Business plan for establishing a sleep disorders research laboratory

Business Plan for a Sleep Lab

National Institutes of Health - National Center on Sleep

Disorders Research

Necessity of Sleep Reviewed

Sleep Industry

Types of Sleep Lab Business Structures

Mission Statement

Keys to Success

Market Analysis

Equipment

Supplies

Technicians

Business Plan for a Sleep Lab

National Institutes of Health - National Center on Sleep Disorders Research

According to the National Institutes of Health 2007 Fact Book the National Center on Sleep Disorders Research (NCSDR) "...plans, directs, and supports basic, clinical, and applied research, health education, and training in sleep and sleep disorders. It oversees developments in its program areas; assesses the national needs for research on causes, diagnosis, treatment, and prevention of sleep disorders and sleepiness; and coordinates sleep research activities across several Federal Government Agencies and with professional, voluntary, and private organizations. The Center promotes information sharing and coordinates implementation of inter-Agency programs. The NHLBI sleep research program seeks to understand the molecular, genetic, and physiological regulation of sleep and the relationship of sleep disorders to CVD. It also supports efforts to understand the relationships of sleep restriction and sleep-disordered breathing to the metabolic syndrome, including obesity, high blood pressure and stroke, dyslipidemia, insulin resistance, and vascular inflammation. Ongoing NHLBI-funded research projects include elucidating the etiology and pathogenesis of sleep disorders, particularly sleep apnea; determining the role of sleep apnea in CVD and cerebrovascular disease; examining sleep and sleep disorders across the lifespan; and identifying new animal models of sleep disorders." (NIH, 2007)

Necessity of Sleep Reviewed

The work of David W. Sparks addressing the necessity of sleep reports that researchers have not yet identified the precise purpose for sleep however, it is believed by the majority that "it does something important for the continuation of life. It has a rejuvenating effect on the mind and body. Every living thing requires sleep. Without it our mind and nervous system begin to break down. If we stay awake too long, we become irritable and even psychotic. Sleep clinics and sleep labs are all too familiar with this information and have capitalized upon it." (Sparks, nd) When the individual sleeps they are resting however the processes internal to the human body are not idle and in fact during sleep the human body and brain are "highly active, performing an organized series of events that allow our body and brain to rejuvenate, revitalize, refresh, renew and recharge the batteries." (2009)

Sleep Industry

Nichole L. Torres states in the work entitled: "Building a Business on a Good Night's Rest: Entrepreneurs Find Success in Variety of Sleep-Related Avenues" that sleep awareness is everywhere these days. From studies documenting how we don't get enough sleep, to new luxury amenities designed to help us sleep better, to the multitude of books and other products dealing with the dynamics of sleep, it's clear sleep is on a lot of people's minds - entrepreneurs included." (2009) Torres reports the statement of Reiner Evers, founder of Trendwatching.com an industry-trend forecaster who states "It all fits into the trend of massclusivity - that is, more people wanting more luxury products and exclusive products in general. Category by category...room by room, it's all succumbing to consumers' insatiable appetite for the best of the best. Next: the bedroom." (2009) Torres states that it is additionally cited by Evers that the expanding group of baby boomers with money to spend and also wanting a "good night's sleep." (Torres, 2009) Today's boomers are seeking "comfortable, health-conscious and professional-grade beds, and are often willing to pay the hefty price tag." (Torres, 2009) the International Sleep Products Association, U.S. mattress and foundation wholesale shipments grew from $4,76 billion in 2002 to $5.04 billion in 2003, a 5.8% increase." (Torres, 2009) Torres additionally reports:

