Overcoming the Challenge of Commercialization Fragmentation

We turn fragmentation into a unified path to market

Revolutionary Insights & Engineering Excellence in Cardiac Healthcare

From Initial Concept to Market-Ready Device,
We Provide a Unified Path

Bringing a groundbreaking cardiovascular device to market requires more than just innovation—it demands a seamless journey from conceptualization to commercialization. Our expertise in cardiovascular device development, combined with our cutting-edge in vitro and ex vivo testing facilities, advanced computational modeling tools and prototyping technologies eliminate the fragmentation that slows progress. By providing a unified platform for device commercialization, we enable innovators to de-risk their designs, accelerate development timelines, and confidently navigate the regulatory process. We don’t just solve problems; we redefine what’s possible in cardiac healthcare in the most efficient and effective way.

58

Design & development projects

810

Analyzed Patients’ data

16

Secured patents

10,000

Pages of technical report

Cardiac device development consultation from ideation to commercial use in patients

Providing engineering and efficacy and efficiency assessment service to cardiovascular device manufacturers and pharmaceutical companies and clinical teams

Diganics specializes in developing innovative cardiovascular devices and diagnostic tools. A key focus of its activities is providing technical support to medical device companies and physicians in engineering, development, and validation of cardiovascular devices and speed up the commercialization process particularly transcatheter, surgical and mechanical heart valves.

Pioneering extensive analysis of heart valve replacement outcome

Unique arsenal for device development with unprecedentedly accurate prediction of
transcatheter and surgical heart valve outcomes

Design optimization

Advanced patient-specific computational tools to optimize the design based on real-life conditions.

Computational device-efficacy assessment

Advanced patient-specific computational tools to simulate the efficacy of device.

Advanced prototyping

Advanced methods, tools and frameworks to make the patient-specific 3-D prints.

In vitro device efficacy assessment

State-of-the-art patient-specific in vitro simulator to test the efficacy of the devices.

Detailed flow characterization

Advanced high-speed high-resolution 4-camera particle image velocimetry measurement.

Verification with clinical imaging

Advanced imaging systems and advanced clinical ultrasound machines for verification.

Ex vivo device efficacy assessment

Advanced methods, tools and frameworks to make the patient-specific 3-D prints.

In vitro disease assessment

State-of-the-art patient-specific in vitro simulator to test assess and classify the disease.

The FDA has recognized that patient-specific computational modeling applications are continually expanding and becoming a critical component of medical device development. These applications play an increasingly significant role in providing evidence of safety and performance in regulatory submissions. Diagnics’ computational algorithms and experimental setups support all requirements outlined by the FDA in its guidance document.

(Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions November 17, 2023.)

Computational modeling, in vitro and ex vivo testing services

to support medical device innovators and researchers

Transcatheter aortic valves

Surgical aortic and mitral valves

Transcatheter mitral valves

Cardiac Occluder

Cardiac assist devices

Vascular grafts

Transcatheter tricuspid valves

Stents & grafts

Mechanical heart valves

Vascular diseases

Mechanical heart valves

Cardiac diseases

Innovating for Patient Outcomes

The medical device commercialization process is complex and fragmented. Our expertise in cardiac device development, from ideation to commercialization, streamlines the path to market. Our work is driven by a singular purpose: to deliver life-saving solutions that improve patient outcomes.

Do you have an innovative cardiovascular device idea?

Our engineering team—specialized in the design, research, and development of cardiovascular devices—offers comprehensive, end-to-end support to companies, clinical teams, and individual innovators. From conceptualization to bedside application, we guide you through every stage of development and commercialization, transforming your vision into a tangible, life-saving solution.