With healthcare products being produced under strictly controlled manufacturing conditions known as current Good Manufacturing Practice (cGMP), ensuring the integrity of the product is paramount.
When they leave the cGMP environment of the manufacturing facility and enter the opaque supply chain pipeline, how does a company ensure the product arrives at its destination ready for human consumption? How can we trust that nothing has happened to compromise the product from the time it leaves the shipping area and reemerges at the customer's final point of use? Wouldn’t it be great if someone could travel with the product through its entire journey and constantly report back what they’re seeing and experiencing?
Well, with the latest technology in healthcare supply chain, we are able to remove the opacity and transform into a transparent pipeline with full visibility and control during every step of the entire complex journey. Here are some of the challenges that companies have to manage in the supply chain:
1. Increasing variety of handling requirements
As more and more biologic therapeutics are introduced, the supply chain's complexity continues to increase, resulting in a wide variety of temperature ranges and special handling requirements. Each product has its own stability profile that must be validated throughout the entire supply chain. Meanwhile, medical device and diagnostic manufacturers are requiring stricter monitoring of their expensive equipment and accompanying reagents.
2. Unique manufacturing and documentation challenges
Even traditional “big pharma” are looking for lower-cost solutions as patents expire on their key moneymakers, and they become more involved in the generics business. Each of these presents unique supply chain challenges as the manufacturing locale is influenced by tax implications and the availability of a highly-skilled workforce. Quite frequently, that means finished products are made in one location and distributed worldwide. However, no matter how far it travels, the product must maintain full safety and efficacy.
Each product begins with active ingredients being sourced, then manufactured in a cGMP environment before entering the retail distribution chain, where it may pass through several distribution stages before reaching the final point of use. Government regulators require healthcare companies to show compliance to their own established and documented processes. Therefore, cGDP - or continuous good distribution practices - can also depend heavily on good “documentation” practices. Demonstrating compliance with their own established cGMP/cGDP practice entails passing audits from health regulators and being able to show the full chain of custody of the physical product as well as the information that follows.
3. Increasingly complex trade lanes
Free market forces are also at play where the industry's most profitable segments see new entrants lured by high-profit potential. For example, technology companies like Samsung and LG are now competing in medical devices and diagnostics (MD&D) and even biologics against giants like Siemens Healthineers and GE Healthcare. This is creating new complexity in the form of east to west trade lanes for MD&D, while traditionally, this type of product moved from west to east. Demand for MD&D products is also increasing in South America, Africa, Eastern Europe, and South Asia, creating new markets and a need for cGDP-compliant logistics solutions.
4. Supply chain stakeholder collaboration
Due to the COVID-19 pandemic and cost pressures, the current trend is growth in telehealth and remote patient monitoring. Augmented reality with AI is being used for visualization by remote physicians, collaboration among remote physicians, robotic surgery, and integrated systems that offer connected care for physically distanced patients. These integrated systems depend on the manufacturer, care provider, and patient, all interfacing with the same real-time data telematics and a process that is transparent and scalable. All of the above must be supported by 5G data transmission networks. Welcome to the digitization and future of healthcare; it just keeps getting more complex!
Managing this complexity requires all stakeholders in the supply chain, such as warehouses, truckers, forwarders, quality, risk management, and senior leadership, to all collaborate. The enabler of this collaboration is Cargo Signal Vitals. We are able to digitally illuminate all products down to the lot and batch level at every stage of transit and storage. Doing so makes the supply chain truly integrated and connected, such that patients, clinicians, technicians, and manufacturers are all connected through our telematics network.
Taking it a step further, the digital twin of the supply chain produced from the data can show how supply chain resiliency and agility can be enhanced. Advanced predictive and prescriptive analytics can be done using modeling techniques to optimize the supply chain. Models can be generated to quantify significant profit contributions to the manufacturer’s organization by line item to demonstrate direct positive financial results. Not only does Cargo Signal Vitals help ensure the safety and efficacy of the supply chain, but helping our customers become more competitive in the marketplace allows them to focus more resources on R&D and other investments that ultimately improve lives.