Gregory R. Bylo (1958-2018)
Status: Deceased
Career span: 19 years in healthcare; 16 years in other industries
Last title: Vice President, GS1 Healthcare US, Lawrenceville, NJ
Innovative, leading-edge, pioneering accomplishments befitting a Hall of Fame career:
Greg Bylo’s soft spoken, kind and caring manner belied the strength, courage and rugged determination he embodied as a driving force to improve the healthcare supply chain. He was always thinking beyond what was required for today, developing and implementing groundbreaking and industry leading processes and technologies. Bylo maintained a constant focus on continual improvement for the good of the industry, including the companies for which he worked, their customers (healthcare provider organizations), their customers (patients) and for the healthcare industry as a whole.
Never satisfied with the status quo, or the idea that healthcare was incapable of overcoming specific obstacles, Bylo tackled some of the industry’s most difficult challenges head on, most notably the standardization of processes, technologies and data. While others often take a project at face value, performing the bare minimum to accomplish a task or meet a requirement or regulation, Bylo never took the easy way out. He approached every aspect of his work from a systems perspective, with a process-oriented approach that examined the challenge at hand with meticulous detail. Bylo took the time to truly understand the potential impacts on not only the company in which he was employed at the time, but all relevant stakeholders (e.g. hospitals, patients).
During his tenure at BD, Bylo set the foundation for healthcare standards adoption, leading the effort to standardize global supply chain operations through implementation of an enterprise resource planning (ERP) system. Through this effort, Bylo and his team enabled global centralized management of BD’s supply chain, which was a major innovation at the time when most global manufacturers still relied on disparate systems in each region or facility.
At the same time, Bylo established a foundation for standardization of data and analytics not just within the four walls of BD, but out to its business partners. This included his work with AMR and later Gartner on putting into place standard key performance indicators (KPI) to measure BD’s global supply chain performance. Bylo also worked with distributors to develop a common scorecard with common metrics that enabled BD and its business partners to continually improve by measuring and managing the ordering process.
Bylo’s responsibilities and work naturally progressed to standards adoption at the industry level. At BD and later at Integra, Bylo was instrumental in implementing systems and processes to comply with the U.S. Food and Drug Administration (FDA) unique device identification (UDI) regulation. All of his prior work with master data management (MDM) and ERP system execution laid the foundation for successful UDI adoption by not only BD and Integra Life Sciences, but also its trading partners and others who have learned from their journey. What set Bylo 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 UDIs for medical devices.
As senior director of supply chain for Integra Life Sciences, Bylo continued his efforts to advance UDI adoption among device manufacturers and their provider customers. As a strategic business partner to Integra’s internal customers, such as the global operations, sales, marketing and product development teams, he worked to understand how the regulation impacted these various functions. Always with a holistic approach in mind, Bylo collaborated with these stakeholders, and Integra’s provider customers, to successfully address challenges related to the UDI regulation from an internal and external perspective - from master data management to packaging and labeling. His subsequent work at GS1 U.S. further built upon his industry knowledge, as he led initiatives to garner further insights and to support adoption and value beyond manufacturers.
Bylo was not only process oriented, he was people oriented, and sought out the perspectives of various stakeholders throughout the healthcare supply chain. In an industry where many believe collaboration to be an elusive dream, Bylo found ways to bring organizations and people together in order to confront challenges and develop solutions that addressed broader industry needs.
This is particularly important with UDI adoption, as it requires all healthcare supply chain stakeholders – manufacturers, providers, distributors, group purchasing organizations (GPO), technology companies and others – to break down long-standing barriers and coordinate efforts for the common good of the industry. While Bylo’s UDI work began internally within supplier organizations, he always had provider organizations – and their patients – in mind as he developed strategies and processes to support industry-wide UDI implementation.
In doing so, Bylo established a framework and best practices for others to emulate. But he didn’t stop there. A continuous learner throughout his lifetime, Bylo was always gaining knowledge that he could apply to his work, from reading books and literature on the latest supply chain best practices, to attending industry conferences, to simply speaking with colleagues and customers to gain their perspectives. His quest for knowledge was not limited to the healthcare, Bylo looked beyond for best practices that could be applied from other industries. Most importantly, Bylo was always willing to share his knowledge, serving as a mentor to countless individuals throughout his career.
