Shots:
- Product recalls in biopharma and MedTech incur an unanticipated drain on budget, costing the industry between $2.5B to $5B per year on average
- Honeywell’s TrackWise Recall Management helps biopharma and MedTech companies plan and execute recall processes seamlessly, contributing to improved patient safety and faster response times
- Shawn Opatka, Vice President & General Manager, Life Sciences at Honeywell Process Solutions, navigates the proactive and efficient approach that TrackWise employs to expedite recalls in a stimulating conversation
Saurabh: With a higher number of recalls every single year in the pharmaceutical and medical devices industry, how does the integration of TrackWise Recall Management prevent financial and reputational implications for life sciences companies?
Shawn: With recall numbers reaching alarming heights, life sciences companies face unprecedented financial and reputational risks. TrackWise Recall Management provides comprehensive protection through several critical mechanisms.
TrackWise significantly reduces recall costs through speed and precision. The AI-assisted platform can reduce execution time from weeks to minutes by replacing manual spreadsheets with automated workflows, helping minimize the downtime traditionally caused by large-scale recall events. By more accurately bounding the recall of affected batches, the system prevents unnecessary over-recalls, reducing the financial burden of recalling more products than necessary.
This efficiency is crucial given that recalls represent massive financial exposure, with non-routine quality events including major observations, recalls, warning letters, and consent decrees, along with associated warranties and lawsuits costing the industry between $2.5 billion and $5 billion per year on average.
TrackWise enhances organizations’ ability to efficiently plan and execute recall processes, contributing to improved patient safety and faster response times. Quick, decisive action demonstrates corporate responsibility and helps maintain stakeholder confidence.
Saurabh: How does this platform help in improving safety outcomes for patients compared to traditional methods of product recall?
Shawn: TrackWise Recall Management has been designed to enhance the ability of organizations to efficiently plan and execute recall processes, thereby contributing to improved patient safety and response times when recalls are necessary. In industries where the health of patients is paramount, the ability to respond promptly and precisely to potential product recalls is critical.
When a recall is initiated, expediency and efficiency are vital. TrackWise Recall Management will enable companies to execute recalls with well-defined procedures that clarify roles and responsibilities across a cross-functional recall team. This clear delineation of tasks ensures that all team members know their responsibilities, thus facilitating faster, coordinated efforts when addressing the affected products.
Saurabh: How does the TrackWise Recall Management system integrate with the existing workflows, which life sciences companies traditionally follow in case of recalls? How does this help in improving efficiency and reducing significant impact?
Shawn: The system provides a standard workflow for all processes and allows customers to customize it according to their requirements. It enables standardization of the entire recall process in the organization, including email templates, forms, regulatory reporting, and monitoring processes. The system can gather data from all sources of record (SORs), which are critical for workflows during a recall.
Saurabh: Did you face any regulatory or compliance issues in bringing this product from idea to market?
Shawn: No, we did not encounter regulatory or compliance issues in bringing TrackWise Recall Management from concept to market. This success was achieved through extensive upfront preparation and research.
We conducted extensive research and Voice of Customer (VOC) activities with regulatory bodies and life science companies worldwide before development. This groundwork helped us understand regulatory requirements and expectations across different markets.
Through early investment in regulatory research and stakeholder engagement, we developed TrackWise Recall Management with these considerations in mind. This approach ensured a smooth market entry and met the stringent global requirements of life sciences companies.
Saurabh: What are the parameters that the TrackWise Recall Management system uses for managing recalls from the first signal through final resolution?
Shawn: The TrackWise Recall Management system efficiently manages recalls from detection to resolution. It identifies issues, assesses risk severity and product details, supports root cause analysis, and health hazards. Once initiated, it handles regulatory reporting, notifications, returns, quarantine procedures, tracks communication, monitors effectiveness, enforces CAPA, ensures documentation, audit readiness, and closure, with optional ERP, CRM, and quality systems integration.
Saurabh: With the introduction of the TrackWise Recall Management Platform, will it be able to bring a major impact on countless patients who rely on high-quality, life-saving products daily?
