Define a Clear Path to Medical Device Approval
- Are you using an effective speed to market strategy?
- Are you reducing your transportation costs?
- Are you working with an integrated manufacturer who is flexible?
By engaging an engineering team with integrated manufacturing services during product design, the team’s sharp focus on design for manufacturability improves results and achieves a quicker speed to market.
Early Engagement with A Strategic Manufacturing Partner
Our client came to us with a partially completed design after engaging with multiple design firms. The lack of coordination among their previous suppliers had stalled their product development efforts. They knew they needed a structured, disciplined program management service to get their device development back on track. They needed a partner with medical device manufacturing experience that knew the path to FDA approval.
Integrated Manufacturing
Integrated manufacturing allows manufacturers to hyper-focus on different points of design and production to maximize efficiency in the development process as design, prototype, testing and quality system activity are smoothly coordinated.
Their previous design had functional gaps and was not ready to be advanced through the approval process. Nortech’s engineering, program management and manufacturing team went to work to bring the client’s product to market with speed, control over manufacturing costs, good vendor selection, and good test practices in place.
Stack-Up Analysis
Tolerance stack-up analysis is a method used to evaluate the effect of tolerance in establishing dimensional relationships with a part or an assembly.
With vertically integrated engineering and manufacturing services, the Nortech team ensures quality control, product design flexibility, and seamless transitions from design to production and assembly. In this case, we were able to give our client an early comprehensive stack-up analysis, knowing they had not done one. We were able to discover design gaps and solve them on paper rather than waiting for the prototype testing stage.
Results
Our client had learned that managing a variety of suppliers through multiple design iterations created unnecessary setbacks and resulted in unforeseen gaps. Nortech’s disciplined team coordinated all the suppliers under our flexible and robust quality system, resulting in a clear pathway to device approval.
We were able to reduce overall manufacturing costs while maintaining desired product quality all while achieving the necessary speed to market. Today our client continues to gain wider visibility and significant growth.
Learn more about Nortech’s medical device manufacturing expertise.
Get A Free Assessment of Your Design for Manufacturability Process
Our medical device manufacturing experts will meet with you to evaluate your process to design for manufacturability and to provide guidance for ways we can help you improve the process.
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