This dedication to industry-wide learning and improvement positioned him perfectly to assume the role of vice president for GS1 Healthcare U.S., where he led industry-wide initiatives, building and leveraging collaboration among pharmaceutical, medical device, provider and patient care professionals to drive the adoption of GS1 Standards for improved patient safety and supply chain performance in the healthcare industry. This work included use of GS1 standards to support pharmaceutical track and trace and the U.S. FDA Drug Supply Chain Security Act, as well as better post market surveillance of medical devices through implementation of UDI requirements.
Because Bylo had the proven experience to look beyond the manufacturing world to understand the needs of providers and their patients, he brought the industry together with a focus on engagement. At GS1 he built out an infrastructure and team to support standard adoption throughout the industry. Bylo brought various stakeholders to the table and taught them all what it takes to achieve the full value of being able to identify medical devices across the healthcare ecosystem. As a systems thinker, he helped uncover and explain upstream and downstream dependencies and impacts, as well as the respective objectives of various stakeholders, all of which is critical to achieve the intended value of standards and related regulations and to improve business and clinical processes in the healthcare sector.
Bylo believed in the power of standards to impact healthcare costs, quality and outcomes. His passion and dedication were instrumental in shaping the industry today, where healthcare is now progressing closer to its ultimate goal for standards adoption – improved patient safety and care.
Focus on mentoring, education, and/or advocacy to advance other supply chain professionals and executives, and the profession as a whole:
Bylo’s quest for more information and new understandings was relentless. Even with his extensive knowledge gained over a lifetime of work in the healthcare supply chain, he recognized that there was always more to learn. This correlated directly with his commitment to continual quality improvement – the ability to learn, apply the learnings, measure the results, adjust the application and to repeat the cycle. Bylo’s passion in this area was contagious. He set an example for others to keep learning, do the right thing and always make things better.
At BD, Bylo represented the company at what was called the “Process Six Group,” a monthly gathering of companies from various industries that shared ideas on topics such as change management and best practice adoption. In this way, Bylo brought back to BD proven practices from other industries that could be applied to the organization. Bylo didn’t believe in industry barriers when it came to learning: everyone - no matter what their experience or background - has the opportunity to learn from one another.
Later in his career, at GS1 U.S., Bylo is well remembered for leading trainings on UDI for healthcare industry stakeholders. In the spirit of collaborative learning and industry-wide advancement, Bylo would bring a wide range of stakeholders together in a room – providers, suppliers, distributors, GPOs – to understand specific challenges, explore possible solutions and establish a path forward that took into account all of their insights and needs. One example is his work on process mapping for non-sterile implants – bringing all of the parties involved in the process together to flow chart existing processes and seek opportunities to streamline and improve how to capture UDIs for these products.
Bylo has been described as a “stalwart” at industry events; his presence was always noted by the event organizers, whether he was a speaker/presenter or an attendee. People understood the value of his presence as a learner and contributor. If he wasn’t presenting, he was learning and would share those learnings with others. No matter his role, Bylo was there to listen, learn and bring the knowledge back to his organization and to the industry. He was actively involved in industry organizations and events including the Association for Health Care Resource & Materials Management (AHRMM) Conference, the GHX Summit, Health Industry Distributors Association (HIDA), and the Strategic Marketplace Initiative (SMI), in addition to GS1 conferences and forums in the U.S. and internationally.
A lifelong member and leader of Toastmasters, Bylo understood that presenting was a challenge for most people. He was pivotal in starting a Toastmasters chapter at GS1 so that others could benefit from the organization. Bylo saw the potential in people and worked to foster their success. In one case, he coached and mentored a GS1 call center representative, engaging her in the Toastmasters program, helping to develop her career into a manager in the healthcare sector. This is just one example of someone who was a beneficiary of Bylo’s caring and supportive nature as a manager and leader.
