Project snapshot
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’s development team, enabling the company to accelerate their development process and secure FDA approval of their medical device, thus establishing their market presence.
Taking over approval requirements and verification, documentation, and testing, our experts supported the client’s team in streamlining the project flows and ensuring compliance with all approval requirements to facilitate and expedite device approval by the FDA.
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.
Business challenge
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.
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.
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 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.
Solution
We analyzed the existing team setup and project requirements and provided consultants who not only met but exceeded performance expectations. We enhanced the client’s team with the following competencies:
- A firmware development lead, driving the design and development of proprietary software working with the client’s medical device and making sure that all specific requirements were complied with. In accordance with our client’s specifications, our consultant had expertise in RTOS, IAR Embedded workbench, ARM Cortex M processor, C coding, embedded security, and basic lab tools (DMM, oscilloscope, logic analyzer, spectrum analyzer).
- A requirement and verification lead in charge of verification testing and ensuring that all tests prescribed by regulatory authorities are performed and passed successfully. With medical devices, all identified issues are strictly required to be documented and reported. Therefore, it was of the utmost importance that the final product be verified to have no issues.
- A documentation lead, responsible for reconciling the product and test documentation between different systems and converting it into a format consumable by the system used by regulatory authorities.
- A test automation lead, taking over the testing of firmware automation functions driving the PFA device. According to the project requirements, we made sure our test lead was proficient in C#, Microsoft Test Manager, and Team Foundation Server.
- An agile coach and Scrum master, organizing the project flow using an agile methodology and implementing iterative development to ensure expedited completion and effective issue resolution.
- DevOps engineers, implementing continuous integration and continuous delivery principles using features of Jira, GitLab, TFS, Docker, Artifactory, Bamboo, Bitbucket, Coverity, and SonarQube.
Business outcomes
Having streamlined and accelerated project development by filling skill gaps and enhancing the project team with experienced consultants, our client was the first to present an innovative pulsed field ablation device to the market. The new PFA device received the necessary FDA approval in 2023 and became completely ready for commercial use, earning our client a strong competitive advantage.
Based on the success of the initial version of the PFA device, the client is now working on further innovations to design the second version of the product. We continue to assist the client’s development team, contributing technology expertise to make sure the new device is safe, effective, and compliant.