Medical Product Development Portfolio
Automated Liquid-based Cytology Sample Processor
A company that developed requirement specifications for a system to automate the handling and transfer of cervical specimens for molecular diagnostic testing contracted KMC Systems for development services. KMC Systems engineered the entire device, including the electrical, software and mechanical functions and user interface.
Key developed mechanisms included racks to hold the liquid-based cytology vials and the indexing carousel that moved them into appropriate position for processing. KMC Systems also engineered robotic mechanisms to uncap and recap vials, and a mechanical agitation mechanism to create uniform cell suspension. The system also includes a pipette robot that transfers sample from vials to the assay processing disposable.
Bacterial Sample Preparation Automation
KMC Systems was contracted to develop an instrument to automate the manual steps needed to prepare samples for bacterial identification and anti-microbial susceptibility testing. The system automatically processes tubes containing bacterial suspensions by conducting nephelometry analysis to prepare precise sample dilutions to create the appropriate McFarland standard.
Employing expertise in precise robotics, fluidics and mechanisms, KMC Systems engineered the device to transport the tubes by a reusable rack tracked by RFID technology. KMC Systems also developed the graphical user interface to track processes on the instrument’s deck, and a web-based software diagnostic tool to assist field service operations.
After a successful transition from product design phases, KMC Systems is currently contract manufacturing the product.
Laser Scanning Cytometer
A start-up company developed a proof of principle instrument to detect and quantify the presence of cellular markers from samples on microscope slides. However, the company did not have the resources to develop a commercially viable system and chose KMC Systems as its engineering partner The instrument required precision XY stage robotic function and high-resolution microstepping to effectively move the glass slides so that images of the entire surface could be captured. KMC Systems also developed a multi-wavelength fluorescence detection system with user-accessible interchangeable filter blocks allowing the user to employ different filter blocks depending on the type of reagents employed.
After product development concluded, KMC Systems built and tested several prototypes and successfully transitioned manufacturing operations to the customer’s facility.
Real-Time PCR Imaging System
A start-up company with a proprietary thru-hole biochip technology sought an experienced company to develop its product. The company chose KMC Systems due to its expertise in developing and manufacturing advanced medical systems.
To develop a system around this technology, KMC Systems applied expertise in mechanical and electrical engineering as well as embedded software development. Key subsystems developed by KMC Systems included a high-performance thermal cycler and a multi-wavelength fluorescence imaging system. KMC Systems also collaborated with the customer to incorporate the existing user interface and image processing technology.
Automated Microbiology System
For pharmaceutical companies, tight quality controls can often delay time-to-market. One company is seeking to solve this challenge with a device that allows earlier detection and enumeration of potential bacterial contamination, providing more rigorous quality control as well as rapid release of contamination-free materials to production. The medical device automates the microbial culture process and uses image analysis for microbial detection.
Once the company developed the image processing algorithms used to detect microbial presence, it contracted KMC Systems to develop the instrument’s platform. The project required advanced electrical, mechanical and software engineering as well as the development of a robotic transport system to interface the agar cassette with the imager and on-board CO2 incubator. It also included the development of a sophisticated optical-based imaging system within the instrument and a proprietary agar cassette.
KMC Systems is currently in the process of transitioning the product into manufacturing.
Electrophoresis Molecular Diagnostic System
KMC System contract developed a system that automates the testing of donor platelets for bacterial contamination using non-amplified, direct-hybridization technology for the detection of bacterial RNA. The device includes two modules – a lysis and hybridization module and an electrophoretic module – both of which were developed by KMC Systems. The device includes a commercial luminometer that performs signal detection.
The system is able to automate thermally controlled cell lysis and probe hybridization, electrophoretic separation, and membrane target capture.
Minimally Invasive Breast Biopsy System
A surgical device company with expertise in disposable components wanted to develop a vacuum-assisted surgical biopsy system to be used in conjunction with stereotactic imaging to automate the excision and removal of tissue with minimal disruption for pathological investigation. The company had expertise in disposable components but sought a partner with know-how in developing capital equipment.
