Abstracts

Back by popular demand – the Industry Power Hour! Have you ever wanted to get ahead of major changes that are happening in our industry or get a better understanding of what’s to come with consensus on standard changes? Maybe you wanted to get involved to help address tough industry challenges that impact your day-to-day but struggled to find everything available to you. The Industry Power Hour will be an action–packed session on thePACKout agenda with representatives from AAMI, ASTM, HPRC, IoPP MDPTC, KiiP, SBA, and SPMC. Each representative will have 8 minutes to give a brief overview of the organization, working items currently being addressed, and how to get involved. It will be fast-paced, engaging, and educational — leaving you informed and ready to take action.

Each representative will have 10 minutes to give a brief overview of the organization, working items currently being addressed, and how to get involved. It will be fast-paced, engaging, and educational — leaving you informed and ready to take action.

• AAMI Technical Committee 198, Working Group 7 – Jen Benolken
• ASTM F02 Primary Barrier Packaging Committee – Dan Burgess
• HPRC (Healthcare Plastics Recycling Council) – Alison Bryant
• IoPP MDPTC (Medical Device Packaging Technical Committee) – David DiVaccaro and Tyler Boyd
• KiiP (Kilmer Innovations in Packaging) – Haley Gorr, PhD, and Seema Momin
• SBA (Sterile Barrier Association)- Pieter van Gool 
• SPMC (Sterilization Packaging Manufacturers Council) – Dhuanne Dodrill

Welcome to the forefront of medical device packaging, where we’ll be exploring the dynamic changes that have shaped our industry in recent years. Join us as we delve into the lessons learned from significant supply chain challenges and discuss strategies for moving forward without returning to outdated practices. We’ll tackle complex topics such as optimizing inventory, retaining valuable talent, and the endless pursuit of driving continuous improvement. Additionally, we’ll examine the importance of communication and collaboration between packaging engineering and sourcing, emphasizing sustainability, resiliency, and cost-effectiveness. Don’t miss this opportunity to engage with industry experts and discover how we can shape the future of medical device packaging together.

How do you make a powerful impression when you walk in the door – whether you’re introducing yourself to a new client, kicking off a meeting, posting your boss on a project, or getting buy-in for a new initiative? Pitching is a universal skill— and not just for the career changer or job candidate. Whether you’re pitching an idea, a project, or yourself – you’ve got a tight window to “hook” your listener and pique their curiosity.  In this workshop you’ll learn:

• Why you lose your listener up front;
• What to lead with, and what to save for later;
• Your new strategy: Destination > Backstory > Connect the Dots

This not-to-be-missed session will provide clarity on the requirements of ISO 11607-01:2019 as it pertains to usability and aseptic presentation by hosting actual users to speak about their interaction with product/packaging systems in the real world. Panelists will represent a variety of healthcare roles from different use environments, including home healthcare, surgical, vascular, and ambulatory. Panelists will discuss and demonstrate the techniques of aseptic presentation and how a healthcare professional determines what technique to use on a particular product/packaging system. Real-world examples will be shared that showcase these techniques, and attendees will leave with tools to integrate into their design process within their own companies.

Novel technology is inherently risky, often introducing new and unexpected failure modes. Consequently, high-reliability industries like defense, space, and medical must lag in implementing new technology, prioritizing safety when lives are at stake. Preparing new technology for such industries takes years of scientific study to understand its limits, explore new failure modes, and build a case demonstrating that the benefits of implementation outweigh the risks. How can the medical device industry overcome barriers to implementing new technologies and foster innovation without risking patient safety or speed-to-market?

In this keynote session, renowned material science expert Kim Chaffin, PhD, PE will highlight a recent case study involving the introduction of a new material into long-term implantable medical device applications. A key aspect of adoption was the development of accelerated testing methods and the qualification of a Medical Device Development Tool (MDDT). Collaboration with the FDA’s Office of Science and Technology Laboratories (OSEL) served to educate regulators and refine the proposed evaluation method. With the MDDT now qualified, there is a clear pathway for evaluating the risk-benefit of new materials for long-term implantable medical devices.