Case in point: husband-and-wife team Adam Boyce, 44, and Trina Greenbury, 35. In 2002, they launched DreamEssentials.com an online retailer for sleep and relaxation products, as a way to make extra money so Greenbury could be a stay-at-home mom. After a successful holiday season selling products made by local Rainier and Yelm, Washington, artisans, they decided to grow their idea by branding their own line of sleep masks and selling other sleep products, such as body pillows, alarm clocks and soothing sound machines. Sales have more than doubled every year since, with 2005 sales expected to exceed $1 million. "The biggest challenge we face is the inability of our customers to try things on," says Boyce. However, he adds that while many people initially shop the site for a single item, once they see all the other products available, they return again and again to purchase. From throwing grown-up pajama parties to purchasing high-end pj's, consumers are embracing their comfort zones. Just ask Brandon Evans, 27, the founder of Threadcountzzz Corp., a New York City manufacturer, wholesaler and retailer of high-threadcount pajamas. His luxury sleepwear, designed to feel like sleeping in high-thread-count sheets, garnered an immediate following -- after his 2003 startup holiday season, he had more than 1,500 people on his waiting list. "The reception has been unbelievable..." (Torres, 2009)

It is additionally noted that the larger hotel chains are adding high-end beds to their rooms to entice guests. Once consumers have updated their sleep products...the hotels will have to offer quality bedding just to keep demanding guests happy. So if you're dreaming of a sleep-related business, think beds, comforters duvets, pillows, alarm clocks, pj's, sleep masks -- the list is endless. Just think sleep." (Torres, 2009)

Sleep Disorders - Review

Following lost sleep to the unsuitable bedding it is related that the second source "of deprived sleep" or that of sleep disorders among which are at least 70 with the most widely recognized being

1) heavy snoring;

2) obstructive sleep apnea (OSA);

3) insomnia; and 4) restless leg syndrome. (Torres, 2009)

Sleep disorders affect people not necessarily according to what time they go to bed and how long they remain in bed because many individuals with sleep disorders get a good eight hours every night however "some physiological or psychological disorder impinges on the quality of their sleep." (Torres, 2009)

There are two primary classifications of sleep which are:

1) non-rapid-eye movement sleep (NREM); and 2) rapid-eye movement (REM). (Torres, 2009)

There are four depth of NREM sleep as follows:

Stage one - high frequency (fast), low amplitude (small) brain waves;

Stage Two, Three and Four - the brainwaves grow slower (lower frequency) and larger (amplitude) marking the phases as the individual enter deeper and even deeper sleep. Each stage of sleep has been identified to serve the function of delivering a "specific renewal, rejuvenation, and recharging function for specific systems of the body." (Torres, 2009)

Hormones are also known to be "generated during sleep. One such hormone is known as human growth hormone." (Torres, 2009) This hormone plays a major role" in the growth of the individual and in the aging process and the process of metabolizing food. This hormone assists in weight control. REM sleep is a stage of sleep when the eyes are moving both "rapidly and erratically" beneath the individual's eyelids. This is a lighter stage of sleep and the brainwaves are similar to the first stage of NREM sleep and the individual is practically paralyzed during REM." (Torres, 2009) Torres additionally reports that one of every 20 individuals suffer from what is termed 'sleep paralysis' resulting in fright as they experience the feeling of falling or waking up abruptly. For extremely serious cases of this problem REM-inhibiting drugs exist. The REM stage of sleep is the stage in which the individual dreams which tends to play a primary role in the individual's mental health. Dreaming is believed to be the brain's method of processing incoming information and there is stated to appear to be "a transferring of information gained while we're awake from short-term memory to long-term memory." (Torres, 2009)

Some believe that dreams assist in the resolution of real life conflicts or chaos in the life of the individual. Dreams may be both fascinating and frightening. When sleep is interrupted due to a "chronic sleep disorder..." there is a great chance the individual will experience fatigue and have a concentration problem. Normal sleep involves cycling through the stages noted "approximately every 90 minutes to 2 hours." (Torres, 2009) Negative outcomes of a sleep disorder in the life of the individual include the scientific observations as follows:

shortened life span

Greater risk of cardiovascular disease

Gastrointestinal problems

Decreased work performance

Memory lapses

Marital strife

Irritability

Depression

Anxiety

Stress

Problems with weight control

Explosive Outbursts

Mood swings

Greater risk of high speed highway crashes

Road rage

Accident prone

Body aches

Decreased sex drive; impotency

Premature aging (Torres, 2009)

