Regulatory & Compliance Perspectives

  1. New CMS Payment Rates for 2018; Same Challenges for Medtech
    8/21/2017

    On Aug. 2, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates Medicare payment and polices when patients are discharged from hospitals from Oct. 1, 2017, to Sept. 30, 2018.

  2. Flip The Org Chart: Rethink Where A Pharma Company's Focus Should Be
    7/31/2017

    I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. After the session, a manufacturing operator talked to me about employees’ frustration with the situation, saying, "Why don't people understand that if we focus on doing things right, efficiency will come?"

  3. 3 Eye-Opening Takeaways From The MedTech Conference
    7/10/2017

    Three speakers opened our ears, eyes, and minds at Healthegy’s Medtech Conference last month in Minneapolis. Two presentations provided input that reshaped my own long-held notions, while the third helped me to think about value-based outcomes from a more productive perspective.

  4. Two Lessons From A Reproductive Health Startup
    7/3/2017

    Company's progressive regulatory strategy and awareness of market, regulator, and consumer concerns hold insights for other medtechs. 

  5. Seeking A Smooth Transition To The New EU MDR? (Then Start Complying Now)
    6/21/2017

    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. 

  6. Is Your Device An Attractive Value-Based Purchasing Option?
    6/19/2017

    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. 

  7. 3 Pros Keeping Your Device On The Market
    6/13/2017

    In the final chapter of this series, we will discuss three key individuals who sustain a device from release until the device is retired.

  8. Medtech Needs A Clearer Regulatory Definition Of Clinical Decision Support Software
    5/24/2017

    The definition of a medical device in the Federal Food, Drug and Cosmetic Act (FDCA) is purposefully broad — some say too broad. It allows the FDA to reserve potential oversight of many healthcare products, including software, and some software development companies have bristled at the FDA’s potential to regulate their products.

  9. Are You Satisfied With The FDA?
    5/23/2017

    More than half of Americans are displeased with President Donald Trump's performance to date, and nearly four-fifths of the nation collectively sighs when evaluating Congress. So what does the medtech industry think of the U.S. Food and Drug Administration as we near the halfway point of 2017? The answer may surprise you. 

  10. India Introduces Sweeping — And Welcome — Device Regulations
    5/17/2017

    Since 2002, American companies have lobbied for clearer oversight of medical device sales and manufacturing in India. As of January 2018, they will have their wish.