Hemafuse

medical devices

Jun 26

An Innovative Device for Blood Shortages in Emerging Markets

“Sisu” means perseverance in the face of adversity, and true to its name, our friends at Sisu Global Health are breaking boundaries in healthcare with their handheld autotransfusion device - the Hemafuse.

Blood transfusions are life-saving procedures that mitigate internal bleeding and blood loss due to surgery, childbirth, or traumatic injury. Unfortunately, such high-risk procedures requires an ample blood supply and expensive equipment, both of which are often unavailable in low-resource settings and challenging environments like remote villages or war zones.

Hemafuse empowers clinicians to capture a patient’s own blood, filter it, and return it to that same patient. This handheld and electricity independent device eliminates traditional barriers and the need for the time-consuming search for and testing of compatible blood donors during emergencies.

Now, everyone can be saved by their own blood – the safest blood transfusion method.

Harbor Designs and Manufacturing’s Role: DFM review, optimize tolerance stack up for mating components, production planning, turn key cleanroom assembly, final pack out and sealing, quality assurance, inventory control, logistics support.

Innovation in Adversity

CEO Gillian Henker and her cofounders launched Sisu Global Health with the critical mission to democratize access to innovation with solutions engineered to suit underserved and under-resourced markets. With 80% of the words medical innovations serving only 10% of the global need, mostly in Western markets, they set out to devise devices optimized for the realities of the rest of the world.

Massive underserved markets (e.g., Sub-Saharan Africa) have massive patient populations and critical needs, but they also face critical limitations in funding and infrastructure.

Their first product, Hemafuse, was initially developed for Ghana, where hospitals relied on the "soup ladle" method—a highly unsterile and unsafe practice involving collecting blood with a ladle and filtering it through cheesecloth before recycling it to the patient. This cumbersome method requires 9 hospital staff and over 30 minutes to complete!

*Clinicians Ghana trained on how to use the Hemafuse medical device.*

Hemafuse requires only 1 physician and can be operated in just 5 minutes. The inventor and CEO, Gillian Henker, envisioned, designed, and brought to market this manual blood transfusion device suitable for emergencies and under-resourced communities. It is cost-effective and easy to set up and operate—much like using a syringe!

Engineered for equitable and affordable healthcare, Hemafuse prioritizes cost-effectiveness through its electricity-free design. Blood is drawn into the device and filtered to remove clots and particles by pulling up the plunger. The purified blood is then pushed through tubing into an outlet connected to a blood bag, facilitating a gravity-fed transfusion back into the patient's body.

*2000 Hemafuse devices have been sent to war torn Ukraine and have been instrumental is saving countless lives.*

Prioritizing sustainability, the device is designed for long-term use and minimal environmental impact. While the filters are specifically designed to deconstruct in sterilization to prevent repeat use, the Hemafuse itself can be autoclaved and reused up to 25 times, and each can transfuse three units of blood per transfusion. Most importantly, the blood remains safe from contamination since the patient and the device are the only points of contact throughout the operation.

Manufactured to the Highest Quality Standards

As an ISO 13485, ISO 9001 certified, and FDA-registered CMO, we manufacture medical devices to the highest standards, upholding the quality and reliability of each product we produce. Since 2016, Hemafuse assembly and final kitting have been done in our Class 10,000/ ISO 7 cleanroom.

*Our cleanroom assembly team hard at work building Hemafuse bound for Ukraine.*

*Quality Assurance In-process and Lot Inspection.*

In the controlled cleanroom environment we ensure each device is contaminant-free prior to packaging, and sending to sterilization. Our certified cleanroom is designed to maintain an aseptic workplace, from the HEPA filter systems to the rigorous gowning and protocol followed by our expertly trained staff.

“Blood is a matter of life and death, the impact of this device is saving lives that could have been lost due to lack of blood. Achieving Universal Health Coverage requires innovations for essential medicines and health technologies. Hemafuse should be part of the essential medical devices in each hospital.”

— Dr. Elizabeth Wala, Programme Director for Health Systems Strengthening at Amref Health Africa

Scaling Globally for an Equitable Healthcare

Today, Sisu Global serves clinicians and patients, empowers military doctors to save lives, and supports affordable veterinary care. Hemafuse has saved countless lives globally, including in war-torn regions like Ukraine, where 2,000 Hemafuse have been shipped with the help of non-profit organizations.

The device is making an impact in Sub-Saharan Africa, helping to improve maternal health outcomes in response to the alarmingly high cases of ectopic pregnancies. This groundbreaking innovation and team have garnered support and partnerships from groups like TEDCO, FINCA Ventures, and the Abell Foundation. They have also won numerous pitch competitions like SXSW and USAID and even made the Forbes 30 under 30 List.

With its US FDA clearance, Hemafuse has expanded its reach to more than 80 nations.

Eighty percent of the medical equipment in the world is designed for only ten percent of the population—a statistic Hemafuse and the Sisu Global Health team are actively changing. We at Harbor Designs and Manufacturing support this mission for affordable and equitable healthcare worldwide. Click HERE to connect with the expert team at Sisu Global Health and let them know if you can help in their mission to save lives in under-resourced communities!