Medical Device Manufacturer, Surgical Division

The customer, a medical device manufacturer with a surgical division, acquired a business in the early 2000s that specialized in women’s health ablation products. Over the subsequent 10 years post-acquisition and 15 years since the product’s introduction, the surgical instrument emerged as a significant profit generator, claiming the top position in the market.

The supplier for key components (FPGA’s – Field Programmable Gate Arrays) ended the manufacturing of those arrays.

The core of the product relied on FPGAs from Xilinx, but with time, these FPGAs were discontinued, and the last opportunity for purchase had passed. Consequently, the FPGA functionality needed to be ported to a current technology ensuring a predicted availability of at least 10 years. This shift in FPGA technology also prompted the creation of a new power subsystem to meet the different requirements of the updated devices.

Complicating matters, scarce knowledge of the system led to the need for reverse engineering solutions to address manufacturing problems.

iSine engineers meticulously reviewed the existing FPGA code, analyzing the changes necessary for a successful design port. Despite challenges, a suitable replacement for the newer generation FPGAs was identified, meeting manufacturing needs, PCB requirements, and functional performance goals.

Simultaneously, the PCBs were updated to incorporate the new FPGAs, and regulators and support devices were added to accommodate the needs of the updated integrated circuits (ICs). The engineering team successfully debugged the updated systems and delivered ten fully functional units to a third-party verification team.

The technical development was one part of the challenge in the project. The evolving regulatory landscape necessitated a substantial increase in FDA documentation.

The documentation process involved creating Product Requirements Documents (PRD), Hardware Requirements Documents (HRD), Software Requirements Documents (SRD), etc. These documents were generated through a combination of reverse engineering the RTL for the FPGAs and extracting information from notebooks used by the original designers.

All the documentation, including theory of operation documents explaining FPGA and subsystem operations, was integrated into the customer’s document control system. Notably, this complex project was completed ahead of schedule and within the constraints of a firm-fixed contract, a rarity in the medical electronics industry’s design services landscape.