Medical Device Research & Development

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. 


Medical Device Prototypes

The development of medical devices involves the production of prototypes for a variety of applications serving both the customer and the research and development teams.

Integer is experienced in producing functional prototypes, which demonstrate the required capabilities (according to the development stages), including electronics-integrated prototypes using modular development boards etc. The company produces various prototypes:

  • Design prototypes for marketing purposes
  • Functional prototypes
  • Ergonomic prototypes
  • Rapid prototypes

Integer regards the prototype to be “capability demonstrators”, which present the product’s “evolution”. Each stage introduces a more advanced step in the research and development process. Each stage provides its own advantages.

Presentation of a functional prototype to investors can be conducive in funds raising, a design prototype with no technological capabilities for marketing purposes will be supportive gaining feedback from potential customers and a functional prototype, which demonstrates the de-facto functionality of the product, will support in strengthening the technological-engineering development. The prototypes also serve for soliciting comments from external and internal research groups, and the conclusions can be integrated into the development process.


Production & Product File

Production and product files are prepared according to ISO:13485 standard or in accordance with the customer requirements.

The documentation is created throughout the entire development process and enables building the DHF – Design History File – and the DMR – Device Master Record.

The production file consists of the full specification for producing the product according to the required quality processes. It enables the customer to examine multiple manufacturers and to manufacture the product almost anywhere.


The main components of the product file are:

  • Documentation – a summary of the thought and engineering processes, documentation of drawings and tests performed in the development course, such as temperature range design tests, testing of resistance to forces and stresses, ability to integrate with other products, in-tissue tests, documentation of validation processes, sterilization process, packing, biocompatibility, etc.
  • Bill of Materials (BOM) – a compilation of all the product components, enabling locating the most suitable supplier according to parameters such as costs, required materials and unique technological capabilities required for the production.
  • Assembly and Production Instructions – detailed documentation of the assembly processes including visual documentation, criteria for testing and approval, bills of quantities, the appropriate environment for installation and assembly and safety.
  • Packaging – details of packaging developed at Integer (support card, blisters, pouches, etc.), including details of compatibility with required sterilization processes, impermeability tests, and validation of the packaging.
  • Sterilization – a detailed description of the required sterilization processes, including potential providers. Integer obtains extensive knowledge in the field of sterilization (ETO, Gamma rays, Beta rays, autoclaves etc.) and is closely familiar with service providers.


Verification and Validation

The verification and validation processes are a means for testing and confirming the product features, whether these are done as part of the feasibility tests or under the standardization and regulatory requirements. We perform this process in cooperation with the customer, dividing these duties in a manner suitable to the company goals and its budgetary requirements.

As an ISO:13485 certified company, Integer is committed to implementing verification and validation processes, which for the most part include the following tests:

  • Functional tests
  • Electronic and electricity safety ISO:60601
  • Software validation
  • Packaging tests 
  • Sterilization tests 
  • Biocompatibility tests ISO:993


Integer supports the product and the customer from the test specification stage through their execution, the results analysis, the delivery of professional interpretation and their presentation to the relevant authorized entities. The company carries out the verification and validation process in accordance with the customer’s requirements, both at the company’s laboratories as well as at specialized laboratories. The equipment is calibrated and maintained in accordance with the manufacturer instructions and regulatory standards.



Transfer to Production

Once the product has sufficiently matured for mass production, Integer supports its customers in the transition from development to production, whether this is in the production of small batches or in large batches for sale.

Integer manufactures and assembles clinical batches in-house. To this end, it has a clean room certified to the ISO 7 classification. We perform laser welding in our clean room and provide the full range of clinical operation services for production, including: 

  • Purchase orders
  • Incoming inspection
  • Traceability
  • Subcontractors management for subassemblies

Integer collaborates with leading providers specializing in medical devices manufacturing in large batches in a clean environment. An Integer engineer supports the project at the manufacturer (whether domestically or abroad) and is in continuous contact with the entrepreneur. Thanks to this, the engineer that developed the product, to testing, and assembly processes is optimally involved in the transfer to production process, yielding maximum efficiency and professionalism.

Integer carries out quality and standards audits for the suppliers it works with. If the customer is interested in a specific supplier, who does not work with the company on a regular basis, Integer verifies that the selected supplier is compliant with the quality and standard requirements and that they possess the full set of required certifications.


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