Guest Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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 (DMAP), the next leg of the Technology Modernization Action Plan. Why is this a tsunami? Because 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.

  5. Pocket Guide To Medtech’s Market Outlook In 2021 5/3/2021

    Over the last year, medtech original equipment manufacturers (OEMs) and contract development and manufacturing organizations (CDMOs) faced the challenges of the pandemic. Despite experiencing vulnerability in 2020, both industries are positioned to perform strongly in 2021. This article summarizes Alira Health’s findings from its new 2021 MedTech Contract Manufacturing Report.

  6. A Road Map To China’s Medical Device Registration Process 4/28/2021

    China has one of the most promising medical markets and its healthcare industry is currently the second largest in the world. How do you register your device there with the proper authorities? The pre-market or product registration procedures are different for imported products and local domestic products.

  7. The Top 10 Most-Cited Issues In FDA FY2020 Medical Device Inspections 4/26/2021

    The first article in this series discussed the background and a few high-level observations of the FDA’s summaries of its medical device quality system inspections. This article digs into the details of the FY2020 observations. What were the top 10 most-cited issues, and what are the takeaways you can implement?

  8. Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs 4/23/2021

    The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits. 

  9. Dental 3D Printing: Disruptive Trends In The Digital Dentistry Market For 2021 4/21/2021

    Dental 3D printers have experienced a surge in popularity in recent years, reflecting the increasing range of applications and opportunity for revenue generation offered by these systems. How does this market look for 2021, and what is the one dental device disrupting the market?

  10. Overcoming Funding Challenges For Innovative Medtech In Germany: Learnings From The NUB Process 4/19/2021

    This article explores how medtech companies should approach the reimbursement pathway for their devices when seeking to enter the German market. By understanding the strengths and challenges of Germany's NUB process, you'll have a better understanding of how to navigate it.