Freudenberg Medical’s unique Navigate® product development programme drives innovation and speed in the customer design process for hypotubes, guidewires, specialty needles and catheter shafts.
Accelerate time to market with Navigate®
The Navigate® programme is delivered by a team of experienced medical device engineers with a proven track record of successful new product development for the most challenging product solutions.
The Naviagte® programme is supported by dedicated manufacturing and test equipment to support customer R&D teams from new product concept development through to product launch. Our goal is to drive efficiency in your product design, where effective delivery to your project timelines is always our highest priority.
- Materials development
- Project management
- Design for Manufacture & Assembly (DFMA)
- Materials analysis
- Advanced materials selection & development
- Project costing
- Failure Mode & Effect Analysis (FMEA)
- Dedicated manufacturing & test equipment
- Rapid turnaround on prototypes
- Process development & validation
- Biocompatibility testing
How the Naviagte® programme works
We begin by ‘laying-out’ the ideas which have been explored. This evaluation is led by our engineering team and often involves face-to-face meetings with our customers to gain a complete understanding of the project. Ideas that have failed are identified along with the reasons for their failure. Some ideas may be noted for their contribution to the project and retained for further investigation.
Building on the advances already made, our team begins the process of developing new ideas. Drawing on their extensive experience in the field of medical device engineering our team will develop credible alternatives. Working closely with our customers through this research and testing phase we ensure there is a good flow of information in both directions. The protection of our customers’ intellectual property is a high priority and we endeavor at all times to steer away from areas of sensitivity.
Ideas will be assessed on their merits and potential to be successfully advanced through each development stage right through to launch. Prototypes may be produced at this stage to test basic functionality for some deliverables. We encourage our customers to visit our facility at this point so that they can be on hand to make minor adjustments to the concept ideas. This is normally carried out in a day with the support of our Navigate® team.
Following rigorous testing, we typically will have uncovered a number of ideas that we can now progress through to the next development phases. Before we proceed further, we include our operations teams in the Navigate® process to assess the manufacturability of the product ideas. Their engagement at an early stage ensures that there will be a smooth transition to manufacturing later, saving time and cost. All equipment used at this point is mirrored in production so that validations will be able to rely on data captured at the prototype stage.
Design for Manufacture
The input of our operations team ensures that product solutions can be manufactured efficiently and effectively at scale. Navigate® team members have all worked in operations and understand what can and cannot be done. We employ the simple philosophy “to generate the best possible methods in the least overall time.” This stage can be cyclical and may require compromises to develop the most cost-effective solutions.
Once the method of manufacture has been agreed with our customer input, we continue the validation of the product through our processes. Our internal risk analysis and validation procedures will identify any areas of concern that are then addressed with input from the customer.
The timeline here is shortened due to the earlier evaluative work. In addition, the equipment used has been previously validated and therefore much of the framework and risk analysis has been undertaken.
All steps in this process can be treated as stand-alone services or a complete project deliverable from the Navigate® Team. The output from the previous steps can be a comprehensive report for a regulatory body right through to a completed assembly. With an unwavering commitment to both the project and our customers, we steer a course through all challenges and strive to deliver results that exceed our customer’s expectations.