Medical Device Manufacturer, Surgical Division
The customer acquired a business in the early 2000’s for their product in the women’s health ablation market. Over the 10+ years since the acquisition (and the 15+ years the product was first introduced), the instrument has proven to be a significant profit generator for the business. It is also #1 in the market and the customer wanted to continue to maintain that position. The documentation requirements by the FDA has increased dramatically over that time, and they all needed to be re-generated (or created in some cases). Knowledge of the systems was so scarce, that manufacturing problems often required reverse engineering of sections to understand how to address them. The heart or brain of the product was based on FPGAs from Xilinx. With the passage of time, the FPGAs have been discontinued and the Last Purchase Opportunity passed. The FPGA function needed to be ported to a current technology with a predicted availability of at least 10 years. With the change in FPGA technology, a new power sub-system needed to be created to support the different requirements of the new devices.
iSine engineers reviewed the existing FPGA code from the old technology, and performed an analysis as to what changes were required to port the design forward. The basic ‘fabric’ of the newer generation FPGAs had changed, but a suitable replacement was found that met manufacturing needs (PCBs in the system) as well as the functional requirements and performance goals. The documentation for the system were written (PRD, HRDs, SRDs, etc). They were created based on reverse-engineering of the RTL for the FPGAs, and notes found in notebooks from the original designers. The boards (PCBs) were updated to use the FPGAs, regulators and other support devices were added to accommodate the needs of the new ICs. The iSine engineers on the project debugged the updated systems and delivered 10 fully functional systems to a 3rd party verification team.
The updated systems were fully documented (into the customer’s Document Control System), the systems were designed, assembled, tested and delivered ahead of schedule. The documents delivered included some “Theory of Operation” documents that described the FPGA and sub-system operation of the two boards on which the two FPGAs are mounted. These documents will be used in the future by the customer to help with manufacturing issues. The iSine work was delivered ahead of schedule and with a firm-fixed contract; it met the budget (very unusual in Medical Electronics industry).