The company hired KMC Systems to complete a functional prototype in just three months, in time for a major tradeshow. KMC Systems provided rapid prototype development services and delivered in time for the tradeshow, which led to another challenge.
After selling the instrument at the show, the company now needed to quickly deliver a finalized product to its customer. KMC Systems applied its expertise in the surgical market as well as product development experience to accelerate the transition to production. The end result was a high-quality system and a satisfied end user.
Surgical Irrigation Pump
After purchasing the intellectual property for a surgical irrigation pump using a proprietary fluid-pulsing methodology, a medical instrument company contracted KMC Systems to breadboard the system and partner on further development and testing. Compared to continuous-flow pumping systems, this technology provided more efficient irrigation of surgical sites during surgical procedures.
KMC Systems developed a pulsital flow mechanism to perfect the functional performance. Additionally, KMC Systems designed and defined the interface with the system’s disposable component, a key part of the development process. In the development phase, KMC Systems focused on creating a flexible platform allowing the medical instrument company to refine and reuse the pump with other surgery-specific disposable sets.
The manufacturing of the surgical irrigation pump was also outsourced to KMC Systems’ Merrimack, New Hampshire location due to its rigorous quality controls and staff experience.
Therapeutic Cell Processor
Lacking staff resources, a start-up medical company sought a third-party partner to help it bring a therapeutic cell processor to market and selected KMC Systems. The device utilizes high-density magnetic particle cell separator technology to deliver cellular therapeutic products.
KMC Systems developed a manufacturable design using its electronic and mechanical engineering expertise. The final product was developed with two major modules - a Cell Preparation Station and Cell Processor. KMC Systems also served as the contract manufacturer.
Devices for at-home use pose several design challenges as they must be durable, portable and easy-to-use. A start-up company with a technology for home-based treatment of renal failure and fluid overload using hemofiltration and/or ultrafiltration contracted KMC Systems for engineering support. The device’s point of differentiation is its ability to allow patients to receive more frequent and shorter duration therapies, resulting in better patient outcomes.
KMC Systems served as the technical resource team, developing the hardware platform as well as its interface with the disposable. A unique aspect of this device was its ability to house the entire tubing set in the filtration cartridge. KMC Systems developed custom peristaltic pumps, an advanced processing technology, blood detection sensors and an intuitive user interface.
KMC Systems transitioned the project to its manufacturing team for production, using its proprietary Manufacturing Execution System to control quality and speed time-to-market. After a few years, its customer changed strategic direction and KMC Systems seamlessly transitioned production to the company’s internal site.
Intra-Aortic Balloon Pump Control Module
A company was working with a contract development firm to engineer a control console and device to automate the delivery and inflation of a balloon-tipped catheter to the heart via the femoral artery for the treatment of atherosclerosis. However, the company was unsatisfied with its development firm and selected a new partner – KMC Systems - to bring the instrument to production.
The instrument was in the prototype stage when transferred to KMC Systems but numerous systems were not functioning and documentation was not complete. A team of KMC Systems engineers reverse engineered the prototype and then redesigned several aspects of the instrument, including the printed circuit boards and its electronic design. Once the prototype was functional, KMC Systems transitioned the design to production and successfully built several units for clinical testing.
Automated Esophageal Reflex Measurement Device
A company sought to bring to market a device to automate the measurement of the esophageal reflex reaction via delivery of a precisely controlled puff of air through an endoscope to the esophagus. The point-of-care device would be used to monitor therapeutic outcomes for the treatment of swallowing disorders.
Once the company had its proof of principle model, it selected KMC Systems to develop and manufacture the device, which required advanced engineering, including capabilities in software development. KMC Systems developed software algorithms to be used in coordination with a sensor technology to enable the device to characterize the efficiency of the patient’s swallowing mechanism. Additionally, KMC Systems developed customized test equipment to verify that the design would prove functional.
KMC Systems easily transitioned the project to its manufacturing operations and produced the system for several years. When its customer changed its strategy and decided to produce the system internally, KMC Systems seamlessly and rapidly transitioned the project to the customer’s plant.