Volume 7 | Issue 3 | Year 2004

Ask Critical Care Vice President of Marketing Gary Calvaneso what makes his company’s products unique in the medical-device market and he’ll tell you a string of success stories. A boy’s life is saved when a high-frequency oscillatory ventilator (HFOV) establishes and maintains life-sustaining gas exchange when conventional technologies fail. A seriously ill adult patient recovers from critical injuries with support from a unique high frequency oscillatory ventilator designed specifically for adult patients. A premature baby receives life-sustaining support from a tiny nasal continuous positive airway pressure (CPAP) generator rather than through an invasive tube.

Inquire about the products that made those successes possible and Gary Calvaneso will tell you about Critical Care’s proprietary technology: a patented oscillatory mechanism that ventilates at a high frequency to provide support while minimizing the risk of lung injury. The 3100A is the only FDA-approved, high frequency oscillatory ventilator for early intervention treatment for infant patients with respiratory distress syndrome. Developed from the 3100A, the 3100B is the only high-frequency oscillatory ventilator approved by the Food and Drug Administration (FDA) for treatment of adult patients suffering from acute respiratory distress syndrome. The AVEATM is the first critical care ventilator approved to deliver Heliox gas mixtures and the Infant FlowTM system with its unique fluidic nasal CPAP generator.

Breathing Innovation
“Our company has a rich history of successful product innovation,” says Calvaneso. “Critical Care traces its roots back to Dr. Forest Bird. He developed the first mechanical breathing apparatus and is responsible for many innovations in the respiratory-care industry. The Bird brand and its associated products are now part of VIASYS Critical Care, and we have continued to build on his pioneering work.” Dr. Bird, who invented the first medical respirator in 1956 and developed the technology, continues to work in this field.
An overview of the California company’s product brands shows its range of respiratory equipment. These brands include:

• Bird and Bear – mechanical ventilators for adult, pediatric and neonatal patients;
• EME – non-invasive respiratory support systems for infants;
• SensorMedics Critical Care – high-frequency oscillatory mechanical ventilators and nitric oxide delivery systems.

The Critical Care Division, which employs almost 500 people, has its headquarters in Palm Springs, Calif. Here the company makes many of the parts, including the critical components used in its ventilators, assembles the products, then packages and warehouses them for distribution. Electronic components and certain subassemblies are purchased from vendors that specialize in manufacturing precision equipment required for products that must meet strict regulatory standards. The SensorMedics Critical Care manufacturing facility is located in Yorba Linda, Calif., along with the SensorMedics product line that is part of the VIASYS Respiratory Technologies division.

As the largest division of VIASYS Healthcare, a healthcare technology company and research-based medical technology organization, Critical Care is a major part of a global enterprise. Established in 2001 as a spin-off of Thermo Electron, VIASYS is based in Conshohocken, Pa., and has approximately 2,000 employees worldwide.

“We pride ourselves on our innovation,” says Calvaneso. “We were very successful in 2002, and 2003 was even more impressive. VIASYS Critical Care is growing rapidly and this is unusual in the ventilator industry which is currently experiencing only moderate growth.” He interprets this development to mean that the company is taking market share from competing brands.

Strong Product Lifelines
Calvaneso cites the breadth of Critical Care’s product line as a key factor in its success. “Critical Care is unique in that we cover the entire spectrum of patient care, from the tiniest baby to older adults,” he stresses. “We also dominate the high-frequency market.”
The company’s extensive offering includes ventilators, gas blenders, transcutaneous monitoring apparatus, nitric oxide delivery systems and infant nasal CPAP equipment.
Among the products Calvaneso credits with building the manufacturer’s market share is the AVEA(tm) ventilator, which brings in the most revenue. Suitable for all patients from neonatal to adult, the product offers precise monitoring and gas delivery systems, as well as integrated Heliox delivery.

The VELATM ventilator is the product with the highest unit sales. This compact, mobile unit has patented turbine technology, highly responsive inspiratory flow support, a patented exhalation valve, an internal back-up battery and state-of-the-art safety features.

Additionally, Calvaneso says that growing demand for high-frequency ventilators has made the SensorMedics 3100A HFOV another important product for Critical Care. The only high-frequency ventilator approved for early intervention in treating neonatal respiratory failure, the 3100A was awarded the Alliance of Children’s Hospitals, Inc. Seal of Acceptance award. It is the standard of care in more than 90 percent of Level III nurseries in the United States and in 75 percent of pediatric intensive care units. More than 3,000 units are in use around the world.

Calvaneso emphasizes that “the ventilation field is a lifesaving industry” and that all Critical Care products are manufactured to the highest standards. The ventilators, which range in price from $5,000 to $35,000, also have features such as turbines that allow the equipment to be independent of the compressed air supplies required by other brands of ventilators, key-pad controls that are consistent across the product line, and screen displays organized for easy and logical access. Customer service is available 24/7 around the world.

Vital Marketing Signs
Hospitals rank as Critical Care’s top market for ventilators and ancillary equipment. Describing the patient populations in the company’s various markets, Calvaneso names adult subacute patients (patients who are not in acute distress but are having breathing difficulties) as the largest segment and says this group will continue to grow as the population ages. The next largest group is pediatric patients, followed by home-care patients and transport patients who are being moved from one place or facility to another.
Calvaneso says Critical Care is dedicated to maintaining its leadership in the neonatal segment, which includes premature infants and newborns. Projected growth in this market is based on the fact that medical advances are helping physicians to effectively treat more babies born with respiratory problems and to save more premature infants who have underdeveloped lungs and require respiratory support. In 2002, the company purchased Electronic Medical Equipment (EME), a global leader in neonatal non-invasive respiratory support, to strengthen its capabilities in this field.

Critical Care’s sales are currently split between domestic and international customers, and Calvaneso says the company will continue to respond to global market needs, such as shipping ventilators to China during the SARS outbreak last year.

Describing Critical Care as an up-and-coming company that intends to become a trendsetter and market leader over the next five years, Calvaneso adds that emerging needs in the healthcare industry will increase demand for ventilators. He cites the future market drivers as the aging of the population, pressures to reduce costs by moving hospital patients out of intensive-care units to less expensive units and the movement toward more home care.

“Critical Care will continue to bring exciting new technologies and products to market,” says Calvaneso. “Our goal is to provide the best technology while reducing the cost of care. Our passion comes from our mission to improve the quality of human life and I can’t think of a better goal to work toward.”

Previous articleLife-Saving Light
Next articleMining Their Business