Manufacturing operators at Bard Shannon39s plant in Puerto Rico conduct a kaizen event

2015 IW Best Plants Winner: Kaizens Key to Bard Shannon’s Cultural Turnaround

Feb. 18, 2016
The company’s cultural transformation moves it from FDA warning to Plant of the Year.  

Things were not looking good for Bard Shannon's Puerto Rico plant in 2008. The plant, which manufactures 40 medical devices serving the vascular, urology and oncology markets, received a warning letter from the FDA.

If corrections were not made, the FDA could move to shut down the plant. A drastic change was needed. “Once we understood that we needed to create a culture of continuous improvement, we developed a number of rigorous processes that gave us a structure through which everyone, at all levels, could understand both the importance of this tool and how to implement it,” explains Oscar Rivera, business excellence manager.

Applying the same precision needed to manufacture life –saving devices, the company constructed a path to improvement. A Business Excellence Department was formed using strategies such as True North, Hoshin Kanri, Lean Six Sigma and Kaizens.

“Kaizens have turned into an extremely important activity for employees,” Rivera observes. “The process of working in a team, creating a process and solving a problem allows for the concept of continuous improvement to become embedded in how we approach our jobs.”

Kaizens offer a means through which employees can develop creative solutions which are turned into cost and time-saving projects that are fed into a company-wide competition. The dedication and enthusiasm for these projects was quite evident as employees delighted in explaining to an IndustryWeek editor the problems they were able to fix at the company’s Summit Kaizen Competition in December. 

Bard Shannon

Humacao, Puerto Rico

Employees: 565

Total Square Footage: 260,000

Primary Product/Market: Medical Devices

Start-up Date: 1981


Employee suggestions represented 22% of overall plant savings for 2014.  

59% improvement in first pass yield in past three years.

77% reduction in in-plant defect rate within past three years.


The kaizens are part of an overall strategy that provides a roadmap to achieve a continuous improvement environment. A Leadership Academy, which provides job specific training, and the Bard Operating Success System are pillars of that strategy.

“One of the main improvements we made was to be more specific in the metrics that each team was to work on,” explained Felipe Mendez, plant manager. “In fact we turned this into a competition across lines.” An award program, called BARD Circuit, recognizes superior achievements in the areas of service, quality, financials and business excellence.

“The result of our new culture is a complete turnaround of our plant,” says Mendez. “We had not been launching products from this site prior to our transformation. Now, with our new role in R&D, we will take ownership of developing products and processes for new product introductions.”

The high level of quality produced by this plant has been recognized by the parent company who named it Plant of the Year in 2013 and 2014.

“Communication is key to our success,” explains Mendez. “There are many meetings and opportunities to ensure that we discuss issues, as we view ourselves as problem solvers.

“Everyone in this plant is aware that at the end of the day we save lives. The implantable devices are with patients for the rest of our lives, so they must be perfect,” says Mendez.

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About the Author

Adrienne Selko | Senior Editor

Focus: Workforce, Talent 

Follow Me on Twitter: @ASelkoIW

Bio: Adrienne Selko has written about many topics over the 17 years she has been with the publication and currently focuses on workforce development strategies. Previously Adrienne was in corporate communications at a medical manufacturing company as well as a large regional bank. She is the author of Do I Have to Wear Garlic Around My Neck? which made the Cleveland Plain Dealer's best sellers list. She is also a senior editor at Material Handling & Logistics and EHS Today

Editorial mission statement: Manufacturing is the enviable position of creating products, processes and policies that solve the world’s problems. When the industry stepped up to manufacture what was necessary to combat the pandemic, it revealed its true nature. My goal is to showcase the sector’s ability to address a broad range of workforce issues including technology, training, diversity & inclusion, with a goal of enticing future generations to join this amazing sector.

Why I find manufacturing interesting: On my first day working for a company that made medical equipment such as MRIs, I toured the plant floor. On every wall was a photo of a person, mostly children. I asked my supervisor why this was the case and he said that the work we do at this company has saved these people’s lives. “We never forget how important our work is and everyone’s contribution to that.” From that moment on I was hooked on manufacturing.

I have talked with many people in this field who have transformed their own career development to assist others. For example, companies are hiring those with disabilities, those previously incarcerated and other talent pools that have been underutilized. I have talked with leaders who have brought out the best in their workforce, as well as employees doing their best work while doing good for the world. 

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