Inspire for Sleep Apnea Implant – From Circuit Board Design to Volume Manufacturing

Inspire for Sleep Apnea Implant – From Circuit Board Design to Volume Manufacturing

Inspire Medical Systems, Inc. is a medical technology company focused on the development and commercialization of an innovative solution for patients with obstructive sleep apnea (OSA). Inspire has developed the first and only FDA-approved neurostimulation device that provides a safe and effective treatment for moderate-to-severe OSA. Inspire was looking for an expert in microelectronic assemblies and miniaturization and approached Valtronic with a schematic in need of PCB layout as well as electronic miniaturization to meet their implantable size requirements.

Board design with 60% size reduction

Valtronic designed a board with optimal shape and size for the implantable package. By applying state of the art Quad Flat No Leads (QFN) technology, Valtronic obtained a 60% size reduction in a board that measures 1” x 0.39” and meets all of Inspire’s very stringent reliability requirements.

Design for Manufacturing to Increase Manufacturability

Valtronic always utilizes “Design for Manufacturing” (DFM) processes in which manufacturing processes and constraints are considered from an early stage. One aspect of the design that Valtronic helped improve was an electronic board design which took into consideration several key fixed mechanical requirements of the circuitry’s weld block. Valtronic redesigned the weld block and optimized the SMT parameters ensuring proper stability and alignment during the reflow process. The weld block orientation and stability requirements also required a custom waffle pack in order to accommodate an automated manufacturing placement process. By working closely with our supply partners, Valtronic designed and built a suitable waffle pack that addressed this manufacturing challenge. Using DFM we also determined that, due to the circuit board’s miniaturized size and test requirements, an external test panel would be needed in order to effectively test the circuit board in production.  The circuit board was designed such that its traces could be attached to a test panel during and after an elevated temperature burn in process.  The traces and excess board could then be cut once this testing was completed.

 

 

“The Valtronic team has helped Inspire rapidly deliver innovation while building a durable supply chain.”

John Rondoni
VP Product Development, Operations, and Quality
at Inspire Medical Systems

 

 

A close collaboration resulted in improved quality, reduced labor time and product cost

The opportunity to work with a medical device developer from early stages through FDA approval is a role that Valtronic takes very seriously. The relationship with Inspire Medical Systems, Inc. is one in which Valtronic’s experience with implantable medical devices accelerated launching a life-changing FDA approved product. “Collaboration between Inspire and Valtronic from an early product development stage ensured a smooth transition to volume manufacturing, bringing this critical therapy to the market in a timely and cost-effective manner.” states Mike Labbe, Valtronic R&D Manager.

Working closely with Inspire, Valtronic met customer size and functional requirements needed for final product acceptance. An optimized assembly process resulted in improved quality and reduced labor time and hence product cost. Inspire has also benefitted from new state-of-the-art equipment such as the AOI (Automated Optical Inspection) and SPI (Solder Paste Inspection) which ensures product quality, throughput and reliability in volume production.

 

More about Inspire Medical Systems, Inc. at: www.inspiresleep.com