Dr. Chaffin will expand on this case study to share her perspective on the technology challenges facing the medical device packaging industry, such as packaging recycling, the introduction of new packaging materials, and accelerated shelf-life aging. In closing, she will pinpoint the gaps that need to be addressed for the regulatory acceptance of these technologies.

Given that only three of the academic programs within the US that offer packaging science degrees also offer biomedical engineering and health professions (i.e., nursing), is it surprising that cross-disciplinary engagement is a challenge in our professional lives? Engineers and healthcare professionals have different interpretations or limited knowledge of how medical device packaging is manufactured, sterilized, stored, transported, delivered, and discarded. By fostering inter-professional collaboration and interdisciplinary engagement within academia and industry, KiiP’ED seeks to break the “silo working approach” and promote cross functional education of healthcare professionals and packaging engineers to increase patient safety.

The goal of this project is to explore relevant, practical, and actionable techniques in empathic design toward mitigation of common end-user challenges with medical device packaging across the healthcare supply chain. This session will engage the attendees in exploring survey results from healthcare professionals through demonstrations of common challenges faced by healthcare workers when identifying and opening medical device packaging. It will use interactive polling of attendees to support development of a packaging learning module, which is a new academic effort to foster interaction between students in packaging engineering, biomedical engineering, and health professions and support cross-disciplinary learning about medical device packaging.

Key learning objectives include:

• Identify common end-user challenges relevant to medical device packaging design by exploring survey results from healthcare professionals (e.g., emergency medical technicians, nurses, surgical technologists).
• Engage with demonstrations of common challenges faced by healthcare workers to identify and open medical device packaging.
• Assist with the development of a packaging learning module for cross-functional education of packaging engineers, biomedical engineers, and healthcare professionals.

Each year, nosocomial infections contracted during hospital stays are responsible for the death of 75,000 patients in the USA and 37,000 patients in Europe, representing 5-10% of patients in developed countries. To protect patients’ health and that of nursing staff, medical packaging solutions must maintain the sterility of medical devices up to their point of use to help prevent the spreading of these infections. Aseptic presentation is required during packaging opening to minimize the risks of external contamination of the device or patient.

Validation of medical device packaging in accordance with ISO 11607-1 must be assessed along two axes: design validation and usability. Usability must be documented in accordance with the requirements of ISO 62366 to reduce the risks associated with misuse. However, to date, no standardized method has been described to meet the main requirement of design validation, and each manufacturer develops and implements their own testing protocol, mainly based on manual testing. Quality and compliance conclusions might be impacted as package opening is influenced by external human factors linked to this subjective manual method, which is hardly repeatable nor reproducible (opening angle and speed). This gap in design validation may have repercussions on the use of medical devices in healthcare facilities, leading to non-aseptic peel opening.

How to objectively perform a repeatable and reproducible peel opening of medical device packaging, in aseptic conditions, to answer the usability requirement of ISO 11607-1 and validate the design of the packaging?

The objective of this presentation is to share with the medical device packaging community the following studies and results:

• Usability study of healthcare professionals’ behaviors carried out with 70 people (nurses, dentists) via preliminary face-to-face interviews and an online survey.
• Development of a repeatable and reproducible medical packaging peel opening as close as possible to healthcare professional practices.
• Validation approach of the identified automatized method to support the design of packaging requested by ISO 11607-1.

Historical test methods and practices of specifying sterile barrier materials do not necessarily correlate to actual packaging performance outcomes. Oliver HCP and Medtronic are challenging this by exploring new potential test methods and approaches that may better correlate to performance testing. Customized heat seal coatings will be tested in order to find the edge of failure. This approach could be used to bridge design specifications to real-life outcomes. In this presentation, we will review the fundamentals of heat seal coatings and adhesion for sterile barrier systems, the results of exploratory test methods, and test to failure models. The value of these findings will be discussed along with the benefits and challenges of applying the learnings to industry.

