Design and development of medical electronic products based on LabVIEW graphical development platform

LinkedIn's investment in the medical equipment industry has been on the rise in recent years. In the past two years, venture capital investment in medical equipment has almost doubled, reaching US$4 billion in 2007. Whether from a global perspective or in the Chinese market, small, unlisted medical equipment manufacturers are gradually becoming new favorites for investment given their product, market and innovation elements. It is very difficult for these small companies to gain a foothold and stand out from the fierce market competition. Their core technical personnel may be experts in the biomedical field and have mastered certain patents or research results, but how can they quickly transform patents or research results into products and ensure the reliability of the products with very limited team members? And stability is a big difficulty. Through the graphical development environment LabVIEW and the commercial embedded prototyping platform provided by NI, field experts or R&D personnel can seamlessly integrate hardware I/O and algorithms to quickly develop medical devices with a limited team size. The main reasons are as follows: 3 aspects:

1. Most domain experts—in this case, doctors and biomedical engineers—are primarily specialized in improving innovations in diagnostics and treatments rather than complex electronic, mechanical, or embedded solutions. Through the seamlessly integrated software and hardware platform provided by NI, they can focus on the diagnosis and treatment technology itself, rather than the underlying system implementation details.

2. Rapid functional prototyping can attract the next round of venture capital in the early stages of product development. NI is one of the few companies that provides solutions for rapid prototyping, providing many software and hardware features for quickly building system prototypes.

3． The weak signals generated by the human body require sufficiently high simulation acquisition accuracy. NI is a technology pioneer and leader in PC-based test and measurement, providing industry-leading data acquisition equipment.

This article will mainly introduce examples of three start-up companies designing medical equipment based on the LabVIEW graphical development platform.

1. OptiMedica

OptiMedica has developed a new laser therapy instrument for diagnosing and treating diabetic retinopathy based on the NI graphical development platform.

Laser treatment mainly emits laser pulses through aiming to seal microaneurysms and abnormal blood vessel leakage. Due to the complexity and precision of the surgery, this laser targeting has been manually controlled by doctors for nearly 35 years. The innovative laser treatment platform based on LabVIEW FPGA and NI R series equipment uses a high-precision, automated control system to assist doctors in aiming and firing multiple laser pulses at a time in a certain pattern, thereby speeding up surgery and reducing the number of treatments.

OptiMedica's R&D team has some experience in LabVIEW development. In order to shorten the product development and certification cycle, they decided to use LabVIEW FPGA and NI R series intelligent data acquisition equipment, eliminating a lot of work such as board-level design and hardware verification. Through the graphical development environment and commercial hardware platform, the development team quickly and effectively developed the prototype system of the therapeutic instrument and successfully demonstrated the system functions to potential investors. Since the FPGA is built into the R-Series devices, this hardware solution improves system reliability and makes it easier to obtain FDA certification. Using programmable FPGAs instead of custom ASIC chips reduces development time by 30%.

2. Sanarus Medical

Sanarus is a medical device start-up company. They plan to develop an innovative surgical device, the Visica2 treatment system (V2 for short), that kills tumors in outpatients through liquid nitrogen freezing. The V2 is designed to be an instrument that can be placed in a doctor's office or clinic. The treatment involves painless local anesthesia and real-time ultrasound to localize the lesion. The therapeutic treatment lasts approximately 10 to 20 minutes and freezes and kills the target tissue through a small incision. Postoperative patients do not need to seal the needles.

In order to meet the product launch schedule, developers plan to develop a working prototype of the V2 system within four months. In addition, according to investor requirements, they need to produce V2 as soon as possible to meet market demand. Writing firmware for the device and developing a custom circuit board is a lengthy process. Once there is a problem with the firmware or software layer, it will cause additional delays, which is a negative factor for ensuring the progress of the entire project. Since V2 is a medical instrument, it requires that the device must not contain any firmware and software errors that may harm system performance. If the device fails the expendability testing required for 510(k) certification, the entire project fails and V2 cannot be released to the market. Based on these requirements, V2 requires a very reliable development solution.

The developers decided to use the commercial embedded prototyping platform CompactRIO for project development. The CompactRIO system contains a 400 MHz embedded microprocessor, Ethernet controller, and 3 million gate FPGA on the backplane. They run the control algorithms for the liquid nitrogen pump and purely resistive heating components in the embedded controller, and manage the interfaces for the necessary input/output signals to control these devices in the FPGA. This resource configuration allows for prototype construction and final system release in The programming model is very similar. In a very short period of time, developers used it to design and verify the functionality of V2. The benefits of using CompactRIO were clear - what would have taken months with a custom solution took only weeks with NI.

Additionally, with customized firmware, new requirements lead to tedious update efforts. Using CompactRIO's platform, they can modify the code effortlessly. For example, user interaction requires the use of a touch screen instead of a keyboard and LED lights, so developers used LabVIEW under Windows to develop a touch screen control program. Through LabVIEW's shared variable technology, data transfer between the touch screen and CompactRIO can be easily managed. Because the development platform is very flexible, when new functional requirements are proposed, the development process is not delayed.

Since CompactRIO has passed EMC certification, this also ensures that they do not need to consider special EMC-related designs during prototype verification.

3. Fluidnet

According to research, nurses spend 15% to 60% of their time on intravenous infusion and other matters. Therefore, Fluidnet and Boston Engineering developed a series of simple and easy-to-use infusion equipment based on LabVIEW embedded modules to solve the problem of insufficient nurses in hospitals. This new infusion device is more precise and safer, offers a wide range of selectable flow rates, and is less expensive than existing infusion devices.

Fluidnet used the LabVIEW platform and NI data acquisition equipment to design the first closed-loop control infusion prototype system, with patented real-time flow and automatic liquid volume sensing capabilities. In the actual productization stage, Fluidnet cooperated with NI system alliance provider Boston Engineering to develop the final product using the FlexStack micro board based on the ADI Blackfin processor. Because the LabVIEW embedded module can directly program the Blackfin processor and supports C code generation And optimization, this graphical programming method significantly reduces the code development workload and accelerates the system development process. In addition, due to the openness of LabVIEW, it is very convenient to add new features to the system. For example, Fluidnet adds RFID tags to some new infusion equipment to record and identify medical solution information, and nurses can remotely monitor the operation of the infusion pump through Bluetooth.

4. Summary

The LabVIEW graphical development platform simultaneously provides a unified environment from algorithm design, prototype verification to product release, from software debugging, functional testing to production testing, allowing engineers and R&D personnel to design and develop products on the same platform, reducing cyclic development and code corrections, thereby speeding up the design process. At the same time, through the NI commercial embedded prototyping platform, researchers can quickly transform patents or research results into products and ensure the reliability and stability of the products, thereby shortening the development time of medical electronic equipment.