The problem we solve: Frail elderly women, who as a group are highly burdened by urinary tract infections (UTIs), are often unable to comply with the urine collection process because of physical and/or cognitive impairments. Spessel is a game-changing alternative to the current, flawed options: bedpans and catheters. By providing caregivers with a purposefully designed tool, Spessel will help provide timely and targeted diagnosis and treatment of UTIs in a vulnerable population that needs it most.
About our solution: Spessel conforms to the female anatomy and collects a midstream urine sample easily and efficiently. The disposable device sits comfortably next to the perineum and includes an opening that surrounds around the urethra. When the patient voids, the first pass of contaminated urine collects in one section and the remaining clean sample flows into an easy to access receptacle. The patient doesn’t need to follow any instruction or participate in any way and she can remain in bed if needed. Since the device sits outside the urethra, placement is not a sterile procedure. This means it can be used by non-licensed carers in any number of outpatient settings.Progress to date:
Our inaugural prototype has been successfully bench tested and a non-provisional utility patent/PCT is pending. FDA pre-submission review has established that Spessel is 510k exempt based on an appropriate predicate. Surveys of nurses and physicians in hospitals and nursing homes have validated our assumptions about the problem, need for a solution and potential for our product to solve the problem.
- Winner, Shark Tank Competition, Nurses in Business Association national conference, 2016
- Winner, Start-up Pitch Competition, Women in Bio SoCal, 2016
- Winner, Champions of the West competition, manufacturing/innovation category, NSW, Australia, 2014
- Innovate NSW Minimum Viable Product Grant, New South Wales Department of Trade and Investment, 2014
Creator: Naomi Travers
Education: University of California, San Francisco , Mas
Bio: Naomi Travers is a board-certified geriatric nurse practitioner with over 15 years experience in the nursing field. She is the founder of Alembra Medical and inventor of Spessel, a specimen collecting vessel that captures a clean midstream urine sample from physically and/or cognitively impaired female patients.
Hospital Affiliation: Clinic
Advanced Degree(s): GNP-BC, RN, MSN
Managing Director, ide+, product development , Bachelor of Engineering, University of New South Wales
Biography: George Sidis is a Founder and the Managing Director of ide Group. With a degree in Chemical Engineering, Sidis also has a wealth of experience in R&D having previously worked with PWC to help businesses with technology commercialisation, financing, business planning and start-up strategies for new ventures. Sidis is also a Founder and Non-Executive Director at Atomo Diagnostics, an innovative Point of Care diagnostic device company.
Title: Managing Director, ide+, product development
Advanced Degree(s): Bachelor of Engineering, University of New South Wales
Willem Mees van der Bijl
Product Development Manager at ide+, Industrial Design Engineering
Biography: Willem Mees van der Bijl is a Product Development Manager at ide Group. Van Der Bijl has over 15 years of experience developing and implementing new product innovations and has led design and engineering teams in The Netherlands and Australia. Among the products he has helped realise include the Swissray Medical Imaging Digital Radiography System, the ZorgXcel diabetic care innovation program and the DOCKX Medical bariatric surgery chair.
Title: Product Development Manager at ide+
Advanced Degree(s): Industrial Design Engineering
Spessel is a completely new approach to urine collection that is comfortable, easy to use and non-invasive. With this innovative device, frail female patients with physical and/or cognitive impairments will be able to provide a diagnostic urine sample while resting comfortably in bed – no more bedpans, no more invasive, degrading catheterizations. With a reliable collection method, patients can be assured of decisive, timely diagnosis of a urinary tract infection (UTI), or lack thereof. The benefit of accurate detection is that patients are put on appropriate antibiotic therapy only when needed, not “just in case.” And early diagnosis reduces the risk of dangerous, even life-threatening complications of untreated UTI, such as sepsis or kidney damage, not to mention the trauma of hospitalization and illness.
The benefits are not just for patients, but for their family members as well; caring for an aged parent can be emotionally and physically trying. No one wants to see a loved one subjected to an invasive, traumatic procedure such as catheterization when urinary tract infection is suspected. A kindler, gentler and reliable option is possible and should be the new gold standard for empathetic care.
Whether you are the nurse or carer trying to collect a midstream urine sample from an impaired patient, or the clinician diagnosing a UTI, Spessel has the potential to make your job easier and more satisfying. For nursing staff and caregivers, the easy to place, disposable device collects a midstream urine sample easily and efficiently. The patient doesn't need to follow any instruction or participate in any way and she can remain in bed if needed. Since the device sits outside the urethra, placement is not a sterile procedure. This means it can be used by non-licensed carers in any number of outpatient setting, such as skilled nursing facilities and the patient’s own home.