Thermoformed trays play a crucial role in the safe packaging and distribution of Medtronic medical devices. Polyethylene Terephthalate Glycol (PETG) is the incumbent tray material used for most of our devices, but it is not recyclable in the #1 PET recycling stream and is currently a single-sourced material. This study aims to compare the material performance of PETG and Amorphous Polyethylene Terephthalate (APET) with the goal to improve supply chain continuity, sustainability impact, and cost by demonstrating APET equivalency.

Key learning objectives include:

• Methodology for bringing materials science internal to burn down risk and speed up implementation of new packaging materials.
• Sustainable package design considerations.
• Open the door to more material options for thermoformed trays – a critical component of medical device packaging.

The Wicked Stability team is actively challenging the status quo. Stability testing of the sterile barrier system has not changed in 30 years. The current state works, however, it is inefficient, redundant, and has been reduced to a simple compliance test exercise.

The Wicked Stability Project includes more than just the exploration of Oxidative Induction Time (OIT) testing as a method of assessing material stability. Understand more about the areas the team has expanded into, what they are seeking to learn, and why this is important for Wicked Stability.

Key learning objectives include:

• Does historical data truly support the claim that aging studies do not fail due to excessive material degradation?
• Material stability is not a new concept. What relevant historical data for common materials of construction exists and how can it be leveraged for future applications?
• Gain awareness regarding alternative methods for assessing material stability.
• Understanding the opportunity for collaboration. How can groups that regulate the industry contribute to improvements in product development efficiency and patient safety?

This presentation will focus on troubleshooting solutions for common sealing issues as a result of the forming process or materials. Root causes will be reviewed and go-to tips for resolving tray flange curling that can occur during the sealing process will be covered including:

• Male forming tools and material freeze
• Flat flanges vs rolled flanges
• Thin gauge trays with dot-coated lids
• Cold forming
• Seal tool heat absorption

A deep dive into a case study where the typical troubleshooting steps did not resolve the issues will be explored. Alternative avenues for addressing the ongoing tray flange curl will demonstrate successful resolution of the issue by using different gasket materials and surfaces. Data to support the journey of the solution will be shared along with photos and in-person samples (if available).

Developing and validating a sealing process requires evaluating the quality of a seal created during the packaging process. The seals are assessed for common quality characteristics such as seal integrity, tensile strength, and visual quality. Generally, manufacturers choose to use tensile strength as the response analyzed during DOE, primarily through the convenience of its quantitative output.

However, visual assessment is typically the leading indicator of the seal’s quality, as it helps to identify when the package is under- or over-sealed. Due to the difficulty in quantitatively measuring the quality of a seal based on visual evidence, visual inspection with DOE is limited in practical use. Over the past few months, a method has been developed to create quantitative scales used to measure the visual seal quality of a pouch/tray. Additionally, these scales have been used in combination with current statistical methods to optimize sealing processes and characterize the equipment used.

This presentation will delve deeper into how to develop and implement a visual scale to quantitatively evaluate seal quality. A sample case study will also demonstrate how to develop, optimize, and validate a sealing process using the new visual scale and a Response Surface DOE. Finally, the advantages of the visual scale over traditional methods for sealing process development will be discussed.

Key learning objectives include:

• Seal quality basics review and visual indications of seal quality.
• How to create a visual scale for sealing process development and tool characterization.
• Rationale for using a visual scale and DOE over traditional sealing process development and validation.

This presentation aims to outline the successful implementation of a 3-axis vision system to error-proof the kitting process of medical devices. The system, leveraging an affordable vision sensor, offers significant advantages in terms of accuracy, efficiency, and flexibility. By seamlessly integrating with an SQL database, it enables almost infinite flexibility and adaptability to the specific requirements of different medical device kits.

A 3-axis vision system revolutionizes the kitting process by providing real-time visual feedback and quality control during the assembly process. Through the use of advanced algorithms, it can accurately identify and verify the correct components, ensuring that each kit is error-free. This greatly reduces the risk of assembling kits with incorrect or missing parts, thus enhancing patient safety and overall product quality.

