Our product design and development services are complemented by our in-house contract manufacturing offering, providing our clients with a single point of accountability throughout the entire product realization process. Based on the foundation of FDA registered 3015046612 and ISO 9001 and 13485 certified manufacturing and using world recognized Fortive Business System (FBS) tools, our contract manufacturing teams deliver flexibility, IVD expertise and quality products.
Integrated engineering and manufacturing for end-to-end success
Track record in IVD
We have a long track record of successful IVD instrument manufacture for global diagnostics companies including Abbott, Bio-Rad and bioMérieux. Our manufacturing processes, quality procedures, production tools, logistics systems, operator training and resource management are precisely customized to perform in the constraints of the IVD domain.
We provide a flexible set of manufacturing solutions for each step of the product lifecycle and any business case, from prototyping and small batch production, to pilot production lines and full-volume production.
We have manufacturing facilities in the United States and Australia. We are FDA registered 3015046612 and are certified to ISO 9001:2015 and ISO 13485:2016
Design for manufacturability
Our manufacturing mindset begins very early in the product development process with our in-house contract manufacturing engineers joining the core project team. Their role is to ensure the manufacturability of the products we are designing which results in a more cost-efficient manufacturing strategy and helps accelerate the transition to manufacture. To further enable team collaboration, our engineers are trained in design for manufacture (DFM) tools such as the 3P process, DFMEA/PFMEA and critical component management.
Having integrated design, engineering and manufacturing teams leads to increased efficiencies and minimizes risks for our clients throughout the entire product development lifecycle. Utilizing one team with already established communication channels, standardized documentation formats, and shared processes and systems significantly reduces the ramp-up time for a more seamless transfer to manufacturing.
Furthermore, our manufacturing team continues to have rapid access to the design team during process Validation and scale-up. This enables us to resolve issues sooner and get your product to market faster.
As a Fortive company (formerly Danaher), the Fortive Business System (FBS) is part of our organizational DNA. Adapted from the famed Toyota Production System, FBS is a framework focused on continuous improvement, customer-centric processes, visual management and Lean manufacturing.
All Invetech employees are trained in the tools of FBS which are designed to eliminate waste, minimize risk, ensure on-time delivery, promote safety and, on the highest level, provide a superior experience to our customers. We use these proven tools and processes to continuously improve quality and on-time delivery for our contract manufacturing clients.
Partnering for results
It is our mission to take care of the manufacturing of the instrument with both autonomy and transparency so our OEM clients can focus on taking care of their end users, reagents and product distribution. We’ve won multiple supplier awards from some of the top IVD OEMs because of this approach.
Our partnering services are managed by a dedicated product manager who leverages FBS tools for visual and daily management to provide “at a glance” knowledge of key metrics. Product sustaining services include forecast and planning, sustaining engineering and component obsolescence, as well as quality management and tracking.
Below are a selection of case studies highlighting problems we’ve solved to deliver breakthrough innovation and business value for our IVD clients.