Medical Affairs Support of Medical Information Requests during COVID-19 Pandemic

Abstract

Introduction: Medical Affairs teams within Medical Device Companies receive Medical Information Requests (MIR) from Healthcare Professionals (HCP) seeking answers to medical, scientific, or technical information because they cannot be answered based on the individual product’s current prescribing information, indications, Instructions for Use (IFU), as cleared or approved by the appropriate competent regulatory authority (e.g., Food and Drug Administration (FDA), Notified Body in the European Union, or other regional governmental authority). In 2018, Johnson & Johnson MedTech launched a Cloud-based platform to harmonize Medical Affairs’ global management and processing of MIRs from HCPs, seeking scientific or medical information about our portfolio of products. The aim of this comparative retrospective analysis was to critically examine the 2020 MIR volumes in 2020 versus 2019 and assess the impact of COVID-19 on Medical Affairs support of patients and Health Care Providers (HCPs). Methods: The authors conducted a retrospective analysis of Johnson & Johnson MedTech MIR data, across quarters from January 2019 through the December 2020, to evaluate the potential impact of the COVID-19 pandemic on MIR intake volume and key metrics. Results: The Total Global (US, EMEA, and ASPAC) year over year analysis of Total Johnson & Johnson MedTech MIR volume totaled, 2018-656*, 2019-1155 and 2020-1153. When stratifying Global year over year analysis of Regional (US, EMEA, and ASPAC) MIR data: US MedTech MIR volume for quarterly periods, including initial COVID-19 pandemic, Q2 2020 resulted in a 48% decrease in MIR volume across US MedTech MIR submissions, compared to Q2 2019. Q3 2020 resulted in a 43% increase in MIR volume across US MedTech MIR submissions, compared to Q3 2019. EMEA MedTech MIR volume for the quarterly periods, including initial COVID-19 pandemic, Q2 2020 resulted in a 23% decrease in MIR volume across EMEA MedTech MIR submissions, compared to Q2 2019. Q3 2020 resulted in a 22% increase in MIR volume across EMEA MedTech MIR submissions, compared to Q3 2019. ASPAC MIR volume for the quarterly periods, including initial COVID-19 pandemic, Q2 2020 resulted in an 11% increase in MIR volume across ASPAC MedTech MIR submissions, compared to Q2 2019. Q3 2020 resulted in a 90% increase in MIR volume across ASPAC MedTech MIR submissions, compared to Q3 2019. Analysis of Quarterly MIR volume by Region (US, EMEA, and ASPAC) compared to Quarterly MIR volume from Prior Year (2019-2020): US Q1-18%, Q2 -48%, Q3+39%, and Q4+7%, EMEA Q1-29%, Q2-30%, Q3+25%, and Q4+15%, and ASPAC Q1-16%, Q2+11%, Q3+90%, and Q4+256%. Conclusion: Total MIR submissions and responses continued with only small variance from the previous year when compared to annual periods, including the impact from the COVID-19 pandemic (2019 vs. 2020). Across Johnson & Johnson MedTech, Healthcare professionals and the commercial sales teams increased their use of the MIR submission website during the COVID-19 pandemic, while face to face interactions were either prohibited or restricted, due to social distancing guidelines. Despite the COVID-19 pandemic, global customers benefited from the wealth of data and information available from MedTech Medical Affairs, through utilization of our interactive MIR submission website and MIRO digital platform. MIRO allowed for the continuous, timely processing of global MIRs, related to both essential hospital activities as well as elective procedures around the world, while limited face to face interactions were enforced, around the world.