Driving Quality and Compliance Through Cultural Transformation: Insights from the MDIC Excellence in Quality Summit 

August 6, 2024

The MDIC Excellence in Quality Summit brought together industry leaders, regulatory authorities, and quality professionals, all committed to advancing quality practices throughout the medical device lifecycle. Over the course of two days, the Summit explored innovative strategies and shared insights that emphasized the critical importance of integrating a culture of quality within organizations, harnessing advanced technologies, and continually striving for improvement. 

Championing a Culture of Quality 

Day one of the Summit underscored the role of organizational culture in achieving quality objectives. Industry veterans shared real-world examples of successful culture transformations, highlighting how a quality-centric mindset impacts everything from patient safety to business outcomes. Pat Shaffer, managing director at FTI Consulting, captured this sentiment, stating, “Culture impacts everything from your bottom line to patient safety.“ 

A Risk-Based Approach to CAPA  

The summit explored innovative approaches to Corrective and Preventive Actions (CAPAs), a key component of quality management systems. Historically criticized for its emphasis on compliance and documentation, the CAPA process has often resulted in burdensome paperwork and delays. However, MDIC’s Case for Quality Collaborative Community is addressing this by promoting a risk-based approach to streamline and improve CAPA practices across the industry. This initiative was exemplified by a case study showcasing a 25% improvement in CAPA resolution times, offering valuable lessons for adoption and implementation. 

Christine Ketapuram, senior director of Quality Strategy at Veeva Systems, reflected on this approach, stating “We at Veeva see opportunities with our customers to partner and streamline the CAPA process using a risk-based approach.” The discussion emphasized that prioritizing risks, rather than just compliance, can lead to better outcomes throughout the entire product lifecycle. 

Enhancing Quality Excellence through VIP and AI/ML-Enhanced QMS 

A significant theme at the Summit was the emphasis on ongoing quality enhancement beyond regulatory compliance, with the FDA’s Voluntary Improvement Program (VIP) serving as a focal point. Industry experts shared practical strategies for leveraging VIP to drive innovation and improve patient outcomes. Mark Rutkiewicz, founder of Consiliso LLC, highlighted the program’s value, noting, “VIP is a great program incentivized by the FDA, focused on continuous improvement and high-need areas. It’s crucial to constantly adapt to enhance your processes.“ 

Mark Rutkiewicz speaking during the “Elevating Excellence Through Continuous Improvement” panel at MDIC’s Excellence in Quality Summit

The Summit also explored the transformative potential of technology in advancing quality management. Sessions on AI and machine learning delved into how these technologies can optimize processes, enhance data analysis, and improve decision-making. Experts from the FDA Industry CSA (FICSA) introduced Computer Software Assurance (CSA), providing interactive examples of AI/ML validation and implementation. The CSA framework offers a roadmap for integrating these technologies into quality systems while ensuring patient safety.

Embarking on the Continuous Improvement Voyage 

Day two continued with a dynamic lineup of speakers and panel presentations that connected the threads between elevating quality and advanced manufacturing and transforming quality through patient engagement. Michelle Tarver, deputy center director at the FDA Center for Devices and Radiological Health (CDRH), opened the program with a compelling message: “Innovation springs from a culture of introspection and a passion for continuous improvement.” She emphasized the importance of shared learnings, experimentation, and aspirational targets, highlighting that safety is a core value where daily actions identify and mitigate risks before they could cause harm. 

This set the stage for continued discussions on the Voluntary Improvement Program (VIP) and the Accelerate Sustainable Capability (ASC) Pilot Study. Erin Keith, senior advisor at FDA-CDRH, explained how this program offers benefits such as a window of time where typical surveillance inspections are waived, enabling a greater focus on incorporating innovative practices and streamlined submission changes. 

Keisha Thomas, Director, Compliance and Quality, FDA CDRH offers remarks at the MDIC Excellence in Quality Summit

Modernizing Recall Processes 

The Summit also addressed the evolution of recall processes, emphasizing the transition from paper-based to digital systems to enhance efficiency and patient safety. Steve Silverman, president of The Silverman Group, remarked on the significance of this shift, noting, “Moving beyond antiquated paper-based processes is a significant step towards modernizing recalls.” 

Attendees explored the challenges and opportunities of implementing digital recall systems, which can improve response times, reduce costs, and enhance patient outcomes. Mayo Clinic Enterprise Recall Analyst Amy Conway shared her perspective: “Being a healthcare provider… and meeting these manufacturers [while] learning about the process when they do a recall is amazing. I didn’t really realize how much went into it until I was at this event.“   

Pursuit of Excellence Through the Baldrige Framework 

The Baldrige Framework was another highlight of the Summit, presented as a valuable tool for achieving sustained performance excellence. Laura Kinney, board chair of Partners in Performance Excellence (PiPEx), emphasized that the framework “helps organizations go beyond compliance to achieve excellence through effective governance, leadership, and operational efficiency.” 

