Guest Columns

  1. FDA’s Safety And Performance-based Pathway: An Alternative To Substantial Equivalence For 510(k) Submissions 5/26/2021

    The FDA's 510(k) clearance of medical devices is based on proven substantial equivalence with claimed predicate device(s). In concert with the goal of adopting the least burdensome approaches, the FDA provides an alternate pathway based on proven safety and performance characteristics, instead of devices’ equivalence to other predicates. 

  2. Overcoming The Demand Standoff: How To Help Speed Adoption Of Innovative Medical Technology 5/24/2021

    Despite new breakthrough technologies being cost-effective and easy to use, as well as helping patients avoid surgeries, rehabilitation, and opioid exposure, many patients won’t get the coverage they need to access it due to the peculiarities of the physician–insurer relationship. This article shares lessons learned with sam, ZetrOZ Systems' wearable sustained acoustic medicine technology.

  3. Major Shift in Demand For Oxygen Therapy Devices – New Study For 2021 5/21/2021

    Oxygen therapy is used to treat a variety of medical conditions, such as cancer, cystic fibrosis, and chronic obstructive pulmonary disease (COPD). The market is moving away from traditional cylinder-based methods of oxygen delivery toward what technology? And what type of device has emerged as an exemplary delivery system?

  4. How To Eliminate The Gate In Medtech Product Development’s Phase-Gate Approach 5/19/2021

    We all know the phase-gate approach to medical device development is cumbersome and slow – the exact opposite of what’s needed for products essential to critical treatment or prevention of disease or chronic conditions. The good news is that there are ways to make dramatic improvements to the efficiency of the product development process while maintaining project phase controls. 

  5. Harnessing The Power Of AI In MS Diagnosis, Monitoring, And Treatment 5/17/2021

    A prime example of the future potential of artificial intelligence (AI) is in revolutionizing the way we diagnose, monitor, and treat multiple sclerosis (MS), thereby advancing our understanding of the disease course. To maximize the utility of AI in MS, drug developers and medtech manufacturers must strategically incorporate AI solutions into their approach to MS drug development and commercialization. 

  6. The One Trait A Medtech QA/RA Professional Can’t Succeed Without 5/14/2021

    We read studies showing that professionals who are successful and hold top positions in our industry possess certain traits: intelligence, commitment to our jobs, determination, etc. But those traits could describe many professionals. So, what is it that makes us unique and a good fit for this industry?

  7. ISO 10993-23: The “Step-Wise” Approach To Evaluate Potential Irritants In Medical Devices Becomes Effective 5/12/2021

    The new ISO 10993-21:2021 specifies the procedure for the assessment of the biological irritating potential of medical devices, materials, or their extracts. It is relevant to all directly or indirectly contacting medical devices regardless of the nature and duration of body contact.

  8. How To Maximize Medical Device Patient Retention 5/10/2021

    The accelerated shift to telehealth during the COVID-19 pandemic has given patients greater autonomy. However, this benefit is not without its challenges, particularly for patients who use medical devices at home to manage chronic health conditions. Fortunately, there are opportunities to remedy these issues.

  9. Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise 5/5/2021

    With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.

  10. Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare 5/5/2021

    The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.