Guest Columns

51. 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    The FDA's draft guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, is accepting public comments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.

52. 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.

53. 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.

54. 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.

55. 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.

56. 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.

57. 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.

58. Robotic Technology Is Disrupting Traditional Dental Implant Surgery — Here’s How 1/31/2022

    In a field where precision and accuracy within a confined space are essential, robot-assisted technology can enable dental surgeons to operate with unsurpassed accuracy, ensuring the best functional as well as aesthetic results for patients. This article shares the limitations of traditional dental implant surgery and the opportunities for developers of surgical robotics technology.

59. 3D Printing For Pharmaceuticals & Medical Devices: A Primer With Risk Considerations 1/28/2022

    Implementation of single-use technologies for pharma and medical device manufacturing has introduced advantages in terms of design, sterility assurance, and a reduction in energy usage. 3D printing can deliver precise measurements to production facilities. This article describes the 3D printing process, risk considerations, and limitations — but the future is bright.

60. Regulatory Requirements For A Clinical Investigation For Medical Devices According To MDR Annex XIV 1/24/2022

    On May 26, 2021, the Regulation EU 745/2017 (MDR) entered into force. A clinical investigation must be performed for novel implantable and Class III medical devices to demonstrate that the device is compliant with the general safety and performance requirements. This article also discusses related guidance from the Medical Device Coordination Group.