II. LITERATURE REVIEW

The work of Rich Smith entitled: "Sleep Health & Wellness NW Strikes Success in Oregon" relates that it is "no secret that sleep is a rapidly growing field. Business analyst Frost and Sullivan projects that the next 5 years will bring double-digit growth for the U.S. sleep service provider market." (2006) Smith states that the key to the success of 'Sleep Health & Wellness NW' is the decision that was made concerning staffing and specifically the decision to "staff each site with multispecialty teams, thereby transforming those centers into convenience-oriented, one-stop shops. Offered under the same roof are "consultative, diagnostic, and treatment services" which are stated to be provided "by board-certified practitioners in the fields of pulmonary medicine, otolarngology, family medicine and more." (2006)

Smith reports that the laboratories experiencing the most dramatic growth are two which are located the "farthest from the Hillsboro flagship" as they are located in two areas that were "formerly underserved." (2006) Smith additionally reports that the demand is stronger in the areas where the two fastest growing centers are located which supplies "plenty of fuel for expansion."

Smith states that the Sleep Health & Wellness NW is attempting to "fill a gap so that patients who previously were overlooked or not being reached or who fell through the cracks no longer are," she says. "We have no plans to open centers in areas where there are already quality sleep services programs. We only want to go into areas where needs are not being met." (Smith, 2006) Smith reports that some of the laboratory locations were chosen on the basis of "community demographics" but others "were selected for their potential to support a provider partner." (2006) Since the first of the centers was to be one that was unknown it was located in a community "...where the only access to sleep services of any kind was at a hospital..." (Smith, 2006) the second laboratory is reported to have been set up "in a similarly hospital-dominated market, but this time the choice of location was at the behest of an otolaryngologist...a community where he wanted to make inroads..." (Smith, 2006)

According to Smith "as awareness of the Sleep Health & Wellness NW model of multispecialty integration spread, other medical providers stepped forward with offers to participate. "These board-certified physician specialists sought us out because they wanted more say in how their customers were handled, more say in the delivery of the outcomes. They understood that it was harder to be community- and service-based at this level when the laboratory you are involved with is owned by and operated from a hospital. Our third, fourth, and fifth centers all came about in response to overtures from doctors."(Smith, 2006)

Each of the centers is stated to feature "six beds (save for one laboratory which operates with three) and while the "look and feel of the laboratories are not cookie-cuttered, all are meant to be uniformly comfortable and home-like so as to make them as conducive to sleep as possible." (Smith, 2006) the centers make provision of "attended overnight and unattended home diagnostic studies." (Smith, 2006) Furthermore, the centers deliver "...fully analyzed summaries, which usually are available the first business day after the study is completed." (Smith, 2006)

After diagnosis the centers further attempt to meet the needs of treatment "...with CPAP/bi-level equipment and help with treatment compliance. It offers a CPAP support clinic that delivers patient education and durable medical equipment services at no extra cost." (Smith, 2006) Smith states that the laboratories are: "...semiautonomous entities, with only limited oversight from a core management team...Certain functions -- such as contracting, accounting, and purchasing -- are handled centrally. Consequently... locations can reflect the character of the neighborhoods they serve while, at the same time, the company can lay claim to a consistent, smooth-running operation that benefits from economies of scale." (2006)

It is stated that promotion of quality is through use of "...one common set of clinical systems and protocols from laboratory to laboratory..." And the centers put its sleep studies "...puts its sleep studies through a stringent review process." (Smith, 2006) the sleep lab also pays its employees above-the-average wages and states that the team it has assembled is "creative, progressive and very entrepreneurial-minded.

