We combine user insights, deep technical capability, and regulatory strategy to create Point-of-Care (POC) platforms that deliver significant value to our clients and improved healthcare experiences for all.
Developing a new Point of Care platform is an extraordinarily challenging task, and while the overcoming the technology development is a key part of the journey, the success of a new device once launched is not always assured. Companies can face hurdles throughout the development process, but equally, there are other forces at play beyond traditional design and engineering that will influence the success or otherwise of the development. Considering how to better integrate regulatory strategy and compliance within the development process, ensuring you are developing feature sets and performance characteristics that your target market actually wants, and most importantly, designing for the ‘real’ end-user are all variables that must be considered.
At Hydrix, we offer a staged development process for POC development, from proof of principle design through to functional prototypes and transfer to production. We develop our platforms by first focusing on the assay, then cartridge and instrument subsystems, then the instrument. We also offer more than the traditional outsource product development journey. At the front end, we have an insights team that helps you better understand your intended market, the real end user and their issues, healthcare economics and other potential barriers to market entry. We can assist with regulatory insights and strategy through to usability design and the latest GUI trends and implementation options.
However, possibly our biggest differentiator is a unique partnerships model to ensure the best skills and technologies and science are always available for your specific development program. Our approach has been to build relationships with best-in-class technology providers including optics designers, fluidics specialists, cartridge development providers and a range of contract manufacturers. Our mission is to be a single source developer, but one where we identify and manage the best fit, most efficient partner to ensure your project is delivered to your requirements, in your timeframe, and becomes a market success.
What We Do
Design and Engineering
We offer the full suite of product design and engineering services for the entire development journey, with experience in POC platform development and CLIA waiver design. Our team also includes medical industry professionals with decades of invaluable real-world experience, whose unique insights are integral to our design team.
Cartridges and Consumables
With our knowledge of consumables challenges such as fluidics, optical characteristics, thermal transfer, and cartridge-instrument interfaces, we can either develop in-house or where appropriate, collaborate with the best-in-class microfluidics/cartridge design partner for your specific application.
Our insights team uses unique exploratory methods to extract important information from industry personnel, including unspoken needs and pain points, which is crucial in designing the best product and features for the appropriate user.
Regulatory & Clinical Strategists
Navigating the complex landscape of national and international regulations for PoC devices can be challenging, particularly for small or emerging companies unfamiliar with the requirements, resulting in costly corrective actions when not addressed in time. Our team can investigate, advise and help strategize on regulatory strategy.
UX and UI expertise
Through our insights and market knowledge, we are able to design and implement UX/UI strategies that not only place the user first, but also generate adoption and preference through providing a unique, intuitive and desirable user experience. Beyond this, through our interface development capabilities, we also create a positive brand impression, leading to increased reputation and brand loyalty.
Safety Critical Design
We are experienced in Safety Critical design, including FDA Class III software and firmware. It’s this experience that enables us to understand regulatory bodies expectation of evidence and how higher risk profile likely results in these committees/bodies seeking more concrete and more mature evidence of compliance.
Our expertise in Point-of-Care (POC) development includes:
- Market insights
- System architecture definition
- Cartridge-instrument interfaces
- Class II and Class III devices
- Embedded and Application Software
- GUI development
- Digital interface development
- Thermal analysis considerations
- Excitation and detection methods
- Optical detection and image analysis
- Biosensor detection and analysis
- Algorithm development
- Usability and Human Factors Engineering
- Observational & contextual research
- Regulatory compliance consulting
- QMS establishment
- Consumable development
- Sample collection devices
- Reagent sampling and dispense
Developing the award winning Memphasys FELIX
Hydrix and its client, Memphasys, were recipients of two 2020 Good Design Awards for the design of an instrument and cartridge system that helps improve outcomes in IVF.
Hydrix was recently recognised with multiple Good Design Awards for its role in 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.”
Memphasys Executive Chair
Our medical device design process is compliant with:
- ISO 14971 – Application of Risk Management to Medical Devices
- IEC 60601, IEC 61010, IEC 60950, IEC 62368 – Safety for Programmable Electrical Medical Systems
- IEC 62304 – Medical Software life cycle process for medical devices
- 21CFR820 – Good Manufacturing Practice
- IEC 60601-1-11 – Home Healthcare
- IEC 62366 – Human Factors Documentation & Usability Design for medical devices
- ISO 13485, ISO 9001 – Quality Management System
- AMMI HE74/75 & ISO 62366 – Regulatory compliance