Guest Columns

31. Best Practices To Use Virtual Reality Methodology For Medical Device Design & Development 2/25/2022

    In medical device R&D, virtual reality (VR) technology has rapidly gained traction as an attractive alternative to in-person evaluation methods, which have been largely suspended during the pandemic. This article reviews how VR methodology can augment or even replace configuration modeling.

32. FDA Issues Proposal To Amend The Medical Device Quality System Regulation 2/24/2022

    The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to align more closely with the requirements of the internationally recognized ISO 13485:2016. The proposed amendment will also affect 21 CFR Part 4: Regulation of Combination Products.

33. What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices? 2/23/2022

    This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions in pharma and medical devices. Also covered are a spectrum for risk appetite, best practices for risk communication, and events and conditions that can shape risk appetite and tolerance.

34. FDA Proposes Guidance On Discontinuation Or Interruption Of Medical Device Manufacturing 2/21/2022

    The FDA's draft guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, is accepting public comments through March 11, 2022. When the FDA concludes that there is, or is likely to be, a shortage of a device, then inspections as well as review of submissions may be prioritized and expedited to help mitigate or prevent shortages.

35. How Medical Device Developers Can Create Better Dental Medtech 2/16/2022

    Today, many physicians use continuous positive airway pressure (CPAP) and other supportive treatments, but these fail to address the root cause of obstructive sleep apnea (OSA) and can even make matters worse. This article shares how medtech developers can address OSA issues in new medtech that helps patients better.

36. How To Set Up An Effective Quality Risk Management Program 2/16/2022

    The author of this article has taught courses on quality risk management (QRM) and its implementation as well as seen it in action in many companies. This article, Part 1 of a 2-part series, shares some of his observations and lessons learned in setting up an effective QRM program.

37. 3 Takeaways From The Elizabeth Holmes Trial For The Diagnostics & Medtech Industry 2/14/2022

    In January, Elizabeth Holmes, the former CEO and founder of Theranos, was found guilty on 4 charges of defrauding investors regarding the company’s development and use of in vitro diagnostic testing. This article shares the 3 important takeaways of the trial for the diagnostics and medtech industry.

38. FMECA: Relevance In Context Of ISO 14971 & EU MDR Compliance 2/9/2022

    This article focuses on failure modes and effects and criticality analysis (FMECA) and the hazard-based approach in ISO 14971. It uses these definitions and discussions to illustrate EU MDR compliance, and how a top-down approach of FMEA can help.

39. Growth In Store For The Cardiovascular Ultrasound Devices Market 2/7/2022

    Types of cardiovascular ultrasound devices are interventional cardiology devices, cardiac rhythm management devices, cardiovascular monitoring and diagnostics devices, & more. Read this article for an outlook on how the market will look through 2028 — and discover the key growth driver to seize for your next cardiovascular ultrasound device.

40. These Spinal Implant Devices Are Seeing A Resurgence In The Asia-Pacific Market 2/2/2022

    There are three major types of implants used: metal-based interbody implants, polyetheretherketone (PEEK) devices, and machined bone interbody devices. This article provides an explanation of each, and shares which type is seeing a resurgence in the Asia-Pacific market. Additional insights are discussed, including the rise of 3D printing and local manufacturing.