The centers are also reported to desire the role of "leading resource of community education" intended for consumption by patients, providers, payors and employers" which includes such as "sponsorship of numerous health fairs." (Smith, 2006) Other initiatives includes visiting the offices of "medical referral sources, which are conducted by individual Sleep Health & Wellness NW providers who also meet with large employers to acquaint them with sleep-related conditions that can affect employees and cause unnecessary absenteeism, hobbled productivity, higher corporate health care costs, and reduced marketplace competitiveness -- all detrimental to the bottom line. These efforts are supplemented with comprehensive advertising campaigns that take in print and broadcast media, plus the Internet." (Smith, 2006)

Smith reports that many individuals are not aware of the link between existing health problems and sleep and just as well are not away of the outcomes of those problems. Others, however, possess a good "basic understanding of that already, but are unaware of Sleep Health & Wellness NW being the best equipped to help address those problems." (Smith, 2006)

Types of Sleep Lab Business Structures

There are reported to be three basic business structures of physician-practice sleep labs:

1) hospital-owned;

2) independent diagnostic and testing facility (IDTF's); and 3) extension of physician practice. (Sleep Doctor Blog, 2008)

The third type of structure comprises merely 5% of all sleep labs and it is stated that the differences existing between the three types of sleep labs are complex in nature. This article states that the reduction in the number of sleep labs identified in the third structure or the extension of the physician practice sleep lab is worrisome and states that the Sleep Review Magazine reports that a "...new interpretation of an old Florida law has led to a severe restriction on this type of lab..." (Rack, 2007; Sleep Doctor Blog, 2008)

Apparently the State of Florida Board of Medicine finds that a physician of physician-owned labs must directly supervise sleep studies." (Sleep Doctor Blog, 2008) the article relates that the State of Florida Board of Medicine stated "If the Sleep Center does provide services under the direct supervision of Jax Heart, the Petitioner's proposed arrangement does not constitute a 'referral' that is precluded by Section 458.053(5), Florida Statutes. We found that the law dictated that patients needing a sleep study would be supervised differently depending upon whether the lab was owned by a physician group rather than an IDTF/Hospital." (Rack, 2007; Sleep Doctor Blog, 2008)

III. MISSION STATEMENT

The 'Mission Statement' of the Sleep Lab proposed in this work in writing is to penetrate a market that has not yet been penetrated with the provision of an integrated multi-service provider sleep lab and to inform and educate the surrounding community, its physicians, and potential employees in regards to the importance of sleep and the necessity for identification of and treatment for sleep disorders in the population in maintaining good health.

IV. KEYS to SUCCESS

According to the work entitled: "Planning for Success in Sleep Medicine and Sleep Center Practice Marketing and Advertising" the key to success has been effective and "...Nationwide, it's the same story. The winners all have, and faithfully use, a comprehensive sleep center marketing and advertising plan which guides them strategically on a daily basis. Reaching, convincing and attracting diverse market segments requires cost-effective and solid programs to increase revenue and profitability, through many marketing "gateways" into the practice. Don't let the Treatment Plan get ahead of the Diagnosis. In our consulting work with healthcare entities around the nation, someone often calls to say they "need a flyer" or "have to have a newspaper ad" or whatever else they think is right for them at that moment. Imagine if a patient presented himself with a request for a specific prescription medication in advance of any history, exam or tests. The same principle applies in successful marketing programs, especially with sleep disorder centers. Don't jump ahead. Invest the time to ask these questions of yourself, and get a clear and unbiased perspective on where you are and what you need to do." (Healthcare Success Strategies, 2009)

According to the work of Duane Johnson entitled: "Are You Really Managing Your Sleep Lab?" sleep law owners who are successful as well as their physicians and managers "invest valuable time determining and planning actions of a profitable 'patient first' service oriented business plan and budget. They map out an effective plan and budget to make the things happen that they want to have happen. They assertively pursue success rather than being 'too busy' and not doing this essential management activity." (2009) the sleep lab owner ask how they will integrate "the new emphasis on portable monitoring into the current sleep lab operations and menu of services" and "to whom and how they will market." (Johnson, 2009; paraphrased)

The preparation and use of a detailed business plan and revenue/expense budget guides a manager in marketing for patient revenue, controlling costs, pricing services and negotiating third party payer contracts. Both the business plan and budget are tracking tools. You do not develop these on an annual basis and only look at them at the beginning and end of your fiscal year. But these tools should be broken down into monthly segments and tracked as budgeted monthly vs. actual monthly. This allows a manager to monitor revenue and expenses and adjust for corrections before problems become serious or excellent results marketing become overwhelming causing de-marketing results." (Johnson, 2009)