Attendees explored practical applications of the Baldrige Framework and its potential to drive organizational improvement, alongside discussions on robust risk management strategies essential in the complex medical device industry. Garth Conrad, vice president of Quality at Flex Health Solutions, shared insights on proactive risk management, underscoring the importance of identifying and mitigating challenges before they escalate.

Accelerating the Adoption of Advanced Manufacturing  

Daniel Matlis kicks off the “Accelerating the Adoption of Advanced Manufacturing” panel—featuring Daniel Walter, Policy Analyst, FDA-CDRH

Finally, the Summit delved into the future of medical device manufacturing, exploring the transformative potential of AI, automation, and digital technologies. Panelists discussed how companies are addressing barriers such as ROI and internal expertise, while debunking fears and misconceptions surrounding advanced manufacturing. Daniel Walter, policy analyst at FDA-CDRH, emphasized, “Organizations should prioritize improving and transforming their processes rather than focusing solely on technology. Technology should be viewed as a tool that enables these improvements.”

The MDIC Excellence in Quality Summit provided a wealth of knowledge and inspiration, equipping attendees with actionable insights to drive quality excellence within their organizations. As the medical device landscape continues to evolve, a steadfast commitment to quality, innovation, and patient safety will be essential for future success. 

Learn more about future MDIC events.

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The Future is Here: Advanced Manufacturing in Medical Devices with Daniel Matlis

In an era characterized by unprecedented change and technological advancement, the message from industry leaders is clear: digital transformation is no longer optional but a critical necessity for survival and growth.

In this MDIC Studio session, hear from Daniel Matlis, President and Founder of Axendia, as he describes the current state of advanced manufacturing in the life sciences industry and what is yet to come. Matlis offers a comprehensive overview of how novel and innovative applications of existing technologies are reshaping manufacturing processes to enhance product quality and improve patient outcomes. Drawing from Axendia’s extensive primary research and interactions with regulatory officials, industry executives, and clients, Matlis discusses the current landscape and the critical need for broadening the adoption of advanced manufacturing technologies throughout the total product lifecycle.

“We’re living in the age of continuous disruption as and as organizations. We need to realize and prepare for that. And as a result, digital transformation. It’s not a nice to have. It is an imperative for our industry.” As the pace of technological change shows no signs of slowing, the importance of digital transformation will only grow. Companies that embrace this shift will be better positioned to navigate disruptions, meet customer needs, and drive sustainable growth.

Daniel’s insights serve as a reminder that in the age of continuous disruption, digital transformation is not just a strategy but a fundamental requirement. Organizations that recognize this imperative and act accordingly will be the ones that thrive in the digital future.

We invite you to learn more about the Advanced Manufacturing Clearing House and reach out to us with questions about how you can participate at AMCH@MDIC.org.

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Excellence in Quality Summit Session Guides

July 23, 2024

MDIC Excellence in Quality Summit Session Guides

 

Make CAPA Cool – A Risk-Based Framework Workshop 2024
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Medical Device Innovation Consortium Selects Simon Mason to Lead National Evaluation System for health Technology Coordinating Center

April 17, 2023

Senior health care executive moves to advance the role of real-world evidence in medical device ecosystem

April 17, 2023

FOR IMMEDIATE RELEASE

[Arlington, VA.] – The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has named Simon Mason as its new President. In his new role, Mr. Mason will lead strategy and operations for NESTcc to serve its stakeholders, including patients, providers, payers, medical device manufacturers, regulators, and others.

With a thirty-year career spanning roles in executive management as well as product and business development, Mr. Mason joins NESTcc from Pharmaspectra, a business acquired by IQVIA, where he most recently served as Chief Operating Officer. At Pharmaspectra, he led development and commercialization of a data lake of scientific and medical affairs information utilized by pharmaceutical and medical device companies.

“I’m honored to join the great team at NESTcc and work with this unique organization’s network collaborators, partners, customers, and other stakeholders to change the paradigm of clinical research through the appropriate use of real-world evidence,” said Mr. Mason. “Together, we will drive continued innovation for the benefit of patients and all medical device stakeholders.”

NESTcc is focused on advancing the use of medical device real-world evidence (RWE), and Mr. Mason’s experience in building healthcare data businesses positions him strongly to advance NESTcc’s mission. As President, he will lead NESTcc’s continued development of a trusted not-for-profit platform for the timely generation of RWE and its collaborative work on advancing RWE methodologies to address pre- and post-market challenges in the medical technology space.

“We’re thrilled to welcome Simon to NESTcc to build on the organization’s strong foundation and accelerate its development to support medical device innovation,” said Andrew Fish, JD, President & CEO of MDIC. “Simon’s operational and commercialization expertise make him an excellent candidate to lead NESTcc’s work in advancing the use of real-world evidence for the benefit of patients and all medical device stakeholders.”

