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.
Wound Management Cloud Data Platform
Client specializing in predictive analytics, with a system that leverages AI to predict how a wound will heal using specialized image capture and analysis, was looking to expand their ecosystem to include a centralized datastore and cloud backend to enable clinical workflows and algorithm research, add connectivity with hospital and clinic networks, and support interoperability with clinical record keeping (EMR).
Connected Devices – Smoking Cessation
Development of a visionary approach to disease management by pairing a programmable passive transdermal drug delivery wearable with mobile applications to provide behavioral coaching, with initial focus on smoking cessation
Connected Devices – Health Hub Appliance
Full Spectrum was the software development partner for our client, collaborating with their Systems, Electrical and Mechanical engineers to develop the first release of a countertop medication-dispensing appliance that integrated with the client’s pharmacy automation systems.
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.
PIM POC for Robotic Vascular System
A surgical robotics subsidiary of a large multinational healthcare organization was seeking a partner to develop several proof-of-concept (POC) patient interface module (PIM) prototypes to serve as part of the user interface for manipulating up to four devices with linear and rotational degrees of freedom.
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.