Pelvic organ prolapse is common and may affect 50% of women, though the severity of the condition varies and, in some cases, may be resolved with non-surgical treatments. As of 2019, however, approximately 15% of American women needed surgical repair for POP at some point in their lifetime. This article analyzes the current device market and describes the opportunity for innovation.
A retro-validation is a re-execution of the method validation with the method parameters, setup, and everything kept the same as before to retrospectively cover all prior generated data. It is not the same as past validation because you would shore up the validation deficiencies or gaps. This article discusses the 6 important considerations.
It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.
While medtech firms have had proven success with scaling and short bursts of innovation from special projects and acquisitions, many firms have struggled to achieve a steady stream of disruptive innovation. This article provides three strategies for leveraging agile methodologies for better innovation.
How Reengineered Components Optimize Medtech
Reengineering is useful in replicating discontinued components or parts whose original designs no longer exist. The process also empowers designers to improve part performance, fit, and/or production speed.
Hospitals and healthcare providers are going well beyond the basics of patient care these days. Years ago, hospitals took good care of patients by providing the best quality medical care they could. Today, they’re tasked with that and so much more.
The shift to virtual care is transforming healthcare. Thanks to ever-improving technologies and digital tools, virtual care was gaining traction before the COVID-19 pandemic, but accelerated dramatically last year, as providers and patients sought ways to minimize the virus’ spread.
Taking full advantage of bioresorbable materials in medtech requires an understanding of each material’s strengths, production challenges, and ideal applications.
RFID technology provides life sciences applications with product and component traceability while safeguarding against human error, unsterilized tools, outdated materials, and more.
MED DEVICE ONLINE CONTENT COLLECTIONS
The EU’s Medical Device Regulation (MDR, effective May 26, 2021) and the In Vitro Diagnostics Regulation (IVDR, effective in May 2022) are certainly hurdles for medical device manufacturers to tackle. However, those aren’t the only new regulations in Europe to prepare for.More Content Collections