Our disruptive innovators and designers, engineers and scientists, regulatory consultants and strategists, combine to help you realise your unique product development goals.
End-to-end product development & commercialisation expertise
Product Development
Industrial design, UX, HFE
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:
- User-centred Design
- VoC insight and interpretation
- Human factors engineering (Physical Ergonomics, Usability & User Interaction)
- Ideation, innovation facilitation & creative conceptualization
- HF Documentation & Usability Design for medical devices to IEC 62366
- Structural Packaging & DFU support
- GUI Development
- Product Vision & Marketing Collateral
Mechanical design
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
- Laboratory automation
- Diagnostic Imaging
- Defence and Aerospace, including ruggedized solutions
- Consumer durables and FMCG
Software design
The Hydrix software development team offers deep experience across the product development domain, developing solutions for applications from 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
Electronics design
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:
- Digital, Analogue, Mixed Signal Electronics
- High-Speed, RF, Rigid, Flex, Rigid-Flex PCB Design
- EMC & Safety Compliance
- Wearable & Handheld Low Power Portable Devices
- Safety & Mission Critical Design
- RFID, Wi-Fi, Bluetooth
Project management
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.
Systems engineering
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
- Value Engineering
- Failure Modes and effects Analysis (FMEA)
- Dedicated independent Verification and Validation analysis and testing
Regulatory consulting
Increasingly complex regulatory requirements and rapidly evolving technology can create headaches for medical device developers. Our regulatory consulting team is a unique resource that helps navigate this complexity.
Through strategic guidance and input into the product development process, our regulatory team’s involvement leads to more of a mature regulated product. We help our clients navigate changing regulatory environments including US FDA, European CE, Australian TGA, and other areas of APAC such as China (NMPA) and Singapore (HSA). Our regulatory experts, clinical affairs specialists and product development professionals are supported by a mature Quality Management System.
We have tailored our services to suit medical developments with different levels of maturity and projects of a variety of scope and complexity.
Our integrated regulatory consulting 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 strategy development for global markets including FDA, CE, TGA, and other areas of APAC such as NMPA and HSA
- Standards compliance
- Regulatory gap analysis and preparation of mitigation plans prior to regulatory submission
- Regulatory assessment and remediation to address new regulatory requirements
- Regulatory submission support
- New markets regulatory support
- MDR transition support
We can support your medical device strategy with expertise in design and implementation of clinical strategy from clinical evaluation planning, clinical investigation design, through to final clinical and regulatory submissions and journal publication, service delivery design and implementation. Our services include:
- Clinical Evaluation Plan (new requirement under MDR)
- Clinical Evaluation Report
- Clinical Project Management
- Clinical investigation design (first in human, pilot, pivotal, post-market clinical follow up)
- Clinical Investigation Plan (protocol)
- Investigator Brochure
- Clinical Investigation Report
- Human Research Ethics Application (HREA)
- Participant Informed Consent (PIC)
- Journal article creation, review and submission
- Service delivery design and implementation
- Periodic Safety Update Reporting (new requirement under MDR)
We are able to provide Australian reimbursement support for surgical, diagnostic and pathology procedures, medical devices, and prostheses.
Our services include:
- Reimbursement strategy development for start-up companies
- Reimbursement risk assessment for new medical devices
- Prosthesis List applications (PLAC) and amendments
- Medical Services Advisory Committee (MSAC) Applications
- Reimbursement training courses
- Valuation of custom medical devices
- Economic models for sales team use
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 devices are greatly enhanced by an effective and efficient QMS and 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)
- Dedicated Improvement Management System
- Corrective and Preventive Actions (CAPAs)
- Non-Conforming Management Reports (NCMRs)