How a Top 10 MedTech firm restored value to its infusion pump product line, overcoming end-of-life and regulatory challenges
The Challenge
Partnering with a technology design firm that understands the life-and-death complexities of a highly regulated healthcare industry
To restore market confidence following a Class 1 recall, our client required a new and rigorous approach to rectify hardware vulnerabilities and safely reintroduce its industry-leading devices back into the market. This meant 510(k) filings with the FDA for commercial market clearance. To address this challenge, they needed a partner that understood the complexities, discipline, and serious responsibility required to support and reengineer mission-critical medical devices.
"Beyond the technical challenge of FDA approval, the real test was nurturing the trust and demonstrating the integrity required of an industry-leading brand."
While the technical goal was to drive cost savings and prolong revenue-generating years for each device, there was much more at stake than quality engineering. This initiative was about patient safety and brand reputation.
“For anyone receiving intensive care at a hospital, chances are you’ve been connected to and benefited from an infusion pump. So this initiative was critical to patient outcomes.”
Our Solution
Goods & Services established a hardware engineering lab in Merida, Mexico dedicated solely to our client partnership
Goods & Services stepped in as the primary engineering and testing collaborator to navigate this high-stakes recovery phase. Our primary objective was to address the non-uniform silicone tubing defects that led to the recall. By implementing stringent quality management protocols and exhaustive testing methodologies, Goods & Services helped engineer solutions that ensured the structural integrity and precise medication delivery of the redesigned Alaris pumps.
After gaining approval on a single 510(k) filing, Goods & Services expanded its relationship into a long-term partnership.
A critical component of the remediation process involved satisfying regulatory mandates. Goods & Services played a pivotal role in facilitating the release of these updated solutions by driving the technical documentation and validation required for multiple FDA 510(k) filings.
Ongoing Compliance & Long-Term Partnership
Beyond the initial recovery, Goods & Services’ dedication is reflected in its ongoing support of three subsequent 510(k) submissions. These efforts directly addressed complex concerns raised by the FDA, ensuring all modified devices met or exceeded stringent federal quality standards.
“In every case, the team at Goods & Services was such a key contributor to meeting the very real challenges we faced this past year.”
The Impact
A lasting and powerful partnership rooted in trust
Through this collaborative effort, Goods & Services effectively mitigated risks associated with the initial product recall of infusion pumps, successfully protecting patient safety while restoring trust in critical healthcare resources to hospitals globally.
Additionally, the hard work of the Goods & Services team has since paid off in many other ways. Our client now has a system in place to guard against future recalls by engaging closely with customers to ensure remediation or replacement of devices in the field, emphasizing compliance, and prioritizing patient safety. The Goods & Services lab in Merida, Mexico, remains a permanent engineering facility in our portfolio and continues to support solutions across a variety of critical projects.
“It's a wonderful experience to work with products that effect patient outcomes. Both my dad and uncle were beneficiaries of our client's infusion pumps. There are hundreds of thousands of cases where these devices provide live saving support on a daily basis. For this I’ll forever be grateful.”