“Simon is an innovator and accomplished leader in building healthcare data companies, and I’m excited to collaborate with him to guide NESTcc’s strategic priorities and deliver ever greater value for stakeholders across the medical device ecosystem,” said Diane Wurzburger, Chair of the NESTcc Governing Committee and Executive of Regulatory Affairs & Quality for GE Healthcare.

“CDRH congratulates Simon in his new role as the President of NESTcc,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH). “We look forward to working with Simon and leveraging his expertise to support our shared goal of advancing medical device safety and innovation.”

NESTcc is delighted to welcome Simon Mason as its new President and looks forward to working with him to continue advancing the use of real-world evidence across the medical device ecosystem.

About the National Evaluation System for health Technology Coordinating Center

In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is advancing the use of real-world evidence (RWE) in medical devices for regulatory decision-making and committed to transforming the way medical device technologies are tested, approved, and monitored. The Coordinating Center combines RWE system infrastructure with the unparalleled expertise of its network collaborators to accelerate patients’ access to safe and effective medical technology and provide Quality Evidence by Design™. For more information, visit http://www.nestcc.org.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to break down barriers in the medical technology life cycle to accelerate innovation and adoption of safe, effective, and high-quality medical technologies. The consortium brings together medical technology manufacturers, researchers, regulators, payers, patients, and health care providers as trusted collaborators to solve complex challenges in the scientific and technical disciplines that propel medical technology development, approval, adoption, and access. MDIC’s work improves regulatory pathways, advances medical device quality, enhances patient safety and access, and facilitates the development of better evidence for approval, coverage, and utilization decisions. For more information, visit http://www.mdic.org.

Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (U01 FD 006292). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

Contact

Todd West
twest@mdic.org

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Use of Bayesian Decision Analysis to Maximize Value in Patient- Centered Randomized Clinical Trials in Parkinson’s Disease Released

March 17, 2023

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MDIC Publishes First Landscape Analysis of 5G in Healthcare

December 15, 2022

MDIC’s new report surveys the role of 5G connectivity in current and future states of the healthcare continuum of care.  The report highlights key challenges and knowledge gaps to help deliver the benefits of 5G in healthcare more safely to patients.

 

ARLINGTON, Va. – The Medical Device Innovation Consortium (MDIC), has released the Landscape Analysis of 5G in Healthcare report. This report, accompanied by a one-page overview on 5G Security Enhancements, details the role of 5G connectivity in the future state of medical devices utilizing the technology that will contribute to the continuity of care.

The report developed by MDIC’s 5G–Enabled Health Technologies Working Group highlights key challenges and knowledge gaps to deliver the benefits of 5G in healthcare more safely to patients. This report was championed by MDIC 5G Working Group members Dr. Omar Al-Kalaa, PhD, Staff Fellow FDA; Inhel Rekik, MS, CISM, Sr. Director, Product Security, Bracco Medical Technologies; and Mark Wehde, Chair, Mayo Clinic Engineering, Mayo Clinic, with contributions from experts in the sector.

The MDIC 5G–Enabled Health Technologies Working Group is comprised of leading experts from the FDA, United States Department of Veterans Affairs, academia, medical device industry, telecommunications sector, standards development organizations, and chipset and network equipment manufacturers. For this report, they convened to develop a better understanding of how 5G can improve patient safety across the entire continuum of care – from prevention through diagnosis, treatment, post-treatment monitoring, and beyond.

Key topics covered in the report include:

  • 5G-enabled simulation with extended reality (XR)
  • 5G-enabled robotics, remote surgical robots
  • Mobile units, remote care, and telemedicine
  • Supply chain and cost
  • Network coverage
  • Ongoing QoS monitoring
  • Communication Key Performance Indicators (KPIs)
  • Lack of evaluation methods for device functions enabled by 5G
  • Roles, responsibilities and service level agreements
  • Electromagnetic environment and wireless coexistence
  • 5G cybersecurity and privacy considerations.

“MDIC convened over 150 global subject matter experts from various stakeholder groups to establish the common understandings of the technical and operational requirements for
5G-enabled devices, which in turn contribute to the safety and effectiveness of the device as well as accelerating patient access to this technology,” said Jithesh Veetil, PhD, Senior Program Director, Digital Health & Technology, MDIC.

Advances in wireless technologies can contribute to continued technical advancements in healthcare delivery.  In this rapidly evolving environment, technology moves quickly, especially with a healthcare model moving to more remote, virtual care of patients. 5G plays a significant role in this care evolution.

“It was a truly rewarding experience to work with subject matter experts from around the globe through MDIC on the 5G landscape analysis.  5G technology will enable advanced home healthcare as well as allow hospitals including those in rural areas to provide cutting edge procedures and therefore narrowing health disparities among less favored communities while allowing them access to their highest level of care,” said Inhel Rekik.

