Great ideas, engineered for the real world. DFMA + validated processes + testing.

In our world, great ideas come with the roadmap to reality. We know what it takes to engineer innovative, robust, highly manufacturable medical components and sub-assemblies. Collaborating with customers, we guide innovative ideas from concept to solid designs, through validated processes for manufacturing and assembly, to finished products in hand. We help you create the specification, test to it, and go through validation with multiple builds.

Design for manufacturing and assembly (DFMA) is second nature at Pulse. How could it be otherwise? We’ve been manufacturing medical devices for more than two decades. Perfecting intricate processes, from machining platinum to laser-welding ultra-fine wires onto electrodes and other devices. Our engineering team has been there from the start, helping customers enhance designs for manufacturability and performance.

Our advanced innovation experience developing coatings, alloys and finishes gives us unique insights into innovative technologies that can be applied to your design and successfully manufactured.

Our design engineering specialties include:

• Electrode design for tissue stimulation. With unmatched knowledge of coating technologies, and in-house capabilities for special coatings and laser welding, we engineer electrode designs to optimize performance, for example delivering the exact voltage you need for a specific application. We understand cardiac tissue stimulation, neurostimulation, stimulation or blocking for treatment of obesity and hypertension, and much more.
• Highly-engineered assemblies with multiple complex elements. For example, we created a complex assembly with multiple layers of different materials and devices welded together and with .002 wire attached.

We develop, validate and fully document processes for fabrication and assembly. It’s a natural part of product development at Pulse. We collect and evaluate data from process design through production, presenting scientific evidence that our processes have very high Cpk.

Our process design includes risk assessment, design of experiments and modeling. We verify the limits for critical process parameters and validate the process boundary to establish a control strategy. With complete process documentation, your path from idea to market is that much smoother.

We create tests and protocols, run tests and report results. We include both short-term tests such as load testing of laser-welded lead wires, and long-term accelerated life testing. All test procedures are fully documented and ready for you to submit for CE approval.

Our engineering services team guides you through the successful transition from prototype to manufacturing, whether you take advantage of Pulse’s contract manufacturing expertise or manufacture the product yourself.

You need to move fast when you’re creating next-generation medical devices. We understand that. See how we make it easier for R&D engineers.

We work with innovators. Incubators and start-ups, as well as leading design services firms, turn to Pulse for our expertise in design for manufacturing, process development, design performance testing, and medical manufacturing. They stay for the relationship and results. Contact us today