Guest Columns

41. 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.

42. 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.

43. 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.

44. Medtech At A Turning Point: The 5 Areas To Address In 2022 1/19/2022

    From 2020 to 2021, the medtech industry's revenues grew and the industry entered a period of recovery and renewal. However, as 2022 begins and we look to a future where COVID-19 becomes endemic, the medtech business model must evolve in these 5 key areas.

45. Building The Right Team for FDA Approval of Your Innovative Medtech 1/17/2022

    Navigating the complexities of the FDA’s approval and regulatory process for medical devices can be daunting for all companies and particularly stressful for new technologies with disruptive innovation. However, the FDA is best regarded as a partner and not an obstruction. If your device development team does their homework, you'll have a successful product.

46. AI & Intelligent Technologies: Finding The Right Fit For Your Pharma Or Medtech Company 1/14/2022

    This article takes a closer look at AI and intelligent technologies in biotech, medical devices, and pharma, and what we can expect to tackle in 2022 and beyond. The article also identifies some of the new concerns and challenges with disruptive technologies and risk management, and discusses a technology and generation timeline.

47. 4 Tips For Medical Device Design Success 1/12/2022

    We are all eagerly anticipating what 2022 will bring us. This author found that when developing a forward vision, it always helps to look back and see what we learned in the past. He uses some personal experiences of designing surgical robotics for these 4 tips.

48. Top Growth Drivers & Trends In The Global Spirometer Market 1/10/2022

    Spirometry is a medical test used to measure lung function. It helps to diagnose and follow patients with lung disorders such as asthma, chronic obstructive pulmonary disease (COPD), and other conditions that affect breathing. This article shares key findings and growth drivers of the market over the forecast period (through 2028).

49. How Can We Use The UDI To Improve The Device Recall Process? 1/7/2022

    The Unique Device Identifier (UDI) was expected to improve patient and medical device safety by enhancing key patient safety systems like the product recall and adverse event reporting processes and improving device evaluation. AHRMM recently completed a survey of various stakeholders; this article delves into the survey's findings and the recommendations for improving the device recall process.

50. How To Untangle Your Medtech Regulatory, Engineering & Business Decisions 1/3/2022

    Making decisions in medical device development is tough. From initial concept to market introduction, countless factors influence almost every decision. It’s easy to confuse and intermingle engineering, regulatory, and business decisions. Knowing which type of decision you’re making can make all the difference in how effectively you can bring your device to market.