Hemafuse autologous blood transfusion device

Hemafuse autologous blood transfusion device

Ann Arbor
Year Founded:
2011
Organization type: 
for profit
Project Stage:
Start-Up
Budget: 
$50,000 - $100,000
Project Summary
Elevator Pitch

Concise Summary: Help us pitch this solution! Provide an explanation within 3-4 short sentences.

DIIME is dedicated to improving maternal and infant health in resource limited settings through collaborative design of appropriate medical devices.

About Project

Problem: What problem is this project trying to address?

Every year, millions of women in the developing world suffer from ruptured ectopic pregnancies. When this occurs, she can lose half of her blood volume and desperately needs a transfusion. However, because of a worldwide blood shortage of more than 40 million units, she is unlikely to receive a transfusion. Instead, clinicians must salvage and reinfuse blood using a procedure commonly called “soup ladle” autotransfusion. During this procedure, clinicians scoop blood from her abdomen in open surgery using a soup ladle or cup, filter it through a few layers of gauze, mix it with anticoagulant, and then pour the mixture into a blood bag to be transfused. This method is fraught with potential problems for both patient and clinician, including high rates of infection and clotting disorders.

Solution: What is the proposed solution? Please be specific!

We have developed a new product through collaboration with clinicians at Komfo Anokye Teaching Hospital in Kumasi, Ghana. Hemafuse is a simple handheld, reusable device, which will replace “soup ladle” autotransfusion during surgery, specifically designed to address ruptured ectopic pregnancies. The tip of the device is inserted into the patient’s abdomen during surgery, pooled blood is removed through manual suction, and the blood passes through a filter to remove clots and particulates before transfusion. Hemafues is safer, cheaper, and more efficient than the current process, resulting in better health outcomes through reduced risk of infection, clotting disorders, and adverse reaction to donor blood. Hemafuse is designed for use in limited resource hospitals and clinics, primarily focused on sub-Saharan Africa. By creating a solution in collaboration with the end-users, we are able to develop technology which is uniquely appropriate for these settings.
Impact: How does it Work

Example: Walk us through a specific example(s) of how this solution makes a difference; include its primary activities.

This solution provides a safe transfusion to patients who would otherwise risk their lives by going without a transfusion or undergoing the dangerous soup ladle procedure. Replacing the current procedure with Hemafuse will result in fewer patient complications, shorter hospital stays, lower procedure costs, and decreased mortality rates. Our primary focus is on perfecting the design and performance of this technology, leading to regulatory approval and implementation in clinics and hospitals. Hemafuse has undergone several iterations over more than a year to arrive at the current prototype. Key to the design process is the close collaboration between the engineering design team and American and Ghanaian clinicians. Clinician feedback is incorporated throughout the design process to ensure that the final product meets the needs of the clinicians who will be using it.

Impact: What is the impact of the work to date? Also describe the projected future impact for the coming years.

We haven’t yet determined how to most effectively measure the impact we might have. Possible markers include units sold, improved patient outcomes, or cost saving for the hospitals. More specifically, we would hope to have some of the following outcomes: decreased infection rates, shorter hospital stays, fewer complications, decreased procedure time, and fewer necessary clinicians. We estimate that our product, Hemafuse, should reach first sales by late 2014 or early 2015. The extent and exact nature of clinical testing is currently being determined. While our first target will be ruptured ectopic pregnancies, we have found that many other procedures exist in which blood can be collected for autotransfusion and this could represent a possibility for Hemafuse to address the 40 million plus shortage of donor blood units every year.
Sustainability

Financial Sustainability Plan: What is this solution’s plan to ensure financial sustainability?

Hemafuse is composed of two pieces: an external housing which can be reused for up to 50 patients, and an internal filter which must be replaced after each patient. These would retail for approximately $50 and $5. DIIME’s pricing is based on market research interviews with African clinicians and government officials, and an assessment of the competitor prices to determine what the market will bear. Donor blood costs about $50 per pint to process.

Marketplace: Who else is addressing the problem outlined here? How does the proposed project differ from these approaches?

No device is currently available which could replace the “soup ladle” procedure at a locally affordable price. Autologous transfusion devices currently on the market are prohibitively expensive, and are not designed for low-resource settings. Donated devices experience issues with unreliable electricity, lack of training, necessary ongoing maintenance, and a lack of consumables. This problem is so pronounced that it has been estimated that 96% of donated equipment does not function after 5 years and 39% arrives unusable. Large medical device companies are primarily focused on creating high-end devices for more profitable markets; however, competition in our target market may come from large corporations or local medical device manufacturers.
Team

Founding Story

In the summer of 2010, our founding team spent one month performing clinical observations at Komfo Anokye Teaching Hospital in Kumasi, Ghana, where we witnessed firsthand a snapshot of the challenges faced by clinicians in delivering quality medical care to pregnant women, who suffer disproportionate hardships in childbirth due to an unlucky circumstance of geography. One day in the operating room, a woman with a ruptured ectopic pregnancy was brought in. The doctors explained that she had a lost an enormous amount of blood. They opened her abdomen and we watched as they scooped out the pooled blood with a ladle, picked out the largest clots by hand, poured it through a layer of gauze into a blood bag, and then started the transfusion. During the procedure, the surgeons kept repeating to us that there must be a better, safer way to accomplish this. This experience provides the inspiration to develop Hemafuse, in hopes of having a tremendous impact on patients and clinicians.
About You
Organization:
Design Innovations for Infants and Mothers Everywhere L3C
About You
About Your Organization
Organization Name

Design Innovations for Infants and Mothers Everywhere L3C

Organization Country

United States, MI, Ann Arbor, Washtenaw County

Country where this project is creating social impact

Ghana

How long has your organization been operating?

Less than a year

The information you provide here will be used to fill in any parts of your profile that have been left blank, such as interests, organization information, and website. No contact information will be made public. Please uncheck here if you do not want this to happen..

Innovation
How long have you been in operation?

Operating for less than a year

Which of the following best describes the barrier(s) your innovation addresses? Choose up to two

Cost, Quality, Equity.

Social Impact
Please describe the goal of your initiative; outline what you are trying to achieve

DIIME’s goal is to change the landscape of global health through the creation of medical technologies which are designed specifically to serve the needs of facilities, clinicians, and patients in limited-resource settings. The current aid industry primarily donates equipment, which is ineffective in addressing the real issues, creates a market expectation of free or nearly free equipment, and perpetuates a dependence on foreign aid which rarely creates a lasting, sustainable impact on the local community. We seek to change this by creating a sustainable business focused specifically on this market and designing specifically to their needs. To accomplish this, we intend to see Hemafuse in use in clinical settings at a sustainable price point.

What has been the impact of your solution to date?

We have successfully created a new technology that has tremendous potential to positively improve the challenges of blood shortage. Hemafuse has undergone several design iterations to arrive at the current prototype, and the feedback of both Ghanaian and American clinicians was heavily incorporated during the design evolution. Testing and validation of Hemafuse is at the forefront of our current activities. The design has received positive feedback from Ghanaian physicians indicating that Hemafuse is a device they want to use. The device was described by clinicians as “simple, efficient, and life-saving.” We have completed preliminary testing with reconstituted human blood, which shows no clinically significant damage to blood processed through the device. DIIME’s next step is to initiate a pilot study at Komfo Anokye Teaching Hospital, where we will begin the process of obtaining regulatory approval. The goal for market entry is 2013.

What is your projected impact over the next five years?

Over the next 5 years, DIIME intends to complete the clinical development of Hemafuse and release it to facilities worldwide. Our initial target market is in Ghana, and we are currently exploring possible geographies of expansion. Our focus is sub-Saharan Africa but we are also actively investigating implementation in Haiti and Cambodia. Within five years, we intend to reach annual sales of approximately 10,000 devices, affecting the lives of 500,000 patients. Additionally, we are researching potential uses in surgical procedures beyond ruptured ectopic pregnancies, especially blunt abdominal trauma resulting from road accidents. Finally, we plan to continue development of several other devices, all centered on maternal and infant health issues.

What barriers might hinder the success of your project? How do you plan to overcome them?

Regulatory hurdles present a significant barrier to success, as significant testing and regulatory approvals are required before medical devices can be implemented in a clinical setting. This presents a significant barrier in both time and cost, requiring multiple rounds of clinical testing to achieve. Additionally, the clinicians who will use our devices frequently have little influence on hospital purchasing decisions. We are preparing for a pilot study in Ghana, which we intend to complete by the second half of this year; this is the first step in obtaining regulatory approval. We have a basic understanding of the purchasing process and are pursuing several different customers, including individual hospitals, centralized government purchasing, and individual non-profit organizations.

Winning entries present a strong plan for how they will achieve and track growth. Identify your six-month milestone for growing your impact

Begin pilot testing of Hemafuse at Komfo Anokye Teaching Hospital, Kumasi, Ghana.

Identify three major tasks you will have to complete to reach your six-month milestone
Task 1

Complete fresh animal blood testing

Task 2

Complete regulatory and logistical requirements

Task 3

Finalize pilot testing protocol

Now think bigger! Identify your 12-month impact milestone

Finalize manufacturing, sales, and distribution plans for the initial product launch in 3-5 tertiary hospitals in Ghana

Identify three major tasks you will have to complete to reach your 12-month milestone
Task 1

Identify and reach an agreement with appropriate manufacturing and distribution partners

Task 2

Pass all necessary regulatory requirements to begin unrestricted clinical use of Hemafuse

Task 3

Obtain commitments from 3-5 initial customers

Sustainability
Tell us about your partnerships

We have received ongoing support from several University of Michigan departments, including the College of Engineering, the Center for Entrepreneurship, and the UM Health System, particularly the obstetrics and gynecology and pathology departments. We are exploring a more formal partnership with Komfo Anokye Teaching Hospital and currently have the support of numerous individual clinicians, including the head of the Obstetrics and Gynecology department.

Are you currently targeting other specific populations, locations, or markets for your innovation? If so, where and why?

Geographic expansion beyond Ghana is essential for the growth of the company. The initial target market for Hemafuse is Ghana, due to the connections established during primary research. Ghana is also one of the most stable and fastest growing countries within sub-Saharan Africa. Beginning there will allow us to assess business practices and gain credibility that will allow us to scale to other areas with similar conditions and blood shortage. We are currently investigating the most promising potential markets for expansion.

What type of operating environment and internal organizational factors make your innovation successful?

DIIME’s office space is located in a student start-up incubator with other social and commercial enterprises in fields ranging from global health to software development. This environment allow us to tap other creative and experienced mind on a daily basis. Additionally, our organizational structure is very flat and our culture of open communication lends itself to continual brainstorming and innovation.

Please elaborate on any needs or offers you have mentioned above and/or suggest categories of support that aren't specified within the list

The most pressing barrier we face is in the initial capital needed to manufacture Hemafuse and complete clinical testing to ensure that the device is safe for clinical use.

randomness