Industry Perspectives - Design & Development
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How I Developed The Next-Gen Prostate Biopsy System
9/27/2021
Once prostate cancer is suspected, a prostate biopsy is required to establish a diagnosis. The transrectal biopsy has been the standard of care for several decades, but it has limitations and presents several risks. That's why I developed a new, safer, more effective biopsy system, and here's how I developed it.
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FMEA Vs. System Risk Structures (SRS): Which Is More Useful?
9/24/2021
In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?
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9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations
9/22/2021
The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.
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How To Build An Exceptional Medical Device Biocompatibility Program
9/17/2021
In recent years, biocompatibility and compliance with the ISO 10993 family of standards have been an area of significant attention. Demonstrating biocompatibility is an integral part of any device development. This article explains how to integrate a biocompatibility toxicologist into your team and his/her role within the development process.
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How Do We Achieve The Promise Of Using Digital Health Measurement? DATAcc Leads The Way
9/15/2021
Digital health measures are redefining our understanding of health and disease by changing what we measure and how we measure it. It is the perfect time for the field to build the digital health measurement toolbox with intention – and build it right. The Digital Health Measurement Collaborative Community is a new pre-competitive collaboration dedicated to this, and you can get involved!
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5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
9/15/2021
Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.
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What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?
9/3/2021
When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?
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Digital Health Apps & SaMD: Incorporating Privacy In Design & Development
9/1/2021
Some digital health apps are regulated by the FDA and other regulatory bodies, and some are not. But all software as a medical device (SaMD) and digital health apps have a common expectation: privacy. This article delves into the related regulations and how to go about developing your app or SaMD using the 7 principles of privacy by design.
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How One Company Developed The Next-Generation Electronic Stethoscope
8/23/2021
A pressing issue driving improvement in stethoscope technology is the change in modern-day healthcare. There has been a greater need to provide a diagnostic tool that goes beyond amplified sound with the ability to change the way medicine is practiced. This is the story of how HD Medical developed the next-generation electronic stethoscope.
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The 5-Step Checklist For A More Mature, Robust Quality Management System
8/20/2021
Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.