Industry Perspectives
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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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Polymeric Materials in Bioresorbables and Point of Care Medical Devices
9/22/2021
The latest generation of polymers, as well as forward-looking generations of polymer composites in medical devices, discussed in this article include bioresorbable polymers (from drug delivery to surgical implants), wearable point of care testing devices, inherently conducting polymers and composites, thermal conductive polymer composites, and calcium phosphate-based composites.
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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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Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity
8/18/2021
The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.
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How Will India’s New Healthcare Budget Help Medical Device Manufacturers?
8/18/2021
India's Finance Minister Nirmala Sitharaman announced an astounding 137% increase in spending for health and well-being for the fiscal year. This article focuses on the $8.2 billion portion of the budget allocated for the prime minister’s Healthy Indian Plan, which affects medical device developers.
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Medical Device Labeling: New ISO 15223-1 & FDA Guidance Recommend UDI Symbol Use
8/16/2021
Accurate UDI scanning is important to ensure improvements in electronic medical device adverse event reporting, recall tracking, electronic patient health record accuracy, and efficient charge capture and billing. The recent ISO 15223-1:2021 advocates for new UDI symbol that addresses this. An even more recent FDA guidance follows suit.
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Medical Device Packaging Considerations For Product Developers: Begin With The End In Mind
8/11/2021
By incorporating packaging early in the process, medical device developers can alleviate stress, minimize risk, create a more effective product, and eliminate cost surprises. This article shares best practices for how to do so.
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EMA Publishes Guideline On Quality Documentation For Medicinal Products
8/2/2021
This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.
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FDA Seeks Public Comment On Draft Guidance On Remanufacturing Medical Devices
7/26/2021
On June 24, 2021, the FDA released a draft guidance, Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff, for public comment in the Federal Register to help clarify whether repair, servicing, and reprocessing activities performed on devices are likely considered remanufacturing.