The Back Story
Our client acquired a manufacturer of an automatic external defibrillator (AED) that had been recalled. Challenges reintroducing the defibrillator to market were compounded because the majority of its components were now obsolete. To avoid heightened regulatory mandates, the client also needed to accelerate its 510(k) submission process before the effective date of the FDA’s defibrillator reclassification. Strategically, the company required FDA clearance as part of its plan to clear China’s regulatory process and enter this fast-growing market.
The Boston Engineering team managed product redesign to improve manufacturability, replace obsolete parts, and review the acquired company’s previous submissions and performed tests. Boston Engineering also created documentation that complied with the current standards for hardware and software verification and validation. The project included:
- Sourcing advanced replacement components that are readily available
- Developing new drivers and software
- Implementing new protocols (timing and sequences) to meet current American Heart Association (AHA) guidelines
- Redesigning for manufacturability
- Verifying product hardware and software
- Revising the labeling
- Creating and submitting the FDA 510(k) prior to regulatory changes
The FDA reclassified AEDs from Class III to premarket approval (PMA) devices, and required all currently marketed AEDs to go through the FDA’s PMA process. The client needed to link existing clinical data to its rebranded product to negate the need to run expensive and lengthy clinical trials to support the upcoming PMA.
In nine months, the Boston Engineering team completed the product redesign, and verified software and hardware changes. We also developed and managed the FDA submission process. The FDA accepted the 510(k) submission for substantial review prior to the device classification change. Once cleared by the FDA, the client will then submit the AED to the China Food and Drug Administration (CFDA).
By meeting a very aggressive schedule and completing this project prior to the federal AED reclassification, the Boston Engineering team significantly advanced the client’s AED launch strategy for the growing Chinese market.