The Silicon Review
With over two million medical devices available today, belonging to thousands of types, the need to ensure that they are reliable, safe, and affordable is obvious. Medical devices are primarily the brainchildren of engineers, in comparison to pharmaceuticals derived from chemical specialists' work. Moreover, the segment to which either of these goods is marketed is quite different, the risks involved, and the methods used to evaluate the efficacy and effectiveness of the item in question. Medical devices help diagnose, treat or monitor individuals with potential disease states. To do so, they must fulfill the purpose for which they were designed, be robust and avoid harm to the patient and operator. Several studies have noted that with the global marketing of medical devices, more and more adverse events are being reported, including severe and fatal events.
Hydrix is one such medical product development company, specializing in complex, regulated and safety-critical projects. For 20 years, they have been the development partner of choice for companies creating first-of-type products and technologies. They work across multiple industries partnering with clients to help design, develop and commercialize transformative technologies in Class II & Class III MedTech devices, consumer and industrial products and safety critical applications. The customers choose Hydrix for their unwavering focus on the technical and commercial needs, successfully delivering challenging projects on time, on budget and to their complete satisfaction.
Cardiovascular Device Development: Addressing the Global Health Problem
Hydrix's comprehensive medical device development team offers the complete journey, encompassing funding and commercialization, regulatory strategy and QMS establishment, the full range of product design and engineering services through to product distribution where appropriate. Over 20 years of developing medical devices the company has helped clients ranging from start-ups to multinationals. Currently Hydrix is working with cardiac technology innovators, research teams, healthcare professionals and patients to deliver better cardiovascular solutions & devices, user experiences and health outcomes. Their cardiovascular device development technology includes;
Mechanical Circulatory Support: With heart disease on the increase, demand for cardiac assist devices is growing. The company assists in the development of specific cardiovascular devices including Mechanical Circulatory Support (MCS), Ventricular Assist Devices (VADs) and Total Artificial Hearts (TAHs). Hydrix's10 year track record of MCS system development, including safety critical software and electronics, and transitioning from proof-of-principle to First-In-Human (FIH) trials is enabling their clients to develop better MCS solutions for patients and patient experience with human factors engineering investigation.
Cardiac Monitoring: Demand for monitoring and alerting technologies in the form of implantable and external cardiac devices for physician and patient alerting is 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 development work includes technology integration for an implantable cardiac device and human factors engineering to develop novel concepts for cardiac Holter monitors.
A Novel Platform Technology Accelerating LVAD/TAH Development
Hydrix has created a first of kind Mechanical Circulatory Support ‘platform technology’. Developed for emerging MCS innovators, it allows them to more rapidly and accurately control their pump, enabling them to de-risk and accelerate their MCS device development program. Hydrix has an established track record in the development of Mechanical Circulatory Support (MCS) technologies, specifically control systems and power management solutions for Left Ventricular Assist Devices (LVAD) and Total Artificial Hearts (TAH). With control system development also comes the human element. Whether the device is a bridge-to-transplant or destination-therapy, you are developing a complex system that must be worn and managed by people that are often elderly, very frail and unwell or otherwise incapacitated, while affording them an improved quality of life. Hydrix's team has worked on a variety of projects exploring and brainstorming options for improved usability, for both adult and pediatric scenarios. Projects have encompassed usability trials through to market insights, including recent interviews with VAD coordinators, who liaise with the patient from evaluation and initial implant onwards, and who have an inherent understanding of the real-world struggles faced by patients.
Gavin Coote | Executive Chairman
Gavin is Executive Chairman of Hydrix, an ASX-listed diversified Medtech company. Gavin’s 30 years Executive and Board leadership experience includes roles in financial advisory services, corporate mergers and acquisitions, early-stage venture investing, private equity turnarounds, and capital and debt raisings for listed and private companies. His experience is gained from a diverse range of industries and companies, with sizes from start-up through $1 billion revenues and includes 11 years in the USA. Companies include Hydrix Limited, Imperium Capital Group, Platinum Technology International and PwC. Gavin completed an MBA at the University of Michigan, a Bachelor of Economics at Monash University and is a member of the AICD.