Development of a medical device for ophthalmology using custom microfluidic instruments from ELVEFLOW

1- Scope of the project and use of Elveflow’s custom microfluidic instruments

FR-Systems is a technology company developing custom turnkey hardware and software solutions. In the context of our collaboration with Elveflow, FR-Systems developed a whole hardware and software platform for a customer aiming at developing a brand-new medical device intended for ophthalmology.

The custom microfluidic instruments from Elveflow were used as testing equipment for the product testing and validation. The test rig required very precise characterization of the device’s input pressure, for which we used Elveflow’s equipment. This task was quite complex, as the medical device intended for ophthalmology is based on the measurement of air pressure flow received from a special sensing unit.

FR-Systems conducted a product benchmark but could not find any acceptable solution available on the market until they identified Elveflow as a potential provider of a solution fitting the requirements of the project.

Gennady Zubkov, FR-Systems:

“The overall experience using the Elveflow instruments and interacting with the Elveflow team has been very positive all along the project and most importantly, beneficial for our customer.”

2- Purchase & delivery of a specific microfluidic setup corresponding to unusual technical requirements

We sent a product inquiry to Elveflow through their website. From the very first contact, we received very professional and quick responses from the Elveflow team. 

The very first challenge we faced was selecting the most appropriate set of equipment that would match our task, as the specifications of the project were quite unusual in terms of technical implementation.

Our engineer contacted Robin Oliveres (Elveflow Head of Sales, Integration & OEM responsible) who helped us select the system configuration, including the controller and additional equipment required for the project. 

We discussed all the initial requirements with Robin and received a very structured and correct proposal of the components we would need to purchase from Elveflow in order to implement the test bench. 

All along the characterization of our requirements, we benefited from a very professional interaction as well as a high level of technical expertise to address our specific challenge. We particularly appreciated the obvious willingness of Robin and his team to help and find the right technical solution. 

The delivery process required us to communicate with a third party partner company, since the equipment we bought was intended for our customer. All stages of the delivery were completed with the same professionalism, protecting our relationship with the end user.

3- Hardware integration – design of a custom microfluidic solution for testing the medical device for ophthalmology 

Overview of the testing setup:

The initial requirements of the testing environment that could provide us with an accurate dynamic airflow to emulate an external pressure change to be measured by the end device are as follows:

• The pressure controller shall provide a dynamic pressure flow in the range of: 0 – 400 or 500 mbar (0 – 300…375 mmHg)
• Expected pressure accuracy of 0.25 mbar (0.19 mmHg)
• Expected flow change rate is between 10 – 300 times per sec, with an accuracy of 1%
• The pressure controller shall provide the possibility to generate a pressure flow based on specific input data (based on the user’s application). Note: this requirement was supported by the development of the Python-based application using the ESI SDK

The overall setup of the testing environment designed and set up by FR-Systems is depicted below.

FR-Systems have been working with the Elveflow pressure controller for over a year and have had good experience with this device.

Controller installation & initial testing:

The installation process of the controller, additional equipment and software was very straightforward and easy, since we received all the required detailed documentation (user guides and datasheets) and software installation packages. 

Gennady Zubkov, FR-Systems:

“It has been much appreciated to benefit from a very well documented overall process and great documentation including video recording of step-by-step initial installation. We were able to easily and quickly run the system despite its apparent complexity.”

4- Software development based on the Elveflow Software Interface SDKs

SDKs to automate the testing platform:

It was very crucial for us to develop our own software to control the Elveflow system. Our test scenarios required more complex patterns than the constant or sinusoidal ones available through the Elveflow Software Interface (ESI). We wanted to generate different types of periodic signals with custom amplitudes or frequencies. This was achieved by using the SDKs, a very thrilling moment when we tested their capabilities. We were now able to develop a simple Python application which would take some predefined test data from an external file and fulfill the automatic test scenario. 

Interaction with the Elveflow customer support:

We then started to have some issues. For some reason, our Python application was not working properly with the Dynamic-link library (DLL). We contacted the Elveflow customer support and again received a very quick and professional response from Guillaume Colas, Customer Advocacy Manager. He rapidly resolved the first issue (we were using 32-bit Python with a 64-bit DLL). The second issue we encountered was more complicated. After starting the application, opening the DLL and calling the “init” function, everything was working great except that the controller was not responding to the pressure changes in the command. Together with the customer support team, we finally figured out that we needed to use another version of the ESI SDKs. Since then, all issues were fixed and we started our excessive testing program as illustrated in the application screenshots of some test scenarios below. 

5- Bottom line of the interaction of FR-Systems with Elveflow

Gennady Zubkov, FR-Systems:

“Thanks to the Elveflow controller we performed lots of different testing, ran hundreds of complicated test scenarios while we were developing our medical device for ophthalmology. We wouldn’t get such results as we have in our project without the Elveflow systems and expert support.”

Acknowledgments

Many thanks to the Elveflow team! We’re very glad that we used your products in our project.

About FR-Systems Ltd. https://fr-systems.ru/en/About/ 

“FR-Systems” is a technology company developing software and hardware solutions based on electronic components from global manufacturers such as: Texas Instruments, STMicroelectronics, Microchip (Atmel), Analog Devices, Marvell, NXP (Freescale) and others.