The integration of the vision system with an SQL database allows for seamless information exchange and enables the system to adapt to changes in the medical device kit requirements. This flexibility enables manufacturers to easily update and modify the kitting process as needed, accommodating changes in regulations, product variations, or customer preferences without significant reconfiguration or downtime.

Key learning objectives include:

• Understand the importance of error-proofing in the kitting of medical devices and its impact on patient safety and operational efficiency.
• Gain knowledge about the key features and benefits of a 3-axis vision system in error-proofing the kitting process, particularly with the utilization of an affordable vision sensor and its integration with motion control and an SQL database.
• Acquire the necessary skills to effectively implement and utilize a 3-axis vision system in error-proofing the kitting of medical devices, including knowledge of setup, calibration, troubleshooting, and data analysis.

While the term AI can feel like an overused buzzword nowadays, it has real-life applications in many aspects of our day-to-day lives. Specifically for packaging processes, the future is here with machines that utilize AI to optimize, predict, and maintain the processes that we use to create our medical device packages.

AI technology is using predictive modeling, sensors, and inspection technology to adjust process conditions on the fly, ensuring that key inputs are met and high-quality output is maintained. In addition, machines can now start to predict when components need to be replaced or repaired and alert users and operators while ordering spare parts simultaneously.

This presentation will look at how industries like food and consumer products are leveraging the power of AI to optimize their packaging processes and squeeze more capacity from their HFFS equipment while ensuring high-quality output. It will also demonstrate how AI can connect machines with maintenance staff and machine vendors to keep machines running at peak performance. Finally, it will look at the opportunity that this type of capability can unleash within the context of medical device packaging now and into the future.

Key learning objectives include:

• Understand how AI can play a role in optimizing processes for higher throughput.
• Leverage the predictive capability of AI for JIT maintenance to maximize up-time.
• Realize the value of using AI to maintain high-quality output from your packaging machines through sensors and monitoring.

This presentation draws parallels and metaphorically aligns the principles of cultivating a successful career with the art of planting and nurturing seeds. Attendees will embark on a journey though the stages of seed selection, planting, nurturing and harvesting, discovering valuable insights and strategies for personal and professional growth along the way.

Just as a gardener carefully tends to each seed, individuals can cultivate their careers with intention and dedication. Through this presentation, attendees will learn how to identify their unique seeds of talent, passion and ambition, and strategically plant them in the fertile soil of opportunity.

From providing practical tips for nurturing skill development and fostering professional relationships to exploring the importance of resilience and adaptability in overcoming challenges, “Sowing Success” equips attendees with the tools and mindset needed to thrive in their careers.

Through engaging storytelling, actionable advice and tips for success, this presentation inspires attendees to embrace the journey of career growth with enthusiasm and purpose. By tending to their professional growth, individuals can achieve a robust and fulfilling career that flourishes over time.

Navigating the medical packaging industry as an early career professional can be daunting. Amidst the web of challenges and opportunities, the guidance and support of mentors can be a beacon of light illuminating the path to success. This presentation will delve into the pivotal role of mentorship in shaping the careers of emerging talent.

Through the lens of two early career professionals, this presentation will explore firsthand experiences, lessons learned, and the transformative impact of mentorship on professional development. Drawing from real-world examples, speakers will highlight the diverse ways in which mentorship fosters growth and resilience. From providing invaluable industry insights to offering strategic guidance, mentors serve as trusted advisors, empowering young professionals to navigate the intricacies of the medical packaging landscape with confidence and clarity.

Through candid discussion and practical advice, attendees will gain actionable strategies for cultivating mentor-mentee relationships that drive personal and professional growth. Whether you’re a seasoned industry veteran or a budding young professional, this presentation promises to inspire, educate, and ignite a passion for mentorship in shaping the future leaders of the medical packaging industry.

