Case Study | 25 August 2025
How a Medi-Tech Company Overcame Repeated Product Recalls with Proactive Regulatory Compliance and Risk Management
Posted by : Radhika Pawar
A well-recognized global manufacturer of critical medical-technology devices such as neurostimulators, insulin infusion systems, and advanced orthopedic implants was struggling with frequent product recalls that threatened both its market credibility and compliance status. Experiencing regulatory pressure from international bodies like the FDA and EMA due to non-conformities in product validation, the company collaborated with Research Nester to design a customized framework for proactive regulatory compliance, risk mitigation, and traceability in its end-to-end operations.
An overview:
The medi-tech giant had long established itself as a leader in advanced therapeutic devices, highly known for groundbreaking developments in minimally invasive surgical instruments and neural stimulators. Its innovations transformed areas such as spinal cord stimulation and pain management. However, underlying challenges in post-market monitoring and quality recordkeeping gradually began to arise. The situation escalated when several batches of orthopedic implants were found to have structural defects and bio-compatibility issues. What started as minor quality lapses turned into full-scale recalls in 2021 and 2022, affecting over 150,000 units globally. To avoid long-term reputational damage, the company turned to Research Nester to establish a risk-proof compliance management strategy.
The Story
Established in 1951 as a small surgical instrument maker, the company expanded over the decades into a multi-billion-dollar medi-tech enterprise functioning across North America, Europe, and Asia-Pacific. Its flagship innovations, such as sensor-embedded spinal implants and auto-regulating insulin infusion devices, set standards in therapeutic efficiency. However, as the company rose rapidly, the complexity of its operations and supply chain widened. The firm began to struggle with maintaining consistency in product validation protocols across different geographies. Multiple orthopedic implants manufactured in their Asia-based facility were later found to have microcracks that could compromise patient safety.
After this, the U.S. FDA issued warning letters and a subsequent Class II recall in August 2021. Investigations discovered the implants lacked adequate fatigue testing and traceability documentation. Despite having internal quality review systems, the firm failed to harmonize its procedures with global compliance standards.
Our Solution:
After a comprehensive audit of the company’s compliance rules and quality management systems, Research Nester pointed out a series of systemic problems, such as:
- Disjointed quality assurance practices at different manufacturing facilities
- Inadequate fatigue and tensile testing during product validation
- Poor end-to-end traceability for inputs and batch processing
- Lack of a unified system to capture and respond to post-market feedback
- Misalignment between domestic regulations and international compliance standards
To overcome these systemic failures, Research Nester designed a phased, five-tier quality assurance and compliance framework:
- Global Regulatory Alignment: Research Nester supported the client align all product development and testing protocols with the latest FDA 21 CFR Part 820 and EU MDR 2017/745 regulations. This included thorough documentation of Design History Files (DHF), Device Master Records (DMR), and Risk Management Files (RMF).
- Digitized Traceability System: A blockchain-integrated traceability system was launched, assuring end-to-end visibility of each product’s lifecycle from the sourcing of titanium alloys to the final sterilization process. This created a tamper-proof log of each unit’s compliance path, useful for both internal audits and external regulatory checks.
- Predictive Risk Management: AI-driven tools were employed to assess patterns in historical recalls, failure reports, and customer complaints. This helped the company to predict and reduce potential failure points before they became larger issues.
- Supplier Risk Audit Program: Vetting procedures were standardized, and a Quality Index Score was given to each raw material supplier based on past performance, compliance certifications, and delivery consistency. Suppliers scoring below a defined threshold were either onboarded into a corrective training program or disqualified.
- Post-Market Surveillance Dashboard: A central digital dashboard was built that collated real-time feedback from hospitals, clinicians, and distributors worldwide. This significantly enhanced response time in managing difficult events and product performance deviations.
Additionally, Research Nester enabled the client to:
- Appoint dedicated Compliance Officers at all global facilities
- Introduce GAMP 5 validation for all software-integrated products
- Execute automated documentation systems for ISO 13485 certification updates
- Plan quarterly compliance workshops for design and manufacturing teams
These steps helped the company to move from a reactive to a proactive compliance culture, which became key to its new product development cycle.
Results
By mid-2022, the client had effectively taken back command over operations and re-established regulatory confidence. This transition led to many significant achievements:
- Recalls Reduction: The number of product recalls dropped by more than 70% in 2023 as compared to the previous two years.
- Regulatory Reinstatement: Both the FDA and EMA withdrew their warning letters, mentioning adequate corrective and preventive actions (CAPA) by the company.
- Revenue Growth: Sales went up effectively, from USD 8.4 billion in 2021 to USD 12.6 billion in 2023, fueled by re-established confidence from hospitals and distribution partners.
- ISO and CE Accreditations: Within 10 months of rolling out the new framework, all manufacturing sites achieved updated ISO 13485:2016 and CE Mark certifications, meeting international quality and safety standards.
- Operational Efficiency: Production downtime due to quality issues was decreased by 35%, and first-pass yield improved by 18% across important product lines.
- Market Reputation: The company was listed among the Top 10 Most Reliable MedTech Innovators by a leading healthcare analytics firm in early 2024.
What began as a quality control crisis was transformed into a success story of compliance-led innovation. The company not only stabilized its operations but also transformed compliance into a strategic advantage, enabling it to win new tenders across Europe and Southeast Asia.
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