V. MARKET ANALYSIS

The work entitled: "Planning for Success in Sleep Medicine and Sleep Center Practice Marketing and Advertising (2009) states that the first seven marketing audit questions necessary to ask are those as follows:

1. Are you using an evidence-based marketing approach?- Does your marketing system include Proven Strategies, a well-designed Marketing Plan, Effective Implementation and a means to Evaluate Results? All four of these components drive the process. If you're missing one or more you are not operating at maximum strength or capturing full potential.

2. What's the date on your marketing plan? - Even well-considered plans become dated if they are not challenged routinely-at least quarterly. If it's been six months or more since you took a fresh look at your sleep center marketing plan, carve out some quiet time to seriously evaluate. Do you need "refreshment" or a completely new course of action?

3. Do you have clear and specific goals? - Not everyone is clear about the marching order -- goals are quantified and at the top; strategies support goals; and tactics implement the strategies. How have your goals changed? What are the new goals and how did you set the goals? What strategies and tactics are needed to achieve the goals, new or otherwise? Did you realign your budget for what's changed?

4. Is your marketing budget right for the job?- There are no less than six different methods for setting a marketing budget. How did you set your budget and does it achieve the goals? Do you have enough resources-time, dollars, people-in the right places to make this a winning plan? Above all, marketing is a revenue center-not a cost center. You should expect performance to be 3- to 4:1 overall. (See item #7 below.)

5. Does your branding message clearly differentiate your practice? - if you are the "only game in town," branding and positioning for a sleep center might go unchallenged. But increased competition means there's no sliding-by-physicians, patients and the community need to clearly hear and understand how you are different and better.

6. Are your internal, external and referral programs working together or independently? - Some components of a well-tuned plan run all the time, while others may be seasonal, and still others are keyed to a target audience segment or needs. Does your plan carefully coordinate all these elements, providing desired overlap or avoiding conflict?

7. How do you measure response and Return-on-Investment? - Sadly, many centers don't have a reliable tracking system to identify the source of new patients and to measure the effectiveness of their marketing, advertising, promotion or referral efforts. Regardless of the size of the facility, the program or any of the strategic or tactical parts-if you don't track you just don't know what's working. Do you have a tracking system? Is it working? Is it reliable and accurate? it's impossible to manage the plan or calculate your ROI without this part of the equation. (Healthcare Success Strategies, 2009)

According to Healthcare Success Strategies (2009) "The principal challenge factors in sleep center marketing and advertising are tough and increasingly complex. Sleep medicine, sleep disorders treatment and the operation of a diagnostic sleep lab or clinic is a multifaceted business -- and one that is relatively new. For added difficulty, the competition among sleep disorder laboratories in many areas is also increasing. But despite an underserved public and an acknowledged role for sleep study clinics, some labs find it difficult to advertise and market sleep labs effectively." (2009) This requires that the Sleep Center address "...the educational component of sleep advertising, sleep disorders center marketing, sleep practice marketing and sleep laboratory promotion has begun to increase public awareness and with it, public demand is growing. Demand drives competition." (Ibid, 2009)

Additionally reported is: "A few sleep clinics have been around for decades, but the number of American Academy of Sleep Medicine (AASM) accredited facilities has skyrocketed only in the last few years. Once limited mainly to medical and sleep research centers, today sleep disorder study centers or sleep related breathing laboratories are operated by or in association with hospitals, ambulatory surgery centers, specialty hospitals, universities or as privately owned, freestanding businesses.:" (Ibid, 2009)

The report states that sleep disorders are "...now a growing part of many professional practices. No longer a small sub-set exclusive to sleep disorder specialists-individual and group practices now have a sleep disorders advertising message for prospective patients. Sleep related healthcare issues have become more mainstream in the medical community, with marketing messages from primary care physicians, internists, otolaryngologists, pulmonary physicians, psychiatrists and behavioral sciences, cardiologists, neurologists and other disciplines all having a promotional voice." (Ibid, 2009)

