As I was sitting down to write this month’s Standard Practices column, I received a heartbreaking email letting me know that a good friend and admired professional colleague — Greg Bylo from GS1 US — had passed away.
Greg was well known by many in the industry who, no doubt, share my deep sense of loss, not only for a friend but also a true champion of the value of standards in healthcare. For the past three years, Greg served as vice president, healthcare for GS1 US, but his dedication to standards began much earlier in his roles with BD and Integra Life Sciences. He helped both firms implement systems and processes that would help them comply with the U.S. Food and Drug Administration (FDA) UDI regulation. What set Greg apart from many is that he looked far beyond what it would take to comply with the regulation; he sought to help those organizations and their customers realize the full potential of unique product identifiers (UDIs) for medical devices.
Last year, I had the opportunity to interview Greg extensively for a Capstone project I was conducting in conjunction with the FDA as part of my master’s in the Science of Healthcare Delivery. I would like to share some of Greg’s perspectives as I believe they can help all of us in our continued pursuit of UDI adoption and value. While I am saddened that Greg will not be with us to see those efforts to completion, his legacy lives on in the foundational work he performed first as an operational leader and more recently as a standards advocate.
Greg is perhaps best remembered for his gentle leadership style and someone who was always willing to lend a helping hand, to create a teachable moment, and to express appreciation for his own mentors. In the interview, Greg specifically called out Larry Smith (another of my favorite leaders) who served as Greg’s manager at BD. Greg admired Larry for his forward-looking perspective, inviting Greg and others to consider how the company could use regulation to achieve operational excellence. Greg took Larry’s advice and leveraged GS1 standards to reduce the multiple codification systems in place for BD products, yielding significant savings. But Greg’s work did not stop there.
BD is also known in the industry for working with customers to help realize joint value from the use of standards in transactions. Greg carried that customer focus to his work at GS1 US, where he encouraged others to consider how and where UDIs could be used in the healthcare delivery environment. As someone steeped in the tradition of continuous quality improvement, Greg kicked off an effort to address how to use UDIs for non-sterile (orthopedic) implants by taking the team to “gemba,” which in LEAN terminology is the place where work is done and value is created. In this case, the team — including manufacturer and provider representatives — visited operating rooms to observe how multiple implantable items housed in procedural trays are documented as they are used and the challenges encountered in the process.
Greg spoke frequently on the topic of UDI at industry events, gearing his message specifically to help younger, less experienced manufacturer employees who had been given responsibility for UDI compliance; they told Greg that their supervisors wanted the “project” done in relatively short order. Greg would explain how UDI is not a project with a distinct beginning and end, but rather an ongoing program that requires cross-functional participation and synchronization across multiple external stakeholders, including regulatory bodies and customers.
UDI is fundamental to development of a learning healthcare system, one in which we can better understand how medical devices are performing in routine clinical practice and apply those learnings to improve how we deliver care and how we design and bring new technology to market. Individuals like Greg Bylo are equally essential to continual learning and improving what we do — for our individual organizations, for our business and clinical partners, and ultimately for the patients who depend upon the products we produce and procure for use in their care.
Greg will be missed by his friends, family and professional colleagues, but he has left healthcare exactly as he intended — better because of his contributions and poised for continual improvement.
