing cost savings through decreased material usage. While innovation is at the center of all packaging endeavours, packaging teams must also remain compliant with regulatory guidelines set forth by the FDA and international regulatory bodies. Without hindering progress within the medical device industry, packaging executives must find a happy medium in identifying and creating innovative packaging while also adhering to strict regulations.
Challenges of developing innovative packaging designs
Understanding regulatory expectations US/OUS
Design implications on regulatory submissions
Paul Marshall, Manager, Global Packaging Technologies, SMITH & NEPHEW
8:45 HOW WILL UDI IMPACT YOU IN 2015?
This UDI session will take look back on the September 2014 deadline for class III medical devices, looking to understand how effective implementation has been and will provide lessons learned for the future deadlines.
How class II medical device companies can have a execute a successful UDI implementation
Lessons learned from implementation – where are the gaps?
The US implementation was just the beginning – international UDI guidance, where do we go next?
Discussion around UDI implementation – real case studies
Dawn Fowler, Senior Manager, Labeling & Documentation, ENDOLOGIX
9:15 COFFEE & NETWORKING BREAK
9:45 PANEL DISCUSSION: BEST PRACTICES FOR IMPLEMENTING UDI REQUIREMENTS
With phase one of the UDI program in place, medical device companies are either already implementing UDI requirements for class III device and or preparing for the next round of implantable, life-supporting and life-sustaining devices labeling and packaging requirements. How this new requirement is affecting packaging professionals as well as how the FDA is dealing with noncompliance is of high concern within the industry. Through this panel discussion industry experts will share firsthand experiences on the challenges specifically facing packaging professionals in regards to UDI implementation as well as examine how the FDA is handling noncompliance.
Dawn Fowler, Senior Manager, Labeling & Documentation, ENDOLOGIX
Art Castronovo, Director of Labeling and Packaging Engineering SMITHS MEDICAL
Philip Desjardins, Counsel, ARNOLD & PORTER LLC
10:30 SMALL GROUP DISCUSSIONS: ANSWERING TO THE HEALTHCARE PROVIDER CONCERNS
As the healthcare landscape navigates towards a patient-centric driven industry, it is more important than ever that medical device manufacturers produce products that fit seamlessly into this model. Oftentimes the deciding factor for devices selected ends with the nurse or clinician choosing the most appropriate product for the patient. Ease-of-use, sterilization abilities and historical success rates are just a few examples of the elements customers evaluate in choosing a medical device. By inviting nurses and other clinicians to lead small groups and analyze packaging from medical devices provided by conference attendees, engineers will have the unique and valuable opportunity to receive first-hand feedback from healthcare providers.
Dawn Hamblett, OR Clinical Product Coordinator GEORGE WASHINGTON UNIVERSITY HOSPITAL
Maimunatu Mansaray, Operating Room Nurse HOWARD UNIVERESITY HOSPITAL
Shirley Gibson, Associate Vice President of Nursing VCU HEALTH SYSTEM
Catherine Olson Catherine Olson, MSN, RN Director, Institute for Quality, Safety and Injury Prevention EMERGENCY NURSING ASSOCIATION
11:30 ADDING VALUE TO MEDICAL DEVICE PACKAGING WITHOUT INCREASING COSTS Utilizing packaging not only to protect and sterilize devices but also to provide end users with a positive experience will increase profits and create value in the product. Packaging design, both structural and graphic, that is focused on user and stakeholders’ needs has the enormous potential of adding value. However, designers often face challenging economical constraints while trying to enhance packaging performance. In this puzzling scenario, it is critical to understand how users interact with packaging and what are the design features that might reduce or keep costs low while adding value. This session will explore the following topics:
Understanding how people interact with medical device packaging.
Analyzing how design can add value without increasing costs.
Measuring the effect of individual design changes to improve usability and reduce user errors.
Dr. Javier de la Fuente, Assistant Professor CALIFORNIA POLYTECHNIC STATE UNIVERSITY
12:15 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS
1:30 PANEL DISCUSSION: CHOOSING COST EFFECTIVE AND INNOVATIVE PACKAGING MATERIAL
Medical device manufacturers need to develop packaging that not only protects and sterilizes a product but also satisfies end-user desires to maintain competitiveness within a market. Packaging engineers must carefully analyze the properties of various foams, films and plastics to select the best material combinations for a product. Several factors including budget, a medical device’s components, shape and size along with expected handling and use are crucial factors when determining appropriate packaging materials. This panel discussion will examine various packaging materials that have been validated and approved to highlight new material options and combinations available for engineers.
Examining name brand vs. generic packaging materials
Identifying innovative packaging material suppliers
Lessons learned through combination trial and error
Ewald Heersema, Technical Business Manager, ZOTEFOAMS INC
Ron Valerio, Senior Manager Medical, UFP TECHNOLOGIES
Dan Penny, Director of Packaging Engineering, CARDINAL HEALTH
2:15 OVERCOMING CHALLENGES IN DESIGNING AND UPDATING A PACKAGING PROTOTYPE
Evaluating the performance of various packaging prototype designs allows engineers the ability to identify flaws or potential risks within designs prior to production. Outlining the packaging design inputs like device classification, shelf-life expectations, packaging materials and manufacturing processes will streamline design decisions ultimately leading to successful validation of a package. Examining best practices for developing an accurate prototype while also addressing changes after a prototype has been designed ensures successful packaging development is achieved.
Working with prototyping firms and material manufacturers
Managing effects of device design changes in packaging prototype
Collaborating with marketing on prototype design input
3:15 DRAFTING A ROBUST PACKAGING VALIDATION PLAN
Validation of the packaging process is an important step to ensure that the equipment used to form, seal and assemble a sterile barrier system is in fact qualified. The first step in aligning an organization with ISO 11607-2 is drafting an effective validation plan which will outline the packaging process, qualifications steps, sterilization procedures and intended materials and equipment to be used. Utilizing this plan throughout the organization will reduce risk and variations used throughout the packaging process.
Best practices for effectively developing a validation plan
Harmonizing validation processes throughout an organization
Identifying non-conformities to mitigate risk
Charlie Rivera, Corporate Packaging Operations Manager, CONMED CORPORATION
4:00 STRATEGICALLY EXECUTING A VALIDATION PLAN ACROSS AN ORGANIZATION
Drafting a validation plan early in the design process will set the stage for downstream success allowing for collaboration between packaging engineers and team members to set clear parameters for potential design issues. Identifying implementation strategies for IQ, OQ, PQ, peeling test and documenting quality properties will produce a robust validation report resulting in validation approval. Attendees will leave this session with tools and techniques to improve and harmonize their packaging process validation plans.
Obtaining accurate IQ, OQ and PQ documentation
Best practices for conducting the peeling test
Inspecting quality properties including: seal, tear and separation
Tomas Pla, Sr. Development Packaging Engineer, EXACTECH
Darian Flewellen, Development Engineer, Packaging, EXACTECH
4:45 COFFEE & NETWORKING BREAK
5:00 STERILIZATION PROCESS AND MATERIALS: MAKING THE RIGHT CHOICE
With an abundance of various sterilization options including steam, ETO, radiation and E-Beam, it can be difficult for packaging engineers to correctly identify the best method for testing a particular package. Crucial factors that must be taken into account include the composition of materials used within a package and identifying when changes should result in retesting. Attendees will delve below the surface in this presentation that examines proven testing combinations of sterilization and material selections.
Combining materials and sterilization methods for success
Understanding what types of changes require retesting
Sterilization methods of the future reviewed
Strategies for stability testing
Jonathan Bull, Director Gas and Heat Sterilization, JOHNSON & JOHNSON