Creating Confidence When Shipping Critical Products
by Carl Asmus, Vice President, Supply Chain Solutions & Market Development, FedEx Services
A famous maxim in healthcare is, “If you didn’t document it, it didn’t happen.” This advice stresses the importance of information reporting in order for providers to meet regulatory requirements, get paid and deliver the best care possible. But how do healthcare products companies overcome the challenges of reporting and documentation in an increasingly complex industry?
This answer comes in sensor-enabled technologies, which ease the common challenge of weak visibility into product status across the supply chain. In a field where the quality and delivery time of a product is of utmost importance, competitors in the field will be turning toward these tracking technologies in greater numbers to reduce their own risk exposure. Companies in healthcare and other industries are increasingly turning “dumb” assets into “intelligent” ones by leveraging the power of sensors that can be added to or packaged with their products. These systems can monitor a wide variety of indicators that may be important to maintaining supply chain integrity, such as:
- Current location
- Temperature/barometric pressure
- Evidence of tampering
- Alerts (route, location, time-based, proof of delivery)
Integrating sensors that have these capabilities with the products and their packaging in transit, stocking and use will be a critical step in the ultimate integration of the healthcare products supply chain. With seamless, real-time tracking of a product’s supply chain over its entire lifecycle, users would be able to query a database all the way to a patient’s bedside to confirm a product was not tampered with, defective, expired or recalled. As in other fields, healthcare products companies and their customers will be leveraging analytics and big data mining in the supply chain for healthcare products and services. Companies should identify supply chain vendors with a highly connected network where goods and information about the products in the system are captured at every level. Connectivity means not just connecting distribution hubs and modes of transportation but also data about products in transit. This is increasingly important when expanding into global markets and into new customer settings, such as patients’ homes.
Providing product assurance in a highly regulated market
Security and theft are real risks in the healthcare products supply chain, especially when high-value medical devices and pharmaceuticals are involved. Beyond the significant amount of money lost from theft, security lapses may impact patient safety and tarnish the company’s reputation. The Drug Supply Chain Security Act of 2013 was the United States’ first step in securing the pharmaceutical supply chain from theft and counterfeit products, requiring more stringent oversight of companies handling sensitive medical products.
In 2014, the U.S. Food and Drug Administration (FDA) announced that manufacturers would be required to track certain medical devices to facilitate product notifications and recalls. It’s expected that the FDA will eventually expand this rigorous monitoring and reporting to pharmaceuticals, especially those that require temperature control during transport. In addition, the FDA is phasing in its unique device identification program through 2020, which will provide new ways for manufacturers and providers to track how a wide range of medical devices is used and to then report that information in a public database. As the complexity of the supply chain increases, the burden of medical product safety no longer falls on the manufacturer alone. Medical device safety is a significant investment for distributors, providers and patients, and the drive for improved security is expected to only increase.
What can innovation in supply chain visibility and reliability bring to healthcare?
- Expansion of healthcare beyond the hospital: One of the greatest opportunities for innovation in sensing technology in the supply chain is the delivery of highly sensitive and expensive products outside of the hospital. In general, hospitals excel at managing products that are temperature-sensitive, fragile, time-dependent or at high risk for theft, but that degree of security drops dramatically in other healthcare settings and, most especially, patient homes. If the promise and potential of expanding the reach of healthcare services into the home is to be realized, then a robust, reliable and secure bidirectional supply chain must be established between healthcare products companies, their distributors, providers and the millions of homes where patients live.
- Expanding adoption of temperature-sensitive tests and treatments: An estimated 25% of all healthcare products are temperature-sensitive, so maintaining a specific temperature range from pickup to delivery is a key concern of manufacturers, labs, providers and their supply chain vendors. Use of biologic treatments and tissue-derived devices, which are highly perishable, has skyrocketed in recent years, and growth is expected to continue. Clinical diagnostic tests, which require the transportation of biologic samples from collection location to labs under controlled conditions, continue to grow as well. Healthcare companies with temperature-sensitive products should look for supply chain vendors that offer innovative sensing, packaging, storing and transportation solutions that can maintain temperature integrity and eliminate unnecessary costs due to product wastage.