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Innovative System for Pressure Ulcer Prevention, Early Detection, & Management

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RAS device on skin
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Letter of Support from Nursing home - Baptiste
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RAS device
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INTRODUCTION. The RAS is a medical device that serves as a decision support for nurses in home care, nursing homes, and hospitals to prevent and management pressure ulcer (bedsore care). The technology can be used at non-profit health facilities like UPMC and Baptiste Homes (nursing home) in addition to for profit healthcare facilities to improve patient care and save lives. A US and global market exists for the RAS technology. Rubitection is current in prototyping phase and clinical testing of the RAS.  We are completing our clinical tests with local long term care facilities in the Pittsburgh area: Vincentian Collaborative System and Baptist Health. If selected as a UpPrize finalist we will use the funds and network to support technology development and the clinical testing in addition to position the company for product development. An overview of the problem, the RAS, and its market is provided below.  

PROBLEM. Pressure ulcers (PUs) are commonly known as bedsores. PUs are a major healthcare expense around the world. They are a common cause of patient distress in hospitals (initial market), home care, rehab centers, nursing homes, hospices, and for diabetics – who develop diabetic foot ulcers. In the US they cost the US healthcare system $11 billion in 2006. Every year in 2.3 million people are diagnosed with PUs; 60,000 die annually in the US. PUs can be prevented if caught early lowering PU related healthcare cost. However, the standard early clinical technique for PU detection, the manual blanch test (MBT), is unreliable. It relies on 1) visual identification of skin color changes (erythema and blanching), and 2) the care giver’s ability to “feel” differences in skin firmness and temperature with their finger. The reliability of the tests is therefore affected by ambient lighting in the room, clinician skill level, and the color of the patient’s skin. As a patient’s skin gets darker diagnostic skin color changes are no longer visible. Therefore, darker skinned people get the most advanced stage of the condition.  

PRODUCT.   
The RAS provides caregivers with a low cost easy to use objective tool to assess the health status of the skin. It quantitatively measures the blanch response and erythema, the primary diagnostic cues of an early stage PU. It can detect these cues whether or not they are visible due to the patient’s skin color and independent of the skill of the caregiver. It also quantitatively measures complimentry properties of the skin such as temperature and skin firmness. The RAS is used with a high volume consumable, a disposable skirt, that maintains sterility between patients. The RAS also includes data tracking software that allows clinicians to monitor the health of the skin to personalize care. The RAS will also integrate with electronic health records systems.  The Rubitect is a class I FDA device exempt from 510K.  It will be priced at $850/unit (37% margins) and $3/sterile skirt (73% margins). The app will be priced as t Rubitection is currently working with Vincentian Collaborative System and Baptiste Health System to evaluate the technology.  

CLINICAL IMPACT
. The RAS will revolutionize early pressure ulcer management by providing caregivers with a reliable tool and system to assess, monitor, and estimate PU risk at the early onset. The RAS will provide caregivers with the ability to a) administrator preventative proactively, b) assess the impact of care based on quantitative data, and c) to customize early PU care based on the patient specific data. This will lead to improved patient outcomes and a reduction in severe pressure ulcer cases. The additional clinical impact of the RAS are improved wound care documentation, liability assignment, and nursing compliance. It will  improve the accuracy of wound documentation by integrating with a facilities electronic health records system to automatically include the quantitative results into a patient’s medical charts. It will help healthcare facilities assign liability and monitor compliance by tracking the frequency of PU assessment provided to each patient. By providing alerts when the skin checks are missed the RAS will assist nurses in complying with PU care interventions.

MARKET.
The primary PU at-risk population, the elderly, is projected to grow to over 70 million people in the US by the year 2040 [2]. In 2008 Medicare, stopped reimbursing cost of care for facility acquired PUs [1].  This Medicare policy change transferred a large portion of the cost ($11 billion) and legal liability to healthcare facilities [3]. The lack of Medicare reimbursement yielded a huge demand for reliable, objective and effective early PU assessment tools. The RAS’ ease of use, low cost, and objectivity make a competitive product. It represents a $5.4 billion/year addressable US market with a larger penetrable global market. Our initial market entry point will be long term care facilities (non-profit and for profit).  The target user for the RAS are nurses and consumers. The target customer will be the healthcare facility administrator and consumers.  Rubitection aims to launch the product on the market within the next two years.

COMMERICALIZATION, SALES, & MARKETING STRATEGY.
To get to market, Rubitection is collaborating with leading healthcare facilities like UPMC, Highmark, and Vincentian Collaborative System, to collect clinical feedback to ensure clinical relevance and to complete Beta trials. The results from these studies will be published in peer reviewed journals (J. of Wound Care, Skin & Wound Care Journal, etc). It will also be showcased at industry trade shows/conferences such as the Symposium on Advanced Wound Care (SAWC) to market the product and initiate sales. It will be marketed based on its low cost and ROI. The Rubitect is estimated to save up to a $166K/year per hospital with just a 5% reduction in advanced stage PUs.  Large research hospitals, starting with our clinical collaborators, will be our initial customers.  Rubitection will utilize a hybrid sales and distribution model to access the greater US and global market by leveraging strategic sales and distribution partnerships with companies with a global presence such as Hill-Rom, 3M, and Medline.


Submitted

Nov 30 2016

Organization Organization Type

For-profit

Challenge

Technology

Product Name

Rubitect Assessment System

Product Stage

Concept


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