Sponsored by Elite Biomedical Solutions
Innovators in Healthcare: How Elite is Redefining the Medical Equipment Marketplace
“We have a passion for patients and patient safety.”
Jeff Smith’s words as CEO and co-founder of Elite Biomedical Solutions and Elite Precision Plastics are equal parts corporate mission, personal mantra and family motto.
The driver of the family business – about 20 percent of Elite’s 50 employees are Smith family members – has always been a greater purpose. As one of the country’s first manufacturers of high caliber, U.S.-made third-party replacement parts for infusion pumps and telemetry units, Elite is transforming the medical equipment industry to make a difference in health care.
When Jeff and his nephew, Nate Smith, co-founder and Chief Revenue Officer, established Elite Biomedical Solutions in 2012 in Cincinnati, Ohio, only one other company made new replacement parts for infusion pumps to provide savings. Hospitals had to buy used equipment and harvest the parts themselves or purchase parts from original equipment manufacturers (OEMs) at a higher cost.
Elite saw a need and forged a niche by manufacturing OEM-quality replacement parts, combining the OEM’s focus on engineering with the innovation and flexibility of a biomedical start-up. Elite stands out by focusing on better quality, accountability and unmatched integrity. Every Elite new replacement or re-certified part – crafted and tested by Elite – must pass the rigorous FDA CFR 21: Part 820 (cGMP) and International Organization for Standardization (ISO 13485:2016 and ISO 9001:2015) certification processes. The industry doesn’t require it, and few competitors bother with it, but Elite doesn’t cut corners. Passing the highest industry standards ensures optimal reliability and patient safety.
By treating customers as part of the family, Elite has grown its revenue to over $20 million annually and has a client list of over 1,500 hospitals and a slew of national awards. From 2017 to 2021, INC. 5000 magazine named Elite as one of the Fastest-Growing Private Companies in America and they are a four-time Manny Award winner for Top Growth in Manufacturing. But profits or accolades are not the top priority, they are a by-product of the Smiths’ commitment to helping patients and creating a better industry.
In addition to their core business and as a result of the pandemic, they founded Elite Precision Plastics (EPP), which contract manufactures custom plastic medical products and disposables, to address ongoing supply-chain issues. EPP continues to grow quickly due to the large need for onshoring manufacturing. Recently, Elite was approached by one of their larger independent service organizations to begin training the ISO’s newly hired biomedical technicians. Thus, Elite started an AAMI-certified program that provides training on both OEM and Elite products. They are currently in the process of creating a national networking group of biomedical technicians. With many biomedical technicians about to retire and fewer people entering the profession, Elite saw this as an opportunity to train these unsung heroes of hospitals who are responsible for maintaining aging, critical equipment.
Though only 11 years old, the seeds of Elite were sown during summers in the late 1970s when Jeff worked for his dad’s heating and air conditioning business in Bryan, Ohio. He watched his dad, a former salesman, focus on people, not profits. And he saw the pride his hometown had for manufacturing. Though only a community of 10,000, Bryan was home to the Etch A Sketch, Dum-Dum suckers, and played a key role in supporting Detroit’s auto manufacturing.
Those summers sparked his dream to someday own a company with the same values shared by his father, and his hometown. After studying finance at Ohios Miami University, he chose to go into health care. “There are plenty of other widgets I could sell, but I wanted to sell something that I believed in,” Jeff says.
He started his career in sales for original equipment manufacturers (OEMs).
“When I started, the OEM sold the best product in the marketplace,” he explains. “Unfortunately, we kept getting bought by other companies focused on improving profit and cutting engineering costs.”
He watched much of the manufacturing move overseas. But the turning point was when the president of the board of a large hospital system, demanded accountability over the OEM’s product quality and the company’s position was to deflect, Jeff knew what he had to do.
For two months, he worked nearly round-the-clock securing rental pumps until the product he sold was fixed and ready for patient care. But Jeff was done with OEMs. For the next 11 years, he was COO of a start-up that repaired, rented and sold infusion pumps. It was then, that he tapped his oldest nephew Nate as a sales representative, who eventually became vice president of sales.
