Higher Quality: Charting the Path to Continuous Improvement

Since it began in 2011, the Case for Quality has helped medical device stakeholders elevate the standards for sustained, predictive practices that advance medical device quality and safety.

This event will provide exciting perspectives on the successes of the MDIC Case for Quality Collaborative Community (CfQcc) highlighting the CAPA risk-based framework methodology (#makeCAPAcool), Championing a Higher Culture of Quality, Continuous Quality Improvement (VIP and ASC) leading to unique regulatory flexibilities, and featuring the utilization of Artificial Intelligence and Machine Learning for higher Quality Decisions and Management. 

Attendees will be inspired by the advances, impacts, and ROI from CfQcc participation, including enterprise transformation towards higher quality medical devices, improved patient safety, and greater investment returns.

Event Details

Why should you attend?

The MDIC Excellence in Quality Workshops are a unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across your total product lifecycle. Participants will be guided by industry experts and thought leaders through examinations of enterprise transformation, enhanced patient safety, and increased returns—all through the lens of the most advanced approaches to elevating quality.

The workshops will also provide opportunities to network with peers from companies at all phases of development, explore personal use cases to bring back real solutions, and discover the empowerment of engaging with the Case for Quality Collaborative Community. These unique events will home in on strategic and practical adoption techniques in hands-on workshops led by innovators in successfully having surmounted the summit of holistic, integrated quality. Participants will be inspired by a dynamic line-up of speakers and panel presentations connecting the threads between elevating Quality and patient safety.

Breakfast and lunch will be provided with ample networking time to participants. We look forward to hosting you this August in Minneapolis for this not-to-be-missed event for all medical device professionals committed to continuous quality improvement!

Mentoring Thought Leaders

Agenda

Value Story, Successes, and Lessons Learned 

7:30 – 8:00 AM  |  Breakfast & Registration

8:00 – 8:15 AM  |  Welcome

8:15 – 9:55 AM  |  Championing a Culture of Quality: “Better Than A Bagel - A Breakfast Conversation”

• The culture mindset of compliance-only leads to Quality devices persists within the medical device industry. Hear from and converse with thought leaders on the importance and challenges of elevating organization culture to one of Quality excellence from a variety of perspectives.
  
  
• This inspiring workshop will bring together industry thought leaders to engage in the important conversation focusing on enterprise organizational quality culture. Explore various challenges facing professionals and companies that directly impact elevating quality culture to the next level as we offer personal insights with successful best practices. Drawing from the Leadership Engagement Playbook and their firsthand experiences, experts will have an enriching dialogue as part of their multifaceted strategy development for implementing best practices, regardless of an organization's stature. Attendees can expect to gain valuable knowledge and tactical advice to navigate the evolving landscape of quality culture management. This group is dedicated to enhancing quality throughout the entire product lifecycle, and their efforts will serve as a demonstration to the importance of fostering a culture of quality within organizations. By emphasizing the significance of leadership engagement and sharing innovative methodologies, attendees will be provided with the tools and insights needed to drive positive change and achieve excellence in quality management.
  
  

9:55 – 10:15 AM  |  Networking Break

10:15 – 11:50 AM  |  Make CAPA Cool – A Risk Based Framework: “The Rosetta Stone of CAPAs”

• Are you interested in closing Corrective and Preventive Actions (CAPAs) in 60 days or less, leaving more time to focus on improvements and problem solving? What about finding out why almost 90% of participants were satisfied with their experience using a transformative, risk focused CAPA framework? Join us in this follow-up to the impactful #makeCAPAcool pilot study and White Paper release to find out the answers to these questions and much more!
  
  
• Led by MDIC’s Case for Quality Collaborative Community, this initiative transforms the corrective and preventive action (CAPA) process for medical devices by taking a risk-based approach, rather than the traditional resource-draining one-size-fits-all CAPA method. Featuring experts from the pilot study, industry and FDA, this workshop will provide in-depth details of the risk focused CAPA framework and discuss successes, lessons learned, and adoption approaches that elevate from the challenging traditional CAPA processes and why this framework is the Rosetta Stone of CAPA. Allow this #makeCAPAcool session to equip you with the tools to revolutionize CAPA practices and achieve better outcomes in medical device quality and safety.
  
  

11:50 AM – 12:30 PM  |  Lunch (provided)

12:30 – 1:00 PM  |  FDA Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP)

1:15 - 2:55 PM  |  Elevating Excellence Through Continuous Improvement: "Committing to Higher Quality Beyond No Actions Indicated (NAI), for Safety's Sake"

• Continuous improvement leads to higher quality devices, greater organizational efficiencies, and investment returns. Industry and FDA Experts share successes, lessons learned, adoption perspectives, and the overall impact on organizational and product improvement through participation and investing in the Voluntary Improvement Program (VIP).
  
  
• This workshop will provide in-depth details of the Voluntary Improvement Program (VIP) and the appraisal value framework and discuss successes, lessons learned, and adoption approaches that can elevate continuous organizational and Quality improvement journeys. Allow mentors and experts equip you with the tools to improve your practices for achieving better efficiencies and outcomes in medical device quality and safety.
  
  

3:15 - 4:55 PM  |  Accelerating Quality Excellence: CSA for AI/ML Enhanced QMS: "Artificial Intelligence as an Adjunct to Higher Quality Decisions"

• Digitalization, Advanced Manufacturing, Cloud, Cybersecurity, AI, ML…there are many technology focused initiatives across the Medical Device and Diagnostics industry. While most of the focus is on specific technology use cases, many organizations have failed to adequately prepare for adopting these technologies from a validation lifecycle perspective. To help support the industry for faster responsiveness and “time-to-value” in technology adoption using critical thinking, the FDA published a Draft Guidance on CSA (Computer Software Assurance) in 2022 with plans to finalize in 2024.
  
  
• In this workshop, the FDA-Industry CSA (FICSA) team will introduce CSA and the value proposition, facilitate two interactive “CSA for AI/ML” use cases for Quality Management System related technology, while integrating high level CSA approaches and clarifying CSA myths vs facts as part of the workshop. Participants will review the “As-Is” vs “To-Be” (using AI/ML), assess the risk, and develop a risk-based assurance approach leveraging critical thinking. The workshop will end with a Panel of executives who will share their insights on the value of CSA.

4:55 - 5:00 PM  |  Closing Remarks