Our team of mechanical, mechatronics and product design engineers combine to create extraordinary technologies. Their engineering capability is augmented by an array of simulation, test and analysis tools, in-house prototyping and test laboratories.
Our team works across all areas of market focus, developing robotics, custom automation and complex mechanisms. Our market segment experience includes:
FDA Class II and Class III devices
IVD and POC platforms
Defence and Aerospace, including ruggedized solutions
Consumer durables and FMCG
Hydrix's industrial designers work across markets, helping to realize breakthrough solutions in mining, medical, consumer markets and more. A common focus for the design team is to ensure all stakeholders are considered in design solutions, with many projects commencing from a User Experience (UX) perspective. Our team offers expertise in:
VoC insight and interpretation
Human factors engineering (Physical Ergonomics, Usability & User Interaction)
HF Documentation & Usability Design for medical devices to IEC 62366
Structural Packaging & DFU support
Product Vision & Marketing Collateral
The Hydrix software development team offers deep experience across the product development domain, developing solutions for applications more medical devices through to Critical Systems compliance at Class A, Class B and Class C level. We can implement a fully integrated system solution that includes multiple devices e.g. Smart Phone, PC, custom electronic devices, or just assist with one of the elements.
Development of firmware down to bare metal for Medical, Industrial, Commercial devices
Implementation for connected devices (IoT)
Integration with our design and user experience experts to provide GUI, control interface solutions
Working with scientists and engineers to convert mathematical and scientific models into software algorithms.
Mature software development processes suitable for safety critical applications
Our electronics work extends from initial concept selection and feasibility, through to supporting manufacturing ramp up. We follow a stage-gated process, aligned to key milestones to ensure requirements are met and suitable technical solutions are implemented to achieve the customers goals.
Our specific capabilities include power electronics, RF and wireless communication, high-speed digital and analogue electronics, and other areas including:
The complex nature of our projects in medical, defence and aerospace markets often require a dedicated systems-level engineering focus to ensure success. The ability to manage multiple interfaces, subsystems, stakeholder requirements and opinions, is a key component of the system engineer’s capabilities, helping guide and inform our specialist designers and engineers. Their expertise includes:
Helping to define and scope customer needs, requirements and desired functionality
Management of client needs and requirements, integration of customer technology
Verification and validation methodologies and testing
Functional Analysis and Modelling
Failure Modes and effects Analysis (FMEA)
Dedicated independent Verification and Validation analysis and testing
The selection of the ‘right’ project manager is critical to the success of any project. We pride ourselves on the quality of our project managers, as individuals, as communicators, and as domain experts.
From technical excellence to advanced leadership skills, our project managers plan and control every aspect of the project life-cycle, from concept to definition, implementation to handover. They have the best tools and processes at their disposal to successfully deliver your project, regardless of your location or time zone.
Regulatory consulting, Quality systems
We help our clients navigate regulatory environments including US FDA, CFDA, European CE, and Australian TGA. Our regulatory experts and product development professionals are supported by a mature Quality Management System.
Increasingly complex regulatory requirements and rapidly evolving technology can create headaches for medical device developers. Our regulatory consulting team is a unique resource in managing this complexity, through strategic guidance and input into the product development process, leading to more a mature regulated product, and increasing the opportunity for better compliance outcomes.
This integrated approach helps our global clients overcome regulatory hurdles, assisting from one regulatory milestone to the next, reducing risks and facilitating compliance on the way towards a successful submission. Our services include:
Regulatory assessment and remediation to address new regulatory requirements
Preparation of mitigation plans prior to regulatory submission
New markets regulatory support
Regulatory Gap Analysis
Regulatory Submission Support
Our culture of quality and compliance is driven by our Quality Management System (QMS) leadership. Developing innovative products for highly regulated industries such as medical device are greatly enhanced by an effective and efficient QMS wand the Hydrix framework has been matured to expedite product development activity.
With a strong foundation of procedures and work instructions, our QMS is compliant with ISO 13485 and ISO 9001. Hydrix’s QMS experts are available to assist with:
Implementation of Electronic Quality Management Systems (EQMS)