Guest Columns

1. Incorporating Injection Molded Plastics In Medical Device Design — Initial Considerations 7/29/2020

   Even a great component idea can be undermined by gaps in knowledge surrounding plastic materials, from engineering and design considerations to optimal procedures for turning that idea into a reliable plastic part that can be consistently produced, affordably and with high quality.

2. Why The Chronic Lower Back Pain Market Vexes Most Medtechs 7/22/2020

   The chronic lower back pain market is one of the most difficult to break into, even though an estimated 35 million patients in the U.S. alone seek treatment, and a vast treatment gap remains between the go-to standards of conservative care and surgery.

3. MDR’s Impact On The European Trauma Device Market 7/20/2020

   The MDR could prove detrimental to the EU trauma device market, while COVID-19’s impact should be minimal. Will key market drivers be enough to prompt growth?    

4. How To Drive Powerful CAPAs With Lean Six Sigma 7/10/2020

   Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.

5. Implications Of COVID-19: EU MDR Implementation Update 7/8/2020

   Learn how the EU 2020/561 Article 59 update, progress on guidance documents, formation of Expert Panels, and more affect your company. 

6. Paclitaxel-Coated Medical Device Markets Recovering After Difficult Year 7/6/2020

   Despite recent positive evidence validating the use of paclitaxel in the peripheries, sales of devices that incorporate paclitaxel remain low. However, a turnaround appears to be on the horizon.

7. 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.

8. 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?

9. 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.

10. 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.