In the dynamic landscape of professional growth, understanding the intricacies of personal branding and breaking free from traditional molds are indispensable. This session presents a comprehensive journey into the development of your professional persona, offering practical strategies for applying your brand in real-world scenarios, and empowering you to stop seeking permission and instead, take the helm in driving innovation. These insights will be delivered through two enlightening small talks, closing in an interactive Q&A session.

Sarah Rosenblum Ptach will start by delving into the art of defining and cultivating a distinctive personal brand. Through insightful anecdotes and practical strategies, attendees will learn how to craft a narrative that authentically represents their unique skills, values, and aspirations. From leveraging digital platforms to mastering effective communication techniques, this talk equips participants with the tools to amplify their professional presence and leave a lasting impression in their field.

Following this, Charlie Webb invites attendees to challenge conventional modes of thinking and embrace a mindset of innovation and adaptability. By dissecting the constraints of legacy ideologies, individuals are encouraged to explore uncharted territories, seize unconventional opportunities, and cultivate a conviction of continuous learning and evolution. Through real-world examples and actionable insights, Charlie empowers participants to redefine their career trajectories and embrace change as a catalyst for growth and success.

Join Sarah & Charlie for an enlightening exploration into the realms of personal branding and innovative thinking and unlock your full potential in today’s dynamic professional landscape.

Key learning objectives include:

• Understand the fundamental principles of personal branding and its significance in today’s professional landscape.
• Gain practical strategies for applying personal branding.
• Learn strategies to challenge the status quo and adopt a mindset oriented towards innovation and adaptability.

For some, “sustainability” may seem like a trendy term gaining traction in corporate agendas. However, for the medical device industry, which faces unique challenges in embracing such initiatives, the question remains: How can we realistically adopt more eco-friendly packaging solutions? The answer might be closer than we think – right next door.

In this panel discussion, we will explore how lessons from the consumer goods sector can shed light on implementing sustainability practices from e-commerce into medical device packaging. By delving into various methodologies such as the waste hierarchy and the 5 R’s, we will uncover practical strategies to integrate sustainability into packaging design. Through the lens of multiple case studies, we’ll illustrate how these approaches can be effectively applied.

Let’s move beyond the realm of buzzwords and embrace actionable ideas that can transform sustainability from a concept into a reality in the medical device industry. Join us and leave with tangible packaging solutions that you can implement today.

To meet the material demands of the future, transitioning waste streams to value streams is a vital step in ecological and economic sustainability. Linear production design disposes of resources before their optimal value has been realized and loses recyclable resources to waste streams. The economic infrastructure of the planet needs to be reimagined to meet human and ecological needs. Developing and implementing circular systems are vital to creating sustainable global production. Through the analysis of the copper used in medical devices, this session will illustrate the considerations systems engineers can take to close the waste resource gap. Developing wasteless design mimics the resiliency seen in ecosystems and accelerates the evolution of the global economy to meet the needs of companies, the environment, and humankind.

Explore the intersection of healthcare and environmental responsibility with a thought-provoking panel discussion on the EU’s Packaging and Packaging Waste Regulation (PPWR). Historically, the healthcare packaging industry has savored an exemption from Extended Producer Responsibility (EPR) legislation. However, with the introduction of the EU’s PPWR, the landscape of sustainable regulation has undergone a significant shift. The PPWR eliminates the previous exemption, bringing healthcare packaging compliance to the forefront as healthcare stakeholders must now align with PPWR targets. This regulation serves as a catalyst for fostering collaboration across the healthcare packaging sector. During this session, we will dive into how industry leaders are navigating compliance with the regulation while also ensuring product integrity. Our panel of expert speakers will share practical perspectives on strategies tailored for the healthcare sector, discuss key targets and timelines of the regulation, and address challenges the healthcare industry faces with EPR legislation. This insightful discussion aims to bridge the gap between healthcare packaging innovation and environmental stewardship in the European market. By developing an understanding of the EU’s PPWR, we hope to spark conversations of collaboration and equip attendees with actionable insights to meet evolving environmental standards.

