Low Cost Tool to Empower Anyone to Detect a Bedsore Early

Empowering anyone to prevent a bedsore through early detection and monitoring

A. What is the problem that you are committed to solving:

Pressure ulcers (PUs) are commonly known as bedsores. PUs are a major healthcare problem and 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. As a results, PU get missed at their earliest stage when they are the least costly and  easiest to treat. 

B. What is the solution you are proposing?

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 complimentary properties of the skin such as temperature and skin firmness. The RAS is used with a disposable skirt that maintains prevents the spread of contamination between patients. The RAS also includes a mobile app for patient data tracking that allows clinicians to monitor the health of the skin to personalize care. 

C. How will your solution change the world?

 The RAS is posed to have a significant impact on healthcare by addressing a common human health problem known as bedsores which affects millions who suffer from chronic health conditions like diabetes, cancer, muscular dystrophy (MS), disabilities, and individuals who are elderly. If caught early bedsores can be prevented. Detecting them early can be very difficult since the early diagnostic test is unreliable and the indicators on the skin can be hidden by skin color. By providing a reliable tool for early detection and monitoring Rubitection will change the world by improving healthcare by: 

• Providing an effective, reliable, and affordable decision support tool that can guide healthcare services based on patient specific information, and
• Expanding clinical expertise needed to prevent bedsores to non-clinically trained individuals through an easy to use hand held tool and easy to follow training. 

Our solution, the Rubitect Assessment System (RAS) is a new novel technology that consists of hand held probe that can easily measure the properties of the skin and mobile app that allows the user to easily monitor incremental changes in the health of the skin. Its novelty lies in its unique combination of sensors which enable various properties of the skin to measured simultaneously. The RAS  probe is a patented system. Part of its novelty lies in its ability to be used in any care environment (hospital, nursing home, clinic, etc) without clinical expertise in wound care and prevention.

Currently the clinical standard approach to detect bedsores is a manual test called the manual blanch test. It is unreliable and can’t be used on darker skin tones. We are applying a technological solution to detect the indicators of a bedsore more reliably on skin. Our solution is a an optical-mechanical device that allows any user to reliably assess the health of skin overcoming the limitations of the manual test.  Technology is therefore integral to our  solution. We have already built an initial proof of concept prototype and collected initial data which supports it diagnostic capabilities. 

Over the next 12 months we have four primary goals:

• Complete clinical prototype – we are developing a second generation prototype
• Complete initial clinical pilot testing – we are in the process of collecting data on patients in nursing homes to compare our system to nursing care
• Raise a seed investment round of $1.5 million – to support business growth and pilot testing,
• Expand our team – we will add a full time business operations and clinical research coordinator, and Secure additional partnerships – we are looking to connect with additional nursing homes and hospitals in the US and internationally.

Our vision for the next 3-5 years is to get our technology to market. To achieve that goal we are collaborating with leading healthcare facilities like the Jewish Health Association to collect clinical feedback and to complete clinical trials. The clinical results will be published in industry journals to market it to our customers. Industry conferences such as the Symposium on Advanced Wound Care will also be used to market the product and initiate sales. Strategic sales and distribution partnerships with companies like Smith and Nephew will be used to obtain boarder US and global market penetration. 

A. Solution be deployment:

Initial sales of the product in the US will be deployed through strategic sales and distribution partners and by marketing the technology at industry conferences. We will initially deploy in nursing homes and hospitals with a long term vision of entering the home care market.

B. Technology accessibility?

In the future customers can buy our product on our website or through our sales/ distribution partners. With the appropriate FDA approval we aim to sell our product on Amazon in the future to make it accessible for the home care market. 

We are currently in the prototyping phase of our development. We are performing prototype testing in nursing homes in the Pittsburgh area. We will be recruiting up to 800 individuals to participate in our clinical study. As part of the study the patient receive skin evaluation with the RAS twice a day. Once deployed on the market our the RAS will have a boarder impact on millions of patients each year. Each person who is admitted to a hospital or nursing home are evaluated for a bedsore. Our vision is to have that assessment be completed with the RAS.

Each year in the US 36 million people are evaluated for a bedsore. All individuals who are admitted to a hospital or nursing home. At risk patients include those with limited mobility and the elderly. Over the next 12 months we will be working with 800 elderly patients in nursing homes in an initial clinical pilot study. In 3 years once on the market in  5-10 nursing homes and hospitals the RAS will be used on hundred of thousands of patients. The impact will be patient specific skin health data that will drive care preventative and support care coordination.

Dr. Gaspard is the CEO of Rubitection and the primary inventor of the RAS. She has a PhD in Biomedical Engineering. She is experienced with business strategy, IP strategy, technology development, and market research. Dr. Gaspard has surrounded herself with a group of experienced and knowledgeable advisors who include:  

• a)Business: Peter Decomo (business advisor, CEO of Alung),
• b)Technical: Todd Przybycien, PhD (scientific, co-inventor, Professor at Carnegie Mellon),
• c)Legal: Steve Cherin (Corp. attorney, Strassburger McKenna Gutnick & Gefsky ),
• d)Clinical: Elizabeth Ayello  (clinical advisor, wound care nurses, Former president of NPUAP); 

Rubitection will utilize a razor blade business model and a SAAS subscription business model. The RAS probe will be provided to customers for free and revenues will be generated from unit sales of the disposable skirt ($5.00/day/patient) and the mobile app ($3.50/day/patient). The use of disposable skirt and mobile app will generate sales from two recurring revenue which will allow Rubitection to grow a sustainable business and reach profitability within a year of product launch.

To expand our customer base Rubitection will utilize a hybrid sales approach. Rubitection will employ a small internal sales team. Initial sale orders for the product will be sought from our clinical partners and collaborators. To access the broader healthcare market, Rubitection will establish relationships with corporate partners in the wound care space such as 3M and Medline to access their existing sales and distribution channels into home care, long term care, and the hospital market. Rubitection will work with sales and distribution partners to quickly penetrate the market. Rubitection also aims to target the global market to bring the technology to low and medium income companies in partnership with Non-profits organization like USAID and local governments.

We are applying to Solve for several reasons. They include:

• To get connected to the Solve network of non-profits, government, for profit partners, and MIT who Rubitection can build partnerships with to accelerate our growth
• The 12 month of personalized support and mentorship from experts  associated with Solve at MIT who can provide guidance business growth strategies
• Meet other social entrepreneurs from around the world
• Strengthen our investment pitch and network of potential investors
• Opportunity to educate a larger audience about bedsores, they potential health risk, and our solution to prevent them.

1.Raising funding – Solve can assist us with mentorship around how we can strengthen our pitch or position to successfully raise funding. Solve can also assist by connecting Rubitection to potential government and private funding groups.

2.Identifying team members and board members – As Rubitection grows we will need qualified and experienced team members. Rubitection can utilize Solve’s network to identify appropriate future team members as well as board members.

3.Connecting with top clinical partners – We want to connect with larger clinical partners in the Boston area and the Solve network could assist with introductions.