Guest Columns

1. Brazil’s Medical Device Market: Patient Demographics, Healthcare System, And Outlook 6/24/2020

   Government initiatives, favorable demographic conditions, and increased patient purchasing power are among the factors that make Brazil an attractive medtech investment definition. Challenges are weighed against opportunities in this article, the second of a two-part series examining the Brazilian medtech market and factors that affect it.

2. A Novel Medtech Strategic Framework For Post-COVID-19 6/22/2020

   As healthcare systems begin again to expand beyond emergency and urgent cases, pent-up demand will exist for elective procedures. But, which procedures will take priority?

3. 4 Preparatory Moves For A Post-COVID World 6/19/2020

   While we don’t know how different the post-COVID world will be, we do know that pharma and medtech leaders are looking ahead and planning to work differently.

4. Understanding Medical Device Regulation In Brazil 6/15/2020

   Latin America’s largest medical device market is streamlining its registration process and attempting to harmonize with globally recognized standards. Challenges are weighed against opportunities in this article, the first of a two-part series examining the Brazilian medtech market and factors that affect it.

5. After COVID-19: Time To Rethink, Redesign, & Reprioritize Everything 6/8/2020

   As we navigate the uncertainty ahead, two things are certain: 1) We will get through this, and (2) the post COVID-19 environment will be very different — but will it be better?

6. Are You Ready? FDA’s Transition From Computer System Validation To Computer Software Assurance 6/3/2020

   The FDA is preparing to release new guidance, "Computer Software Assurance for Manufacturing, Operations and Quality Systems Software," in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.

7. The European MDR: Impetus, Impacts, And Current Status 6/3/2020

   This article explains the MDD’s shortcomings, details the MDR’s history, highlights expected transition timelines, describes the most significant changes, and discusses the anticipated impact on medical device markets. It has been updated through June 1, 2020. 

8. How Military Thinking Can Improve Medtech Decision-Making Under Stressful Conditions 5/27/2020

   As a result of the COVID-19 pandemic, many companies are struggling to make both typical day-to-day decisions and those required in the current environment. This article explores what military decision-making practices can teach us about how to reach appropriate conclusions under stressful conditions.

9. MDR Delay Is An Opportunity To Excel, Not An Excuse To Relax 5/25/2020

   While the MDR date of application has been delayed a year, the Regulation’s final compliance date has not changed. This article discusses general concerns medical device manufacturers should keep in mind as they adjust to the new timeline, as well as four critical MDR factors to address (or revisit) moving forward.

10. Navigating The FDA’s Emergency Use Authorization Process 5/14/2020

    The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ.