Guest Columns
-
3 Steps For A Smarter Medtech Supply Chain
9/21/2022
Our medtech industry has a huge opportunity to make our supply chains “smarter" by making the most of digital technologies and data. But we need to work in an agile manner to adopt and scale technology. This article shares three main steps to take.
-
Identifying The Early Adopters Of Your Medtech
9/19/2022
Every medtech company aims to build a successful product and have a seamless launch. But for this to happen, you must first identify early adopters of your new product and engage with them before product launch.
-
Lab-On-Chip Devices: Materials Considerations
9/15/2022
Material selection and testing can often be one of the critical challenges to developing microfluidic devices for the healthcare and life sciences markets. This article shares recommendations related to determining which physical properties are needed, potentially suitable materials, processing techniques, and analytical techniques.
-
Biomarker Testing: A Key Component To Advancing Precision Medicine
9/13/2022
Biomarker testing isn’t always the standard of care for many people living with cancer today. Providers and patients need to be better educated about biomarker testing, we need a consistent standard of care across oncology institutions, and we need to advocate for equitable access to biomarker testing.
-
Genetic Testing For Prostate Cancer Tackles The Black Demographic Disparity
9/9/2022
Inherited factors account for 57% of the risk for developing prostate cancer. Advances in genomic research have an opportunity to improve the health and survival of all men, but the focus of progress has been on people of European ancestry and has excluded Black men, who have a substantially higher incidence of prostate cancer. Genetic testing will help lessen this demographic disparity.
-
8 Best Practices For Global Medical Device Patent Protection
9/8/2022
Medical devices demand unique intellectual property protection strategies. Preserve the valuation of your medtech during the early years of development and maximize revenue potential following regulatory approval with these eight best practices.
-
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.
-
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?
-
Medtech Cyber-Incidents: A Costlier Problem Than You Think
8/17/2022
Harnessing advanced computing technologies gives medtech companies almost unlimited profit opportunities, but it also comes with almost unlimited liability from cyber-attacks. This article discusses different harmful events and their costly ramifications to your medtech company. Don't be underprepared for a cyber-attack.
-
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.