Medical Innovation Exchange

Inga Hansen

Nudging Towards Safer Decision Making

Nudging Towards Safer Decision Making     In recent years, the impact of evidence-based decision-making on patient safety has been under close examination. Despite technological advances, the gap between theory and practice remains a challenge to both clinicians and allied health professionals. Due to the complexity and dynamics of health systems, ‘doing the right thing’ is …

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Life Sciences Labeling for Patient Safety

Life Sciences Labeling for Patient Safety     Labeling regulations from the FDA and European Union (EU) are continuously changing to protect public health and improve patient safety. The Drug Supply Chain Security Act (DSCSA) enhances FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. These …

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Critical Manufacturing Partners with Dataworks To Enhance CSA Support

Critical Manufacturing Partners with Dataworks To Enhance CSA Support     Critical Manufacturing, developer of multi-site manufacturing execution systems (MES), has entered into a strategic partnership with Dataworks, a provider of software solutions and validation services for the Life Sciences sector. “Dataworks focuses on the provision of transformational software solutions and validation services within the Life …

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CDRH Launches Pilot Program To Reduce Device Approval Times

CDRH Launches Pilot Program To Reduce Device Approval Times     The FDA Center for Devices and Radiological Health (CDRH) is launching the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. “TAP is a voluntary program intended to de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with …

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FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies

FDA Issues Final Guidances on Postmarket Surveillance and Post-approval Studies     This month, the FDA issued two final guidances related to post-approval studies and postmarket surveillance of medical devices. Per the FDA announcement, these guidances are “intended to enhance patient safety by facilitating timely initiation and completion of post-approval studies (PAS) and postmarket surveillance under …

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Improving Image Integrity in Clinical Research

Improving Image Integrity in Clinical Research     Clinical research is the foundation upon which breakthroughs in medical devices and pharmaceuticals are built. To bring a novel therapy to market, researchers must collect data and publish sufficient evidence proving that the product meets its intended purpose. The evidence shared in clinical research must be accurate, or …

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Taylor Named Chief Technology Officer of ETQ

Taylor Named Chief Technology Officer of ETQ     ETQ has appointed John Taylor, its former Senior Vice President of Engineering & Operations, to Chief Technology Officer (CTO). Taylor will be responsible for overseeing the strategic direction of ETQ Reliance, the company’s cloud-native Quality Management System (QMS). “Over the past four years, John has been instrumental …

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The Real Impact of IVDR on Clinical Evidence Requirements

The Real Impact of IVDR on Clinical Evidence Requirements     For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work. With the shortage of notified bodies and resources, numerous outstanding guidance questions, as well as …

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White Houses Releases AI Bill of Rights Blueprint

White Houses Releases AI Bill of Rights Blueprint     Against a backdrop of growing concern surrounding biased data and rights to privacy and informed consent, the White House has released the “Blueprint for an AI Bill of Rights” that lays out five principles and associated practices to protect the American public against potential harm. “Among …

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AHRQ Announces Real World Data Competition for HCOs

AHRQ Announces Real World Data Competition for HCOs     On September 27, the Agency for Healthcare Research and Quality (AHRQ) announced a new challenge competition to explore the feasibility, resources and infrastructure needed to integrate real-world healthcare system data into AHRQ’s systematic review findings to improve healthcare practice. The top award winner could earn up …

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