FROM: Industrial design renderings
TO: Manufacturing ready prototype and emerging market patient use, patent application
Between 2014 and 2021, in2being had multiple engagements with Sisu Global Health, a med-tech start-up company. Sisu Global is focused on saving lives with an affordable device for autologous blood transfusions (autotransfusions) amid global blood supply shortages.
Doctors worldwide routinely perform blood transfusions—intravenously supplying patients in need with donated blood. However, donor blood isn’t always available:
- According to the World Health Organization (WHO), 40% of the global blood supply is donated in first-world countries that represent only 16% of the world’s population, leaving many third-world nations short of donor blood.
- Even in the U.S., the Red Cross reported as recently as September 2023 that “blood supply has fallen to critically low levels.”
In some instances, doctors can collect and reinfuse a patient’s own blood. This is known as an autologous blood transfusion or autotransfusion.
Gillian Henker witnessed doctors in Ghana performing an autotransfusion with blood gathered with a ladle and strained through a piece of gauze. This alarming process, fraught with infection risks, prompted her to take action.
She co-founded Sisu Global Health to bring a game-changing autotransfusion device—Hemafuse—to market and asked in2being to help.
The Starting Point: Industrial Design Renderings
Henker and her team at Sisu Global knew that existing autotransfusion technology was too expensive for most providers in the developing world. In addition, existing autotransfusion devices required electrical power, which is not always available in rural settings.
They brought in2being’s industrial design renderings for a hand-held, reusable autotransfusion device that requires no electricity and can be operated by two trained health care personnel.
Sisu Global had a great idea but needed help finding funding, creating a functional prototype, and obtaining Food and Drug Administration (FDA) clearance.
“in2being felt very much like an extension of our team,” Henker says. “That was extremely valuable for us…They have been a multifaceted resource for us in what we’ve needed as we’ve been growing. Their process and approach to design helped us build a better product.”
The Process: From Design to Manufacturing and Market Readiness
When Sisu Global started working with in2being, they needed seed funding and a working prototype for Hemafuse.
in2being assisted Sisu Global in the following areas:
- Prototyping: In about two weeks, in2being developed a visually appealing and functional Hemafuse demo.
- Funding: With the prototype and additional guidance from in2being, Sisu Global won a $250,000 competitive grant. “That was a game-changing amount of funding for us at the time,” Henker says. “It was all enabled through the work with in2being on that grant.”
- Manufacturing design and readiness: in2being developed the first manufacturable version of Hemafuse, built molds for Hemafuse’s filter parts so Sisu Global didn’t need to have them made externally, and sourced suppliers.
- First-in-human testing: in2being built samples for sterilization and biocompatibility testing. In addition, the grant money proved critical: “We got the device from a 3D-printed prototype to a clinical pilot in human beings in Ethiopia because of that funding,” Henker says.
- Patent applications: in2being assisted Sisu Global in preparing patent applications to protect their intellectual property.
- FDA clearance: in2being helped Sisu Global prepare a successful 510(k) submission and earn FDA clearance to market the Hemafuse in the U.S. “Thinking of the FDA not as a barrier but as people who have a perspective that needs to be valued in our industry was so important,” Henker says. “in2being really instilled that into me when approaching the FDA. They understood the regulators’ perspective and helped us make strong arguments for the viability of our product.”
The Results: Saving Lives at Home and Abroad
Today, Sisu Global is marketing the Hemafuse in the U.S. and several other countries, where it makes a difference for surgical patients, mothers in childbirth, trauma victims, and more.
Sisu Global even coordinated with a nonprofit organization to raise funds to send Hemafuse to war-torn Ukraine, where it’s been used to save lives in five civilian hospitals and a military field operating unit.
“The in2being consultants have a variety of experience,” Henker says, “not just on the engineering, technology, and scientific side. They are also well-rounded and understand the needs of the business. They understand what pressures there are outside of the engineering bubble and how to help founders with those business aspects. When start-ups approach me for advice, I almost always send them to in2being.”
If you’re developing a new medical device—no matter what stage you’re at—in2being has the experience and expertise to make your idea a market-ready reality.
Contact us today to learn more about our full-service med-tech consulting.