Cardiac & MedTech
User insights and deep technical capability improving healthcare for all
Technologies that transform lives
At Hydrix, our passion is developing Cardiac & MedTech products and technologies that transform lives.
With a proven track record of more than 18 years in product and technology realisation, and a flexible commercial approach to structuring projects, we deliver successful product outcomes, sooner.
We collaborate with our clients in a broad range of medical device markets.
- CARDIAC
- IVD / POINT OF CARE
- IVF
- NEUROSTIMULATION
- ORTHOPEDICS / BIONICS
- PERSONALISED DEVICES
"The Hydrix team's collaborative
approach, controller development
experience and innovation capabilities
in user design were the best fit for Calon
for our Ventricular Assist Device controller
development".
Stuart McConchie
CEO
Calon Cardio
We offer flexible business models. These include fee for service, co-invest, and incubation. We'll work with you to identify the best model to get your development challenge underway sooner.
An end to end offering
Our development process is unique. In addition to our product design and engineering teams, our in-house expertise in clinical, regulatory and quality systems implementation provides our clients with more options, and greater development confidence.
Our ability to call on these specialist skills helps inform the development process, and deliver better product outcomes.
- CLINICAL AFFAIRS
- REGULATORY STRATEGY
- USER EXPERIENCE DESIGN
- DESIGN & ENGINEERING
- QUALITY SYSTEMS
- PRODUCT DISTRIBUTION
Cardiac & MedTech Expertise
We have extensive experience in the development of Class II and Class III medical devices.
From sophisticated cardiac support devices involving heartbeat assistive technologies, to implantable aortic devices, to wearable neurostimulation products and cutting edge diagnostic portable x-ray machines. Hydrix has helped clients demonstrate proof of principle designs, manage the inherent challenges faced in proving core technologies, create functional prototypes and find manufacturing partners. Underpinning the development effort we navigate the regulatory pathways which preclude market release, helping our clients transition from the benchtop through animal, first-in-human and clinical trials, and ultimately out into the market.
Certifications & Design Standards
We have a dedicated and fully ISO 13485 certified Class II & III medical device development group with deep portfolio experience and the know how to deliver high end, high risk projects. Our dedicated regulatory group understands the need for a regulatory strategy, and so throughout the research and development lifecycle, plan and implement a regulatory approach to support the submission process. Working with our Clients we develop the necessary documentation to support all De Novo, IDE, PMA, 510(k) or other new product introductions.
Our medical device design process is also fully compliant to:
-
ISO 14971 – Application of Risk Management to Medical Devices
-
IEC 60601 - Medical electrical equipment
-
IEC 62304 - Medical Software life cycle process for medical devices
-
21CFR820 – Quality System Regulation
If you have a medical device concept, prototype or product and need some hands-on support to get it to market, contact us.