Solvay (Brussels, Belgium) has been in existence for almost 150 years – founded by Ernest Solvay in 1863. The Belgium chemist built the company around his ammonia-soda process for the manufacture of “soda ash” from brine and limestone.

Since those relatively humble beginnings, the company has grown into an international chemical and pharmaceutical and plastics group that can boast of generating $13.6 billion in revenue in 2006. (The company even had the distinction of having Pope John Paul II in its employ before he embraced his papal calling.)

It maintains offices throughout the world and has an R&D facility in Alpharetta, Georgia, a north-Atlanta suburb.

“The facility was originally a new headquarters for the technical and R&D teams supporting Amoco’s Performance Products division, which encompassed performance plastics back in the early 1990s,” Mark Wheeler, manager, public relations and corporate communications for Solvay, told Medical Device Daily. “However, it quickly turned into the corporate headquarters for that business. It held that distinction during the BP purchase — roughly 2000 through 2002 — and it has remained the headquarters for Solvay Advanced Polymers.”

There’s no question about Solvay’s rich history and its ability to diversify its products list to address the new requirements, and opportunities, in healthcare.

Recently — this past Oct. 24 to be exact — Solvay expanded its product offerings even further, reporting its decision to enter a new sector of the healthcare market with the launch of a biomaterial line, brand-named Solviva.

“In the past 10 years we’ve gotten [quite close] with the medical device sector,” Shawn Shorrock, global market manager, healthcare for Solvay, told MDD. “It was clear to us that [device manufacturers] needed more material options.”

The end result was the Solviva line — a group of “ultra” polymers — those materials that have an extremely high performance profile in terms of thermal, mechanical, and chemical resistance. Additionally, Shorrock said, the new biomaterials line is distinguished from its legacy line of polymer/plastic offerings by use in products that come in contact with the body or blood for more than 24 hours.

Solvay says its biomaterials are typically differentiated from other high-performance polymers by having multiple “best-in-class” attributes — e.g., high-temperature resistance in chemicals. “Ultra” polymers are those with very precise performance characteristics for particularly demanding applications. They can be either amorphous or semi-crystalline in structure.

Polymers are a diverse group of molecules formed by combining smaller molecules, or monomers, in a replicating pattern. This occurs during polymerization, in which many monomer molecules link to each other.

Following are the biomaterials in the Solviva line:

• Zeniva Peek (polyetheretherketone) — one of the most chemically resistant plastics available, exhibiting high strength and stiffness along with excellent toughness and fatigue resistance.

• Proniva SRP (polyphenylsulfone) — one of the stiffest and strongest unreinforced thermoplastics available, offering exceptional chemical resistance and hardness.

• Veriva PPSU (polyphenylsulfone) — offering toughness combined with transparency and chemical resistance.

• Eviva PSU (polysulfone) — providing practical toughness in a strong, transparent polymer.

Wheeler said that the launch of Solviva Biomaterials was the culmination of more than 18 months of planning and extensive investments by Solvay in its production facilities, biocompatibility testing and the installation of one of the industry’s most stringent production processes.

Specifically, those efforts included meeting the relevant aspects of the current Good Manufacturing Practice guidelines of the FDA’s CFR Part 820 Quality Systems Requirements, and ensuring manufacturing operations are in compliance with relevant aspects of the ISO 13485 Quality Management System for the manufacture of medical devices.

“These are the higher, more expensive polymers to develop,” Shorrock said of the Solviva line. “They differ from our legacy products which are not for use in implants. Only the Solviva Biomaterials are used in implants.”

Shorrock emphasized that the company doesn’t tell med-tech companies how to specifically use the materials in the design of a product, since it is an OEM, not a device manufacturer. However, the company’s chemists and engineers provide advice concerning the biomaterials properties and how to work with them.

“I’m afraid that we cannot make a statement regarding specific end use applications,” Shorrock said via email. “We can say that we are offering these products into such end use segments as cardiovascular and orthopedics, among others.”

The company is currently in active product trials for its Solviva line with big orthopedic maker Zimmer Medical (Warsaw, Indiana), and talking to many other device manufacturers.

To date, response to the Solviva line has more than “exceeded expectations,” according to the company, with Wheeler saying its goal is not to compete with other biomaterials manufacturers but to increase the available “pie” of biomaterial options for manufacturers.

Wheeler and Sherrock said that a major driver for new biomaterials is the increasing cost of metals. It has caused engineers to look toward alternatives to keep down costs, reduce product weight — often with added colors, or complete see-through transparency (an important attribute for exact placement of an implant) — while boosting Solvay profits.

Still another of the contributing factors enticing Solvay into this market, Sherrock said, is the Biomaterials Access Assurance Act of 1998. The act provides protection from lawsuits in the case that some of their materials are found in a defective medical device, with the lack of such protection driving companies out of this market prior to this law.

“We are very proud to leverage our technology in creating this family of products,” said Roger Kearns, president/CEO of Solvay. “The ability to supply our customers with biomaterials that are the foundation for products that may help to extend and improve the quality of life in critical healthcare applications is tremendously rewarding. We look forward to a successful rollout and further enhancement to our line in the near future.”