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A Risk Worth Taking

Thu, 09/26/2013 - 9:49am
Mike Schmidt, Editor, Surgical Products

All products are designed with one or more specific applications in mind. What remains unclear during the development process, however, is just how effective the product will be when compared with what’s already available on the market. It is the difference – whether it is positive or negative – that often ends up defining the product in the eyes of the public.

About 10 years ago, Ethicon, a developer of wound closure and other surgical products, saw an opportunity to develop a product – an antibacterial suture – that aimed to help reduce risk factors for surgical site infections.

“Our company had considered antimicrobial products in the past, as the clinical need was evident,” said Stephen Rothenburger, PhD Associate Director, Product Microbiology and Performance Evaluation for Ethicon. “We were given the chance to think big, to solve a problem for patients, to shoot for the moon and see if we could make an antimicrobial product work.”

It was a lofty goal, especially because there was nothing on the market with which it could be compared. In fact, there were no antibacterial sutures available from any of the major medical device companies during the early 2000s. However, an understanding of surgical site infections and the harm they can cause in surgical procedures across the United States and around the world convinced Ethicon to develop a product aimed at targeting a key risk factor – the colonization of bacteria.

“We basically took on the challenge with the idea of really making a difference, removing the suture as an element, because foreign bodies can really contribute to the ability of colonization and ultimately infection,” said Ed Dormier, Vice President, Research and Development at Ethicon.

The product development process commenced with the creation of a list of all the criteria the product needed to address. The team then studied all known antimicrobials and tied them back to the list.

“We were able to leverage some of our early understanding of antimicrobials and couple that with our decades long understanding of science, how tissue reacts in a given situation, from our involvement on other device innovation,” said Howard Scalzo, Principal Engineer, Antibacterial Sutures Group for Ethicon.

While the primary objective of the R&D team was to design and develop an antibacterial suture, they did not want to do so at the expense of other characteristics its users would look for in the product.  As the process got under way, the biggest challenge Ethicon faced during the process was incorporating a microbiologically active ingredient in an absorbable product for the first time. 

“If you think back 10 years, the ‘microbiology’ language and its use in characterizing the device was unique at the time,” said Rothenburger. “There was a need to develop new biological and analytical chemistry testing as well as new manufacturing practices. Everything was new. That’s what made it so exciting for us. But you can see the types of challenges that would also bring.”

The final product – the Plus Antibacterial Suture – differed a bit from the R&D team’s original concept. According to Scalzo and Rothenburger, initially the team thought it might may incorporate multiple antibacterial components, or potentially leverage different active ingredients for different uses. However, Ethicon eventually settled on one antibacterial chemical.

Once the Plus Antibacterial Suture was released in 2003, it took some time for the healthcare industry to adopt the unique product. This did not come as a surprise to Scalzo, Rothenburger and the rest of the Ethicon team.

“It was adopted gradually,” said Scalzo. “Surgeons are careful about changing practice, and we were self-replacing our already popular suture.”

Since the release of the product, Ethicon has continued to refine its suture offerings to reflect the ever-changing clinical needs of the healthcare industry and its mission to deliver better surgery for a better world. Among their many efforts, the company has looked at other suture products being used frequently by surgeons who make deliberate choices as to the layer of closure they are doing and the healing characteristics and attributes of those layers.

“The other thing that we’ve been working on and done some implementation on is in terms of making the product more effective against the primary bacteria of interest in surgical site infections,” said Dormier.

Now a decade later, the R&D team appreciates the significance of this product and the design and development process that brought it to market.

“The process was challenging, as we were on a tight schedule from the beginning,” said Scalzo. “But it was also invigorating and inspiring, too. There’s nothing specific that we’d do differently. But the knowledge gained from that innovation certainly is something we carry forward to other development and design projects and has helped shape our thinking moving forward.”

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