Articles From Our Expert Network
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Will Transcatheter Valves Continue Cannibalizing Surgical Aortic Valve Replacements?
11/30/2020
In 2019, the transcatheter aortic valve implantation (TAVI) device market garnered nearly 7 times that of the surgical aortic valve market. TAVI procedures are expected to account for an even larger share of aortic heart valve replacement procedures in Europe in 2021.
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ISO TR 24971:2020 — Bringing Clarity To Risk Acceptability In ISO 14971
11/19/2020
With ISO TR 24971:2020, the technical committee responsible for the medical device risk management standard has finally addressed the confusion around the policy for risk acceptability criteria and the difference between that and the criteria themselves.
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Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions
11/11/2020
In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.
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Digital Health Apps In Europe — The Road To Reimbursement Goes Through Security
11/9/2020
In September, Spain’s National Cryptologic Center issued a road map to minimum security requirements for digital health applications and e-health mobile apps. This article highlights important recommendations from the 11 sections of the publication, serving as a preliminary checklist when preparing for market entry in Germany and/or Spain.
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How To Implement Continuous Process Monitoring Of Validated Processes
10/28/2020
It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.
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Infusion Therapy: Growth In Home And Alternate Care Sectors Supports Market
10/19/2020
The U.S. infusion therapy device market is a fairly saturated space, but that doesn’t mean opportunities for growth do not exist.
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ISO 14971: Harnessing Preliminary Hazard Analysis (PHA) To Develop Safer Medical Devices
10/19/2020
Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.
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How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data
10/14/2020
Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?
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Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity?
10/12/2020
Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.
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How To Prove (Or Improve) The Trustworthiness Of Your Medical Devices
10/7/2020
What objective evidence is necessary to show that your medical device performs as intended for its specific purpose, when needed, with operational resiliency, and without unwanted behaviors or exploitable vulnerabilities? These suggested activities will provide the type of information and objective evidence regulators require to prove the trustworthiness of a device.