“Nate and I were running everything and knew we wanted to build it into something that was what the OEMs used to be, but we didn’t have the fiscal responsibility and the ownership,” Jeff says. “Nate and I controlled all sales and operations and successfully grew that business.”
Other Smith family members joined Jeff and Nate, including Jeff’s daughters, Alex Heileman, Elite’s COO, and later Madison Trejo, now Elite’s Chief Vision Officer. In addition, they recruited and hired Nate’s two brothers, Travis Smith, and Tyler Smith, for sales.
“We were very successful but unfortunately the owner ended up having to declare personal financial bankruptcy in 2012 and the company ceased all operations.” Jeff explains. This left the Smith family without jobs and in search of potentially new careers.
Jeff and Nate saw their chance to make high-quality, American-made replacement parts. They bought the manufacturing end of the business and opened Elite Biomedical Solutions with a team of eight (also known as “The Elite 8”). Along with family members, they recruited key employees from the former company to join them in June 2012. Nate and his brothers plus Sarah Noggle focused upon sales. While Jeff, Alex, Jeff Diesel and Jeremy focused on operations. “We center ourselves on our commitment to patient safety, our customers, our employees and our community,” says Nate.
It’s an approach that earned a solid reputation for dependability and savings. “We use a fair pricing structure that offers an average of 30 percent annual savings for our customers,” Nate explains.
The secret sauce is in the process. Every Elite part begins with the product development team – biomedical engineers, process engineers, plastics engineers, quality engineers, biomedical equipment technicians and leadership team – taking an OEM part and reverse engineering how to improve it. FDA requires form, fit and function restrictions that can’t change, but other variables are examined, tested and explored to extend the life of the part. They analyze competitors’ products and compare them to their own product lines. Frequently resulting in products that outperforms the competition.
When patients’ health is on the line, validation, verification and documentation matters. Elite performs the highest level of testing to ensure the highest level of product quality. “We have to test for every possible scenario,” Jeff explains.
The lifespan of an average infusion pump is seven to 10 years, with a 20 percent failure rate after the first couple of years. “Most hospitals are changing out a fleet to parts once, if not twice,” says Nate. “Parts can degrade due to the level of cleaning agents utilized and the amount of wear and tear they endure. This is why it is critical not to utilize cheaper resins to manufacture the part.”
Madison Trejo adds, “We’re creating parts that can save or prolong a device’s useful life. The same devices that are utilized on hospital patients. You can’t mess that up.”
“Our goal is to have a competitive advantage and ensure that those companies follow the same rules to ensure patient safety,” Nate explains. “If you’re going to do this, you need to do it the right way.”
Elite is one of the first third-party companies to earn true ISO certification, registered and recognized by the U.S. government. And it remains one of the only companies to withstand three FDA audits to date.
Quality control is just as critical at the manufacturing and assembly stages. At Elite, employees are empowered with authority to stop the process if something doesn’t meet the quality standards. Such safety scrutiny hardly slows down Elite’s production. The company’s Cincinnati plant handles thousands of pieces per month and maintains several months of inventory to meet any backorder issues that an OEM might have.
Jeff and Nate knew the difference they wanted to make with Elite, but they never envisioned that a global pandemic would change health care. Thanks to their healthy inventory, they could pivot in early 2020. “We were able to facilitate the needs of hospitals right off the bat by putting pumps on hospital shelves,” COO Alex says.
Deemed an essential company, Elite worked hard to ensure that infusion pumps would not be part of the same supply woes as the other supply shortages. They increased their technical support to fix IV pumps and rented pumps to assist in helping their customers.
Early on during the pandemic, the company researched manufacturing syringes, which were being sold to other countries for the highest profit and creating a shortage in the U.S. during the pandemic. After several months of investigating the feasibility for Elite, instead the exercise inspired a new product – a collection container for the pharmaceutical and biotech companies in Cincinnati – and launched Elite Precision Plastics. Creating a new contract manufacturing business that customized biomedical products is a new way to further the Elite culture of making an impact.
With new medical products developed by Elite Precision, Elite is poised to enhance its presence in the medical marketplace. Each innovation and opportunity to help keep patients safe is anchored by the Smith family values, which are at the very heart of Elite.
“We put patient safety first, always,” Madison reflects.
For more information, visit elitebiomedicalsolutions.com.