Surgical and Therapeutic Medical Devices
Minimally Invasive Breast Biopsy System
A surgical device company with expertise in disposable components wanted to develop a vacuum-assisted surgical biopsy system. This would 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 the 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 then 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, NH, location, due to its rigorous quality controls and staff experience.
Radiation Delivery Device
For a minimally invasive radiation delivery device, KMC Systems provided contract design services. The device provides automated delivery and control of a radioactive catheter tip to ablate 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.
Therapeutic Cell Processor
Lacking staff resources, a start-up medical company selected KMC Systems to help it bring a therapeutic cell processor to market. 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.
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 apheresis 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 due to imprecise delivery. To improve patient treatment, one company sought to create a device to non-invasively and more precisely deliver therapeutics. The idea was to automate the delivery of cryogenic fluids for the ablation 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 and partnered with KMC Systems for contract engineering support. Together, the two companies 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.
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 that would automate the measurement of the esophageal reflex reaction through the 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. This task involved 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.