Guest Columns

  1. Industry 4.0 Technologies Address Challenges Of Class III Medical Device Manufacturing

    Innovation in Class III medical devices — such as pacemakers, defibrillators, and implantable nerve stimulators — continues to accelerate at a rapid rate. Medical OEMs are designing more innovative and technically complex products in smaller form factors. Manufacturing is creating the tools to keep up, though. 

  2. Managing QMS Disparities Between Drugs And Devices For Combination Products

    Combination products represent a remarkable opportunity as one of the most dynamic segments in the life sciences and are projected to grow to $115 billion by 2019.

  3. 5 Ways To Engage Clinical Trial Sites With Technology

    Clinical research has a reputation for being notoriously slow to adopt new technologies. This should come as no surprise to those in the industry, since we operate in a highly regulated environment.

  4. European Orthopedic Trauma — Anomalies & Disruptors In A Mature Market

    Orthopedic trauma is a long-established market influenced by predictable drivers and limiters. Still, new technologies, increasing unit sales, and average sale prices in decline make this a dynamic market. 

  5. Beyond Usability: What It Means To Humanize A Medical Device

    When a medical device fits into the user’s life, he or she is more likely to use it as intended. Patients are much more than the disease being treated. They are human beings with full lives, and they don’t always want to be reminded that they are “sick.”

  6. Will Bioresorbable Vascular Stents Overtake Drug-Eluting Stents As The Gold Standard In CAD Treatment?

    Despite the success of drug-eluting stents, the cardiology community has long recognized the disadvantages of leaving a metal object in the coronary vasculature.

  7. New “Realities” In The Life Sciences And Health Care Industry

    While the public at large tends to think of virtual reality and augmented reality mostly in the context of video games and smartphone applications, no industry has done more to put VR and AR technologies to use - or has more untapped potential - than the life sciences and healthcare.

  8. Seeking A Smooth Transition To The New EU MDR? (Then Start Complying Now)

    The new regulation has a word count nearly four times higher than its predecessor, the Medical Devices Directive (MDD), contains five more annexes, and uses the word “safety” 290 times, rather than just 40 times. 

  9. Is Your Device An Attractive Value-Based Purchasing Option?

    Traditional Medicare payment to the nation’s 3,500 hospitals is undergoing an historic transition with the Value-Based Purchasing (VBP) Program. The program is not about negotiating price discounts, but rather attempts to address quality while still promoting healthcare cost controls. 

  10. Using Risk-Based Thinking To Manage Suppliers

    This article will first present the definitions and requirements regarding risk pertaining to the control of suppliers and then introduce some tools to incorporate and integrate risk management techniques within the QMS specifically applied to supplier management/purchasing controls.