How to Minimize Risk in Global Health Care Logistics

The global health care logistics market — and especially the cold chain market — grows by leaps and bounds every year.

Thanks to the combination of an aging population, the increasing dominance of e-commerce solutions, emerging markets and greater attention from groups like the EU, CDC and WHO, cold chain logistics for health care will likely reach $16.2 billion in value by 2023.

That means companies in this space need to be better prepared than ever to mitigate risk and navigate various regulatory environments. Here are a few areas which demand your focus.

Bring Your Packaging Test Facilities Into Compliance

Thoughtful and compliant packaging design is one of the most important factors when it comes to mitigating risk in the health care supply chain. Because world markets are proliferating and it's now possible to ship pharmaceutical and medical products almost anywhere, seeing to it that cartons and their contents survive the rigors of unpredictable shock, vibration, humidity and temperature fluctuations is a first-order concern.

Whether you intend to develop in-house packaging solutions or build a relationship with a third party, peace of mind begins with the right testing environment. The International Safe Transit Association (ISTA) provides certification guidance for packaging test labs.

These certifications are valid for two years and ensure your lab facility or partner covers the following types of packaging test protocols:

• Corner drops
• Face drops
• Vibration
• Compression
• Rotary motion

These describe the physical damage types you need to account for as you develop designs for the case pack and outer shipping container. The other variables you need to consider for, especially for perishable pharmaceutical goods, are temperature and humidity.

Seek Accreditation — or an Accredited Partner — for Environmental Testing

In addition to the above testing protocols for physical damage, the ISTA) and other groups also provide standards by which a health care supply chain entity may achieve certification as a thermal transport laboratory. Seeking this certification serves two purposes — it provides peace of mind for your stakeholders, and it signals to customers that you take these risks seriously.

ISTA Standard 14 covers a variety of process ownership areas that fall under temperature control and environmental mitigation. Several of these incorporate standards first drawn up by governing entities like the National Institute of Standards and Technology (NIST) and the U.S. Food and Drug Administration (FDA).

Here's an abbreviated list of some of the requirements needed to achieve certification as a thermal testing laboratory:

• Instruments used in the measuring and recording of temperatures must receive regular calibration according to NIST standards. Labs must prove the equipment they use to test packaging against environmental factors operates within an established margin of error.
• Test chambers and associated instruments must meet FDA guidelines for environmental testing.
• ISTA Standard 14 outlines minimum requirements for preventive maintenance on testing equipment and provides guidance on quality management systems, effective data handling and employee training.

Achieving certification to these standards — or seeking out a third party with such certification — is ultimately optional. This state of affairs may not last much longer, however, as some major players in the e-commerce world, including Amazon, require certification by ISTA or their in-house lab. In any event, it's a signal to your current and future partners that you take product integrity in transit as seriously as the quality of the product itself.

Become More Familiar With Potential Legal Entanglements

Another risk to watch for involves incurring delays at the border when shipping medical and pharmaceutical goods across the globe. As mentioned above, entities like the EU and the WHO have standards of their own — but so do individual nations. These standards cover the following points and others.

• Ecological standards:
  Different countries have different rules for cargo vehicles entering their borders. Active refrigeration systems are known emitters of greenhouse gases, and not every territory operates under the same set of rules concerning those. If you do business in regions with stricter emissions standards, you may have to swap active cooling for passive cooling. Packaging designed for passive cooling can still maintain the desired temperature for up to 96 hours, however.
• Mitigation for security concerns:
  Some nations take security risks in the supply chain more seriously than others. One of these risks comes from the potential for theft of high-value, experimental or personalized drugs as they cross national borders. In the case of high-value drugs, which represent an attractive item for thieves, geo-fencing is becoming a popular deterrent and a means for tracking down lost merchandise.

Even something as mundane as incomplete or erroneous shipping manifests and customs records may result in a delay of your products reaching their intended consumer. For some products, that means the possibility of spoilage and customer harm. Some companies which trade in sensitive or high-value health care products outsource some of the effort to customs brokerage services to ensure nothing goes amiss and shipments don't get unnecessarily waylaid.

Use Technology and Culture to Reduce Human Error

Ultimately, it takes a wise mix of technology and culture to reduce risk in the health care supply chain. Success in this field requires intelligent investment — and that means focusing on technologies which reduce the time between detecting exceptions and taking the appropriate action.

Look for tools such as:

• The Real-time alerts for stakeholders in the event of movement anomalies and temperature exceptions
• Two-way data telematics so suppliers, shippers and third-party logistics companies can exchange relevant data in real time
• Location tracking and route optimization software for delivery vehicles, plus immediate alerts for missed deliveries or pickups of perishable goods

As for the cultural element, never underestimate the importance of training. Some of the entities named above provide guidelines for safe and efficient material handling and recordkeeping. But building a culture from the ground up that balances integrity, safety and expediency ultimately falls on your shoulders.