Compared to bedpans and catheters, Spessel is more ergonomically useful and can enhance the highly task-driven workflow of busy nurses. Care giving of the aged care population is challenging enough; informal as well as licensed caregivers deserve the right tool for the job; Given the current urine collection options, it is not surprising that 21% of urine samples from women are contaminated compared to 9% in men.(1)
For providers, Spessel delivers the diagnostic precision that is fundamental to giving good care. Results from an uncontaminated sample allows for decisive, timely treatment instead of repeat tests, delayed treatment and gambling with antibiotic therapy. We all want to give the best care, not have to choose between the lesser of two evils. I know this from my personal experience and the frustration from feeling like I am giving suboptimal care is what has motivated me to take the entrepreneurial journey.In the words of one respondent to a survey conducted by Alembra:“If there were such a device to obtain a clean specimen, it would take the ‘guess work’ out of prescribing suitable antibiotics,” - Director of Nursing, residential care home.
(1) Shamsundar, BV, Urine culture contamination: A one year retrospective study at the tertiary care hospital, Journal of Evolution of Medical and Dental Sciences, December, 2014, 3(74), p. 15552-15557.
“Beware of little expenses. A small leak will sink a great ship” – Benjamin Franklin.
Contaminated urine samples are the small leak that no health care institution can afford. Consider this analysis: In 2014, Medicare alone spent $79 million to perform 7.4 urine bacterial colony counts at a cost of $11 each.(1) Given that UTIs predominate among females, it is a fair assumption that the majority of those tests were on female patients. There is scant research on the topic of contamination rates, but one recent study found that approximately 21% of samples were contaminated among women, versus 9% in men.(2) At that rate, Medicare alone wasted approximately $17 million in lab fees for inconclusive data.
More importantly, each contaminated sample represents a patient who either had to repeat the sample collection and delay treatment, or was put on potentially inappropriate antibiotic treatment. Repeat urine testing incurs approximately $900 for extended hospitalization (3), not to mention that each contaminated sample represents misdirected/wasted laboratory resources.
Nursing time and resources are too valuable to waste on inefficient workflow practices such as mobiliizing an impaired, sick patient to the toilet - which may take two people for an unsteady patient - and waiting for the unpredictable act of urination in an incontinent patient who may not be able to detect or articulate their need to void.
There do not appear to be any studies or data on the costs and health care repercussions of delayed diagnosis directly tied to poor collection practice in our target population; If a patient is in the home or skilled nursing home setting, in theory the infection should be able to be diagnosed and treated in that setting, and yet Medicare data shows that the incidence of costly emergency visits and inpatient stays for UTIs consistently increases with age. Women aged 65 and over account for almost nine times the number of inpatient admissions for UTI compared to all women aged 18-64. (4)
Early detection of UTI in patients is by far a more cost-effective proposition than hospitalization for complications and advanced infection. A visit to the emergency room alone can incur thousands of dollars and sepsis - the worse-case scenario of advanced or under-treated UTI - is one the most expensive hospital diagnoses at approximately $18,000 per hospitalization.(5)
As a nurse-led startup, we hope affiliation with Alembra Medical's mission would be an especially attactive opportunity for Magnet institutions to demonstrate their commitment to nursing innovation and enhanced practice environment; our goals are perfectly aligned, as they are with insitutions with Nurses Improving Care For Healthsystem Elders (NICHE) protocols.
(1) HHs OIG Data Brief, September 2015, OEI-09-15-00210 Medicare Payments for Clinical Laboratory Tests in 2014: Baseline Data, Department of Health and Human Services, Office of Inspector General).
(2) Shamsundar, BV, Urine culture contamination: A one year retrospective study at the tertiary care hospital, Journal of Evolution of Medical and Dental Sciences, December, 2014, 3(74), p. 15552-15557.
(3) Data on file.Becton,Dickinson and Company: Franklin Lakes,NJ; 2010)
(4) Litwin MS, Saigal CS, editors. Urologic Diseases in America. US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Washington, DC: US Government Printing Office, 2012; NIH Publication No. 12-7865, p. 368.
(5) Torio, C. and Moore, B., National inpatient hospital costs: the most expensive conditions my payer, 2013, Statistical Brief #204, May 2016, Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality.
Stakeholders in Spessel's success include home health agencies, skilled nursing facilities, hospitals, laboratories and insurers - virtually any organization dedicated to providing care to female geriatric patients. Partners will have the benefit of providing input in the early development stages and thus ensuring the final product incorporates desired elements.
