“Sleep is the golden chain that binds health and our bodies together,” written by Thomas Dekker. Sleep apnea is a chronic condition that interrupts patient’s breathing during the night repeatedly, which exerts significant stress on the heart, lungs, and other organs not to mention hundreds of thousands of serious vehicle accidents each year due to daytime sleepiness. It affects over 20 million patients in the U.S and more than double that number worldwide. In the U.S, 80% of those patients remained undiagnosed and untreated due to cost and encumbered access to sleep diagnosis which requires multiple visits to doctors’ offices and sleep testing facilities. Cleveland Medical Devices (CleveMed) manufactures and markets small patient monitors and associated services that allow healthcare providers to test sleep apnea patients in their homes. If there is one medical condition that can benefit from diagnosis in the home, it would be a sleep disorder because patients remain in familiar surroundings that are conducive to natural sleep.
In addition to convenience, recent technology improvements have lowered the cost of home-based sleep testing to become one-fourth that of facility-based testing. The result is a dramatic growth in home-based diagnosis. Annual home sleep studies that used their system have grown from a few tests in 2011 to nearly 20,000 last year. Although, market timing was critical for their success, their technology and business model are just as important.
Quality of service makes CleveMed unique
CleveMed offers the smallest and lightest home sleep monitor that exceeds clinical guidelines; yet, it requires a very simple sensor hookup. Therefore, they can achieve high-quality recordings in a very easy-to-use process. In addition to testing simplification, CleveMed offer services that are unique to monitor manufacturers in this market space. These services range from scoring and interpretation of sleep studies by qualified specialists to fulfillment capabilities that many healthcare providers lack, such as mailing monitors to patients’ homes, replenishing supplies, and patient phone support. This multitude of offerings allows customers to pick and choose the solution that best fits their needs, especially with regards to practice workflow, local sleep specialty availability, and insurance contracts.
Therefore CleveMed is coming with a unique business model. Unlike competitors who handle the testing process through a virtual national provider, they improve access to sleep care by keeping it local and by expanding the number of healthcare practitioners who participate in sleep care. Whether it is to expand services of existing sleep facilities to outlying clinics, start a new outreach program, or engage primary care providers, their products and services make sleep testing more accessible. Not only will this method maintain the local patient-doctor relationship during diagnosis, but during treatment as well. To succeed, business models need to maintain continuity of care.
A shrewd leader behind CleveMed
Hani Kayyali, President of CleveMed has over 25 years of medical device experience and has been president of CleveMed since 2005. Prior to joining CleveMed, Hani held managerial positions in two startups, Biomec and Axon Engineering, and played critical roles in their technology growth and ultimate successful exits. Hani received his masters in biomedical engineering and MBA from Case Western Reserve University (CWRU), has 13 issued patents, and more than 25 publications. He also sits on the Industrial Advisory Board for the BME dept. at CWRU.
Hani’s greatest contribution to building a winning team
Hani successfully transitioned the company from a research firm to a fast growing company by spinning off three companies, building a highly talented team focused on sleep disorders, establishing strategic partnerships, and securing significant investments in CleveMed. As a result, CleveMed developed a wide array of sleep products and web-based solutions that are leading the market with consistent double-digit growth rates.
Hani says,“We can offer a number of products and services because we are the original designers and manufacturers of the technology. In addition to allowing us more control over costs, customer support, and speed of upgrades, our technical capabilities generated an unparalleled Intellectual Property (IP) position (we have over 20 issued patents and another 25 patents pending). Our patents cover current products and new technologies under development. One area of focus for future development that mustered four issued patents and many more pending patents relates to continuity of care; namely, conducting cost-effective home studies to assess therapy efficacy. I believe we are the only home sleep testing company that offers this kind of product flexibility with such patent strength.”
Successful Clients, Successful Business, Successful Future
Sleep apnea care will be better, faster, and cheaper. However, it will not be easy due to declining reimbursement. One area that can save costs without compromising quality is stronger engagement of First Encounter Providers; healthcare providers who first see the patient like family doctors, nurse practitioners, and many others. Uncomplicated sleep apnea patients are commonly referred to a sleep physician; however, as many research studies have shown, First Encounter Providers, under the purview of sleep specialists, can effectively screen those patients and order the sleep study during the initial patient encounter; thus saving time and money. This is especially true for patients who are unable or unwilling to go to a sleep facility. So, as long as sleep expertise supervision is afforded, there are certain steps that can improve access to care without compromising it. Healthcare providers need not create completely different solutions to lower costs; rather they need to retool current workflows. Their solutions allow for those new workflows to happen.
The best part of the company is its people. Future projects will hire like-minded resources that will be trained and empowered by the current team. “The upcoming years will be transformative,” says Hani.
Hani’s attribute for success
Hani attributes his success to perseverance and surrounding himself with the right team. Perseverance and relying on talented, caring resources seem like a cliché answer, but it is the right one.
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