There is stated to be more to sleep disorder marketing today that simply "...communicating the value and availability of diagnostic polysomnography (PSG) or CPAP titration. Sleep marketing communication has to work on many fronts and with many target audiences-conveying a positive and differentiating message, protecting the existing base as well as growing the business profitably. Fortunately, we know how to handle complex and competitive marketing and solve some of the toughest advertising issues." (Ibid, 2009) Stated as 'good news' in relation to advertising and marketing for a sleep center is "...that this complex landscape provides an amazing and rich spectrum of audiences and opportunities. In fact, sleep disorder practices and diagnostic laboratories -- and related private practices-have a wealth of promotional gateways, more than many medical and healthcare specialties." (Ibid, 2009)

For example there is the "...wide range of prospective patients that ranges from pediatric to geriatric: infants, children, teenagers, single adults, parents and senior citizens are all part of the mix. Medical marketing-for either the sleep facility or the private practice-crosses many professional lines and prospective diagnoses. Each sector is a prospective sleep marketing segment." (Ibid, 2009)

It is stated that added to the most common of sleep disorders are other prospective segments as follows:

Preoperative prospective bariatric surgery patients

Pediatric sleep and bedtime problems, night wakings and special needs of younger patients

Diabetic patient screenings, education and treatment programs

Medically supervised weight loss programs

Psychology or psychiatry evaluations (Ibid, 2009)

The marketing message is in actuality "multiple messages" in which a "...sleep laboratory reaches out to diverse and sometimes overlapping audiences including physicians, patients, prospective self-refer patients, insurance plans and others. " (Ibid, 2009)

The work entitled: "Inspiration! Sleep Study Results & Analysis (2006) reports a study conducted by Wachovia Securities of U.S. sleep centers. Stated specifically is: "Wachovia Securities completed its study of U.S. sleep centers. Ninety sleep centers participated in the survey, however, participation in individual questions varied as responses were not mandatory. The number for respondents for each question ranged between 58 and 90. Overall, results show strong secular growth for the sleep therapy market. Some of the specific findings include:

1) Snoring is nothing to laugh about and should receive proper medical care and diagnosis to determine if a person has a significant breathing problem which can lead to serious consequences such a stroke, heart attack, motor vehicle accidents and cardiovascular disease among other issues;

2) on average, sleep centers report 21% growth in beds during the past 12 months. Respondents expect the number of beds to increase 31% during the next 12 months. Results support Wachovia's 20% obstructive sleep apnea (OSA) market growth forecast through 2007, which assumes nearly 30% mask revenue growth and flow generator revenue growth in the mid-teens;

3) Respondents reported bed growth -- an average of 12.9 beds per respondent vs. 10.7 beds per respondent 12 months ago. Respondents expect greater sleep center capacity expansion this year;

4) Currently, around 15% of sleep centers sell masks and flow generators with the remainder referring patients to a home medical equipment dealer. Around 15% of sleep centers plan to start selling equipment directly within the next 12 months. According to the survey, "sleep centers are more likely to provide patients high-end equipment and are less price sensitive than HMEs;

5) the majority of sleep physicians and sleep center staff surveyed report sending their patients to an HME for equipment purchases. Currently, around 16% of sleep centers surveyed sell masks directly while around 13% of sleep centers sell flow generators directly. Over the next 12 months, an additional 14% of centers plan to start selling masks directly while an additional 15% plan to start selling flow generators directly over the next 12 months; and (6) Brand specific flow generator prescriptions account for 47% of prescriptions according to the survey, up from 29% of prescriptions in Wachovia's previous survey. Brand-specific mask prescriptions account for roughly 64% of total prescriptions (compared to 62% of prescriptions in the previous survey)." (Wachovia Securities, 2009)

In an interview with Ron Richard it is reported that when asked the question of whether he thought "...increased awareness of the sleep apnea market in the mainstream press has led to increased diagnosis?" Richard replied by stating: "Yes, we have seen positive results based on feedback and increased activity in the sleep centers due to the efforts of joint public relations campaigns. The AASM, ASAA and NSF have all been very active in their communication with various outlets of the media. ResMed and Respironics have jointly funded and established an educational awareness site, www.sleepapneainfo.com, alongwith working closely with several media outlets and physicians to increase the level of awareness at the level of the general public. Just last week, sleep apnea was in a topic covered on the "Today Show" hosted by Matt Lauer. So sleep is a hot area right now and people are getting the message -- snoring is nothing to laugh about and should receive proper medical care and diagnosis to determine if a person has a significant breathing problem which can lead to serious consequences such a stroke, heart attack, motor vehicle accidents and cardiovascular disease among other issues. Early detection and treatment is key to reducing health care costs associated with chronic diseases such as sleep apnea. The economics of treated vs. untreated sleep apnea is staggering. Untreated patients cost the health care system billions of dollars each year, and the treatment is simple and they can get to feeling better very quickly after treatment is initiated." (Ibid, 2009)

The question is asked of Richard " How has ResMed's marketing efforts toward sleep physicians and sleep centers facilitated this awareness?" To which Richard states: "ResMed over the past four years has spent a great deal of time educating primary care, cardiology, internal medicine and other medical specialists regarding the link between sleep disorders and other comorbidities. Specifically in the areas of cardiovascular disease and recently Type II diabetes, the prevalence and links to sleep apnea is overwhelming. This is really becoming a game of "connect the dots" for the patients and physicians. Oftentimes the patient may present with the chief complaint of being tired and the physicians are looking beyond that to other issues such as sleep, exercise and diet. These elements provide the doctor with a better overall view of patients' activity both asleep and awake. For years, many people have recognized the importance of diet and exercise, but finally they are waking up the fact that they need a good night's sleep. Our marketing efforts have increased the awareness of the problems associated with sleep and other comorbidities and helped to establish the links with these diseases in cooperation with professional medical groups and partnerships. Ignorance is our biggest competitor in the sleep market, so this is an industry-wide issue and needs to be attacked from many angles." (Ibid, 2009)

The question is asked of Richard: "Is it true that as many as 90% of people who have sleep apnea are currently undiagnosed?" And Richard answers by stating "Based on recent studies published in peer reviewed journals, this appears to be the case. And at the rate we are doing sleep studies and setting people up on treatment, it would take 20 years to test and treat just the people with moderate to severe sleep disordered breathing (SDB) at the current rates. Prevalence just in adults is thought to run as high as 20 million people and SDB does affect adolescents as well. SDB in children is thought to be as high as 3 to 4%, so this would be additive to the overall SDB number creating a problem of epidemic proportions. Obesity is considered a major contributor to SDB, and as noted by multiple medical journals and TV programs, we are in a crisis mode dealing with obese or morbidly obese patients in this country. Prevalence of SDB in patients with a BMI over 30 is 80% or more." (Ibid, 2009)

VI. EQUIPMENT

ASM Standards relate that the following items listed in the table labeled Figure 1 in this study may be utilized as a "general framework to help formulate...start-up needs" of a Sleep Center. (PSG Laboratories, 2009) Costs are stated to be dependent on the local market and project estimation costs requires consulting of local market experts.

Description of Items

Source: PSG Laboratories (2009)

Recurring Costs Based on a Sleep Center with two beds operating four nights per week.

Source: PSG Laboratories (2009)

PSG Laboratories states that there are benefits of leasing which includes the benefit of allowing deferred payments until the sleep center has started to "generate revenue." (2009) Leasing can additionally assist with matching equipment expenses to reimbursements..." As well as allowing for preservation of "bank lines of credit for working capital or other financing needs." (PSG Laboratories, 2009) Leasing allows the sleep center to make acquisition of equipment and technology if the capital budget is already full for the year through provision of a monthly payment that is within the sleep center's operating budget." (PSG Laboratories, 2009) the types of leases that are in existence are stated to be those as follows:

Capital and Fair Market Value (FMV) Leases - Operating Lease Customer has options of: (a) purchasing the equipment at a negotiated FMV at the end of the term; (b) return equipment with no further obligation; or - negotiate a continuation of the lease (renewal). (PSG Laboratories, 2009)

2) Capital Lease - Equipment is purchased and financed over time. Specifies purchase option at end of the lease with options of: (a) $1.00 purchase price; (b) 10% fixed purchase option; or - balloon payment buyout. (PSG Laboratories, 2009)

3)Lease plans - Contract terms come in a variety to suit different needs: 12 to 16 months with options of: (a) advance payments require first payment due at signing; (b) skip payments allows you to pay nothing at signing, or; - 30-180 days deferred, no security deposit required in most cases. (PSG Laboratories, 2009)

4) Express Programs - 90 days same as Cash followed by 9 monthly payments; or 180 days same as cash followed by 12 monthly payments;

5) Interest Free Programs - 12 months interest free. (PSG Laboratories, 2009)

VIII. SUPPLIES

Supplies that will be needed for marketing and advertising include those as follows:

Educational Materials; including videos, workbooks, screen and projector or overhead.

Brochures for distribution to other physicians, hospitals and clinics;

Flyers and Newsletters.

Supplies that will be required during the course of treatment include those shown in the following figures.

Starter Kits

Source: MVAP Medical Supplies, Inc. (2009)

Sleepmate Cannutherm Kit

Source: MVAP Medical Supplies, Inc. (2009)

Dymedix Apollo

Source: MVAP Medical Supplies, Inc. (2009)

Source: MVAP Medical Supplies, Inc. (2009)

Psyche Sleep Pillow

Source: MVAP Medical Supplies, Inc. (2009)

IX. TECHNICIANS

According to AASM Standards the Sleep Center must have a 'Sleep Director who is responsible for the patient's care and for reviewing patient history, ordering of appropriate testing and as well for review and interpretation of tracing upon scoring as well as ensuring that patient receive quality education. The following chart provides the median salary by years experience for the Director of a Sleep Lab.

Median Salary by Years Experience - Sleep Lab Director

Source: PayScale (2009) Salary Survey Report for Job: Sleep Lab Director (2009)

AASM Standards require that standard technologist staffing and support is stated to be sufficient if it addresses the "anticipated workload for patients being assessed by the laboratory; and assuring that the safety of all patients and staff within the physical confines of the laboratory. (PSG Laboratories, 2009)

Workload - This is defined for a technologist and is depending upon the complexity of patients who are being studied as well as the number of patients, and the anticipated or potential interventions or the standard operating procedures and the type or types of study or studies along with the "capabilities of the technologist and the availability of additional personnel." (PSG Laboratories, 2009; paraphrased) the tasks and duties performed or required to be perform by the technologist and this includes those not related specifically to the "performance of overnight polysomnography within the facility, must be included in the assessment of the workload." (PSG Laboratories, 2009)

Safety: This is a separate but related issue and "...must be considered in the determination of workload. There must be sufficient personnel to assure the safety of all patients and staff within the physical confines of the laboratory."(PSG Laboratories, 2009) the required "level and continuity of monitoring that is required is dependent upon the severity of the patients being studied and the procedural requirements of the Laboratory/Center. Adequate and appropriate additional staff must be available in a timely manner (less than 30 min) to provide urgent assistance. It is important to recognize that the sleep evaluation is being performed in a medical facility. Should an emergency occur while the patient is in the facility, the staff must be able to respond promptly, appropriately and without significant compromise to other patients. This is particularly true when the patient(s) is (are) asleep and may be unaware of or unable to request help in the event of an emergency. Therefore, the safety standard for a sleep facility requires reasonable and nearly continuous monitoring of every patient's status while undergoing physiological recording in the facility. The level and continuity of monitoring that is required is dependent upon the severity of the patients being studied and the procedural requirements of the Laboratory/Center. Adequate and appropriate additional staff must be available in a timely manner (