Contents Cover story
surmount the regulatory mountains they’ve traditionally faced. Andrea Valentino speaks to experts across the field to explore the historical challenges of SaMD regulation, how flexibility on both sides of the Atlantic is changing the situation at speed – and some of the hurdles regulators may still need to overcome.
Contract manufacturing 12 News & numbers In this issue 44
The headlines and vital statistics impacting the market.
Regulatory 14 Above and
beyond compliance As deadlines for Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) implementation have been pushed back once more, manufacturers are increasingly feeling inclined to procrastinate on a number of MDR compliance activities. Leeanne Baker, managing
director and quality and regulatory consultant at IMed Consultancy, explains why medical device manufacturers need to be proactive, and how doing so could benefit their core business outside of meeting regulatory requirements.
18 Barriers to entry The phrase ‘there’s an app for that’ might be a cliché now – but it could soon become the case in modern medicine just as it currently is for consumer devices. That is, at least, if the companies behind so-called ‘Software as a Medical Device’ (SaMD) products manage to
22 The heart of the matter Given the degree to which diseases of the cardiovascular system contribute to mortality statistics, devices that treat them have always been a priority in medicine. Multiple forecasters are pinpointing this area as one of the fastest growing segments in the medical device contract manufacturing market. But what’s driving the upwards trend, and what factors define a strong manufacturing partner? Jim Banks asks Jabil Healthcare’s director of business development Christa Schnider, and technical business development manager Ramy Awad, for their insights.
27 Promoting hydrophilic coating Argon Medical
29 Supplying despite the global struggle Halkey-Roberts
30 Choosing the right medical device
component manufacturer Custom Wire Technologies
35 A global manufacturing network for customers Carclo
36 Biocompatibility: A strategy for medical devices Qosina
18 4
39 Tipping the scales It’s one thing to come up with a theoretical design for a medical device, or even to prototype it and reach proof of concept, but quite another to assemble the manufacturing conditions necessary to produce it at a scale that make it a viable business. Of course,
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