Bylo 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. When speaking on the topic of UDI at industry events, he geared his message specifically to help younger, less experienced manufacturer employees who had been given responsibility for UDI compliance. They would tell Bylo that their supervisors wanted the “project” done in relatively short order. Bylo 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.
Bylo also shared his knowledge through industry publications, including Healthcare Purchasing News, Today’s Medical Developments, Med Device Online, Packaging Digest, Automation World, and 24X7 Magazine to name a few.
In these ways Bylo taught others to teach. Observing his wife who was a Speech-Language Pathologist in special education for many years, he recognized that people learn in different ways. Rather than teaching someone that there was one way to do something - his way - he gave them the knowledge and tools that they could use to address an issue in their own unique style. Furthermore, he was always open to new perspectives and willing to change his point of view or direction based on new knowledge gained from others.
On an individual level, Bylo’s colleagues describe how he always took the time to help, and did so with a smile. He was never too busy to answer a question or provide his insights on a situation. His quiet, non-boastful, non-selfish style endeared him to those around him. His passion and enthusiasm for healthcare was contagious and inspired many to assume the path he had set through his work.
Demonstrations of leadership:
Bylo was the embodiment of the idea that true leaders are about advancing overall objectives and their teams, as opposed to themselves. His quiet, leadership style was non-threatening, but also effective at making things happen. He was never afraid to take the blame when things went wrong, or give credit to others when things went right. Nor was he afraid to bring up difficult or controversial subjects, although he did so in a way that was always focused on making things better. A believer in collaboration for the greater good, Bylo was inclusive in all that he did, attracting table individuals and organizations to the table by overcoming historic barriers to communication and information sharing in the healthcare industry.
As a leader, Bylo was an innovative thinker, which helped him set the foundation for standards and advance their adoption. During his work to implement a global ERP system at BD, he brought together supply chain leaders from across the globe to relay the significance of a single platform, processes and data, so they in turn could engage their teams in its use and maximize the benefit. In many cases this was an uphill battle because there is always resistance to change within any organization. Much of his work involved sharing his innovative thinking and pushing the limits to enact effective change management. But, as always, he did so in a way that was respectful and unpretentious, and conveyed his understanding of the impacts on systems and stakeholders.
When he joined Integra Life Sciences, Bylo continued to apply a holistic, collaborative approach to UDI that encompassed both internal and external stakeholders. Working with Integra’s global operations, sales, marketing and product development teams, he sought to understand the impact of UDI implementation across departments and systems. This collaboration also helped him understand how regulations impacted upstream operations, e.g. to packaging and labeling, and how changes made upstream would impact the end users of the company’s products. Once again, Bylo took the time to execute UDI in a way where the standard would provide true value to the healthcare industry, rather than simply checking a compliance box.
When Bylo was appointed vice president of Healthcare at GS1 U.S., the organization needed a strong leader focused on healthcare who could steer the team forward in its efforts to support standards adoption. Bylo came in and established an entirely new engagement model that brought together medical device, provider and patient care professionals to collaboratively drive GS1 standards adoption for improved patient safety and supply chain performance in the healthcare industry. He made sure everyone had a voice at the table, they were heard and their insights were taken into account.
Bylo helped strengthen and focus GS1’s commitment to healthcare. His focus was on the patient – how the industry could implement standards in a way that truly impacted patient care and safety. Recognizing the amount of time, labor and costs are required to successfully adopt standards in a healthcare supplier or provider organization, Bylo was sure to communicate the business benefits as well, in terms of process efficiency, waste reduction, etc. But beyond words, Bylo knew what it takes to put those benefits into action through effective implementation of standards.
Bylo changed the conversation around standards so that it appealed and applied to not just large suppliers and providers, but the mid-sized to smaller ones as well. These stakeholders were now paying more attention as Bylo effectively communicated how standards adoption could deliver clinical and business value to them.
As one of three issuing agencies for unique device identification, GS1 has a strong leadership opportunity and responsibility, working with the FDA, AdvaMed and other regulatory and healthcare industry organizations. Bylo took that to heart and was very comfortable interfacing with these entities on behalf of GS1.
One of his most significant leadership opportunities came forward at the time when the European Council and Commission passed a European regulation similar to the U.S. FDA’s UDI regulation. The European and U.S. regulations had some key differences, so recognizing Bylo as a UDI expert, the GS1 global office asked him to lead a workshop and community effort around understanding these differences and how global manufacturers could shape their approaches to address both regulations. Under Bylo’s leadership, more than 100 manufacturers came together to collaboratively understand how UDI implementation in Europe would work, what attributes were needed, the pros and cons of the European approach, and how they could meld it with the U.S. approach. In this way, Bylo cultivated and developed an industry point of view to help inform and guide UDI implementation on a global level.
Recognizing Bylo’s UDI knowledge and experience, and his amazing ability to foster collaboration among various stakeholders for the greater good of the industry, AHRMM appointed him to the steering committee of the organization’s Learning UDI Community (LUC), a collaborative effort designed to address issues impacting the implementation and use of unique device identifiers. In this role, Bylo took his learnings from GS1 – both in the U.S. and globally – and his work with AdvaMed to help industry stakeholders collaboratively tackle very specific, detailed challenges related to UDI implementation.
Innovation in practice:
While many in the industry focused on compliance when it came to UDI adoption, Bylo always focused on value, looking beyond his individual role within a company or organization to help create real, sustainable change for the industry.
His innovative work began at BD as he laid the foundation for standardization and data sharing through implementation of a global ERP system. With centralized supply chain management, the company for the first time had global visibility into its operations. It allowed for improved inventory management, transportation, customer service levels and financial management. At the time provider customers were demanding more efficient ways of transacting with their suppliers. Instead of dismissing this demand or placing the ball in somebody else’s court, he rolled up his sleeves and helped to get it done on his own.
This forward-thinking approach to supply chain management set the stage for additional advancements, including the establishment and use of industry standard KPIs from AMR, later Gartner. This provided a way for the company to standardize measurement of its operations globally around the world.
Master data management was critical focus and area of innovation for Bylo. When the FDA issued its UDI regulation, he looked beyond compliance to how the company could leverage the regulation to achieve operational excellence. At the time BD had 400 computer systems and multiple codification systems for products in place throughout the enterprise. Bylo led an effort to leverage UDI as a way to reduce these codification systems, saving the company millions of dollars.
Under Bylo’s leadership, BD built UDI into the company’s ERP system so it could transact with either a product’s catalog number or its device identifier (DI). Because of Bylo’s dedication and commitment, the company made this change well in advance of the UDI regulation deadline. He was also instrumental in the company’s work to achieve joint value from standards with its customers.
Upon assuming his role at Integra, Bylo recognized the company’s need for a master data management (MDM) strategy and system. Within the company’s ERP system at the time, each packaging level was identified as an “each,” so a single unit was an “each,” a shelf pack was an “each,” and a case was an “each.” Therefore, a change of unit of measure for a product required the deletion of the existing record and the creation of a new one. Bylo and his team corrected this issue as it entered product data into a newly established MDM system, saving the company significant time and labor.
As Bylo and his team prepared and delivered data into the GS1 Global Data Synchronization Network (GDSN), it raised questions around the company’s labeling and packaging organization approach. They moved to a centralized design and template approach and decentralized pricing approach, which further streamlined processes and reduced costs, while helping to facilitate UDI compliance.
When Bylo joined GS1, his focus on innovation centered on the patient benefits derived from data standards. He asked the question, “Are we doing standards for standards sake or are we actually improving healthcare?” His new engagement model for GS1 Healthcare U.S. centered on provider recruitment, and understanding the challenges and opportunities for using UDI at the point of use (POU) in clinical areas. He developed and executed a charter under which the GS1 team conducted audits at provider sites of all sizes to examine use of GS1 standards in clinical areas to determine if they were truly making a difference, and if not, what changes could be made to deliver greater value. He engaged in face-to-face conversations with the clinicians and saw UDI use in action, and then brought this knowledge back to GS1 Healthcare U.S. so that the end user – even those in smaller organizations - had a say in the standards conversation.
