Guest Columns

11. 5 Key Steps For FDA Q-Submissions 4/18/2022

    Most medical device designers and developers have some familiarity with the FDA's Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.

12. Market Research: Demand For Dynamic Compression Devices Shifts Among Types 4/13/2022

    The administration of pressure through a sleeve system, known as compression therapy, has been traditionally used to treat a variety of medical conditions, including lymphedema and deep vein thrombosis. This article discusses the market for such compression therapy, including pneumatic compression devices and mobile compression devices.

13. The Importance Of Risk Documentation In Medical Device Design 4/11/2022

    Risk documents guide the design team to understand all the ways a device could fail or create a potential harm/hazard and the best way to minimize or eliminate the identified risks. This living process, when properly applied, helps ensure a device is safe, efficacious, and reliable.

14. FDA Issues Guidance On Initiation Of Voluntary Recalls 4/5/2022

    This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time. 

15. Peru’s Growing Medical Device Market In Latin America 4/4/2022

    With a population of 32 million, Peru is the fifth most populous country in Latin America. Its medical device market is $390 million, and it imports more than 97% of the medical devices that it uses. This article covers Peru's health system, its medical device regulatory framework, and opportunities for medical device imports.

16. How To Design Medical Devices With Sustainability In Mind 3/30/2022

    Sustainability has risen to the top of the corporate agenda in many industries, including the medical device market. To maximize success, medical device manufacturers must prioritize it at the beginning of the design phase and must consider the entire life cycle of the device while balancing the need for safety, functionality, and durability.

17. Making The Case For AI-Enabled Coronary CT Angiograms 3/28/2022

    For more than 50 years, cardiovascular disease has remained the leading cause of death in the U.S. While heart disease mortality has experienced a steady decline in recent decades, our progress has now stalled. This article makes the case for artificial intelligence (AI)-enabled coronary CT angiograms to personalize cardiovascular care.

18. How Do I Need To Update My QMS For FDA QMSR Amendment Compliance? 3/23/2022

    The FDA has officially announced its intention to harmonize and modernize 21 CFR Part 820 Quality Management System Regulation (QMSR) for medical devices. This article describes what you need to do with your QMS in order to meet compliance.

19. The Large Market For Medical Devices In Colombia May Surprise You 3/21/2022

    Colombia has a population of approximately 50 million inhabitants, making it the third most populous country in Latin America after Mexico and Brazil. This article covers the general Colombian health social security system, the current medical device regulatory framework, and the size and trends of the market.

20. FDA Seeks Public Comment On Quality Metrics Reporting Program 3/17/2022

    The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.