Solutions Services Markets About Connect Expertise Our people are our greatest asset and provide you with deep expertise and leadership within a culture built on collaboration and great client experience. A Wide-Range of Capabilities, Under One Roof We ensure that we have a strong mix of senior-level staff ranging from experienced commercial executives to scientists, engineers, designers, and technicians to provide you with speed to market. 200+ Engineers Engineering is the core of what we do. We stand strong in the areas of mechanical, electrical, software, fluidics, and optics engineering. Gener8 is focused on medical and biotech instruments, devices, and consumables. 185+ Manufacturing Staff Our team specializes in highly complex electro-optical and electro-mechanical assemblies. The majority of our manufacturing services are biotech and medical. Gener8 is certified to both ISO 9001:2015 and ISO 13485:2016. We are licensed for medical device manufacturing by the FDA. 50+ Scientists Gener8 is differentiated by having experienced, entrepreneurial scientists on staff. Our backgrounds include areas of physics, chemistry, and other scientific disciplines. Our team members are able to address your technical performance needs within your commercialization timeframe. 40+ PhDs Gener8's deep expertise in optics, spectroscopy, and condensed matter physics are unique. Our Ph.D. staff has the ability to take on your toughest technical challenges. World Class Engineering Gener8 is a full-service company. Our engineering department has the skill set necessary for cutting-edge consumable and instrumentation development. Mechanical Electrical Software Optics Fluidics Manufacturing & DfM Our mechanical engineering spans the internal instrument mechanisms, to the external product housings, as well as the disposable cartridge development. Our core competencies include: System-Level Design and Integration Fluidics Handling and Microchip Integration Design for Modularity and Assembly Thermal Management Mechatronics and Actuators Precision Motion and Automation Optomechanical Stages and Trains Package and Enclosure Design Gener8's Industrial Design Team Provides User Experience Design, Quality, and DfX Our industrial design (ID) services will help you achieve the look, feel, and usability that is critical to the success of your product in the marketplace while ensuring full functional performance. Our highly experienced Industrial Design service talent works closely with the engineering team to ensure great ID. Industrial Design User Experience Design Quality & DfX Our industrial designers integrate Gener8's full engineering expertise into a great product experience for the user. Our designers have industry-proven experience in optimizing user, business, and technical needs into beautiful and commercially successful instruments and products. Our core competencies include: Design research to find the unique blend of business, user, and technology needs for each product. Human factors, ergonomics, and product workflow development to finely tune the instrument to the needs of the user. Concept visualization in sketching, models, and CAD to demonstrate the vision for how the product will look, work, and feel. User testing and mockups to walk through the actual usage of the product before it is built. Color, materials finish, branding, and design to integrate them fully into the product look. Full rendering and animation to fully show the product before it is documented and produced. Documenting all the detail in order to maintain design intent all the way through production. Design for manufacturability and serviceability so that the product will be economical to produce and maintain. We also specialize in design language development to create a unified look and feel for an entire product line. View our case studies here. Helixbind RedshiftBio Galt Inc First Light Diagnostics Regulatory and Certification Support We offer support through our team of medical device regulatory professionals to reduce risk and safety testing capabilities. Regulatory Conformance UL/CE Certification Verification/Validation Gener8 has a team of medical device regulatory professionals who can support your pre-market and post-market regulatory needs and assist in developing clinical evidence for product submissions. Our expert team has deep regulatory experience working with a broad range of medical products including surgical, therapeutic, and diagnostic/IVD. Biotech Product Development Learn more Medical Product Development Learn more Industrial Product Development Learn more Gener8 Success with Us Click below for more information on how we can help. Contact Gener8 Copyright © 2021. Gener8, LLC. All rights reserved.