Packaging, supply and logistics
“Medical devices have fared better than pharmaceuticals, as margins are obscenely high compared to pharma products, so there is an economic incentive to have continuity and back up in the supply chain,” he adds. “When I was in medical device manufacturing, business continuity was a major focus because we were making high-profit products. Smaller margins mean less incentive to have that continuity in place.”
Defining and delivering resilience NASEM defines resilience in simple terms. It is the ability of medical product supply chains to match supply with demand under both normal and emergency conditions, so that patients and providers can count on access to medical products when they need them. The report, entitled ‘Building Resilience into the Nation’s Medical Product Supply Chains’, sought to examine the root causes of medical product shortages and identify ways to ensure that supply chains are less brittle. Ultimately, its goal was to map a path through volatility, uncertainty, complexity, and ambiguity and change the game by introducing better visibility, planning and risk assessment. “The most important piece in the report is to help make the supply chain more transparent in terms of where everything is made,” believes Ball. “A common theme is that not knowing where things are made means it is difficult to know how fragile the supply chain is. Resilience is more of a problem with drugs than devices, as generics can be made in very low-cost markets.” As an example, India and China are the biggest producers of generic pharmaceuticals. “That is less the case with medical devices, as they are more complex and require highly skilled labour,” Ball adds. “Devices have inherently more robust supply chains spread across the world.”
The focus of Ball’s work is on product recall causes and effects, as well as the recall decision-making process, FDA regulatory policy, and supply chain quality in the pharmaceutical, medical device and automotive sectors. This gives him uniquely detailed insight into the challenges the industry faces, and he firmly believes that the report’s seven key recommendations start with the most important steps. The first two recommendations are to enhance awareness of medical product supply chain risks and remedies, with the FDA making sourcing, quality, volume and capacity information publicly available for all medical products approved or cleared for sale in the US; to establish a public database to share this information; and to promote analyses of this data by interested parties that could lead to novel approaches to address the other
Medical Device Developments /
www.nsmedicaldevices.com
priorities identified in the report – mitigation, preparedness and response.
Mitigation strategies focus on reducing the risk and magnitude of disruptive events that cause supply shortages by making health systems deliberately incorporate quality and reliability – in addition to price – when making contracting, purchasing and inventory decisions. The recommendations on preparedness aim to prevent or reduce shortages from disruptive events that do occur. The committee suggests that the Office of the Assistant Secretary for Preparedness and Response (ASPR) modernise and optimise inventory stockpiling management, and that the ASPR and the FDA complement the stockpiling of medical products with capacity buffering policies to enhance cost efficiency and improve protection in major emergencies.
pharmaceuticals, as margins are obscenely high compared to pharma products, so there is an economic incentive to have continuity and back up in the supply chain.”
In the response part of the committee’s resilience strategy to protect against supply shortages that do impact end users, there is a recommendation to negotiate an international treaty with other major medical product exporters to make more effective use of limited global supplies by ruling out export bans on key medical products and components. Furthermore, it suggests that the ASPR and the Centres for Disease Control and Prevention (CDC) establish a domestic working group to examine ways to improve the final delivery stage of the supply chain.
The recommendations make perfect sense, but their implementation hinges on the first step – improving transparency – and that is where Ball sadly expects some pushback. Better visibility through the supply chain, he says, may not be to the industry’s liking.
“Consumers and group purchasing organisations will drive the market to be more resilient if they have more information about where and who makes a product,” Ball explains. “They could take a more informed view on risk than they can now, as they currently have very little view on risk at all. Consumers trust a medical product to do what it says it will do, and they have no way of knowing if it is a risky product. That is not true of any other product, like a phone or a car.”
117
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140
