Recalls are among the most challenging events a medical device company can face. Beyond the financial costs, they can jeopardize patient safety, erode trust, and disrupt years of work. One recent case sheds light on why leading MedTech companies are shifting from traditional development processes to connected, holistic platforms to mitigate these risks and drive innovation.
The recall involved a cardiac monitoring device[1], hailed as a breakthrough in its field. Although the technology was sound, the recall stemmed from a preventable interoperability issue. A software update, introduced late in the development cycle to optimize battery life, inadvertently caused communication failures with hospital network systems. This issue only became apparent after the devices were already in use.
The problem wasn’t the lack of technology or talent—it was the fragmented systems and siloed workflows that failed to bridge critical gaps between engineering, quality, manufacturing, and regulatory teams.
What Are the Hidden Risks of Siloed Development Processes?
A comprehensive FDA review has shown that 44% of voluntary medical device recalls could have been prevented with proper design controls[2]. However, the root cause often lies deeper than inadequate processes—it’s the lack of integration across teams and systems that undermines those controls.
In this particular case, the organization had well-documented procedures for design reviews, testing protocols, and compliance. However, the actual execution revealed significant disconnects. Engineering decisions weren’t always communicated to quality assurance. Feedback from manufacturing teams often arrived too late for meaningful changes. Regulatory documentation was completed only at the end of development, exposing inconsistencies that required costly, last-minute corrections.
For instance, the software update that triggered the recall was fully tested within the engineering environment and performed as expected. But its impact on device interoperability wasn’t caught because the teams responsible for testing and compliance were using separate systems. Engineering logged the update in their PLM system, quality tracked it in their database, and manufacturing updated their processes independently—none of these systems communicated with one another.
The result? Critical information remained isolated, creating blind spots that ultimately led to the recall.
The Cost of Disconnected Systems
The consequences of siloed workflows extend far beyond compliance issues. Development teams spend significant time managing information instead of driving innovation. In this case, engineers were found to spend 60% of their time coordinating across systems rather than solving technical challenges. Design reviews were conducted with outdated specifications because changes weren’t communicated effectively. Feedback from early testing often reached decision-makers too late to influence development. Financially, the impact was profound. Late-stage design changes can cost up to 100 times more to implement than addressing issues early. Yet, the organization found that 80% of design issues weren’t discovered until after prototyping. Their traditional development process—intended to ensure quality—had become a bottleneck that slowed innovation and increased costs.
Even more significant were the lost opportunities for user-driven innovation. Feedback from surgeons during testing suggested several usability improvements that could have enhanced patient outcomes. However, the rigid, stage-gate process didn’t allow for iterative changes without delaying the entire timeline. Ultimately, valuable insights had to be sacrificed for the sake of meeting the market launch date.
The Future of Medical Device Development
The lessons from this recall highlight the importance of rethinking how MedTech companies approach development. Traditional processes and disconnected systems can no longer meet the demands of modern innovation or regulatory scrutiny. By adopting connected platforms, organizations can align teams, improve compliance, and focus on delivering groundbreaking medical devices that enhance patient care.
The Role of Collaboration in Driving Innovation
Collaboration is at the heart of driving innovation in the rapidly evolving MedTech industry. Successful product development relies on seamless communication, efficient knowledge sharing, and cross-functional teamwork. By fostering an environment where diverse teams work together toward shared goals, organizations can break down silos, accelerate decision-making, and improve problem-solving capabilities. Effective collaboration not only enhances operational efficiency but also ensures that every stakeholder, from engineers to compliance officers, contributes their expertise to create safer and more effective medical devices. Establishing clear communication channels and utilizing collaborative approaches allows businesses to adapt to complexities and deliver innovative solutions that meet the highest industry standards.
Having advanced PLM capabilities enable real-time data sharing, seamless coordination across teams, and end-to-end traceability. This connectivity reduces inefficiencies, mitigates risks, and accelerates the delivery of innovative medical devices, ultimately benefiting providers and patients alike.
A Connected Solution for MedTech Innovation
ENOVIA on the 3DEXPERIENCE platform, offers a comprehensive solution purpose-built for MedTech innovation. By centralizing all aspects of product lifecycle management, ENOVIA enables teams to streamline development, enhance cross-functional collaboration, and maintain regulatory compliance with ease. Its data-driven approach leverages real-time collaboration and visibility across stakeholders, enabling agile decision-making and reducing the risks associated with traditional, linear development processes. Furthermore, the platform’s robust configuration management ensures traceability and effective management of design iterations, allowing industry professionals to integrate critical user feedback without compromising project timelines. For MedTech organizations aiming to innovate at scale, ENOVIA on the 3DEXPERIENCE platform provides the tools needed to optimize workflows and deliver breakthrough solutions faster than ever before.
Unlike traditional PLM systems, ENOVIA offers GxP-compliance, creating continuous visibility across the entire product lifecycle. For example, when a design engineer updates a specification, the platform automatically identifies affected stakeholders, initiates review workflows, and updates compliance documentation in real time. Quality teams can access engineering decisions as they happen, manufacturing teams receive instant notifications about production-impacting changes, and regulatory teams maintain up-to-date compliance records.
This level of integration eliminates the silos that often cause miscommunication and delays. It ensures that critical decisions are made with complete context and that potential issues are caught early, reducing the risk of recalls and accelerating time to market.
To learn more about how connected development is transforming the medical device industry and driving innovation, download our eBook. This resource provides actionable insights, proven strategies, and expert guidance to help your organization stay ahead in a rapidly evolving landscape.
[1] https://www.fda.gov/medical-devices/medical-device-recalls/outpatient-telemetry-correction-philips-issues-correction-monitoring-service-application-used-mobile
[2] https://www.kapstonemedical.com/resource-center/blog/design-controls-for-medical-devices-what-to-know