7:45 REGISTRATION & WELCOME COFFEE
8:05 CHAIRPERSON’S OPENING REMARKS
8:15 POSITIVELY IMPACTING LOCALIZATION THROUGH DITA/CMS IMPLEMENTATION
Decisions made by medtech organizations upstream during configuration and technical writing can have a drastic impact on the localization process. Thorough implementation planning for a component-based CMS platform takes into account downstream activities, not just technical requirements, and requires an implementation team comprised of many different functional areas, including localization. This presentation will provide practical advice for teams just getting started with their CMS or for teams looking to rebuild a dysfunctional CMS platform.
Karla Haynes, Localization Manager, Global Labeling
EDWARDS LIFE SCIENCES
9:00 INSIGHTS INTO R2D2 RESEARCH: FOCUS ON ELEMENTS IMPACTING HUMAN FACTOR INTEGRATION IN DEVICE IFUS
This interactive part-presentation, part-quiz session will shed light onto ongoing research led by UWM’s Rehabilitation Research Design & Disability “R2D2” Center. R2D2 performs interdisciplinary basic research investigations, applied research and development, as well as innovative instruction related to technology and disability, and has led many initiatives in patient population- specific IFU development incorporating direct feedback from patients with disabilities. With a strong focus on human factor integration in device IFUs, and the importance of clearly understanding the target patients’ needs, diving into R2D2 key findings and learnings will provide valuable comprehensive IFU development advice to labeling executives.
- Understand perspectives of people with disabilities
- Human factors in the design of device IFU’s
- Impact of IFUs on medical device purchase & use decisions
Rochelle Mendonca, Research Fellow, R2D2
Assistant Professor, TEMPLE UNIVERSITY
9:45 COFFEE & NETWORKING BREAK
10:15 UNVEILING THE END-USER’S PERSPECTIVE ON MEDICAL TECHNOLOGY LABELS & IFUS
This interactive session will enable participants to volunteer a packaged device or diagnostic product with the IFU, to be handled and scrutinized by nurses and physicians as if in routine day to day work in the hospital setting. Focusing on label and IFU readability, ease of critical data and symbol identification, as well as areas commonly reviewed or disregarded, HCPs will directly communicate perspectives to the audience through live demonstrations followed by an open discussion allowing for all questions to be addressed. The opportunity to experience the HCP’s approach to medical device and diagnostic labeling, and further engage in Q&A enables participants with a better understanding of end-user needs, allowing for label and IFU development optimization.
Jordan Venegas, Staff Registered Nurse, UC SAN DIEGO HEALTH
David Samuelson, President, CALIFORNIA EMERGENCY NURSES
11:00 CASE STUDY: PRACTICAL INSIGHT INTO LABELING PROCESS SET-UP & IMPROVEMENT
With the variety of device and diagnostic products developed each year, comes an equal number of potential labeling process structures to address specific market needs. Labeling professionals are continuously looking for strategies that will positively impact process flows and successful outcomes, in the effort of ensuring optimized operations all while decreasing timelines to label printing. These short case studies will shed light into peers’ experience in planning, implementing and driving distinct labeling initiatives, with a focus on efficient process architectures and use of appropriate technology to expedite label development, manufacturing & validation.
- Identifying & understanding the company need
- Establishing a team of experts & clear responsibilities
- Communicating the group’s existence to the organization
- Becoming the subject matter experts
Aneta Waliszewski, Director of Quality Assurance
11:45 BREAK-OUT SESSION: SHARING KNOWLEDGE & EXPERIENCE IN LABEL-SPECIFIC CHALLENGES
During this interactive session, executives will gather in small groups to discuss challenges in various areas of labeling development, data and compliance. This peer-to-peer learning environment, allowing for exchange of strategies and savvy tips will enable individuals to understand how other companies overcome similar hurdles through sharing of perspectives and real-life experience. Each topic will be moderated by a subject matter expert, who will report key findings to the rest of the audience at the end of the session, maximizing all participants’ number of take-home messages.
- Pros & cons of submitting label data in XML format
Karla Haynes, Localization Manager, Global Labeling, EDWARDS LIFE SCIENCES
- Expediting label change management & documentation
Tim Fischer, Sales Manager, PRISYM ID
- Label verification & validation strategies
Shannon Russell, Global Labeling Manager, INTUITIVE SURGICAL
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:45 PRACTICAL KEYS TO A SUCCESSFUL E-LABELING STRATEGY IMPLEMENTATION
With increasing corporate focus on sustainability and cost-saving opportunities, in addition to further international markets accepting e-labeling each year, many organizations from the device and diagnostic industry are eager to learn more about implementing a fully electronic labeling strategy. Moving away from the paper route involves the use of appropriate technology and acquiring new IT skills, in addition to integrating specific e-labeling regulatory requirements that differ from one market to another. The complexity of eIFU and related web portal development and management must also be taken into account in the overall electronic strategy development to ensure successful outcomes.
- E-Labeling rules review: US & OUS
- Software capacities & relevant tools
- Developing an eIFU & website
- Key considerations
- Getting IFUs online
- Integration into existing business systems
Lenore Frank, Director, R&D, STRYKER
2:30 PANEL DISCUSSION: OPTIMIZING THE LABELING FUNCTION BY DRIVING AN ORGANIZATIONAL SHIFT
In device and diagnostic corporations, labeling holds an important place as it is an essential component of pre and post-market operations. Too often are labeling teams struggling to source the right data, standardize processes and deliver results in time due to common lack of proper positioning of the labeling function. With differing corporate structures and label prioritization efforts in all company sizes, labeling professionals are analyzing methods to re-structure overall workflows and make labeling more prominent to ensure efficiency.
- Positioning labeling as an early-on priority
- Structures to address significant labeling initiatives
- Establishing centralized labeling control & function
Christie Larson, Senior Manager, R&D Labeling & Packaging
FRESENIUS KABI, USA
Seana Hurd, Senior Director Quality Sys. & Technical Documentation, UDI Program Manager
3:15 CLOSING REMARKS & CONFERENCE CONCLUSION