It's all about the customer experience
Market-readiness is about more than simply getting a product ready to be sold.
At PhaseThree, we embrace a holistic approach to market readiness—ensuring that your deliverable is ready to be effectively implemented by the end user (and not just bought), and that it meets or beats the regulatory standards.
Above all, we focus on a rewarding customer experience for all parties—the vendor, the provider, the end-user—through a suite of skill-sets, services, and technologies that put you and your customers first, always.
Point of Care
Healthcare is all about the patient experience. At PhaseThree, we have the engineering expertise and technological tools to shrink down laboratory instrumentation to point-of-care scale, ensuring the patients’ experience meets your expectations, and theirs.
For point-of-care products, our customers typically have some proprietary sensing or chemistry technology, and are seeking a means and methodology to commercialize and/or mass produce. With a focus on efficiency and usability, we turn these technological plans into commercial products.
Oftentimes, innovators must choose one firm for instrument development and another for consumables. With PhaseThree, our systems engineers, chemists, disposables and engineering specialists design both parts of the system (disposable and instrument) to 1) ensure consistency in system performance and behavior 2) lower costs and 3) expedite global commercialization.
Customers requiring system solutions benefit from PhaseThree being “manufacturing neutral.” We approach each project by understanding our customer’s requirements and we develop manufacturing methodologies that can be utilized by several different manufacturers. This approach gives our customer flexibility in manufacturing—and competitive pricing in what’s often the most costly phase of product commercialization.
Before we design a disposable, we address critical questions on performance: What’s the fluid movement scheme? Which reagents must be present and in what volumes? What materials are compatible with required reagents? How will the reagents be stored?
And as we move into production, we address equally critical business concerns: How will both users and instruments interact with the disposable? What’s the most cost-effective, compliant means of assembly? What is the cost-per-piece as the product volumes grow? How do we scale?
By combining our expertise in high volume manufacturing and our manufacturing neutral design philosophy, we have developed disposables that are easily mass produced and at a lower cost.
Our deliverables are typically a verified disposable design and manufacturing process, a Design History File, and a fully qualified contract manufacturer.
Beginning with industrial design and systems engineering, the PhaseThree team works with you to design an instrument that is functional, easy to work with, and that presents well to consumers to help establish and enhance your brand.
We bring deep talent in technical specialties such as optics, electrical, mechanical, software, and disposable engineering. We also have skills and competency in Assay Development to help you move from the bench top to a functioning system.
Usability engineering requires asking and answering the right questions: How will the deliverable perform in the real world? Will first-time users get the experience you intend? Will they be able to interpret the information and make decisions? Will they be able to properly and easily manipulate a device and/or its components?
We approach risk-management holistically, and that means targeting usability—interactions between people and devices—at every step. Where some firms treat this as an afterthought, at PhaseThree we believe this step in your go-to market plan must be overestimated.
The “human factor” is our priority, and PhaseThree adheres to the guidance provided by the FDA for Applying Human Factors and Usability Engineering to Medical Devices. Design and manufacturing FMEA’s (Failure Modes and Effects Analysis) are conducted periodically to mitigate risk.
Each specific customer project requires specific engineering expertise, and PhaseThree delivers with accomplished engineers in electronics, mechanics, software, and optics.
Electronic: solve new or persistent electronics design problems; assure quality and security with rigorous third-party testing and compliance measures; streamline manufacturing/production processes development.
Mechanical: design mechanically in SolidWorks; thermal and structural simulation expertise; deep skills in opto-mechanical and electro-mechanical design; experts in heat transfer and temperature control.
Software: fluent in assembly for all current microprocessor and embedded processor architectures as well as popular high-level platforms such as C#, .NET, .NET related support platforms such as WCF, WPF, Entity Framework as well as C++, Qt, Delphi (Pascal) and a number of other application frameworks.
Optic: experience in novel optical fiber based instrumentation, laser flow cytometry instrumentation, and medical imaging instrumentation; a diverse skill set and tool box in optics ranging from imaging to fluorescence; experienced in creating new intellectual property.
Assay Development and Validation Assistance
Most of our customers arrive with an assay or technology that works on the bench. Our on-staff experts in chemical and biological engineering then assist, to use one example, in scaling down the assay for microfluidics. We also get to know the application at both a macro and micro level so that we can assist the customer in the product validation.