Shawn: TrackWise Recall Management prioritizes patient safety by removing dangerous or defective products quickly. It identifies only affected batches, ensuring safe products remain available. The platform also detects quality issues early to prevent harmful products from reaching patients.
Clear communication about recall status enables immediate protective action, reducing supply chain disruptions, and maintaining access to essential medications and devices. This efficiency helps healthcare providers minimize treatment interruptions and maintain patient trust.
Overall, TrackWise transforms recall management into a proactive system that enhances product quality and safety standards, offering patients greater confidence in their treatments.
Saurabh: Could you elaborate on how AI is integrated into this product and how it provides leverage compared to traditional recall systems?
Shawn: The integration of artificial intelligence (AI) into the TrackWise Recall Management system enhances recall processes through faster detection and response, improved recall effectiveness and coverage, reduced regulatory risk, minimized manual workload and cost, and increased visibility for decision-making. Compared to traditional, manual recall systems, AI-powered TrackWise offers a more proactive and efficient approach with the following key capabilities:
Early Detection & Signal Recognition
- Analyzes large volumes of structured and unstructured data (e.g., complaints, service reports, social media)
- Uses Natural Language Processing (NLP) to detect early warning signs of potential product issues
- Flags risks before they escalate, reducing recall scope and impact
Risk Assessment & Prioritization
- Applies machine learning models to assess severity, likelihood, and impact
- Prioritizes recalls based on customer risk, geographic spread, and regulatory classification
- Enhances decision-making with data-driven risk scoring
Automated Workflow & Compliance
- Automates recall steps such as stakeholder notifications, form generation, and task routing
- Adapts workflows dynamically as new data becomes available
- Reduces manual errors and improves audit readiness
Real-Time Monitoring & Effectiveness
- Tracks return data, response rates, and unresolved cases in real time
- Identifies gaps in recall execution and suggests corrective actions
- Supports faster and more accurate recall closure
- Continuous Learning & Improvement
- Learns from past recalls to improve future recall strategies and CAPA processes
- Provides predictive analytics and dashboard insights to support ongoing quality improvements
- Helps reduce recurrence of similar issues over time
Saurabh: As per your report, medical device and pharmaceutical recalls have increased by 13.8%. Do you think your product can help in improving these numbers?
Shawn: Yes, TrackWise Recall Management can significantly help improve these alarming statistics through both preventive measures and enhanced response capabilities.
TrackWise addresses the root causes that drive the 13.8% increase in recalls by providing comprehensive quality oversight and trend identification. The platform helps organizations identify quality issues and trends before they escalate into recall situations, effectively preventing recalls from occurring in the first place.
By offering real-time visibility across the entire product lifecycle and integrating with existing quality management systems, TrackWise enables proactive quality management that can catch potential issues during manufacturing rather than after products reach the market.
When recalls do occur, TrackWise transforms the process from a reactive crisis into a managed, efficient response. The platform reduces recall scope through batch identification, minimizing the number of products that are unnecessarily pulled from the market. This accuracy helps reduce the overall impact and duration of recall events.
As more life sciences companies adopt comprehensive recall management systems like TrackWise, we anticipate industry-wide improvements in recall statistics. The platform’s AI-assisted capabilities and automated workflows set new standards for recall management efficiency and accuracy.
While external factors like increased regulatory scrutiny and supply chain complexity continue to drive recall numbers upward, TrackWise provides the tools necessary for companies to buck this trend. Organizations using the platform should see measurable improvements in both recall prevention and recall execution metrics.
TrackWise doesn’t just manage recalls better; it helps prevent them altogether while making unavoidable recalls faster, more precise, and less disruptive to both companies and patients.
About the Author:
Shawn Opatka
Vice President & General Manager, Life Sciences at Honeywell Process Solutions (HLS)
Shawn Opatka is Vice President and GM Life Sciences at Honeywell Process Solutions. He is responsible for client success and profitability for the Life Sciences Honeywell Process Solutions portfolio. Shawn joined Honeywell in 2021 and he has been integral to strengthening its Life Sciences portfolio. He has been in the Life Sciences industry for over 15 years. His extensive experience includes identifying opportunities and technology to help improve life sciences manufacturing operations and data management challenges.
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