Innovate for Excellence: Quality Management in Medical Device Production

Quality management and structured practices are required for the production of medical devices regulated by countries throughout the world.

Prosthetist Making Artificial Leg — *Image Source: SeventyFour / iStock / Getty Images Plus*

The ASQ Chicago Innovate for Excellence 2024 Summit is an exemplary case study of industry, academia, government, and ASQ collaborating to advance the continuing quest for excellence in the Medical Life Sciences industry.

I’m a dedicated volunteer leader for ASQ. I’ve been doing this for 10+ years because I relish the opportunities for professional collaboration, networking, and service to others that ASQ provides. The kind of personal and professional growth that can only be found in a community of passionate and dedicated volunteers like ASQ. I know there are many others out there that feel the same way; please consider joining our Summit team after you finish reading this article. I work year in and year out as Program Chair for the Innovate for Excellence Summit, so please read on to allow me to share with you the story of our conference and how its quintessential example shows the unique value creation provided by professional volunteer organizations like ASQ. I don’t do it for the money (there is no financial compensation of any kind). The work I do for ASQ offers rewards for myself and our community that are truly priceless. I hope to inspire every reader to activate ASQ volunteer service, to find ways to succeed in building and working in teams to create a gift to our world.

Source: All images were collected by and are the property of ASQ Chicago Section 1201

Imagine a perfect early autumn afternoon in Palatine, in suburban Illinois. A beautiful view across the lake from the Wojcik Conference Center on the campus of Harper College drew out contemplation and reflection of the many facets of excellence that had just transpired. Following the closing address of the ASQ Chicago Innovate for Excellence 2024 Summit for Medical Life Sciences, it was time to savor the fulfillment of a job well done. The kind of feeling can only happen after a team comes together to work out their heart in good cause and lies exhausted on the field of battle... victorious (please forgive me the classic Vince Lombardi quote; the 2024 Summit was THAT good). A great measure of this success: all attendees remained for the closing presentation of our two-day conference on Friday afternoon! One expression of the high caliber of professionals in our conference program was that “it is like having the Rolling Stones play at your birthday,” and then hanging out with them after their set was done, so to speak.

Opening Keynote — *Source: All images were collected by and are the property of ASQ Chicago Section 1201*

Distinguished speaker. — *Source: All images were collected by and are the property of ASQ Chicago Section 1201*

The Summit theme for 2024 was “Innovate for Excellence, Medical Life Sciences”. As an ASQ event the foundational element is to achieve excellence through quality (which is also ASQ’s mission) by leveraging the disciplines of accountability and consistency. With innovation as a central theme and quality management as one key area of focus, the concept is applicable to many industries, processes and continual improvement efforts. This becomes key to having a recurring annual summit. In 2024, the focus was directed to Medical Life Sciences, referring to the broader medical devices and pharmaceutical industries and supporting areas of academia. Medical Life Sciences proved to be a perfect fit to bring into focus how innovation and quality work together for industry, government, and academia.

Distinguished panel. — *Source: All images were collected by and are the property of ASQ Chicago Section 1201*

Quality management and structured practices are necessary and required for the production and use of medical devices and pharmaceuticals regulated by government in countries throughout the world. This regulatory requirement is manifest as the requirement to implement standards-based Quality Management Systems for companies that produce and use medical devices and pharmaceuticals. Critical concerns in these industries center around risk management of the safety and efficacy of products. At the 2024 Summit, several thought leaders from the U.S. Food and Drug Administration and regulatory experts on ISO standards committees shared their perspectives on governing regulations and standards for Medical Life Science industries. It was exhilarating to have the unique opportunity to talk with the speakers and share thoughts over coffee, lunch, or happy hour mixers.

Workshop Collaboration — *Source: All images were collected by and are the property of ASQ Chicago Section 1201*

Managing innovation is an essential survival skill for any technology company, and especially for Medical Life Sciences companies. At the Innovate for Excellence Summit, innovation means much more than clever invention; it means something new that benefits society at large, like the microwave oven or the cell phone. Successful Medical Life Sciences products certainly meet this definition, as well. Innovation can even apply to quality practices. The summit also hosted Innovation workshops led by thought leadership from academia and industry, including the prestigious University of Illinois-Chicago, Xavier University, Ohio State University, and many regional companies large and small.

Networking_Lunch — *Source: All images were collected by and are the property of ASQ Chicago Section 1201*

Neworking Lunch — *Source: All images were collected by and are the property of ASQ Chicago Section 1201*

Innovation management, quality management, standards, and regulations all come together to innovate great Medical Life Sciences products. The Innovate for Excellence 2024 Summit is sponsored by many renowned medical life science companies, and the speakers and conference committee cumulatively represent decades of professional experience in the medical life sciences industry. Discussion topics included innovative approaches for manufacturing operations, risk management, cybersecurity, and AI.

A particular highlight of the summit was expert panel discussions leveraging multiple speakers to further explore and build on prior material to help realize new insights.

View of a pond with a fountain from the Conference Center. — *Source: All images were collected by and are the property of ASQ Chicago Section 1201*

The complete program including speaker biographies may be found at: https://asq-chicago.org/Innovation_Summit_Program.

UIC Professors and Grad Students — *Source: All images were collected by and are the property of ASQ Chicago Section 1201*

Speakers, leaders, experts, practitioners, and professionals from industry, academia, government, and ASQ members and volunteers benefited from a uniquely collegial, interactive, and collaborative environment at the Innovate for Excellence 2024 Summit. Connections were made, ideas discovered, plans developed, and partnerships formed. The Innovate for Excellence Summit in Chicago offers an unparalleled environment that synergizes in ways that are rare to find in individual sectors of work and life. The Summit is successfully growing bigger and better each year. Make plans to attend the Innovate for Excellence 2025 Summit. Better yet, get involved with the planning team or as a sponsor of the next summit. Please check out the ASQ Chicago website and watch for opportunities get involved at https://asq-chicago.org/index.php.

We look forward to meeting you at Innovate for Excellence 2025 Summit!