“5G in healthcare advancements are accelerating device innovation and will allow us to treat, diagnose, and track patient health anywhere the patient is. Health management solutions that aren’t tied to a physical location such as a hospital, clinic, or home will fundamentally change how we provide healthcare, who provides healthcare, and most importantly, it will democratize who has access to healthcare. The two publications from MDIC will be excellent resources for anyone interested to learn more about 5G in healthcare,” said Mark Wehde.

In addition to Landscape Analysis of 5G in Healthcare and MDIC 5G Working Group released “5G Communication in Healthcare: Background, Landscape, and Use Cases Webinar” in August 2022.  A collection of MDIC resources across the total product lifecycle of medical devices that highlights the dynamic and evolving technology advancements in healthcare is available in the online Resource Library.

 

About MDIC

The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, NIST, and other agencies, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, and review of new medical technologies.

MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

We are driving faster, safer, and more cost-effective innovation for patient benefit.

 

Contact

Todd West
twest@mdic.org
202-684-8371

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MDIC Publishes White Paper on Using Patient Preference Information for Coverage Decision Making

December 6, 2022

ARLINGTON, VA (BUSINESS WIRE)—The Health Economics and Patient Value (HEPV) initiative at the Medical Device Innovation Consortium (MDIC) has released the white paper, How Can Patient Preference Information Be Used in Payer Coverage Decisions and Health Technology Assessment?

As patients become more engaged with their care, healthcare stakeholders want to understand how to better incorporate patients’ wants and needs into their own processes. In the development of this technical paper, MDIC set out to understand how to incorporate patient preference information (PPI) in coverage decision making by payers and health technology assessment (HTA) organizations. It is the first MDIC resource focused specifically on awareness of patient preference and methods as a tool for payers and the medical device industry.

This MDIC initiative seeks to encourage the use of patient preference information by clarifying the standards and role of generating this data and presenting it in a more consistent, systematic format. “This report can serve as a resource for payers and health technology assessment organizations’ decision-making process. This is especially true for patients with diseases associated with shortened lifespans, high-cost impact, serious complications, and those with unmet medical needs,” said Harry Kotlarz, Assistant Vice President of Health Economics and Patient Value at MDIC.

MDIC sponsored a series of interviews with representatives from seven organizations including the Centers for Medicare and Medicaid Services (CMS), commercial payers, integrated delivery networks, and health technology assessment organizations. A Working Group comprised of 18 members from the medical device industry, patient organizations, and regulatory agencies provided input for the interview questions.

“This report confirms that payers want to hear a diverse and representative patient perspective. Quantitative analyses of patients’ preferences, when done right, can fill an important evidence gap for payers.” Barry Liden, Director of Public Policy at USC Schaeffer Center, and former Working Group leader.

The report highlighted how patient preferences and conventional clinical outcomes assessment must be integrated to provide robust means of evaluating what will be more acceptable to patients and increase the likelihood of favorable outcomes. This white paper helps guide firms to benchmark, select, and structure a roadmap aligned with their company’s business and technical priorities.

About MDIC
The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, NIST, and other agencies, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, and review of new medical technologies.

MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

We are driving faster, safer, and more cost-effective innovation for patient benefit.

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Contact
Todd West
twest@mdic.org
202-684-8371

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Ready to Volunteer for a Case for Quality Workgroup?

August 30, 2022

The CfQ Program is a dynamic collaborative exchange and engagement of diverse experiences and professional insights in advancing innovation to the forefront of patient safety and accessibility. Below are some examples of current work groups moving the dial forward in that quest.  

Volunteer Improvement Program (VIP) 

The CfQ VIP Program involves working groups engaged in strategic adoption and sustaining initiatives for exploring potential regulatory flexibilities that provide incentives for industry participation, enable quality improvement, and streamline processes. These working groups also ideate possible new regulatory flexibilities that encourage expanded VIP adoption, while providing least burdensome oversight that maintains FDA regulatory standards for safe and effective products while affording continual quality improvement. 

Leadership Engagement 

 The Leadership Engagement program was developed to understand the impact of leadership engagement on company performance and the quality and safety of its products. While the focus of the program is to advance the medical device industry, the principles apply to all industries.  

During the June CfQ the Leadership Engagement team presented the benchmarking quality metrics survey results conducted earlier this summer which was open to companies representing all industries with a goal to:  

  • Determine the level of use of metrics in managing businesses 
  • Identify companies’ objective for using metrics 
  • Understand the effectiveness of the metrics 
  • Understand what metrics are being used
  • Benchmark and analyze the most effective use of metrics 

Please feel free to reach out to cfqcc@mdic.org if you are interested in volunteering for these workgroups or would like information on some of the numerous projects within the CfQ Program. 

 

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