Our client was developing a 6 degrees-of-freedom robotic patient positioning system for use in image-guided radiation therapy and seeking a software development partner to design and develop the product software. This is a Class III medical device.
Blood Handling Product Portfolio
In light of the latest FDA cybersecurity guidance, a leading blood handling equipment manufacturer sought help in developing and maturing their cybersecurity practice for their broad portfolio of fielded legacy products.
Endovascular Surgical Navigation System
Our client, a spin-off from a leading US-based cardiovascular innovation center, was commercializing a 3D GPS-like surgical navigation technology that enables highly accurate minimally invasive vascular surgery with reduced radiation exposure. This is a Class III medical device.
Multi-Channel Infusion Pump
Full Spectrum teamed with a company developing a new multi-channel infusion pump. The program was a government-funded, dual-phase engagement that begins with the development, build, and verification of a proof-of-concept (POC) prototype, with successful demonstration of POC functionality and performance to be followed by a full development and commercialization effort under design control and submitted for FDA approval.
Multi-Channel Infusion and Diuretic System
Our client, an early-stage company, was working on a novel fluid management system to get through IDE for clinical trials. Delivery challenges with the existing vendor had already delayed clinical trials and eroded client confidence in the outcome. This is a Class III medical device.
Infusion Pump Software, System Design and V&V
Clients developing, updating, or remediating infusion pumps rely on Full Spectrum expertise. Full Spectrum has focused engineering practices in software and system design, system integration, system compliance, V&V of the system and software, and experience with various infusion pump technologies, including syringe technology, peristaltic, ambulatory, combination delivery devices, and ACE controllers.
Implanted Neurostimulator for Chronic Pain Relief
As an early-stage company new to medical device development, the client came to Full Spectrum due to serious quality issues related to Bluetooth wireless communications and sought a partner capable of implementing advanced features not part of the original design.
First Responder Portable AED
Early-stage client developing an AED designed to be carried in a pouch for first responders and other professions that regularly interact with the public, like ushers or stadium employees. Full Spectrum was engaged to help improve requirements, create test plans/test cases, execute system and software verification, and improve the verification approach for the proprietary ECG analysis algorithm for this Class III medical device.
Patch Pump with Mobile Application
Full Spectrum partnered with a client in the late stages of developing a patch pump with companion mobile app and cloud services for chronic disease management.