Guest Columns

1. Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications 10/22/2021

   While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.

2. How To Create A Pathway For Diversity In Medtech 10/20/2021

   When different perspectives and backgrounds come together, it sparks innovation that can drive significant technological advancement. The most diverse companies are now more likely to outperform their less diverse peers. Beyond company performance, ensuring adequate representation throughout the product development pipeline leads to better outcomes for patients in underserved and underrepresented communities.

3. The Role Of Trust And Communication In Successful Medical Device Teams 10/18/2021

   Why do we experience teams that seem to start out well, then stumble throughout the project, resulting in delayed launches, product defects, and poor sales? How do they differ from teams that start out similarly yet appear to breeze through the project development stages to launch a successful product? This article also examines each team member's role in improving trust and communication.

4. Medical Device Commercialization: Traits For You To Be Successful, Part 2 10/13/2021

   In this author's first article, he examined the first five of nine traits to “BE” as you move your medtech innovation further along the path to commercialization, growth, and profitability. This article focuses on the other four traits.

5. The Impact Of Market Restrictions On The U.S. Stem Cell Biomaterials Market 10/11/2021

   Biomaterials are biomedical materials that can be safely implanted or injected into the body and are, more often than not, a form of biologically active tissue themselves. This article examines stem cell research and the market of cell-based products for orthopedic biomaterials.

6. Medical Device Commercialization: Traits For You To Be Successful, Part 1 10/8/2021

   There are virtuous ways to “BE” when you’re working hard to move your promising medtech innovation further along the pathway to commercialization, success, and prosperity. This article shares insights from a Med Tech Gurus podcast episode and shares 5 traits for you to pave the way to commercialization success.

7. A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk 10/6/2021

   In Part 1 of this 2-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.

8. 4 Strategies for Medtech Compliance With FDA’s Upcoming Computer Software Assurance Guidance 10/6/2021

   As the FDA finalizes and publishes the Computer Software Assurance (CSA) guidance later this year, companies that have not already started the transformation process to CSA should get started now. Here are 4 strategies to be successful.

9. A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I 10/4/2021

   This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.

10. Medical Device Biocompatibility Testing: Best Practices & How To Minimize Risks 10/4/2021

    In Part 1 of this two-part series, the author discussed strategies to ensure biocompatibility success from an organizational standpoint. In this second article of the series, he discusses some of the ways to ensure biocompatibility study successes and how to minimize risks.