DENVER –“Critical mass.” It was a buzz phrase marinating the activities of last week's BioWest 2006 conference, that gathering clearly designed to increase that mass in the areas of biotech and medical devices for the Mountain State and raise a new kind of profile for the region.

But the icing on the “critical mass” cake is sector leadership, a term that is heard less often in what is clearly an ongoing developmental effort for a region best known for Coors beer, fantastic skiing and the various Rocky Mountain “highs” celebrated by Denver — the songster, first name John.

But let's give that generalization a significant amendment.

Sector leadership, even dominance, is currently being claimed by Baxa (Englewood), the largest privately-held med-tech firm in Colorado and a major player in developing products that improve the preparation, handling, packaging and administration of fluid medications more safely and more efficiently. And Baxa can now bold-face that claim with its recently constructed STAR Center, a facility attached to the company's corporate headquarters southeast of metropolitan Denver (and just around the corner from the training center of the NFL's Denver Broncos on Broncos Drive).

Officially opened earlier this month, the STAR center will provide professional education to the pharmacy industry in pharmacy practice, cleanroom principles and compliance to regulatory requirements

“The thing that makes this facility so interesting is that it is unique – not another one like it in the world,” Marian Robinson, vice president of marketing for Baxa, told Medical Device Daily.

She said that the “idea” behind STAR is that “since we opened in 1975, we have been a thought leader in this whole game, a leader in best practices in the pharmacy, and so we can teach the best practices in the pharmacy.”

Costing about $1 million for construction alone, the 4,400 sq. ft. facility is “purpose-built” she said, featuring equipment and cleanroom facilities to demonstrate cleanroom design and layout, engineering controls and airflow science, media fill testing and the principles associated with work flow, staff training, cleaning, monitoring, validation and documentation, primarily in the smaller hospital pharmacy.

The facility will offer regular classes in these activities, with the very first session, titled “Compliance Tools and Aseptic Certification for USP 797,” to be held this month – USP 797 being relatively new governmental guidelines dictating the proper preparation of sterile compounds.

Those regulations, Robinson said, “sent the industry into a tizzy. People were misinterpreting them and they were confused.” She added that much of that confusion came from what appeared to be mixed or unclear messages concerning the equipment necessary to meet the regulations.

Thus, a key feature of the facility, Robinson noted, is the provision of a variety of equipment – the target “students” for the STAR facility and Baxa's products – but from a variety of vendors and suppliers.

Robinson said that the intent of the facility is not to push Baxa products (and its brand names can't be specifically mentioned in the classes) to provide the broadest range of experience with the equipment used in the field. (Though the STAR facility is attached to the company's headquarters building, it has a separate entrance, so as to further separate it from any marketing intent.)

Students in the classes can thus “play with industry equipment,” she said, “without a Baxa product pitch” – though, parenthetically, she tells MDD, that hands-on work with the various products will immediately reveal what works and what doesn't.

While the primary feature of the facility is a full clean room, Robinson assures that the pharmacy students don't need to attempt any replication in their own facilities.

“You can comply [with 797] without spending a million dollars,” she said. “We're trying to take out a lot of the mystery by showing how to do some very basic things, techniques and procedures that go the greatest way for creating safe sterile compounds.”

While Robinson will handle much of the marketing of the STAR facility, overall operations and the development of curriculum will be handled by Tim Kingsford, product manager for Baxa.

Kingsford said he will be overseeing the facility's “profit and loss, the curriculum and classes offered, the appropriate faculty” in an effort he called “exciting, incredible.”

As a part of the facility's state-of-the-art approach, it will feature not only the most advanced equipment but also “designed inefficiencies that we can control to teach what not to do,” he told MDD.

These inefficiencies, for instance, include add-on duct work and fan motors that can be altered to demonstrate how variations in airflow can impact preparation, these systems observable from catwalks to give the best view of design, both correct and faulty. “That way we can show students how they shouldn't design their rooms and why,” he said.

While pharmacy workers will be the primary student pool, “long term, we'll see everyone from facility designers to architects, hospital administrators, pharmacy technicians responsible for room maintenance management.”

In sum, Kingsford billed the facility not so much a profit center but an offering that highlights what he called Baxa's attempt to avoid a copy-cat approach – that is, through added value, not simply repeating what competitors do.

As just one example, he cited the company's Two-Fer Needle, designed for facilitating the movement of drugs from one container to another without requiring a needle exchange. The device's hub design allows vented vial access and non-vented IV bag access, performing the work of two devices.

“We're not a 'me-too' company,” Kingsford said, “We design and offer products with the intent of providing features that aren't commonly available.”

As to the STAR facility, Robinson says that Kingsford is not likely to have any trouble drawing students to the training courses, given the company's reputation in the sector.

“This is a niche sector, and we're pretty much the dominant player,” she said. “We know how pharmacies are run and how things are done.”

Next: therapeutic 'togs' from the Colorado mountains.