Company insight
Early assurance with 3D-printed injection mould tooling
3D-printed injection mould tooling (3DPT) offers dramatic time-to-market reductions and lower tooling costs and is emerging as an attractive path-of-least-resistance from prototyping to production. Freeform Injection Molding (FIM) is a novel 3D-printed injection mould tooling platform that allows the manufacturing of complex injection-moulded parts without tooling investments. Denmark-based Addifab reviews how a medical device developer may use this technology to speed up device verification.
V
erification is a crucial part of medical device design and is embedded in the regulatory frameworks of many jurisdictions. As the FDA eloquently puts it: “Each manufacturer shall establish and maintain procedures for verifying the device design,” and “design verification shall confirm that the design output meets the design input requirements.”
In practical terms, verification requires that manufacturers get their hands on parts that accurately represent the parts that will be used for the final device and use these parts (alone or in assemblies) to verify that all design input requirements have been met. Injection-moulded parts tend to be among the most complex to source, due to the need for high-cost tooling with long lead times. Furthermore, injection-moulded parts are difficult to modify if changes need to be made to correct design flaws that are identified in the verification process. In this context, early assurance – preferably before tooling investments need to be made – has significant value.
Addifab’s Freeform Injection Molding helps to reduce costs and time compared to conventional processes.
assurance that design input requirements will be met.
Research has demonstrated that 3D-printed injection mould tooling may facilitate iterative design by significantly reducing costs and lead times compared with conventional metal tooling. Exploiting these benefits, manufacturers have used Addifab Freeform Injection Molding (FIM) to support critical parts of device verification and gain early
36
Key steps when implementing 3D-printed tooling
Following the decision that one or more device parts must be made with injection moulding to meet specific design input requirements, the manufacturer must determine how to verify their safe and effective performance. Whether
3D-printed injection mould tooling may be used to minimise development risks through reduced verification testing costs and lead times depends on the specific use case. As a rule of thumb, parts made with 3D-printed tooling must be substantially equivalent to parts made with conventional metal tooling if they are to be useful for verification. To help manufacturers determine if such equivalence exists, FIM inventor Addifab has developed guideline workflows for some of the most frequent use cases: ■Part needs to meet specific performance requirements: Performance requirements will typically guide the device developer towards specific materials, and 3D-printed injection mould tooling has matured to the level where almost all injection-mouldable materials may be processed. However, since 3D-printed tooling may differ from the metal tooling that is normally used in the compilation of technical datasheets, it is important to verify that a given material delivers datasheet performance when processed with 3D-printed injection mould tooling before actual parts are made. This part of testing – which demonstrates that parts made with FIM will have equivalent performance
Medical Device Developments /
www.nsmedicaldevices.com
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 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146 |
Page 147 |
Page 148 |
Page 149 |
Page 150 |
Page 151 |
Page 152 |
Page 153 |
Page 154 |
Page 155 |
Page 156 |
Page 157 |
Page 158 |
Page 159 |
Page 160 |
Page 161 |
Page 162 |
Page 163 |
Page 164 |
Page 165 |
Page 166 |
Page 167 |
Page 168 |
Page 169 |
Page 170
