Industry Perspectives

91. 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.

92. 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.

93. 4 Key Considerations For Onshoring Inbound Medtech Supply Chains 12/13/2021

    Many medtech supply chains hold a significant amount of redundant inventory, from orthopedic spare parts to unutilized loose instruments. If the industry can better translate demand signal into supply chain reality and build greater flexibility, the industry could significantly downsize its redundant inventory. This article provides 4 key considerations for medtech leaders.

94. Collaborative Communities: An Opportunity To Contribute To Medical Device Industry Improvements 11/2/2021

    Collaborative communities are a global grassroots effort convened by interested public and private stakeholders who work to solve shared challenges and achieve common goals related to medical devices. These communities do not replace established regulatory mechanisms, are not federal advisory committees, and are not chaired or convened by the FDA, but FDA may participate. Here are the descriptions, goals, and contact information for each of the 12 collaborative communities that have FDA CDRH participation.

95. Robotically Assisted Surgical Devices: Ripe For Innovation 10/25/2021

    In the healthcare industry, the robotically assisted surgical (RAS) device sector is dominated by a few key players. In the future, several new companies are expected to enter the industry. Competition is heating up. Shifting demographic and labor trends will create a significant market opportunity that, if addressed correctly, will benefit device makers, physicians, and, most importantly, the patients.

96. Medical Device Biocompatibility Testing: Best Practices & How To Minimize Risks 10/4/2021

    In Part 1 of this two-part series, the author discussed strategies to ensure biocompatibility success from an organizational standpoint. In this second article of the series, he discusses some of the ways to ensure biocompatibility study successes and how to minimize risks.

97. How I Developed The Next-Gen Prostate Biopsy System 9/27/2021

    Once prostate cancer is suspected, a prostate biopsy is required to establish a diagnosis. The transrectal biopsy has been the standard of care for several decades, but it has limitations and presents several risks. That's why I developed a new, safer, more effective biopsy system, and here's how I developed it.

98. FMEA Vs. System Risk Structures (SRS): Which Is More Useful? 9/24/2021

    In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?

99. Polymeric Materials in Bioresorbables and Point of Care Medical Devices 9/22/2021

    The latest generation of polymers, as well as forward-looking generations of polymer composites in medical devices, discussed in this article include bioresorbable polymers (from drug delivery to surgical implants), wearable point of care testing devices, inherently conducting polymers and composites, thermal conductive polymer composites, and calcium phosphate-based composites.

100. What's The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively? 9/3/2021

     When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?