Guest Columns

11. Risk Mitigation For Homecare Devices: 4 Tips For Anticipating The Unanticipated 8/24/2020

    With the surge in home healthcare these days, designers must approach risk very differently than when devices were being designed solely for use by clinical personnel. This rise in home healthcare is driving the need for increased risk scrutiny for several reasons.

12. Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities” 8/21/2020

    How do we attract the right kind of talent to a role within our organizations? How do we take the same innovative approaches in our talent acquisition processes that we put into our products? One answer can be found in an often-overlooked bullet point in a common job description: “other duties and responsibilities as required.”

13. Less Than A Year Until EU MDR: Are All Your “Economic Operators” Compliant? 8/20/2020

    Although the new requirements relating to economic operators under the EU MDR may still raise questions for manufacturers, the recent delay of the date of application by one year will give the industry additional time to get their regulatory matters in order.

14. Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products 8/11/2020

    The establishment of an environmental monitoring and microbiological control program for sterile medicinal devices is necessary to ensure microbiological safety and finished product quality. The level of environmental control is primarily dependent on the method of product sterilization.

15. Trends In Medical Device Contract Manufacturing — What Medtech OEMs Need To Know 8/6/2020

    The global medical device outsourcing market, worth an estimated $52B in 2019, is projected to grow at an 11.4 percent CAGR through 2025, outperforming overall medical device industry growth. Consequently, the organizational, business, and competency models of outsourcing organizations, as well as the types of client-vendor engagement, are evolving to define novel paradigms.

16. 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.

17. 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.

18. 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?    

19. 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.

20. 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.