Abbott Vascular



Background
Abbott Vascular (AV), a division of Abbott, is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. AV is committed to advancing patient care by transforming the treatment of vascular disease through medical device innovations, investments in research and development, and physician training and education. Offering cutting-edge drug-eluting stents for coronary artery disease, peripheral vascular disease, carotid artery disease and structural heart disease, AV has additional offerings within its product portfolio including bare metal stents, balloon catheters, guide wires and vessel closure devices.

The Absorb Bioresorbable Vascular Scaffold (BVS) system elutes everolimus and then resorbs naturally into the body leaving no permanent scaffold. Absorb consists of four key design elements: a bioresorbable scaffold, a bioresorbable coating, everolimus and the XIENCE V delivery system. The BVS system was launched approximately three years before our engagement. The current BVS regulatory filing requires the storage conditions for BVS to be at or below 25°C with allowable exposures up to 30°C for a maximum of six hours.

The optimization of the current commercial distribution of finished drug product:
  • Assessed regulatory compliance, product quality and patient safety risks,
  • Evaluated the current packaging and monitoring and controls, and
  • Reduced total delivered cost.

The finished drug product is shipped in EPS passive shippers qualified for a controlled room temperature (CRT) range. Each stent is shipped with an electronic pass/fail programmable temperature monitor. Testing of the EPS shipper with the ISTA 7D thermal profile determined that current EPS shipper will maintain payloads below 25°C for 72 hours. This packaging and controls system effectively monitors the cold chain network and nonconformance rates were measured at 0.07% of total stents reported out of compliance at point of use. Root cause of these failure rates was unknown.

The management team was concerned that non-conformances could drastically increase as volume grows in emerging markets. The continuing cost of cold chain management for this product needed review and for opportunities for cost reduction to be identified. In addition to reducing costs in the current commercial supply chain, feedback to the development team on additional testing and allowable excursions was needed to reduce future costs by providing a cost-benefit analysis on different temperature ranges and allowable excursions during transit.

Objectives
First, we created a risk management plan to mitigate any critical or major risks for the logistics processes for distribution. In addition to the risk management plan, the objectives had two focuses/phases including (1) cold chain optimization and (2) temperature monitoring and thermal lane data. For the following phases, we were able to:

Cold chain optimization
  • Examine total delivered cost of shipping by exploring alternative suppliers, technology and processes in the current commercial delivery network
  • Recommend new technologies and technologies to support total lower cost network
  • Prepare RFP documentation and lead selection process for new technologies
  • Provide project plan and technology transfer documentation for implementation of selected technologies

Temperature monitoring and thermal lane data
  • Assist in implementing a series of distribution process improvements identified in the previously completed risk management plan
  • Collect lane data (time of year and temperature data) from current carriers for current shipping lanes and implement a decision matrix for use of lane data to make packaging decisions
  • Implement new technologies for packaging and monitoring to reduce cost while maintaining regulatory commitments and ensuring patient safety

Value to Abbott Vascular
The value of this project includes:
  • Access to experience for marketing authorization (e.g. NDA) approvals for multiple products, presentations, and jurisdictions
  • Learning opportunity across organization to better understand current best practices to validated controlled-environment logistics process
  • Total delivered cost model applicable to other cold chain products

Methodology
In our approach for the cold chain optimization objectives (phase one) including the risk component, we were able to:
  • Conduct a risk assessment (for both US and NL distribution centers) of controlled-environment logistics process
  • Prepare the risk management plan
  • Create user requirement specifications for new cold chain technologies
  • Create total delivered cost model
  • Create RFP document and manage the RFP process
  • Prepare the implementation plan

Our approach to meeting the temperature monitoring and thermal lane data objectives (phase two) was to:
  • Implement distribution process improvements identified in the previously completed risk management plan
  • Collect lane data (time of year and temperature data) from current carriers for current shipping lanes
  • Implement a decision matrix for use of lane data to make packaging decisions
  • Implement new technologies for packaging and monitoring to reduce cost while maintaining regulatory commitments and ensuring patient safety

Results
For phase one, progress was measured by the acceptance of the following deliverables and accomplishments:

  • Risk management plan that identified and proposed mitigation strategy for any critical and major risks in storage and delivery processes
  • Total delivered cost model for Absorb cold chain logistics
  • User Requirement Specifications and weighted average selection model for recommended cold chain technologies
  • RFP document for delivery to targeted vendors

We ensured the completion of protocols, testing, and reports/documentation in support of new technologies and thermal packaging, gel ice, and monitors for shipment of BVS/Absorb.

The implementation and qualification plan for new recommended technologies detailed the project plan for the roll out strategy. The implementation plan also included the following elements:
  • Qualification of new technologies
  • Technology transfer documents
  • Training plan
  • Roll out of new technologies at US and NL distribution center

Phase two included the implementation plan of the identified opportunities. The progress toward those opportunities was measured by the acceptance of the following deliverables and accomplishments:
  • Alternative monitoring technology implemented to replace Tagalert®
  • Lane data collected from current carriers for current lanes
  • Use of no thermal packaging qualified for selected lanes
  • Decision matrix developed to ensure appropriate level of qualified thermal packaging

The three steps of this project: the initial risk management plan; the collection of thermal lane data; and thermal packaging design with temperature monitoring were successful.