Our diverse mix of cross-functional consultants, regulatory professionals, engineers, designers and project managers will drive your product to technical and commercial success
Product Development Consulting
Challenging product development projects require specialist teams. With our unique offering integrating all our services our product development team is experienced developing complex products in challenging markets.
Hydrix’s fully integrated development team have the skills to take your product from concept to completion; from technical excellence to advanced leadership skills. Our design & engineering specialists work across markets, helping to realise breakthrough solutions in mining, medical, consumer markets and more. Our project managers plan and control every aspect of the project life-cycle, from concept to definition, implementation to handover.
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
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)
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
Technology Commercialisation - LaunchPad
Taking a concept to market can be a daunting process with many ‘moving parts’: Less than 1 in 10 technology start-ups survive. The success of any new or emerging technology business depends upon a range of interconnected factors including the team’s vision and ability to execute this vision, the maturity of your technology, your market structure and size, your value proposition and business model, and sources of funding.
LaunchPad is Hydrix’s Commercialisation Consulting Program. The LaunchPad team is comprised of a team of experienced commercial consultants and advisers who have ‘been there’ and ‘done that’. The LaunchPad program provides a structured and analytical approach to help you reveiw your technology and your businesses strategy, and develop a series of recommendations on the best strategic path for growth.
Brings together all of the preceding analysis into a complete “Commercial Plan” which could be reviewed by potential investors. Risk analysis and mitigation strategies are set in place and an implementation plan (immediate and more long term) is prepared.
This process includes:
Capital raising process
The LaunchPad team can provide interim C-level management to assist with the execution of the commercial plan or fund raising.
LaunchPad can prepare documentation to support fund raising activities and arrange introductions and assistance in the fund raising process. These steps can include:
Support for rasing of capital through 3 rounds including IPO
Formed part of core client team in presenting to investors and negotiating with international distributors
Outsource engineering team – turnkey product design and certification
Private Co developing a hip replacement surgical navigation tool
Duration: 36 months
Incubation of client as startup
Active support for two grants
Interim CEO management services
Outsource engineering team – turnkey product design and certification
Quality System set up
Commercial in confidence
US/Australian Counter-UAV company
Duration: 3 months
Strategy for Bill of Materials (BOM) cost reduction
Product roadmap development
Refine market value proposition
Development approach to add additional user requested functionality
Regulatory, Clinical & Reimbursement Consulting
Increasingly complex regulatory requirements and rapidly evolving technology can create headaches for medical device developers. Our regulatory consulting team is a unique resource who help navigate this complexity.
Through strategic guidance and input into the product development process our regulatory team's involvement leads to more 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.
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 developmentfor global markets including FDA, CE, TGA, and other areas of APAC such as NMPA and HSA
Regulatory gap analysis and preparation of mitigation plans prior to regulatory submission
Regulatory assessment and remediation to address new regulatory requirements
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)
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)
Dedicated Improvement Management System
Corrective and Preventive Actions (CAPAs)
Non-Conforming Management Reports (NCMRs)
We have tailored our services to suit medical developments with different levels of maturity and projects of a variety of scope and complexity. You can learn more on our Regulatory & Clinical market page.
We have the expertise to transform your business. Please contact us to explore how we can help you solve your most challenging projects.