Industry Perspectives - Design & Development

1. 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. 

2. 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?

3. 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.

4. 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?

5. 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. 

6. Rating Risk Events: Why Adjusted Risk Likelihood (ARL) Should Replace Risk Priority Number (RPN) 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.

7. 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.

8. 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.

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!