Editor’s note: Conference agenda as of Nov. 18, 2016, subject to change. Check www.healthpack.net for the latest information.
Tuesday, March 7
11:30 a.m.-2:30 p.m. Tour of packaging areas at the University of Colorado Hospital, Aurora, CO (limited to the first 50 registrations)
4:00-5:00 p.m. IoPP Medical Device Packaging Technical Committee meeting (general conference room)
5:00-7:00 p.m. Welcome reception, Denver Marriott City Center
Wednesday, March 8
7:00-8:15 a.m. Registration and Breakfast Buffet
8:15-8:30 a.m. Welcome/Opening Remarks - Jim George, Conference Director
8:30-9:15 a.m. Opening Keynote: UDI to 2020: Leveraging RFID Technologies to Drive Standards and Efficiencies
Jean-Claude Saghbini, CTO and General Manager, Cardinal Health Inventory Management Solutions
9:15-10:00 a.m. TBA
10:00-10:30 a.m. Networking break
10:30-11:15 a.m. Sterility Assurance: An End-to-End Supply Chain Approach
Joyce Hansen, Vice President, Sterility Assurance, Johnson & Johnson
Sterility assurance is a technical competency for end-to-end of the supply chain.For medical device manufacturers, this covers the design of the product from an R&D standpoint, the control of the manufacturing environment from a microbiological standpoint, the validation of the sterilization process, the product packaging and the controls through production sterilization and release. This presentation will discuss the needs for focusing on the end-to-end supply chain process, collaboration needed between the sterility assurance and packaging organizations, and needs for products in the future. The presentation also will explore common pain points, underestimated time and work requirements, and how packaging engineers and sterility assurance can work closely together in the future.
11:15-11:30 a.m. Standards updates
Speakers and topics TBA
11:30 a.m.-1:00 p.m. Lunch and Exhibitor Showcase
1:00-2:00 p.m. The Next Generation of ISO 11607
Nick Fotis, Global Director of Packaging, Cardinal Health
What if ISO 11607 required you to do microbial barrier testing after simulated distribution and aging for every device family or packaging change you make? What if it had a section regarding sustainability requirements?What if there were specific documentation requirements for usability? What if you are misusing the words variable and parameter or device and product? Or what if you had to do simulated distribution on all of your aging samples?Finally, what if you learned that a note in ISO 11607 that you were relying on, was not actually a requirement, but an option? Most engineers might be surprised at the changes that are proposed during the revision of an ISO standard. ISO 11607 is currently in the revision process. If you want to understand where it is at in the process, whether there is still a chance to make your voice heard and when a newly revised document will be available, be sure to attend this session.
2:00-2:30 p.m. IoPP Medical Device Packaging Technical Committee Update
Updates from committee and sub-committee chairs
2:30-3:00 p.m. Networking Break
3:00-4:00 p.m.Voice of the Customer—Nurses & Technicians Panel
A panel of local operating room nurses and medical technicians review medical device packages for examination. (Led by IoPP’s Medical Device Packaging Technical Committee.)
4:00-4:45 p.m. Nurses & Technicians Panel Q&A with Conference Attendees
5:00-7:00 p.m. Networking Reception in Exhibitor Showcase Area
Thursday, March 9
7:00-8:15 a.m. Breakfast Buffet
8:15-9:00 a.m. Live Audience Polling Session
Moderated by Randy Troutman, Business Development Manager, Printpack Medical
9:00-9:45 a.m. Objective Evaluation of Label Design for Healthcare Products
Laura Bix, Professor and Associate Director, School of Packaging, Michigan State University; Eric Joseph Estrada, Second-Year Master’s Program Student—thesis focuses on the standardization of medical device package labeling, Michigan State University
Traditionally, package design has been product-focused, with design decisions driven largely by factors regarding production efficiencies, product protection, sterilization and sterile barrier systems. More frequently, designers also are employing a user-centered approach to package design. When viewed through this paradigm, packaging has the potential to impact health outcomes by moving beyond commodity status. An increasingly global market, rising complexity in care regimens and increasing propensity to rely on ambulatory and home health environments for care combine with limited label space to challenge designers of labels for pharmaceutical and medical products. However, all too frequently, little science is employed to objectively evaluate and design the information conveyed through healthcare labeling. This presentation will discuss several tools that can be applied to measure the interface between people and packaging specific to perception, cognition and product selection. A brief summary of several research projects that apply the aforementioned methodologies tools will be discussed.
9:45-10:15 a.m. Networking Break
10:15-11:00 a.m. Applying Human Factors to Optimize the Usability of Packaging
Stephen Wilcox, Principal and Founder, Design Science
The discipline of human factors has been applied to medical device development for many years. The FDA, in effect, made it a regulatory requirement in 1990 when it created the Design Controls Requirements (21 CFR 820.30). And the February 2016 FDA Guidance Document, Applying Human Factors and Usability Engineering to Medical Devices, provided detailed guidance regarding what the FDA expects vis a vis human factors. It turns out that the same methods that apply to device development also apply to the development of packaging, and the issues are conceptually similar. This presentation will discuss what some of these methods are, and how they apply to packaging. Specific methods to be discussed include real-world observational research (contextual inquiry) and usability testing—how they can be used to make packaging more usable and how they can address regulatory requirements, when necessary.
11:00-11:30 a.m. Case Study: How a New Packaging Material Improves Sterile Barrier Protection and More
Gary Hawkins, Technical Medical Platform Leader, Eastman Chemical Company (additional speakers TBA)
This presentation will cover a case study involving the launch, validation and adoption of a new copolyester packaging material that improved sterile barrier protection, safety, sustainability and design/use while also lowering total costs.
11:30 a.m.-1:00 p.m. Lunch and Exhibitor Showcase
1:00-2:00 p.m. Panel Discussion: 2016 IoPP AmeriStar Medical Device Packaging Winners
(Moderated by James Dwyer, CPP, Director of Technical and Customer Services, Mangar Medical Packaging)
Panelists: Kati Gordon Coll, CPP, Packaging Sustaining Engineer II, Advanced Surgical Devices, Smith & Nephew; Jason Crosby, Medical Business Manager, Plastic Ingenuity; Steve Studee, Senior Design Engineer, Plastic Ingenuity
2:00-2:45 p.m. Compliance and Documentation: A Toolbox of Tips for Audit Preparation
John Derek Thompson, CPP, Lead Sterile Packaging Operations Engineer, DePuy Synthes
This presentation will put the audience in the auditor’s seat with practical examples of audit-flagged documentation and common pitfalls in structure and language, providing a series of questions appropriate for each packaging document type as a takeaway tool to achieve proactive compliance, make auditable documents and be audit-ready. The presentation concludes with tips on preparation for an actual audit, drawing from the speaker’s specific experiences as both the one being audited and having been the actual auditor.
2:45-3:00 p.m. Conference Wrap-Up and Prize Drawing
3:00 p.m. Adjourn