Medical Device Design Portfolio
HPLC Drug Analyzer
KMC Systems contract designed and developed an instrument to detect the presence of drugs in urine samples using high-performance liquid chromatography (HPLC). To engineer the analyzer, which screens for up to 800 different drugs and metabolites simultaneously, KMC Systems engineers applied knowledge of electronics, software, automation and fluidics. KMC Systems also served as the company’s long-term manufacturing partner.
Automated Immunoassay Analyzer
To develop the concept for a fully automated, random-access immunoassay analyzer, KMC Systems first conducted user research to identify important product features. As the contract designer, KMC Systems applied expertise in mechanical, electrical and software engineering to develop the analyzer, which utilizes direct chemiluminescence for the detection and quantification of analytics from serum or plasma samples.
The instrument also includes robotic functions for reagent, sample dispensing and mixing, as well as modules for luminescence detection, magnetic particle separation and wash, and reagent refrigeration All of these were designed by KMC Systems.
KMC Systems performed medical device verification and system and software verification before transitioning the design to manufacturing. The company also successfully contract manufactured the product to high-quality standards.
Point-of-Care Cell Analysis System
A medical device company developed a proprietary disposable cartridge that processes cellular samples. KMC Systems designed and developed a point-of-care cell analysis system based on this cartridge.
KMC managed the co-development of a robust, fully automated, battery-powered point-of-care instrument that processes and analyzes whole blood samples from a disposable microfluidic cartridge. It utilizes an integral digital microscope and fluorescent light sources to illuminate and image whole blood cells.
KMC developed the instrument architecture, system electronics, mechanical mechanisms and enclosure packaging, while integrating the optical subsystem and image analysis software that were co-developed by other companies. Additionally, KMC performed system integration, verification and validation testing, and built several prototypes to support clinical testing.
Automated Immunoblot Analyzer
Creating tools to automate previously manual processes is a major trend in the medical and laboratory worlds. One company recognized a customer’s need for an automated solution to process immunoblot test strips for the confirmatory detection of HIV and HVC in blood. Due to the complexity of the engineering work required, the company contracted KMC Systems to design the instrument.
By applying expertise in software, electrical, systems, and mechanical engineering, KMC Systems created an instrument that automated reagent delivery and mixing, strip washing and incubation, and CCD imaging and analysis.
In particular, automating the assay process proved challenging. KMC Systems solved this by developing a disposable that contained the immunoblot strip. It also developed a multi-functional carousel that provided 37° C incubation, rocked the disposable to mix reagent and had a centrifugal function to move spent reagent into a waste receptacle on the disposable. KMC also developed powerful and robust pattern recognition algorithms to interpret the results and rules for artifact rejection.
KMC Systems accounted for manufacturing during design and smoothly transitioned the project to production to speed time to market. The instrument was contract manufactured at KMC Systems’ Merrimack, New Hampshire location.
CCD Microarray Scanner
A company with a patented resonance light scatter nanoparticle technology contracted KMC Systems to engineer a device to perform multi-wavelength measurements and CCD image analysis. The instrument automates the scanning of microarrays on up to three microscope slides or one 96-well microtiter plate per run.
KMC Systems provided mechanical, electrical and medical software design services and also developed the overall architecture of the instrument. Key subsystems include the multi-wavelength optical system and the high-precision XY-stage robotics. KMC Systems also created all embedded software development and developed the industrial design of the instrument.
KMC Systems easily transitioned the instrument to its manufacturing facility and produced several hundred units.
Cell Analysis System
For a system that analyzes cells in tissue culture plates, KMC Systems provided mechanical engineering design expertise and built prototype systems. A key design requirement was to develop a high precision XY stage with tight alignment needs to eliminate the necessity to re-focus the image between scans. The project is currently being transitioned to manufacturing.
Automated Walk-Away Molecular Diagnostic System
This instrument, which automates a patented nucleic acid probe amplification technology for the detection of infectious diseases, was to be the first completely walk-away molecular diagnostic system of its kind. Early instrument prototype did not work, so the company turned to KMC Systems due to the project’s requirement of advanced engineering and manufacturing capabilities.
KMC Systems enhanced the customer’s design to improve reliability performance and software functionality. Because the system conducts automated functions, such as closed-tube sampling, reagent delivery, magnetic separation and washing, expertise in precision motion software and fluidics was applied. Precision motion control and alignment were especially critical, as the instrument was designed with a disposable that needed to be robotically moved in and out of various modules. The instrument also automates thermally controlled amplification and hybridization and chemiluminescence detection.
The manufacturable design was smoothly transitioned to KMC Systems’ production facility. KMC has continued to provide sustaining engineering support and implemented continuous reliability improvements, which have resulted in the most successful instrument of its type in the market.
Radiation Delivery Device
For a minimally invasive radiation delivery device, KMC Systems provided contract design services for this instrument. The device provides automated delivery and control of a radioactive catheter tip to remove tissue for the treatment of restenosis. The proprietary catheter tip design allows for the treatment of smaller blood vessels and its ability to travel through the femoral artery avoids invasive surgery.
The device required advanced mechanical engineering to allow for accurate delivery of the treatment. The final design created by KMC Systems was functional, manufacturable and easily transitioned to its manufacturing site for the production of systems for use in clinical trials.
Liver Assist Device
In the early days of cell-based therapies, a start-up company sought to develop a solution to help patients with acute liver failure survive the wait for liver transplants. The company’s idea for a bio-artificial liver assist device would automate a proprietary extracorporeal circuit consisting of a hollow fiber cartridge containing primary porcine hepatocytes as an adjunct therapy to plasma pheresis.
To engineer the device, the company contracted KMC Systems due to its mechanical engineering and fluidics expertise. KMC Systems also provided the pumping technology for filtration of the plasma.
The device had several unusual characteristics that complicated the engineering process. First, the bio-artificial liver cartridge included porcine liver cells that were used to clean patient plasma. A key function of the device was to keep these liver cells alive, so KMC Systems designed mechanisms for temperature control and oxygenation. Another unusual feature was the absence of software. KMC Systems designed the device so that an aphaeresis technician could easily use the instrument.
Tissue Cryo-Ablation System
Previous treatments for diseases such as tachyarrhythmia, restenosis, and ischemia included invasive surgery and therapeutics with reduced efficiency because of imprecise delivery. To improve patient treatment, one company sought to create a device to more precisely deliver therapeutics.
The idea was to automate the delivery of cryogenic fluids for the removal of tissue using a catheter-based control fed through the femoral artery. Using a fluoroscope, the device would be maneuvered to the precise location for tissue ablation.
When designing the device, the company ended up with a nonfunctioning prototype. They partnered with KMC Systems for contract engineering support. Together, we implemented design changes to create a manufacturable, functional prototype. The final control console is a microprocessor-based system that regulates temperatures and pressures of the cryogenic fluid delivered through the catheter for precise energy delivery.
KMC Systems manufactured several systems for use during clinical trials and then smoothly transitioned the project to the customer’s manufacturing site for full-scale production.