BMEIdeas

Our Preliminary Proposal:

-What is the problem you have solved? What is the market and/or industry needs that you intend to address?

Maternal morbidity during childbirth is an ever present problem in the United States. A key contributing factor to this is the large amounts of blood lost during birth. While this is a pressing issue, currently, no solution exists to accurately quantify the blood lost. We aim to create a contraption that does just that.  

 

-How does your team intend to address the problem? How does your final design solve the problem?

We aim to create an absorptive pad that absorbs blood and can quantify the blood lost during vaginal child births at an accuracy level helpful enough to aid healthcare professionals provide care to the mother. Our device will be ergonomic, account for other fluids, and be low cost. This design remains non-invasive, but also alerts healthcare providers about potentially dangerous levels of blood loss.

 

-Results of a patent search and/or search for prior art, assessment and patentability (one page). Two excellent resources for this search are www.uspto.gov and your institution’s technology transfer office. Regarding marketplace competition, what is currently being used to solve the problem and/or what are the anticipated alternate methods that could be in competition with you in the future?

The kanga, a garment worn in Africa, attempts to solve this problem in a similar fashion. It is just a garment, but also used as a cloth to absorb blood. Each kanga that has fully absorbed estimates a certain amount of blood. We aim to take this idea, and make a more robust version of it since nothing like this currently exists in the medical market.

 

-Anticipated regulatory pathway (510(k) vs. PMA, etc.) (1/2 page). Consider researching how the FDA has treated analogous devices.

This device is a class I device.

 

-Reimbursement (1/2 page). Do you expect your device to be reimbursable by Medicare/Medicaid? Why or why not?

We don’t expect this to be an issue. The device would be used as a bulk disposable during childbirth procedures, and so would not be billed on a per-unit cost. Rather, the Medicaid bill would be for the general procedure in and of itself.

 

-Estimated manufacturing costs (one page). Provide detailed per unit cost breakdown, including volume discount, for components, final assembly, quality assurance, etc.

We expect the final product to be a small sheet of material, perhaps the size of a sheet of computer paper with the approximate width of a sponge. Given that we wish to design this product with low-resource environments in mind, we hope to have a per unit cost of around a dollar. However, we do anticipate that multiple units will need to be used per childbirth.

 

-Potential market (one page). Who would your customers be (i.e., who will be purchasing the product) and who would the end users be (i.e., who would be using the product)? If possible, quantify the number of potential users and the benefit they would receive from use of the product. Define the potential market size, selling price, and distribution channels.

We would sell our product in bulk (on the order of hundreds or thousands of units) directly to hospitals, with physicians and nurses being the end users. The CDC reports that nearly 4 million births occur annually in the US, indicating a massive potential market size. We could potentially be selling thousands of units to the thousands of hospitals around the nation, thereby producing a sizeable revenue despite a low unit selling price. In the short-term, we would hope to provide units on the order of hundreds to the Vanderbilt University Hospital as well as to surrounding local points of inpatient clinical care.