Cardiac & MedTech
User insights and deep technical capability improving healthcare for all
At Hydrix, our passion is developing Cardiac & MedTech products and technologies that transform lives
Recent projects that illustrate the value delivered:
A novel non-invasive, intra-operative, navigation tool to assist orthopaedic surgeons position the acetabular cup during hip replacement surgery. Our role encompassed program management, design, engineering, quality and regulatory guidance.
Control system design for a Total Artificial Heart (TAH). The project centers around a unique centrifugal pump design that is high flow, low power consumption, utilising magnetic levitation to ensure stable operation and no mechanical wear.
A medical and security imaging system employing novel cold cathode x-ray source technology. Our contribution contributed to the development of a smaller, lighter, more maneuverable system that provides greater operational flexibility.
A targeted MCS platform solution addressing market challenges of developing new cardiac technologies and accelerating time to market.
"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 provide an end to end development offering for Cardiac and MedTech technologies
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.
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 bench-top through animal, first-in-human and clinical trials, and ultimately out into the market.
> CARDIAC MCS (VAD, LVAD & TAH)
Cardiovascular disease is responsible for 31% of all deaths annually and that figure is growing. Heart Failure (HF) is also increasing with the American Heart Association predicting that the number of individuals diagnosed with HF will increase 46% by 2030. For these people, cardiac assist devices including Ventricular Assist Devices (VADs) and Total Artificial Hearts (TAHs) may well becoming a reality.
Our 10 year track record of Mechanical Circulatory Support (MCS) system development is enabling our clients to develop better MCS options for these patients. We are working with cardiac research teams, VAD coordinators, surgeons, nursing staff and patients to deliver better user experiences and enable technology advances, including:
- Driving pump developments with safety critical embedded software and electronics
- Helping partners transition from proof-of-principle concepts to First-In-Human (FIH) trials
- Improving patient experience with human factors engineering investigation
> CARDIAC MONITORING
14% of the global population is afflicted with Cardiovascular Disease (CVD). Therefore, demand for monitoring and alerting technologies in the form of implantable and external cardiac monitoring devices for physician and patient alerting is also increasing. Hydrix’s combined offering of engineering development services for Class III medical devices, and regulatory guidance and strategy, is helping bring these novel technologies to market. Recent experiences include:
- Technology integration for an implantable cardiac device detecting silent ACS events using ST-shift monitoring
- Using human factors engineering to develop novel concepts for cardiac Holter monitors.
- Continuously working with an overall vision for connected monitoring systems for patients, hospitals and care providers.
> SURGICAL DEVICES
Wireless technologies, robotics, artificial intelligence and spatial navigation systems are creating opportunities for next generation surgical tools and devices. The integration of this science is enabling better, more usable tools, faster, more accurate procedures, and an enhanced patient post-operative experience. We are currently working with multiple partners to bring these technologies to market.
- Providing systems engineering, user experience (UX) design, human factors engineering (HFE) and regulatory consulting for a non-invasive, intra-operative surgical navigation tools to improve hip replacement procedure results.
- Supporting novel technologies to aid interventional procedures which work towards the best patient outcomes with the shortest operating times.
> MEDICAL DEVICES
For nearly two decades, Hydrix has helped develop medical devices for clients ranging from start-ups to multinationals. Our comprehensive medical device development team offers the complete journey, encompassing funding and commercialisation, regulatory strategy and QMS establishment, the full range of product design and engineering services through to product distribution where appropriate.
Among our more recent projects, we have:
- Provided Class II embedded software design, algorithm development, usability analysis & design of a point-of-care blood protein test device for improved patient diagnostic analysis.
- Designed and engineered an award winning bench top IVF medical device which uses automated, electrophoretic process for sperm separation.
- Partnered to develop a non-invasive continuous brain pulse oximeter BPOx monitoring system for acutely injured and critically ill patients.
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.
Case Study
Developing award winning products
Development of the Memphasys FELIX
Hydrix and its client, Memphasys, were recently named recipients of two 2020 Good Design Awards for the design of an instrument and cartridge system used to improve outcomes in IVF.
The Memphasys FELIX won a Gold Good Design Award for the Engineering Design category and a Good Design Award for Product Design, Medical and Scientific category. These awards recognised the design and engineering of the FELIX, an automated, electrophoretic laboratory instrument for sperm separation for use in Assisted Reproductive Technology (IVF) procedures. The novel technology aims to improve the chances of achieving a successful pregnancy for infertile couples.
"The device is a world-first technology, so it is highly encouraging when independent assessors review the design and deem the device to be an example of class-leading engineering.”
Alison Coutts
Memphasys Executive Chair
Designing for medical device certification
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
Find out more about our regulatory services here.
If you have a medical device concept, prototype or product and need some hands-on support to get it to market, contact us.