A Better Diagnostic Experience for Patients

As an established name in respiratory care, Arvin, Calif- based Salter Labs has also made considerable inroads when it comes to sleep diagnostic equipment. With the Summer 2008 introduction of its ThermiSense™ product line, Kyle Adriance, COO, says sleep professionals looking to meet American Academy of Sleep Medicine (AASM) guidelines will now have the monitoring equipment they need. Adriance discusses Salter Labs' product focus and the Company's continuing mission to make the diagnostic experience better for patients.

Can you tell us about Salter Labs product focus and market focus for 2009 and how will it better serve the needs of patients with sleep disorders?

Over the past several years, we have been highly focused on developing innovative products designed to promote improved patient compliance, while aiding sleep professionals in their quest to obtain better diagnostic results. Back in August 2008, we launched our ThermiSense™ product line, a new combination airflow thermal and pressure sensing system to meet the new guidelines established by the AASM in late 2007.¹

Initial response from sleep labs to the ThermiSense™ line has been positive. Susan Lutz, BS, CRT, RPSGT, at Mt Carmel Regional Medical Center in Pittsburg, Kan, recently began using the product. Her comments that "it is one of the best investments in monitoring equipment we have ever made" is consistent with feedback we have had from labs across the country.

Can you provide an example of a product change or improvement that directly affects patient care?

When we entered this market roughly 8 years ago, many sleep diagnostic cannulas took a "one size fits all" approach to the market. This was a time when airflow pressure measurement was not common. Over a relatively short time, the market has come to embrace the clinical value of monitoring airflow pressure for the detection of hypopneas and periods of reduced airflow. Sleep technicians recognize that not all patients walking through their doors for a sleep study are the same. Labs are now seeing patients of all different ages and sizes.

Specifically regarding our sleep diagnostic cannulas, the design of the face piece, headset tubing, and connections all impact the pressure reading. Salter Labs uses a proprietary process that has been a closely guarded trade secret to develop its lightweight sleep diagnostic cannulas. The process removes roughly 1/3rd of the weight associated with traditional cannulas and is less obtrusive—reducing the amount of obstruction in the nasal airway passage. Each style is specifically designed to provide the best possible patient signal for a pressure transducer device to process. The pressure transducer in turn splits the signal into Airflow Pressure and Snore waveforms and passes that on to the lab-based or portable PSG system. One of the major benefits of using the newer sleep diagnostic products is better clinical outcomes resulting from more accurate sleep studies.

How has airflow pressure monitoring evolved over the years?

Most labs were doing thermal airflow sensing, and the use of pressure sensing has some advantages over that. The AASM guidelines that came out now require both thermal and pressure sensing. We are going to see that continue where both thermal and pressure are used because they both have pros and cons.

Please describe the supply/support side of your business and how it meets the needs of customers?

Sleep professionals depend on product being available at the time of order. You never know when a sensor may break. If there is not a backup being stocked at the lab, short lead times are critical. We maintain five stocking warehouses across the country, capable of quickly supplying every geographical market in the US. In addition, through our existing specialty distributor network, our products are available through any channel or contracted distributor our customers prefer to utilize. These strong partnerships with distributors and suppliers make it that much easier for customers to access the product line on a timely basis. This keeps inventory costs down and allows for quick access to product for specialty patient cases that may arise.

We have a state-of-the-art manufacturing facility and offices in Arvin, Calif, where our company originally started back in the late 1970s. Over the years, we have expanded our office space, warehousing, and manufacturing, and are now the second largest employer in Arvin. While the company has grown, we have not lost focus on what brought us to this level—our valued customers. Along with our growth, we have continued to expand and improve training of our customer service department to provide the same level of consistent service our customers have come to expect.

What goes into the research and development of Salter Labs products?

Our products are mainly developed from the input of our customers. We routinely gain feedback from patients, clinicians, and physicians through focus groups, sleep conferences, market research, and end-user evaluations. Over the past 30 years we have brought more than 150 new products to market.

This commitment led to new facilities and acquiring the latest in high tech manufacturing equipment and processes. We have maintained our high standards in quality control, design, manufacture, and service through complete in-house control of all manufacturing functions. This has allowed us to provide products that consistently exceed the expectations of our customers and improve our ability to quickly adapt to changing needs and requirements of the sleep market.

