Medical Innovation Exchange

04-Product Design & Development

Harnessing the Potential of Digital Quality: Transforming Manufacturing Outcomes for Long-Term Success

Harnessing the Potential of Digital Quality: Transforming Manufacturing Outcomes for Long-Term Success     Automation and digitization of quality processes are becoming integral to advanced manufacturing operations. Medical manufacturers are using it more often to improve efficiency, reduce costs, and enhance product quality. MTI recently discussed how this digital transformation is improving MedTech manufacturing quality with …

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CDRH Releases New Dataset for Biocompatibility of Medical Devices

CDRH Releases New Dataset for Biocompatibility of Medical Devices     On April 16, the FDA’s Center for Devices and Radiological Health (CDRH) released a new public dataset designed to assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. In a statement from Jeff Shuren, M.D., …

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Flex Recognized as a 2024 World’s Most Ethical Company

Flex Recognized as a 2024 World’s Most Ethical Company     Contract manufacturer Flex has been recognized as one of Ethisphere’s 2024 World’s Most Ethical Companies in the category of industrial manufacturing. The award from Ethisphere requires companies to provide information on more than 240 proof points related to the company’s culture of ethics; environmental, social, …

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Misconceptions of Miniaturization: Smaller is Better

Misconceptions of Miniaturization: Smaller is Better     The world seems to be preoccupied with miniaturization. We make company logos out of a handful of stray atoms[1], we print books in micrograms of DNA[2], and we fight over the title of “smallest computer”[3]. Every device company wants their products to be smaller than the competitions’ offerings …

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The Evolution and Promise of Pharmacogenomics in Precision Medicine

The Evolution and Promise of Pharmacogenomics in Precision Medicine     Across centuries, the intricacies of individual responses to both food and medicine have intrigued scholars and practitioners alike. From the ancient observations of Pythagoras, who noted the haemolytic reactions to fava beans, to modern genomic insights, such variations continue to shape medical understanding. Today, we …

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IDC enhances the Reach Surgical Ultrasonic Shears with Improved Ergonomics

IDC enhances the Reach Surgical Ultrasonic Shears with Improved Ergonomics     Press Release: MTI Staff was not involved in writing this content April 8, 2024 / Berkshire, England – The leading international brand’s ultrasonic shears had once dominated the domestic market and played a pivotal role in introducing, promoting, and educating the market about this product category. A …

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Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines     On April 9, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America (“Philips Respironics”), Respironics California, Philips Holding USA, and Roy Jakobs, CEO of Royal Philips, along with …

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FDA to Host Virtual Workshop on ASCA Program Expansion

FDA to Host Virtual Workshop on ASCA Program Expansion     The FDA has announced a virtual public workshop on April 17 from 11:00am – 1:00pm ET to discuss approaches to expand the Accreditation Scheme for Conformity Assessment (ASCA) program. The ASCA program is designed to streamline conformity assessment aspects of medical device review. Currently, ASCA-eligible …

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IoT: The Next Big Thing in Precision Lab Equipment

IoT: The Next Big Thing in Precision Lab Equipment     Precision is one of the most essential equipment qualities for consistency and authenticity in experimentation. The Internet of Things (IoT) promises to enhance the accuracy of the health and pharmaceutical sectors while integrating smaller, more user-friendly devices. Thanks to its many advantages, IoT is poised …

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From Concept to Market: The Strategic Journey from IND to NDA

From Concept to Market: The Strategic Journey from IND to NDA     Drug discovery and development is a complex, multifaceted process that can be challenging to navigate. The primary goal is to ensure that new therapies are safe and effective for patient use. The process includes several critical stages, each governed by strict regulatory oversight …

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