Medical Innovation Exchange

Focus Article

A Single Source of Truth Helps Regulatory Teams

A Single Source of Truth Helps Regulatory Teams     Regulatory teams participate in every step of bringing a medical device or drug to market. Because of the essential role they play, these teams need advanced tools to keep pace with the latest regulatory bodies and standards. Legacy technology that siloes data across different pillars isn’t …

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M&As: Maximizing the Partnership Process on Both Sides

M&As: Maximizing the Partnership Process on Both Sides     At the MedExecWomen meeting on June 14, 2022, Leslie Storms, U.S. president of Ethicon, a J&J Division, moderated the panel “Making Acquisition Strategy Succeed: Perspectives From Both Sides Of The Deal” and brought M&A experts Martha Shadan, developer of a novel tissue regeneration technology for shoulder …

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The Perils of Biased Data

The Perils of Biased Data     Data is one of the most essential resources in health care. It informs and educates care providers so they can make effective, positive decisions that benefit their patients. But can healthcare data be biased? According to “Quick Safety 23: Implicit bias in health care”, published by the Joint Commission, …

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Prognosis: Medical Device Security Needs Improvement

Prognosis: Medical Device Security Needs Improvement     The Internet of Things (IoT) has brought many improvements to the healthcare industry. Connected devices make it easier to track hospital resources, transfer critical data and enable telemedicine, but the industry’s increased reliance on these tools raises new concerns. Most notably, device developers, hospitals and regulators have fallen …

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Five Most Common Compliance Problems

Five Most Common Compliance Problems     Regulatory compliance in health care is a vital part of patient care. Regulations create frameworks for best practices among different healthcare organizations. But when it comes to compliance protocols, many healthcare organizations are operating suboptimal or inefficient systems. Two of the major issues in this regard are when healthcare …

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Streamlining the Literature Review Process

Streamlining the Literature Review Process     Literature reviews play an integral role in the regulation of medical devices and technologies. We spoke with Evidence Partners’ CEO Peter O’Blenis to learn more about the challenges of literature reviews, their role in supporting patient safety and global regulatory approval, as well as new tools that help medtech …

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Empowering Patients Through RPM

Empowering Patients Through RPM     As more and more healthcare activities take place from home, continuous monitoring solutions—including those that can track a patient’s status overnight—and new technologies, such as artificial intelligence (AI) will be critical to support communications between providers and patients. Solutions that offer continuous and passive monitoring will play a critical role …

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The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR     Equivalence strategies can be used to efficiently demonstrate the safety of a medical device, limiting the need for new studies and testing. Given the level of investment that may be needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may …

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CAPA Management Can Save Resources and Reduce Expenses

CAPA Management Can Save Resources and Reduce Expenses     No company can improve its performance if it does not fundamentally recognize and understand its errors and failures. This approach entails a change of mindset under which failures should not be regarded as disasters but instead reframed as areas ripe for improvement. Here is where implementing …

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Realizing the Promise of Real-World Evidence in MedTech

Realizing the Promise of Real-World Evidence in MedTech     Ever since the U.S. Food and Drug Administration (FDA) enacted the 21st Century Cures Act in 2016 and encouraged sponsors to utilize real-world evidence (RWE) with the intent to increase innovation and accelerate product development, medical technology innovators have been eager to comply. The burgeoning use …

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