Articles From Our Expert Network
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Attributable Data Integrity in Modern Biopharma Using ALCOA Principles
8/29/2022
This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.
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cGMPs For SaMDs
8/23/2022
Unlike traditional medical devices, software as a medical device (SaMD) can blur the lines between the design and development stages and the production aspect of commercialization. So, what are the activities necessary for medtech manufacturers to be compliant with the traditional cGMP framework?
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FDA Seeks Comment On Conducting Remote Regulatory Assessments
8/11/2022
The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.
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US Market Trends For Computer-Assisted & Robotics-Assisted Surgery
8/1/2022
In coming years, the number of procedures using robotics and surgical navigation is predicted to increase at a double-digit rate year over year. This article shares the reasons for slow adoption of these technologies, recent advancements, and more.
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How Medtechs Can Work Best With Value Analysis Committees
7/26/2022
Value analysis professionals are like economic traffic cops at an intersection that includes medical device manufacturer, distributor, negotiator, hospital system, clinician, and patient. Let’s explore a value analysis committee’s expectations of you, the medtech, and how you can work best with them to be successful.
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The Voluntary Improvement Program: FDA Seeks Public Comment On Draft Guidance
6/6/2022
The FDA seeks comments on its proposed guidance describing its policy regarding FDA's participation in the Voluntary Improvement Program. The program is facilitated by the Medical Device Innovation Consortium. Comments are due by July 5, 2022.
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MDSAP Audit Approach Updated From Rev. 6 To 7
6/2/2022
On April 15, 2022, MDSAP Audit Approach AU P0002.007 was updated from version 006 to 007. This article summarizes the changes important for medical device manufacturers to know.
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FDA Releases Guidance On Cybersecurity In Medical Devices
5/31/2022
The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).
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EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused
5/13/2022
The EU's MDR refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I. However, no universally accepted method exists for calculation of such a ratio. This article proposes a method for calculating it in the spirit of focusing on patient safety and the ability to track changes in products' safety profiles.
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From The Military To The Medtech Battlefield: 6 Lessons In Leadership
4/22/2022
Since returning stateside from his time in the military as a U.S. Army Special Ops leader, Charles Fisher Jr. entered the healthcare/medtech field and currently serves as CEO of Aethlon Medical. On a recent episode of the Med Tech Gurus podcast, he shared 6 principles of leadership he learned from his military days that continue to serve him well in medtech.