Point-of-Care Development
Transforming point-of-care device development
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 improve healthcare experiences for all.
Developing a new Point of Care (POC) platform is no small feat. While solving technical challenges is crucial, it’s no guarantee of success once the device hits the market. True success demands more, integrating regulatory strategy early, building features your target users actually need, and designing for the real-world end user.
At Hydrix, we guide you through every stage of POC development, from proof of principle to prototypes and production transfer. Our approach starts with the assay, moves through cartridge and instrument subsystems, and finishes with the complete instrument. But we don’t stop there.
Our insights team helps you uncover market needs, understand user pain points, assess healthcare economics, and navigate regulatory pathways. We also stay at the forefront of usability and GUI design trends.
What truly sets us apart is our partnership model. We work with top-tier technology providers, optics experts, fluidics specialists, cartridge developers, and contract manufacturers, to bring the best talent to your program. As your single-source development partner, we ensure your project is delivered to spec, on time, and set up for market success.
Design &
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 & 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.
Market
Insights
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 & 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.
Case study
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.”
Alison Coutts
Memphasys Executive Chair