For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”
Clinical and commercial adoption are interrelated, but not identical. Successful medical device acquisitions are predicated on a thorough understanding of how these components fit together. Before acquisition, both target and acquirer must first understand the core scientific and clinical support for the technology, as well as anticipate ongoing hurdles in front of commercial acceleration.
Cardiac marker, hematology, and hemostasis tests are relied upon for a multitude of healthcare applications. This article explores these devices’ global market opportunity and analyzes issues expected to impact future sales.
This article examines how to achieve cross-functional ownership of quality and the efforts of the CQO team to build quality for the 21st century, including exploring the creation of formal degree programs in quality.
Segmenting patients, providing physicians with guidance on which ones your technology suits best, and clearly stating expected outcomes helps to drive use, preference, and — eventually — increased adoption rates.
A validation master plan outlines the principles involved in the qualification of a facility, defining the areas to be validated, and provides a written program for achieving and maintaining a qualified facility.
Obtaining early clearance with a narrower claim enabled this company to enter the market earlier, as well as use its own product as a predicate to collect real-world evidence — all while obtaining broader clearance and avoiding the requirement to document patient-informed consent during trials, since the device already had been cleared.
Many medical device project development teams either ignore sterilization challenges until confronted with failed tests late in development, or adopt conservative guidelines that increase cost and lead times. More deliberate, proactive efforts applied to the sterilization topics discussed here can lead to improved outcomes.
This is the second of three articles focusing on an effort to address what appear to be systemic issues across quality departments. This article addresses how to reframe the way we view and discuss quality, how to better engage stakeholders, and an alternate view of how quality can add value to the company.
This article examines a report issued by the Office of the Inspector General of the Department of Health and Human Services, resultant of an audit of the FDA’s internal processes to ensure cybersecurity in the postmarket phase of medical devices – as well as the FDA’s disagreements with the findings and what this means for manufacturers going forward.
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