Using the recent development of the ThermiSense™ product line as a specific R&D example, effort was placed on designing a cost effective system that provided an optimal pressure and thermal reading while meeting the new AASM guidelines for dual airflow measurements of pressure and thermal. The product design team faced many challenges to devise a simple, compact system that was easy and quick to fit to a patient, retained its placement throughout the night, provided accurate quality airflow signals, and was comfortable for the patient. Additionally, it needed to be a common thermistor wire holding system that would accommodate various cannula configurations and sizes ranging from adult to pediatric and infant sizes. The result, after vetting many ideas and creating numerous prototypes, is the unique T-shaped wire and mating cannula with a retention pocket which positions the thermistor precisely in the airflow path for oronasal thermal airflow sensing.

In addition to the typical challenges of miniaturization, signal strength and accuracy, patient comfort and acceptability, and durability, the design team faced several challenges with both the thermistor and the patented cannula/holder. The wire thermistor utilizes specialized thermal resistive elements sealed in special covering and over- moldings to prevent any moisture from impregnating the components during cleaning and disinfection. The covering was developed to be durable enough to withstand long term usage and cleaning, yet thin enough to avoid any interference with the strength and accuracy of the signals delivered to the PSG recorder. Additionally, the location and orientation of the thermal elements had to maximize airstream exposure.

For the cables, we incorporated a *Kevlar® Tinsel cable design. These wires are lightweight and flexible, and yet have ample strength to hold up to patient tugging through the night or the heavy hand of a technician during disinfection and cleaning. The final design incorporates low thermal mass elements that allow better sense and tracking of airflow temperature changes. Through many iterations of testing, an optimal combination of materials and element positioning was determined.

Are there any new products coming down the pipeline that you would like to discuss?

We are in the process of releasing a new Infant Thermistor that works in conjunction with an airflow pressure sleep diagnostic cannula. The compact, lightweight design minimizes the valuable real estate consumed around the nasal airways of these small patients. The Infant ThermiSense™ product complements the adult and pediatric versions already on the market and is the newest addition to the product line which began with Salter-Style® nasal cannulas for children over 30 years ago. Everything about the new Infant thermistor has been designed to work in perfect unison with the anatomy. The shapes and contours work in harmony with the facial framework to create a compact, comfortable fit.

What services does Salter Labs offer to educate health care professionals about the uses of your products?

Over the years, our sales force has expanded from a single individual to now include over 50 personnel across the country and overseas. Many of these sales professionals have a broad clinical background with varying levels of experience on the sleep and respiratory side of the business. Our sales and marketing personnel are in the sleep labs each day and make it a point to always be available to in-service and support our customers.

We also have a large trained staff of experienced customer service personnel and clinical product managers on staff 8:00 a.m. to 8:00 p.m. EST. They have heard it all and can quickly assess a setup issue and provide feedback on how to work through or troubleshoot the problem. We encourage customer feedback and make a number of our product modifications and adjustments based on first-hand experience and letters coming in from customers around the country. And if we do not have the product configuration being requested, we will make it. Realizing that not all setup questions come in the middle of the day, over the past year we have implemented web-based tutorials on our website: www.salterlabs.com. The tutorials lead a sleep professional through the proper settings and connections on their specific PSG system configuration. We strive to make the product transition as easy as possible for our customers.

Are there any emerging technologies that you think will impact the sleep field?

Increased awareness of sleep disorders has fueled the expansion of sleep labs and bed counts across the country with a greater number of patients being diagnosed each year. This growing segment in the medical field has fueled technological advances in equipment. Our technical and clinical support staff have been working in concert with those at the forefront of new and emerging technologies both at the university and the clinical level of practice. Through these channels and our OEM partnerships, we are beginning to see a number of new advances in equipment which should hit the US market in a year or so. The pace at which the sleep market is evolving is exciting.

How does the company intend to maintain its role as a provider of innovative and cost-effective products to sleep specialists?

We are constantly listening to the marketplace and working with sleep and respiratory professionals to determine what areas are affecting them and designing products around that need. It is critical to stay on top of the changing trends. With a healthy pipeline of truly unique products, we look forward to growing along with our valued customers in the years to come.

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