Industry Perspectives - Design & Development
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You Have A Medical Device Proof Of Concept. Now What?
10/5/2022
No matter what the medical device in development, the first major milestone is usually proof of concept. How do you go from a build-of-one device to something you can manufacture reliably and at scale? This article shares key considerations in engineering and design, quality systems, and more.
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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.
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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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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.
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ISO 8655:2022 “Piston-Operated Volumetric Apparatus” FAQs
7/27/2022
Read the FAQs and learn, for example, what the revision of ISO contains and the differences with the previous version.
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The Top 5 Trends To Watch In The Medical Device Industry
7/21/2022
To respond to the unprecedented challenges presented by the pandemic, medical device providers have extensively implemented disruptive innovations in areas such as cybersecurity and 5G technologies. The article shares three additional trends in the space. All five trends will continue to drive innovation moving forward.
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Life Sciences CIO Survey Illuminates Tech Trends
7/15/2022
Clarkston Consulting recently conducted a CIO Market Study aiming to better understand the current priorities, challenges, and goals of upper-level information technology (IT) professionals. This article delves into the survey results of the life sciences portion of the respondents.
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The Shifting Data Privacy Landscape For Femtech & Beyond
6/29/2022
The lack of an overarching privacy framework for all health data has resulted in a wild west of privacy practices, with some health tech companies prioritizing consumer privacy while other companies do not. The leak of the U.S. Supreme Court’s draft decision in Dobbs v. Jackson Women’s Health Organization has reignited demand for privacy standards. This article examines what this means for femtech and health tech at large.
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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).