Gray Optics’ comprehensive New Product Development (NPD) process allows your team to bring your product to market effectively and efficiently. Our Product Development team can meet your technology needs, developing designs and processes that work best for you from ideation to manufacturing.

 

Product Development Process

Gray Optics’ foundation is our customers’ success which is achieved through our New Product Development process. Our process is based not only on industry standards but also on our customers’ needs and future growth plans. The NPD process guides technologies and teams through ideation to manufacturing to quickly get a product to the market. We built the process to offer collaborative engagement with our customers, at any stage, with any goal. The design and modular approach to product development let Gray Optics be your partner for as much or as little as you need, from ideation and concept development to scaling for volume production. We believe we are most successful when our customers can enter the market efficiently after a smooth development partnership.

Our expert staff has built their careers in product development across medical, life science, and industrial markets. They are deeply passionate about product development and have a comprehensive understanding of the process, ultimately benefiting our customers. When partnering with Gray Optics, you benefit from our efficient and effective Product Development Process and a PMP-certified Project Manager who engages and partners with you from the beginning. See How We Work to learn more about our partnership model.  

The NPD process is divided into four distinct stages – Feasibility, Concept Development, Product Development, and Pilot Production – with each stage following a phase-gate process aligned with our customers’ goals and project milestones. The entire process aligns with ISO 13485 for medical devices and ISO 9001 for non-regulated products. Our comprehensive approach helps customers on any development timeline successfully reach their goals.

 

  • FEASIBILITY

    Across industries, readily available expertise in early-stage optical-based product development is rare. Gray Optics’ Feasibility Stage takes on that challenge, and our early involvement can help ensure you develop the right product the first time. The goal of the feasibility stage is to determine the practicality of a proposed idea through problem definition, technology assessments, early solution evaluation, and a practical review of the user, functional and technical requirements. Alignment at this early stage is critical for the success of future stages, and proper engagement can help minimize multiple iterations during later stages. Overall, our Feasibility Stage can provide clarity and groundwork to start your product development journey by proving your concept, defining your requirements, or scoping various paths forward to reach your goal. Contact us to determine what you are missing, organize what you have, and plan the next steps towards your goal.


  • CONCEPT DEVELOPMENT

    Concept Development involves everything from determining how your technology will fit into a usable device through prototyping to producing engineering prototypes for clinical or human factors testing to derisking the design to ensure a smooth Product Development phase. Concept Development confirms technology maturity and understanding of requirements, evaluates initial manufacturing risks and other critical information on the overall system architecture, end users’ needs, and usability, all of which feed into advanced iterations of your product. Our Concept Stage is broader than most companies because our experience shows that entering formal product development before the technology is mature leads to challenges and excessive iterations. Our extensive practice focused on this stage has created a more in-depth process that benefits our customers in the long run. For example, we consider cost-of-goods goals and manufacturability early in the design process, saving time and money in later stages. If your team has a concept for a new optical instrument and wants to move to a prototype, let our Concept Development Stage work for you.  

  • PRODUCT DEVELOPMENT

    The primary goal of the Product Development phase is to finalize the product’s design and transfer it to manufacturing; when Feasibility and Concept Development are done correctly, this phase is fast and linear. Product Development results in design freeze, assembly and functionality risk assessment, and test plan development. We develop the final manufacturing-ready designs and lead verification testing and assembly procedures during this stage while the customer owns validation. We will work with you through regulatory compliance submission, testing, and design changes, finalizing user requirements, confirming final product design, and building beta and alpha versions of your product for your use in regulatory or market testing purposes. Additionally, during the Product Development stage, we can establish a supply chain strategy aligned to your project needs. Let us support your team and product with this stage, where you can see your product for the first time.

  • PILOT PRODUCTION

    Once product development is complete, the next stage is to confirm the accuracy of the manufacturing process and provide your team with sellable, functional units. Designing and planning for manufacturing requires a broad and deep knowledge of precision assembly and metrology and test, which Gray Optics possesses. Gray Optics will build out, test, and refine the assembly line and test verification steps by building up to hundreds of units. The production process is matured in this stage, confirming that a repeatable and high-quality process has been developed. Gray Optics can support Pilot Production manufacturing lines up to hundreds of units and beyond. We have extensive experience in manufacturing partner selection and transitioning overall critical data if your product scales into volume production. We will also help monitor production runs to ensure you get the quality we produce in-house, receive your inventory on time, and maintain supply chain continuity. If your product is ready to scale and enter the market, contact us to review your manufacturability and production options. 

 

MEDICAL PRODUCTS

Our Product Development Process supports our customer’s ISO certification requirements for medical devices requiring ISO certification quality management and, ultimately, regulatory clearance in or outside of the US. Our process is aligned with ISO 13485 and can provide the outcome of the design and development processes required by ISO 13485 while engaging with your organization’s quality management system. The figure below simplifies and highlights where Gray Optics can support your medical device development with the steps in the gray box mapping onto the previously defined Concept and Product Development Phases.

 

Our employees have deep experience in medical product development, and we use that knowledge to benefit you at every stage while you move through our Product Development Process. We understand the additional complexity that medical device development demands, and we aim to ease the burden on you during the development process. We have options to help support documentation, builds, and quality management required to achieve FDA clearance. Whatever your device classification, 510K or PMA submission, or regulatory strategy, we can help you meet your timelines and deliverables.

 

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