We hope that the process of evaluating Spessel will bring attention to an issue that institutions may not even know they have. Consider the case study of Baylor Health Care System, which undertook a comprehensive analysis of urine culture contamination rates in 2012 after being alerted to a high incidence by an affiliate laboratory. Most of the system's 31 affiliated hospitals were not even monitoring contamination rates until a laboratory idenitified the probem, the study noted.(1)
In addition to financial support, partner organizations can provide crucial insights into their own experiences with the lifecycle of UTI management in our target population - How does staff obtain a sample? What challenges do they face? How much time does it take and what are the associated costs? What percentage of samples are contaminated what are the repercussions for patients and the institution? (wasted laboratory resources, repeat tests, delayed treatment, hospitalization...) In our own surveys, with few exceptions, respondents validated our hypothesis that the process is time-consuming, difficult and inefficient but we are eager to have access to more data and assistance with a formal analysis.
Partnering with Alembra provides an opportunity for institutions to demonstrate their commitment to geriatric-focused care. Literature is prolific on the need for geri-centric health care delivery. For example, four prominent agencies collaborated on publication of the Geriatric Emergency Department Guidelines to address a "burgeoning geriatric population" that poses "an unprecedented and overwhelming challenge to the American health care system as a whole and to emergency department (EDs) specifically." Among many recommendations, the document noted that "geriatric patient care requires equipment designed for a patient population with specific needs. Challenges involving mobility, incontinence, behavioral needs, etc. are best met with equipment designed for the effective and comfortable evaluation and treatment of geriatric patients." (2)
Sounds exactly like Spessel....
Lastly, partnership with Alembra Medical - a nurse-led start-up - is a unique opportunity to support innovation in bedside nursing, a sector that is severely underrepresented. The current innovation landscape favors digital technology, surgical interventions, robotics and a seemingly endless slew of apps that have no clinical validation. Meanwhile, one of the most common procedures in a large and growing subset of the patient population has been stagnantly inefficient for decades. By joining in our mission, partners can improve nursing practice in a fundamental and lasting way and demonstrate to the hardworking caregivers in the highly challenging aged care sector that their needs are being addressed.
(2) Geriatrac Emergency Department Guidelines, American College of Emergency Physicians, American Geriatrics Society, Emergency Nurses Association and Society for Academic Emergency Medicine, 2013, p. 13
The market for Spessel is huge and growing. Our target market are physically and cognitively impaired female patients, but the product can also provide a valuable collection tool for able-bodied women as well. Its utility is ubiquitous to multiple health care venues both in the United States and abroad, including home health care, skilled nursing homes and hospitals. There are statistics from multiple agencies documenting the rise in aging populations:
In 2012 there were almost 17 million women 70 and over in US alone and that number is projected to be almost 30 million in 2030. (An Aging Nation: The Older population in the United States, May 2014, US Census Bureau). Worldwide there were approximately 71 million women aged 80+ in 2012 and that number will increase to approximately 250 million by 2050 (“Ageing in the Twenty-First Century: A Celebration and a Challenge” United Nations Population Fund, 2012).
Although there are no sta
Projected 3 Year Growth
Once the product is validated clinically, our goal is to find an established consumable device manufacturer who will license rights and commercialize the product via existing distribution and sales channels.
How We Will Make Money
Revenue will be from sales via a distributor(s) to be determined, which service the same facilities that Spessel targets, both in the US and abroad. Pricing will be determined by final design specifications, manufacturing costs and a more in-depth cost analysis; Feedback to date suggests a target price of $10 per unit will make the venture profitable but also be cost-effective compared to the current standard of care, taking into account staff time, cost of contamination and treatment for complications due to delayed diagnosis.
About our Competition
Our competitive advantage is clear – compared to bedpans and catheters, our product is patient-focused and reliable. At a target price of $10 per unit, Spessel is more cost effective than the current standard of care when taking into account the supplies and staff time. Catheterization is an invasive procedure that requires licensed nursing staff; In contrast, Spessel can be used by unlicensed staff that comprise the majority of the workforce in skilled nursing/assisted living facilities, and the informal caregivers who look after aged women in their homes.
Spessel is a novel innovation in a sector that has remained unchanged for decades. Catheter manufacturers would be indirect competitors, but Alembra is creating ownership of an entirely new segment in the urine collection market with our novel product and pending patent. There are a few products produced out of the UK ( Peezy) and one in Australia (Mittstrom) which are designed to be
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