{"id":77964,"date":"2024-08-06T20:45:44","date_gmt":"2024-08-06T18:45:44","guid":{"rendered":"https:\/\/intellias.com\/?p=77964"},"modified":"2024-08-09T17:12:56","modified_gmt":"2024-08-09T15:12:56","slug":"development-of-pfa-device-firmware-safe-effective-and-compliant","status":"publish","type":"post","link":"https:\/\/intellias.com\/development-of-pfa-device-firmware-safe-effective-and-compliant\/","title":{"rendered":"Development of PFA Device Firmware: Safe, Effective, and Compliant"},"content":{"rendered":"

Project snapshot<\/h2>\n

For a global leader in the medical device industry, we took part in developing special firmware to power a proprietary pulsed field ablation (PFA) device. We provided the skills and expertise necessary to complement our client\u2019s development team, enabling the company to accelerate their development process and secure FDA approval of their medical device, thus establishing their market presence.<\/p>\n

Taking over approval requirements and verification, documentation, and testing, our experts supported the client\u2019s team in streamlining the project flows and ensuring compliance with all approval requirements to facilitate and expedite device approval by the FDA.<\/p>\n

Our client is a global medical device provider that has been operating internationally for decades. Committed to an innovative approach to the treatment of serious diseases and health conditions, the company researches emerging technologies and partners with industry trailblazers to design devices assisting in diagnostics and therapy for a number of serious conditions.<\/em><\/p>\n

Business challenge<\/h2>\n

Our client desired to set a new standard in safety and effectiveness in surgically treating persistent atrial fibrillation. Supported by 15 years of preclinical and clinical evidence, they faced the challenge of leading the market in the design, development, and commercialization of pulsed field ablation surgical technology. To claim the market for this technology, our client needed to augment their development team with skilled engineers who were experienced in fulfilling FDA approval requirements for a new PFA device.<\/p>\n

The client required engineers already familiar with FDA, IEC, and other guidelines for medical device technology considered the highest risk to patients. This included detailed documented system requirements, design specifications, testing, and traceability matrices. Time was the most critical factor, as the company was determined to present the device on the market before the competition.<\/p>\n

Recognizing certain skill gaps, the client turned to us to augment their team with the necessary competencies. For a comprehensive development process, the client needed experts in testing and documentation as well as DevOps<\/a> and firmware engineers to join their team. Also, determined to benefit from an agile methodology, the client was looking for experienced agile coaches and Scrum masters.<\/p>\n

\"Development<\/p>\n

Solution<\/h2>\n

We analyzed the existing team setup and project requirements and provided consultants who not only met but exceeded performance expectations. We enhanced the client\u2019s team with the following competencies:<\/p>\n