At GS1, Bylo had responsibility for both the medical device and pharmaceutical sides of the organization. Recognizing his expertise and proven work on standards in the medical device industry, the FDA engaged with Bylo on an initiative related to the National Drug Code (NDC). Today the NDC is five-digits in length and the FDA is running out of numbers. The agency recognized that it must change the NDC to six-digits within the next 10 years to accommodate a growing industry. Currently, GS1 can embed a manufacturer’s NDC into its GS1 prefix to facilitate identifier continuity and integrity. He collaborated with the FDA in his role at GS1 on how to incorporate the new six-digit NDC into the GS1 system of identification. Although his work in this area was preliminary due to his untimely death, it set a path forward for the industry through which stakeholders will benefit in the years ahead. It is another example of the invaluable legacy Bylo has left behind.
Managing professional relationships and services:
Bylo recognized how supply chain is not about what happens in one department or one organization, but is rather a multi-stakeholder process with multiple inputs and many different customers both internal and external. With this in mind he took the time to understand the needs, perspectives and motivations of various stakeholders, and leveraged this knowledge to see the big picture of standards adoption.
While collaboration remains a challenge for many in the healthcare supply chain, Bylo was also a believer in it and did what he could to advance it. At BD, Bylo implemented initiatives that worked collaboratively both upstream and downstream – including the company’s suppliers, distributors and its provider customers – to harmonize data, processes and technologies. During one specific initiative, focused on vendor managed inventory (VMI), Bylo worked with integrated delivery networks (IDN) to tear down traditional barriers and facilitate data sharing between BD and these customers.
In another initiative, Bylo successfully addressed the challenges of disparate dashboards, report cards and metrics with BD’s distributors. Distributors had been using proprietary dashboards to measure BD’s performance, and BD in turn used its own dashboards. Bylo collaborated with each of its distributors to develop a common scorecard that allowed BD and the distributor to measure each other’s performance using the same metrics and measurements.
While at BD, Bylo learned holistically that the most critical piece of UDI is voice of customer. For example, when designing packaging and labeling, a company must understand the regulation from a holistic intent and take into consideration whether the UDI information is easy for the user to identify and use.
Bylo took this strong customer focus to GS1 when he kicked off the work on how to capture UDIs for non-sterile (orthopedic) implants, he took his team to “gemba,” which in LEAN terminology is the place where work is done and value is created. They met with clinicians in the ORs to observe how multiple implantable items housed in procedural trays are documented as they are used and the challenges encountered in the process. This knowledge helps manufacturers redesign packaging to make the data capture process more operationally efficient for the provider organizations.
This spirit of collaboration throughout the healthcare supply chain permeated Bylo’s work at GS1 on UDI. During UDI trainings he would bring everyone together - providers, suppliers, distributors, GPOs – in one physical location where they could voice their challenges and needs and collectively determine a mutually beneficial path forward.
Bylo’s work with the AHRMM Learning UDI Community (LUC) positioned him in a role of collaborative leader. He successfully enabled healthcare industry stakeholders – suppliers, providers, distributors and GPOs – to take off their individual business hats, examine UDI implementation from an industry rather than separate entity perspective, and find ways to overcome UDI implementation challenges that would benefit all parties involved, most importantly the patients.
On a global level, Bylo’s work with the GS1 global office to understand key differences in the U.S. and European Commission’s unique device identifier regulations presented the challenge of bringing together global medical device manufacturers, who were in some cases competitors in the global marketplace. As a recognized expert in UDI, with proven leadership and success, manufacturers trusted Bylo to “do the right thing” for the industry, and in turn were willing to collaborate on initiatives such as the one to compare/contrast the U.S. and European regulations and propose ways in which they could address both through a common approach.
