Often, healthcare companies view regulations as cumbersome business challenges. The complexities can distract attention from why compliance matters. Recent events in the news, contaminated devices and counterfeit components, have reminded us why regulations are important. Ultimately, patient lives are on the line.
How can you embrace regulatory compliance in a way that improves patient safety and helps create an efficient, flexible supply chain? In the following Q&A, Mark Quinlan, director of global healthcare strategy at UPS, discusses medical device supply chain risks and regulations and how you can respond to both.
MedTech Intelligence: What risks, specific to medical devices, drive the need for regulation?
Mark Quinlan: Regulations are about protecting the patient and giving them the best chance at a positive outcome. Several recent cases in which product integrity and security lapses jeopardized patient safety underscore the need for medical device oversight. Risks from both criminal threats and supply chain vulnerabilities are driving the need for better regulation.
Patients are shouldering a much higher burden of their overall cost of care. With that, sometimes they seek medical devices in non-traditional e-commerce channels and purchase them directly. Criminal organizations prey on these patients and sell counterfeit products that have no regulatory controls.
On the other hand, affable companies can find themselves unintentionally distributing a compromised device. Increased reliance on contract manufacturers for individual components leads to more touch points and more players within the supply chain. If one supplier makes a poor decision – e.g. the supplier manufactures a component in a non-compliant environment unbeknownst to the original equipment manufacturer (OEM) – a company could find themselves with a non-compliant medical device.
MTI: What are the major regulatory issues facing the medical device industry? What types of potential regulations do you see coming in the future?
Quinlan: The U.S. Food and Drug Administration (FDA) has developed a three-pillar approach—prevention, detection, and response—to address the counterfeiting of medical devices. One of the first steps in identifying counterfeit and substandard products has been to implement unique device identifiers (UDIs). The UDI enables device tracking throughout the entire supply chain, from the manufacturer and distributor all the way to the patient making it more difficult to introduce counterfeit devices into the supply chain.
From an international perspective, regulations are driving to the same goal of ensuring patient protection. However, the regulations vary from country to country, making it extremely difficult for manufacturers to comply. Regulators in Europe, Asia and North America need to collaborate more to define uniform regulations and step up control from a criminal standpoint.
One good example of this happening now is the annual International Internet Week of Action (IIWA), a global cooperative effort led by INTERPOL; in 2015, the FDA took action against more than 1000 websites that were selling either counterfeit or illegal pharmaceuticals or medical devices through this initiative. This type of collaboration across geographies is the future in this global market.
MTI: What steps can medical device manufacturers take to address regulations in a way that improves safety and their supply chain?
Quinlan: Companies can approach regulatory compliance in a way that creates a more efficient and flexible supply chain. One of the ways manufacturers can tackle this is from a modernization of and investment in their IT infrastructure. By making IT infrastructure improvements to adhere to UDI tracking and tracing regulations, you can also gain advantages in internal inventory control.
For example, by implementing one IT system to help adhere to regulations across multiple geographies, you’ve also bolstered your supply chain to handle the challenges of entering new markets. And, radio-frequency identification (RFID) technology offers real-time visibility that helps meet UDI requirements and highlight opportunities to reduce a substantial amount of excess inventory.
Another way for manufacturers to address regulations and improve profits is to align with a high-quality third-party logistics (3PL) provider that uses one consistent IT platform and has expertise in dealing with the regulations in different international markets. Aligning with and leveraging a 3PL can expedite adherence to regulations and improve supply chain and inventory control to drive profitability.
More visibility and security in medical device supply chains, for the purposes of regulatory compliance and for efficiency, can help healthcare providers and patients know the products they’re using are safe and offer the best chance possible to improve an individual’s health.