In 2017 AC partnered with Hemex Health to provide rapid prototyping of a medical device that could enter the field as soon as possible.
The Challenge for Remote Testing & Early Detection of Diseases Like Sickle Cell Anemia
In remote areas, treatable diseases like sickle cell anemia and malaria have a devastating impact mainly because access to early detection and treatment is limited. Most people need help to travel from their remote villages to get tested in big cities where test labs and diagnostics are available. For those living outside the reach of these labs, there is typically no testing available and, therefore, no early treatment.
This need for “…creating affordable, life-changing medical diagnostics for more people everywhere” drove Portland innovator Hemex Health to develop a solution to this problem. As described by CEO and Co-Founder of Hemex Health, Patti White, in a video about their partnership with Novartis to advance research and diagnostics together:
“There are definitely countries in Africa where 25% of all child mortality is being caused by sickle cell disease. And if you can diagnose them, 70% of those kids would live. And if they’re not diagnosed, more than half die by their 5th birthday. So we’re talking 750 kids a day are dying from sickle cell disease.”
Medical Device Proof of Concept for Field-Testing & Clinical Trials
In 2017, Hemex secured startup funding to develop technologies with professors at Cleveland’s Case Western Reserve University to commercialize a new blood analysis technology, the HemeChip. At the time, costly and time-consuming laboratory testing was required to confirm a diagnosis. The HemeChip would need to deliver a low-cost, compact, portable, and rapid analysis of blood samples to solve the problem of access to diagnostic blood testing in remote areas of the world.
With millions of dollars of funding at stake, Hemex knew that a successful HemeChip proof of concept would profoundly impact the early detection and treatment of diseases like sickle cell anemia and malaria, saving thousands of lives each year.
Hemex needed an engineering partner with experience in accelerated R&D and MedTech device prototyping. They reached out to Andrews Cooper to design and build a compact, ruggedized solution within a short development window and limited budget. Our Product Development engineers were eager to help them design the vehicle for their emerging HemeChip technology and realize their vision of a “test lab in a box.”
“We were looking for innovation that solved big problems, had proven clinical results, could be developed in 2 years and had a strong business model that would attract investors.” – Hemex Health CEO and Co-Founder Patti White
AC R&D Accelerator: Rapid Prototyping for Medical Devices
AC integrated with Hemex’s design team to develop all aspects of the medical device’s development, including mechanical, electrical, and software engineering, to enable field testing within a short development window and limited budget.
• Prototype Design
• Support for Manufacturing
• Deployment for Field-Testing
The first product we developed was a prototype of the HemeChip portable detection medical device. The prototype would be used in Africa and India by researchers and scientists from Case Western University to gather data on the efficacy of the detection method in the field.
A field-testable prototype was the first and most important milestone. It would ensure proof of concept and enable a multi-phase clinical trial of their technology documented in the HemeChip Study.
Upon successfully deploying the first device, Hemex would need to manufacture additional units to outfit the entire field team quickly.
Critical Aspects of the Medical Device Rapid Prototyping
Guided by our client’s requirements for a rapid development cycle, AC developed Hemex’s first portable test lab. Costs were kept low, and the device used as many off-the-shelf components as possible with minimal customization. This enabled our teams to deliver a field-worthy device into the hands of the researchers at Case Western. Further design refinements could be gathered in the field through additional user feedback.
Engineering Expertise to Solve Key Design Requirements
• High Voltage Medical Device: AC engineers have years of experience designing high-voltage medical devices. This device needed to deliver a fixed voltage or current set to a value determined in the lab before going into the field. The range of variability is 100-500 V and 0-12 mA. The device allows the operator to set the voltage or current and then set the level using an on-screen slider with real-time measurement and display of output. The principal investigators can then establish a default for field testing.
• UX Design: A simple user interface would ease of use and accessibility by a wide range of skills.
• High-Quality Imaging: The actual diagnosis is made by offline image processing. Thus, the device must deliver high-quality images to ensure an accurate result. Fortunately, imaging is an area where AC engineers have spent long periods of their careers and have deep expertise.
• Error-Free Use: The device is designed for use both in the field by minimally trained graduate students and in the laboratory by research scientists. We created a “one big button” user interface for the field and a full functionality interface for configuring the device in the laboratory. AC engineers have prior experience designing user interfaces for life support devices making this an easy task.
• Safety: Since the device could expose operators to dangerous voltages, a multilevel system of safety interlocks was designed to prevent accidental shocks. Again, our experience with high-voltage medical devices came in handy!
• Scientific and Engineering Collaboration: This was a collaborative medtech development effort with the scientists at Case Western. The requirements for the device were roughed out via the telephone and were very rudimentary. However, as development proceeded, AC made discoveries that refined the requirements and improved both how the test was needed and how the samples should be prepared. All of this information was then fed back to the researchers, so they could incorporate our findings into their protocol, resulting in a win-win for all parties.
Additional Details of the Prototype Design
> On-screen slider for easy adjustment of variable voltage and current to test blood samples
> Operator safety ensured by a multilevel system of safety interlocks to prevent high-voltage shocks
> High-quality image capture to ensure the accuracy of offline image processing and diagnosis
> Ruggedized medical design for durability in the field
Andrews Cooper provided a multi-disciplined team executing all mechanical, electrical, and software development tasks while adhering to challenging cost and schedule constraints. The team produced a total of 10 prototype units.