From the first prototype to a market-ready design, we develop hardware, software, and consumables into a fully functional, verified product. Our ISO 13485 controlled processes deliver a reliable, manufacturable solution – ready for clinical testing, regulatory approval, and commercial launch.

We bring your product vision to life through sketches and renderings informed by technical insight. Our experienced product development team will arm you with visuals and ideas to generate investor and key stakeholder excitement, starting your journey toward commercial success. 

Our DFx experts initiate scalable, high-quality manufacturing practices that accelerate the transition from prototype to production. From clinical builds to full-scale manufacturing, our team develops the processes, tooling, documentation, and vendor strategies needed for efficient, reliable scale-up to support commercial launch.

We provide targeted, independent technical insight to help you validate decisions, uncover risks, and strengthen your decision making. Whether reviewing a design or evaluating an acquisition, our experts deliver the clarity and confidence needed to move faster and with greater certainty. 

We systematically address your challenges by understanding needs, architecting the optimal solution, and ensuring that the technical approach is sound based on hard data. Our process builds clarity, reduces risk, and provides the confidence to move faster with fewer surprises. 

From workflows to wireframes, we apply user research, human factors, and interface design to create intuitive, effective products that meet end-user needs. Our process follows FDA guidance and IEC 62366 to reduce risk and ensure your product is optimized for its intended use. 

We design intelligent automation solutions that streamline scientific workflows—reducing manual effort, increasing throughput, and improving data reliability. Through close collaboration with scientific teams, we deliver custom strategies and integrated systems that optimize lab performance, ensure compliance, and enable scalable discovery. 

We help companies – from startups to global leaders – meet health authority requirements through tailored QA/RA consulting. With decades of experience and deep in-house design expertise, we guide regulatory strategy, compliance documentation, and submissions to ensure market readiness across the full product lifecycle.