Commitment to ethical and moral standards and integrity:
Bylo is described by his colleagues and family as an individual with a strong inner compass who always sought to do the right thing, even when that meant confronting additional obstacles and taking on more work. Bylo had a unique ability to raise difficult issues in a way that would not create defensiveness but rather sought to include those with opposing viewpoints in order to develop a strategic path forward. Bylo was a collaborative problem solver who was always in it for the right reasons – never wanting to have winners or losers but instead working toward solutions where everyone’s needs are best ultimately met. Those who worked with Bylo not only praise his outstanding professional achievements, but also his personal qualities – helpful, kind, caring, a good person.
Most importantly, Bylo fought for patients. Throughout all of his career he kept the patient as the focus of his work and developed solutions aimed at improving their care and safety. Even if something was not technically his personal responsibility, he still sought to go beyond what was required to do the right thing. Instead of narrowing the scope of his work in order to speed time to completion he always took into account the bigger picture. He had the courage to raise concerns and propose ideas to senior leaders in organizations, explaining what was required to achieve the best outcomes and why he believed they should take a specific approach that might require additional work.
When Bylo himself was a patient battling cancer, few knew it. He was communicating with colleagues about upcoming conferences just days before his untimely passing. He continued his work for GS1 U.S. and for UDI adoption until his family insisted that he put the computer away. He was working for what he believed in, better patient care and a more effective healthcare supply chain and system, until the end. We are all better because of a leader like Greg Bylo.
IN THE WORDS OF HIS WIFE MARIANNE BYLO…
What are your impressions about Bellwether League Inc.’s mission and philosophy, and how do you feel about becoming an Honoree?
The Bellwether League’s mission and philosophy of recognizing individuals who have demonstrated leadership and made contributions to the healthcare supply chain through their work and innovation is nothing less than remarkable, and all the name “Bellwether” connotes. My daughter and I are thrilled that Greg is a member of the Bellwether Class of 2020, and we sincerely thank the Bellwether League for honoring him in this way.
Greg was a quiet force, not one to praise himself, but he believed in the mission of healthcare supply chain and was committed to continuous improvement in the field. We know he would have felt immeasurably honored and proud to join a class of such accomplished and dedicated honorees, as well as be in the company of past honorees.
What attracted and motivated Greg to get involved in the healthcare supply chain management field when he did?
Greg believed that the work of healthcare supply chain management makes a real difference in people’s lives; the lives of patients, of course, but also the lives of all those who work in the management chain. These individuals and organizations doing the work are many and diverse. They bring varied skills and talents to the process; they lead, create, problem-solve, and strive to make change and improve healthcare delivery. The process changes them as well. Greg loved that. He loved the challenge, being part of a team of exemplary thinkers, and making a difference. This is what attracted him to the field and motivated him to get involved.
For what one contribution would Greg like to be most remembered?
I think Greg would like to be most remembered for the role he played in mentoring others. He was an educator at heart and enjoyed sharing information and observations about supply chain. He truly wanted men and women who were perhaps just beginning their careers, or newer to the field, to realize the impact they could have on the delivery of high quality and efficient healthcare services. He wanted those he mentored to be free to think and to be supported in their roles. He wanted to be the encourager of others. True educators are life-long learners, and Greg was no exception. He persuaded others to seek knowledge and continue asking questions. He hoped to inspire them on their paths, as they learned with, and without, him.
If Greg were to encourage someone – either outside of healthcare or just out of school – to enter healthcare supply chain management and strive to be a future Bellwether League Honoree, what would he tell him or her?
What Greg would say: This is an amazing and interesting career choice that will challenge you to continue learning. You have the opportunity to stretch limits. You are needed. You can make a difference. Do good and right things (as a mentor once told him).
In two sentences or less, how would Greg define healthcare supply chain leadership?
I think Greg would say that Healthcare Supply Chain Leadership is defined by being open-minded and respectfully listening to all parties involved. Have a plan, execute the plan (until you have to change the plan!).
If Greg traveled back in time to when he started in healthcare what would he tell himself?
When Greg first entered healthcare, he felt intrigued and excited by the possibilities before him. I think he would have told himself to take advantage of all he could learn, and when creating change, “slow and steady wins the race.”