Dream It. Do It. From Anaheim to Orlando and across the world, Disney Imagineers are renowned for their creativity and ability to turn dreams into reality. Prepare to be inspired as the curtain is pulled back on the secret techniques of Disney Imagineering. Using real-life examples of Disney creations and recent packaging innovations, your imagination will be sparked into generating groundbreaking package designs.

Key learning objectives include:

• Education and inform the audience of Disney’s innovative techniques which apply to all creative ventures such as thinking differently, knowing your audience, and telling a story.
• Entertain by showcasing these principles in familiar Disney theme park attractions.
• Inspire the audience to use these techniques to create innovative package designs.

Designing for the optimum package involves a challenge for engineers in dealing with the triple constraint of project management (quality, cost, and time). Conventional processes for developing new packaging reliant on in-vitro (physical tests) require significant activity from the limited resources in packaging engineering, test labs, and validation functions, leading to prolonged timelines. In contrast, in-silico design of packaging can offer an alternative to physical design steps, enabling both accelerated assessment of designs and materials, and evaluation of parameters not possible in conventional testing.

This presentation examines the benefits of in-silico design simulation for packaging engineers in pinpointing design flaws and optimizing packaging solutions. A real-world case study illustrates how a leading medical device manufacturer seamlessly integrated in-vitro methods with in-silico design, exemplifying the application of this approach in implementing sustainable design decisions, such as determining the minimum thickness and optimizing the weight for blister packaging.

Packaging engineers strive to have the most robust and innovative designs. However, often the initial users (e.g. production operators and frontline engineers/staff) are not consulted on process usability of the packaging design. After a product has been launched, the packaging design is unable to be changed unless there is a significant cost or quality benefit to change. Being locked into a poor design can be very costly to the business. Hidden and future costs include operator fatigue/injuries, non-compliant material/process events, customer complaints, CAPAs, recalls, and potential lawsuits. With the recent emphasis on end-user usability, Josh will bring attention to the front-end of the packaging usability journey.

Key learning objectives include:

• The value of getting up-front feedback from operations staff.
• The hidden (non-BOM) costs of a design that is prone to process defects.
• Methods to error-proof (Poke-Yoke) the packaging design.
• Methods to error-proof the packaging process.
• Multiple real-world case studies.

As the medical device industry faces growing pressure to bolster supply chain resiliency and transition to more sustainable practices, medical device manufacturers are increasingly focused on diversifying their sterilization supply chain with alternative modalities. Today, gamma and ethylene oxide comprise approximately 90% of sterilization volumes. While proven and effective, these market-dominating modalities have been impacted by cobalt-60 shortages, EO emissions regulations, and site closures causing capacity constraints in recent years. These challenges have prompted medical device manufacturers to evaluate alternative sterilization modalities, and where feasible, validate multiple modalities for supply chain flexibility and continuity.

This panel of subject matter experts will discuss how medical device manufacturers are responding to this challenge, including cross-industry collaboration to share data and insights, challenging assumptions, and influencing regulators to realize a more resilient, sustainable future for medical devices.

As the medical device industry responds to the challenge of making sterilization practices safer, more sustainable, and more resilient, manufacturers are evaluating both alternative modalities and innovating to improve the status quo. As the sterilization landscape evolves, what impact will this have on packaging? Join this panel of industry experts as they answer that question and more in an insight dialogue on topics including:

• Innovation within market-dominating modalities
• Emergence of accelerator-based modalities
• Packaging design considerations for the future of sterilization
• Regulatory, standards, and guidance developments

In 2019, the FDA announced two innovation challenges aimed at encouraging the development of new approaches to medical device sterilization. This spotlight session will feature a case study on supercritical carbon dioxide (scCO2), one of five alternative technologies to ethylene oxide the FDA selected to work with to accelerate development and regulatory review. In February 2024, NovaSterilis received a $1.75MM grant from the NIH to further the development of their scCO2 terminal sterilization platform for the pharmaceutical and biotechnology industries. Attendees will gain an understanding of supercritical carbon dioxide sterilization, the markets served, potential applications, considerations for packaging and terminal sterilization, and how it is implemented and approved.