Regulatory
Staying ahead of shifting regulatory science
The pace of digital health product innovation is eclipsing the pace of regulatory science, and product developers and manufacturers are in a position where they must navigate existing regulations while continuing to develop novel patient care features and product iterations. Smit Patel, associate programme director, Digital Medicine Society; and Megan Coder, vice president, product and policy, Digital Medicine Society, explain how a focus on achieving broad patient access, commercial viability and consolidated evidence-generation strategies can pave the way for manufacturers to navigate the complex landscape of regulatory requirements, ultimately satisfying the demands of various stakeholders.
I 18
n today’s global healthcare systems, marked by challenges related to access, equity, affordability and outcomes, the rapid stride of digital health innovation holds immense potential. However, the combined pressures of delivering innovative patient care and balancing existing regulatory pathways mean that manufacturers do not have the luxury of wasting time or money on pursuing multiple regulatory strategies for a single product line. Furthermore, manufacturers cannot evade the imperative of pursuing a regulatory strategy when in reality it should be a foundational consideration from the outset. A recent survey conducted by the Digital Medicine Society (DiMe) revealed that 25% of digital health product manufacturers did not know
if the product they are developing was regulated or not. Of those respondents who knew their product was regulated, 75% did not know the optimal pathway to pursue. Recognising this void, the DiMe undertook an effort to develop a suite of tools and resources to clarify the US regulatory pathways applicable to digital health products, in addition to highlighting the benefits and considerations associated with each potential pathway.
If not now, when?
Regulatory oversight can offer digital health manufacturers a robust path to demonstrate product safety and efficacy. Fit-for-purpose regulatory strategies that account for review
Medical Device Developments /
www.nsmedicaldevices.com
TierneyMJ/
Shutterstock.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
