Designing solutions for healthcare shippers

Transcription

1 Bio Supply Management Alliance Conference Foster City, California (USA) October 8, 2013 Designing solutions for healthcare shippers Technical Fellow, Cold Chain Management Life Sciences & Specialty Services, FedEx Express

2 Molecular diagnostics & transportation? Words that came to our mind to describe this unique segment within healthcare Small packages Domestic business only until recently Poor volume forecast (number of samples in a box often unclear) Location of pickup and delivery Delivery time Price sensitive transportation Not willing to contract specialized services within FedEx healthcare portfolio such as Priority Alert or SenseAware SM Temperature sensitive specimens Pre-labelled packaging solutions Shipping labels Advanced shipping information and pre-alerts IT portal with minimum information to be entered Security Traceability Page 2

3 Temperature ( o C) Small packages in normal FedEx network Which temperatures can be experienced by small packages during transportation? Origin location: Walnut Creek, CA Phoenix, AZ Dallas, TX Jacksonville, FL New York, NY opened in office in Memphis Temperature devices programmed for 1 data point every 4 minutes and placed inside FedEx boxes :00 PUP scans : : : : :00 Day and time (ET) POD scans at address : :00 FedEx Priority Overnight (PO) shipments: Delivery next day by 10:30 AM local time Page 3

4 Specific customer issue Design and implementation of unique solution Standardization of solution Scalability Collaboration between transportation providers and shippers leads to innovative solutions Page 4

5 Case study: hub extract and re-induction Main condition for program: To be located near the Memphis international airport Packages arrive at Memphis airport around midnight Normal sort at the hub PO delivery by 10:30 AM Packages are segregated at the hub Special delivery at around 02:00 AM Service requested by shippers to take advantage of location near FedEx Memphis superhub Competitive advantage: Send testing results ahead of competitors (some companies moved central laboratory testing facility to Memphis as a result) Re-induction and late pickup near Memphis hub also Page 5

6 Temperature ( o C) Case study: eliminate gel packs Temperature measurements on specific transportation lanes in the summer :00 PO packages placed in nontemperature controlled trailer at shipper site once ready for pickup : :00 Week : : : :00 day and time (ET) PO packages stayed inside air conditioned building until 5:00 PM :00 Week : :00 W1PT_anah W1PT_sacr W1PT_waln W1MT_phoe W1CT_sana W1CT_chic W1CT_hous W1CT_dall W1ET_jack W1ET_rale W1ET_newy W1ET_miam W2PT_anah W2PT_sacr W2PT_waln W2MT_phoe W2CT_sana W2CT_chic W2CT_hous W2CT_dall W2ET_jack W2ET_rale W2ET_newy W2ET_miam Customer requirement: not to exceed temperatures of 38 o C Collaboration on shipping studies from distribution center to main shipping locations Temperature data points collected and shown until proof of delivery (POD) scans FedEx Priority Overnight (PO) shipments: delivery following day by 10:30 AM local time Priority Alert contracted on a seasonal basis Page 6

7 Trend: risk-based approaches As seen at regulatory agencies Page 7

8 FedEx aircraft temperature control Overall approach Customer complaints Temperature measurements to confirm reported issues Literature review Scientific approach towards research studies Establishment of default temperature settings Thermal mapping of aircraft Systematic collection and analysis of temperature data Development of standard procedures Design and testing of innovative FedEx temperature software Compliance and corrective measures Page 8

9 Temperature ( o C) Aircraft temperature mapping Extensive research studies on actual flight temperatures Cargo door Cockpit AFT FORWARD rigid cargo barrier B777F main deck F-ceiling-plane A-ceiling-plane F-L-top A-L-top F-L-bottom A-L-bottom F-R-top A-R-top F-R-bottom A-R-bottom : :00 take-off CDG-MEM : : :00 Zulu date and time : :00 landing Thermal mapping shows that large temperature differences can exist within the cargo Page 9

10 Aircraft default temperature settings FedEx uses best practices based on scientific studies and thermal mapping of aircraft Temperature distribution within each cargo compartment for each aircraft model Temperature gradients along the height of shipments (top warmer than bottom) Conditions vary slightly for each flight: temperature at departure time and conditions on tarmac mixture of shipments within the cargo (cold shipments, live animals generating heat) Page 10

11 Contingency planning Cold storage, gel packs, and re-icing available for delayed cold chain shipments Unexpected events could always arise while in transit: Missed plane connection Plane mechanical failure Bad weather Lack of proper documentation for customs clearance Clearance backlog at regulatory agencies (such as FDA) Dry ice capacity constraints Temperature controlled storage Source: healthcare/tempcontrol/index.html Page 11

12 Risk management: internal documents Example of thermal blanket solution for air freight transportation Risk assessment - Identification of operational parameters (fishbone diagram) - Failure mode and effects analysis (FMEA) - Risk prioritization matrix Risk control - Risk control approaches and contingency plans Sampling, improvement, corrective and preventive actions (CAPA) - Temperature measurements - Internal audits and customer complaints Page 12

13 Security measures FedEx security specifics cannot typically be disclosed, except for the following: People IT systems Employees undergo drug screening and criminal background checks Customer data restricted and not distributed to 3 rd parties (unless required by law) Premises / Vehicles / Aircraft Shipment Controlled access and dedicated security workforce SenseAware devices can be programmed to receive alerts in case of: - Light detection: - has the shipment been opened? - Unexpected routing: - is the shipment outside the desired geofence? - has a package gotten off pace or off track? Page 13

14 Leveraging technical experts is key! Speak to subject matter experts prior to shipping Project engineers trained in cold chain area Packaging solutions Planned routing Special requests Packaging engineers Guidance on packaging Testing laboratory Technical fellow Research studies (temperature profiles, thermal mapping) Knowledge of cold chain quality and regulatory aspects of Good Distribution Practices (GDP) associated with transportation FedEx has an impressive internal network of experts Page 14

15 Questions? Direct contact or Page 15