Investment in the medical device industry has been on the rise in recent years, with venture capital investment in medical devices nearly doubling in the past two years, reaching $4 billion in 2007. Both globally and in the Chinese market, small, unlisted medical device manufacturers, possessing products, markets, and innovation, are gradually becoming new favorites for investment. For these small companies, establishing a foothold and standing out in the fierce market competition is extremely difficult. Their core technical personnel may be experts in the biomedical field, possessing certain patents or research results, but how to quickly transform these patents or research results into products with a very limited team, while ensuring the reliability and stability of the products, is a significant challenge. Through NI's graphical development environment LabVIEW and commercial embedded prototyping platform, domain experts or R&D personnel can seamlessly integrate hardware I/O and algorithms, rapidly developing medical devices with limited team size. This is mainly due to three factors:
1. Most domain experts—referring here to physicians and biomedical engineers—are primarily skilled at improving and innovating diagnostic and treatment methods, rather than complex electronic, mechanical, or embedded solutions. Through NI's seamlessly integrated hardware and software platform, they can focus on the technology itself for diagnosis and treatment, rather than the underlying system implementation details.
2. Rapid functional prototyping can attract the next round of venture capital investment early in product development. NI is one of the few companies that provides solutions for rapid prototyping, offering numerous hardware and software features for quickly building system prototypes.
3. The weak signals generated by the human body require sufficiently high analog acquisition accuracy. NI is a technology pioneer and leader in PC-based test and measurement, providing the industry's most advanced data acquisition equipment.
This article will mainly introduce three examples of medical device design based on the LabVIEW graphical development platform by three start-up companies.
OptiMedica
OptiMedica has developed a novel laser therapy device for the diagnosis and treatment of diabetic retinopathy based on the NI graphical development platform. Laser therapy primarily involves aiming and firing laser pulses to seal microaneurysms and leaks from abnormal blood vessels. Due to the complexity and precision of the surgery, this laser aiming and firing has been manually controlled by doctors for nearly 35 years. This innovative laser therapy platform, based on LabVIEW FPGA and NI R-series devices, uses a high-precision, automated control system to assist doctors in aiming and firing multiple laser pulses in a specific pattern, thereby accelerating the surgery and reducing the number of treatment sessions.
OptiMedica's R&D team, with prior LabVIEW development experience, decided to utilize LabVIEW FPGA and NI R-series intelligent data acquisition devices to shorten product development and certification cycles, eliminating significant work related to board-level design and hardware verification. Through a graphical development environment and a commercial hardware platform, the team quickly and efficiently developed a prototype system for the therapeutic device and successfully demonstrated its functionality to potential investors. This hardware solution, with its built-in FPGA in the R-series devices, improved system reliability and facilitated FDA approval. Using a programmable FPGA instead of a custom ASIC chip reduced development time by 30%.
Sanarus Medical
Sanarus is a medical device startup. They plan to develop a revolutionary surgical device, the Visica2 treatment system (V2), which uses liquid nitrogen to cryo-kill tumors in outpatient settings. The V2 is designed to be a device that can be placed in a doctor's office or clinic. The treatment procedure includes painless local anesthesia and real-time ultrasound-guided lesion localization. The treatment lasts approximately 10 to 20 minutes, freezing and killing the target tissue through a small incision. Patients will not require post-operative sutures.
To meet the product launch schedule, the developers planned to develop a working prototype of the V2 system within four months. Furthermore, at the investors' request, they also needed to produce the V2 as quickly as possible to meet market demand. Writing firmware and developing a custom circuit board for the device was a lengthy process. Problems in the firmware or software layers would cause additional delays, negatively impacting the overall project schedule. Because the V2 is a medical instrument, it required that the device be free of any firmware or software errors that could impair system performance. If the device failed the consumable tests required for 510(k) certification, the entire project would fail, and the V2 could not be brought to market. Based on these requirements, the V2 needed a highly reliable development solution.
The developers decided to use the commercial embedded prototyping platform CompactRIO for their project. The CompactRIO system includes a 400 MHz embedded microprocessor, an Ethernet controller, and a 3 million-gate FPGA on the backplane. They ran control algorithms for the liquid nitrogen pump and purely resistive heating components in the embedded controller, and managed the necessary input/output interfaces for these devices in the FPGA. This resource configuration made prototyping and final system deployment very similar in programming paradigms. The developers designed and validated the functionality of V2 in a very short time. The benefits of using CompactRIO were obvious—a custom solution would take months, while NI's solution only took a few weeks.
Furthermore, using custom firmware, new requirements led to tedious update work. Using the CompactRIO platform, they could modify the code effortlessly. For example, if user interaction required a touchscreen instead of a keyboard and LEDs, the developers created a touchscreen control program using LabVIEW on Windows. LabVIEW's shared variable technology made data transfer between the touchscreen and CompactRIO easy to manage. Because the development platform was highly flexible, the development process wasn't delayed when new functional requirements arose.
Since CompactRIO is EMC certified, this ensures that they do not need to consider specific EMC-related designs when verifying prototypes.
Fluidnet
Research indicates that nurses spend 15%-60% of their time on tasks such as intravenous infusions. Therefore, Fluidnet and Boston Engineering have developed a series of user-friendly infusion devices based on LabVIEW embedded modules to address the shortage of nurses in hospitals. These new infusion devices are more precise and safer, offer a wide range of selectable flow rates, and are priced lower than existing infusion devices.
Fluidnet designed its first closed-loop controlled infusion prototype system using the LabVIEW platform and NI data acquisition devices, featuring patented real-time flow and automatic volume sensing capabilities. In the productization phase, Fluidnet collaborated with NI's system consortium partner, Boston Engineering, developing the final product using a FlexStack micro-board based on an ADI Blackfin processor. Because LabVIEW embedded modules can directly program the Blackfin processor and support C code generation and optimization, this graphical programming approach significantly reduced code development workload and accelerated the system development process. Furthermore, due to LabVIEW's openness, new features can be easily added to the system. For example, Fluidnet added RFID tags to some new infusion devices to record and identify medication information, allowing nurses to remotely monitor the infusion pump's operation via Bluetooth.
summary
The LabVIEW graphical development platform provides a unified environment for algorithm design, prototype verification, and product release, encompassing software debugging, functional testing, and production testing. This allows engineers and R&D personnel to design and develop products on the same platform, reducing iterative development and code modifications, thereby accelerating the design process. Simultaneously, through NI's commercial embedded prototyping platform, researchers can quickly transform patents or research results into products, ensuring product reliability and stability, thus shortening the development time for medical electronic devices.
