Even with two decades of solid proof, industry product knowledge remains a core task for a medical device firm.
Veteran manufacturing and biotech executive Stuart Jones had a stern warning in spring 2013 for the board of Manatee County wound-care products company Biolife.
“I told them, ‘If you don’t want this to be a really large company, then don’t move me,’” from Orlando, says Jones, where he was running a consulting business. “Don’t hire me.”
Now, as the 40-employee firm marks 20 years in business, Jones’ 2013 Biolife vision turned warning is becoming a reality. Its core product, StatSeal, is in some 700 hospitals worldwide, mostly in the United States. Many more medical facilities, executives hope, will be signed in 2019 and beyond — if and when the company overcomes some core consumer education obstacles. “The biggest challenge is getting hospitals to try us,” Jones says. “It’s hard to get doctors who have been using one thing to get to know a small company with something totally different.”
Even so, revenue has doubled in the past five years, Jones says, and he projects exponential growth into the next decade. Company officials decline to disclose specific revenue figures. Says Jones: “We will be growing in the double digits per year as far as the eye can see.”
Jones, 61, had been consulting for Biolife one or two days a week. In the early 2000s, when it was a startup, he was a CFO-for-hire there working one day a week. His vision for Biolife in 2013 when he met with the board was to lead it into the global hospital market behind StatSeal. Then the company’s newest product, StatSeal is a dime-sized disc that uses Biolife’s patented technology to control bleeding from sheath and catheter removals — a significant issue for hospital patients, particularly in the ICU.
To Jones, StatSeal represented disruptive technology in the form of Biolife’s secret sauce: a compressed powder that essentially dehydrates blood and creates a seal around it. “I had a lot of faith in the product,” says Jones.
But for a variety of reasons, from strategic hiccups to financial challenges in marketing, Biolife struggled to gain traction or sustained success with its powder-based products. “It took a whole lot of twists and turns,” says Biolife Executive Vice President Tim Kelly, a medical device veteran who was employee No. 4 when he joined the company in 2001. “When I started, we didn’t have any packaging. We didn’t even know who we were going to sell (the powder) to.”
Through 2013, Biolife’s main business model was to sell its flagship product, WoundSeal, in consumer outlets, like Publix and CVS, and in occupational first-aid kits. While the tally of stores WoundSeal was in increased, margins remained thin. And the competitive over-the-counter retail wound-seal market made advertising cost-prohibitive.
So the Biolife board, including majority owner Charlie Entenmann, part of the family behind the Entenmann’s baked goods company, took Jones at his word about building a big business through a hospital model. It named him CEO in May 2013.
“He’s really focused us on going for our most profitable business lines,” says Kelly, also a Biolife board member, though he didn’t directly promote Jones. “He’s brought us some really strong leadership.”
Jones, says Kelly, also helped shape a company culture of compassionate capitalism. “You have to do well to do good is something we say around here a lot,” says Kelly, 52. “We fund our own growth.”
In the middle
In addition to Biolife, the wound-care market is on the rise, too.
The industry, according to a report from Market Research Engine, is expected to exceed $23 billion by 2024, at a compound annual growth rate of 3.5%. While there are some giants in the industry, such as Baxter International, 3M and Smith & Nephew, there’s also a fragmented side, which leaves room for startups and nimble companies.
For one, down the road from Biolife in Sarasota is Omeza, which is developing regenerative skin care and wound management products from the sea in conjunction with marine laboratories. The company’s founders include former Procter & Gamble and Johnson & Johnson executive Tom Gardner and Chip Bettle, a chemical engineer and onetime head of research and development at Biolife. Omeza, which last year introduced its first product, an Omega-3 oil spray, aims to launch up to four more products in 2019.
Omeza President and COO Sarah Kitlowski says the company intends to grab market share with both patients and medical care providers. “You have to have solutions for both consumers and doctors,” she says. “Wound care is going to grow more and more with the population aging like it is, and we want to have products in the middle that aren’t top of the line but aren’t a Band-Aid.”
Biolife, meanwhile, plows through on a mission to bolster its hospital roster. StatSeal is in 18 of the 20 largest hospitals nationwide, including the Mayo Clinic and the Cleveland Clinic, and 10 of the largest 20 children’s hospitals, including Johns Hopkins Children’s Center in Baltimore.
“Bleeding outside a hospital is a big deal,” says Kelly, “but inside a hospital it’s a really big deal. Patients can get infections quickly and other issues” if the bleeding isn’t controlled.
‘We will be growing in the double digits per year as far as the eye can see.’ Stuart Jones, Biolife
In its attempt to control the market, Biolife executives believe they have an advantage in its strong patents. The patents, combined with the cost of research, development, product testing, regulations, manufacturing and more, officials add, provide a barrier to entry for would-be competitors. The company, for example, recently spent into the six figures on some machines to improve the manufacturing process, says Jones.
Those patents protect the how-it-works of WoundSeal and StatSeal. That starts with the powder, composed of a hydrophilic, or, what the company calls “water-loving” polymer and potassium ferrate. The hydrophilic polymer in the rust-colored powder, after it’s poured onto the wound, instantly dehydrates the blood by absorbing only the plasma or liquid portion of it. At the same time, “the potassium ferrate dissolves, releasing iron that binds together the blood solids to create an occlusive seal,” states the company on its website.
Competitors’ products, says Jones, “don’t stop the bleeding, but try to minimize it. (Our) product actually stops the bleeding, and forms a seal around it.”
Wall of why
The core challenge now for Biolife, say executives, is in customer education at hospitals — a constant battle for the attention of ever-busy doctors and hospital purchasing executives. Change to anything new in that sector, says Jones, can be a hard sell.
“The beauty of this is it doesn’t take a lot of people or cost a lot of money to make,” says Jones of WoundSeal and StatSeal, products assembled, manufactured and packaged at Biolife’s facility on the Sarasota-Manatee County line, not far from the Sarasota Bradenton International Airport. “But it takes a lot of effort and a lot of smart people to get the word out.”
Word of StatSeal’s capabilities is spread through in-house nurses and the company’s network of sales distributors, which run through geographic regions in Europe and the U.S. The three Biolife nurses — the company is looking for a fourth — are key, says Jones, because they have been there, done that experience in the need for the products. In addition to growing its share of current markets, Biolife seeks to enter new markets in the near future, including Japan.
Another way the company has spread the word is though global wound-care industry conferences. In addition to sending executives to many of these events, the AIM-RADIAL Conference, an industry confab of doctors and vendors, was held last year in Sarasota, mostly through the efforts of Kelly. Previous conferences were held in Germany, England, Chicago and New York City.
The what-Biolife-can-do, say Jones and Kelly, also goes beyond medical community conferences and networking. The best part, they say, is in the company’s Wall of Why, with plaques of quotes from retail customers and doctors about the products. “It’s really neat to be able to work with some top hospitals using our technology,” Kelly says. “It’s exciting to be part of this.”