Medical Device Daily National Editor

When Ben Braddock, in the 1967 film "The Graduate" asked a family friend about the best career path on which to place his feet, the advice came back in one word:

"Plastics!"

And Ben, if he were a 1980 graduate, might get this answer:

"Plastics!" – or, more likely, if Ben's advisor is a futurist of the really advanced sort: "Bio-based, biodegradable polymers."

Healthcare, of course, is a magnet for a whole variety of plastic/polymer products, from the simplest forms of packaging, to basic tubing in clinical practice, to the most advanced applications of implantable devices.

And one group, Principia Consulting (Exton, Pennsylvania), is currently in early exploration of alternatives, bio-based plastics, meaning those other than the standard kinds which are derived from petrochemicals, that is, based on oil.

The company is doing two studies on the plastics market outlook, according to Dr. Ashish Aneja, a principal at Principia. The first is looking at the opportunities for the basic petro-based plastics, titled "Plastics in Healthcare 2008"; the second, about to be launched, exploring the long-term possibilities for the bio-based type and the oil-based types that are "compostable."

Concerning its study of the traditional plastic technology in healthcare, Principia puts the demand as growing twice as fast as U.S. gross domestic product and currently a $4 billion industry in North America. And as in many other areas of med-tech, this demand is fueled by aging demographics and longer lifespans, broadening the needs across all areas, including implants, according to the company.

In the prospectus for the study, Pincipia says: "In addition, procedures that utilize plastic-intensive devices, such as joint replacements, cosmetic surgeries, and advanced prosthetics are more affordable and in greater demand than ever." And it notes that the range is technologically very wide: "from commodity resins to high-performance plastics" used "in many of the 5,500 FDA-regulated medical devices."

Besides emphasizing the wide usage of plastics, Principia points to the broad benefit of plastic materials in terms of "flexibility of fabrication" and "end-user characteristics" and that "[e]ngineers continue to learn how to leverage material attributes like transparency, chemical resistance, autoclavability, and biocompatibility to create products with new performance benefits."

Principia says the study will provide forecast estimates out to 2013.

More recently, the company has launched plans for what it calls a new "global" study concerning the potential advanced opportunities for plastics – and similar to the current global effort to bypass dependence on oil and find alternatives.

The new plastics study, titled "Bio-based and Biodegradable Polymers 2008," will focus on developments in "white biotechnology" and the use of renewable resources, such as corn-based feedstock and starch and cellulose derivatives to produce plastics. Additionally, the report will look at petrochemical-based polymers that can be retrieved via composting.

"Under the right temperature and humidity conditions, these plastics degrade," Aneja told Medical Device Daily, and so can be put in the category of biodegradable.

As just one example of this, Dow Chemical last month reported a joint venture agreement with the Brazilian firm Crystalsev to develop a facility to manufacture polyethelene from sugar cane.

The new facility will use ethanol derived from sugar cane to produce ethylene, the raw material required to make polyethylene, the world's most widely-used plastic and produced using either naphtha or natural gas liquids, both petroleum products. The new process, Dow and Crystalsev said, will produce significantly less CO2 compared to the traditional polyethylene manufacturing process.

Aneja puts the market for alternative polymers currently at less than $1 billion worldwide, "but expected to grow 20% to 30% every year." And Principia estimates the global demand for these polymers at $6 billion by 2015.

Aneja said that some bio-based and compostable forms of plastics already have found applications in fairly low-tech uses, such as in fiber products and industrial packaging, but that the company's research will examine how these products will move into a range of complex uses, such as in healthcare.

These first medical uses will probably first be in packaging, Aneja said, since not requiring heavy regulatory oversight, but that there is opportunity – "absolutely," he affirmed – longer-term in the advanced clinical uses, such as implants.

He said that the factors being researched by Principia are complex: "Some of the external challenges that various companies need to be aware of and face include feedstock costs, consumer perception of bio-based and biodegradable polymers, and regulatory and legislative trends.

"In addition, the value chain for some of these polymers is going to look very different as compared to polymers based on petrochemical sources."

Aneja said Principia expects to issue its report on standard petro-plastics by the end of 2008 and the report on the advanced polymer technologies and related R&D and marketing issues in early 2009.

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