Research, Development & Engineering
Integer provides research and development services for medical devices. The company specializes in leading the project from the idea phase up to a finished product while incorporating all engineering, regulatory, marketing and budgetary requirements while paying attention to manufacturing technologies, usefulness and the right fit to targeted anatomy.
As the company is exclusively focused on the medical field, Integer has gained vast experience in developing a broad range of unique medical applications while fulfilling complicated requirements. This enables Integer to introduce creative solutions while slashing timetables.
Specification and concept
The research and development process begins with specifying the requirements that are at the heart of the product feasibility and those which are of the “second order”. This methodology enables quick and efficient presentation of solutions to the primary requirements by implementing and integrating:
- Analytical models
- Laboratory models
- Capability demonstrators (functional prototypes)
We perform a cyclic process consisting of several rounds, in which para-clinical and ex-vivo trials help adjust the product. The culmination of this process is the specification of the process requirements and in proving these requirements’ feasibility. This stage leads us to the PDR – Preliminary Design Review – which specifies the product features and the set of requirements for the detailed design.
In the development phase, we translate the PDR requirements into a detailed design in a cyclic process by the creation of prototypes, optimization and additional methods, until a complete product is accomplished while looking after a range of details including:
- Design to cost
- Assembly processes
- Compliance with regulatory requirements
- Compatibility with sterilization processes
- Use of biocompatible materials
ISO:13485 – Medical Device Quality Management System.
Medical Device Engineering
Integer is staffed with a talented, skilled engineering team consisting of mechanical and electronic engineers with a multidisciplinary approach, who provide the solutions to the engineering challenges of medical systems and products while leading the adjunct disciplines.
A senior engineer heads each project. This Project Leader maintains contacts with the customer and manages the various required resources at Integer to achieve a successful project outcome. Integer has a production and technological support department consisting of production labs and a skilled technical team which is involved in all the development stages, while closely cooperating with the engineers and project leaders.