Guest Columns

  1. 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.

  2. Polymeric Materials And Coronary Angioplasty Devices 4/14/2021

    Polymer physics and mechanical engineering principles contribute significantly to the advancement of percutaneous transluminal coronary angioplasty (PTCA) and balloon catheter expansion. This article discusses controlled drug release from various components and forward-looking applications such as electronic-enabled catheters and stents as well as bioresorbable and 3D printed stents.

  3. How To Increase Your Medtech Growth Trajectory In Indirect Markets 4/12/2021

    In emerging as well as mature markets, we have seen the rise of smaller, more agile partners specializing on a specific sector or market segment. Since the vast majority of the growth in sales is expected to happen overseas, it is obvious that having an optimized indirect sales strategy will be instrumental to deliver results. But how do we evaluate potential channel partners? Read this article to find out!

  4. Why Adjusted Risk Likelihood Should Displace The Risk Priority Number 4/7/2021

    While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

  5. How To Navigate Clinical Data Per EU MDR 4/7/2021

    The EU MDR puts a higher emphasis on clinical data for medical devices and calls for increased scrutiny on the duty of manufacturers to continuously collect clinical data in the postmarket setting. Matthias Fink, MD, of TÜV SÜD America explains the MDR requirements surrounding clinical data.

  6. 10 Actions To Prepare For The U.K. Conformity Assessment Process 4/5/2021

    The transition to the U.K.’s new regulatory regime has officially begun as of Jan. 1, 2021. All medical devices on the U.K. market must be registered with the MHRA. Discover the 10 actions you should take to prepare for the U.K. Conformity Assessment process.

  7. Implementing EU MDR and IVDR: Lessons Learned, Part 2 3/31/2021

    The first article in this two-part series covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.

  8. Life Sciences Dealmaking Aims At Early Stages Amid COVID-19 3/29/2021

    Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets.This article highlights takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook, which tallied 1,138 acquisitions, licensing, and R&D deals in 2020.

  9. AI/ML-Enabled Medical Devices — 4 Keys To Obtain Global Regulatory Approval 3/29/2021

    Application of artificial intelligence (AI) and machine learning (ML) in medical devices is making possible AI/ML-driven diagnostics and personalized treatments. By digesting the different jurisdictional AI/ML regulatory frameworks that have been released (draft or enforceable), along with personal experience with the agencies, John Giantsidis, president of CyberActa, Inc., identifies the common denominators crucial to success.

  10. Implementing EU MDR and IVDR: Lessons Learned, Part 1 3/24/2021

    The transition to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is not an easy undertaking. This first article in a two-part series highlights the sections that need close attention regarding economic operator responsibilities, overall QMS considerations, and common challenges during implementation. Ensure a smooth transition and avoid pitfalls!