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.
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
Our electrical engineering team develops PCBA’s that control all aspects of products from mechanical mechanisms to optics and the user interface and communications. We design and test products for compliance to IEC 60601 and IEC 61010.
Our core competencies include:
- System-Level Design and Integration
- Design for Modularity and Assembly
- Analog Power and Power Management
- High-Speed Digital Design
- FPGA and Embedded Processors
- Low Power Wireless
- Sensor and Measurement Circuits
- Image Capture and Analysis
- High-Performance Audio and Spectroscopy
- Circuit Layout for Signal Integrity
- Design and Analysis for Reliability
Our software experts collaborate with electrical engineers to define the hardware needed for the user interface and communication and connectivity solutions. All medical device software is designed and tested for compliance to IEC 62304.
Our core competencies include:
- Embedded Firmware & Software
- Connectivity & Cloud Solutions
Optomechanics and Optoelectronics are integral to many products we develop.
Our core competencies include:
- Lens Modelling for Bulk and Fiber Optics
- High-Speed Fluorescent Imaging
- Camera, Laser, and LED Design and Integration
- Optics-Fluorescence Filtering
- Custom Polymer Lensing
- High Sensitivity CMOS Cameras
Gener8 is highly skilled in medical and biotech consumable product development. Unmatched in the industry, our experience in cartridge engineering has given us a deep understanding of microfluidics, small volumes, and fluid dynamics. We have developed products entailing fluid handling requirements in small volumes, ranging from milliliters (ml) to microliters (µl).
Our core competencies include:
- Stereolithography (SLA) Prototyping
- CNC Machining / Fabrication
- Prototype Mold Fabrication
- Prototype Injection Molding
- Liquid Injection Molding Simulation and Analysis
- Product Reliability Testing
- Plastics Assembly Expertise
- Material Selection & Functional Testing
Gener8 takes a flexible, multi-tiered approach to balance the needs of each project. Our teams of engineers work right beside our manufacturing experts as a team on every aspect of your product design and development from initial concepts to volume production services.
Our Design for Manufacturing (DfM) and design teams are co-located with our contract manufacturing services for the unbounded collaboration in bringing successful designs smoothly and quickly into production. We provide support across the entire product life cycle – from design assurance, through design transfer, to ongoing manufacturing and post-market quality.
Our expertise provides innovative solutions, fast!
Biotech Product Development
Medical Product Development
Industrial Product Development
Regulatory and Certification Support
We offer support through our team of medical device regulatory professionals to reduce risk and safety testing capabilities.
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.
Throughout development, we design to reduce the risk of EMI exposure and safety concerns. We work with contracted services for EMI and Safety testing to comply with CE and UL certification requirements and to ensure compliance with IEC 60601 and IEC 61010.
We have a test chamber for pre-scans for UL/CE certifications. Gener8 works with testing agencies such as TUV, ELT, and CSA. We have environmental chambers in house and a BSL II lab for blood and chemistry testing in-house
Our design control system assures evaluation of the design and assembly processes while assessing risk early in the design process, thereby providing a seamless hand-off to the manufacturing side of our business.
For medical clients, we have a dedicated group skilled in the deliverables to meet our ISO 13485 requirements.