Accelerating the product innovation journey

In seeking a more convenient , rapid and gentle CGM alternative , GlucoModicum discovered that magnetohydrodynamic ( MHD ) technology could be used to apply a small amount of energy directly to interstitial fluid – the body fluid between blood vessels and cells – to drive it to the surface of the skin for quick and easy extraction of a glucose sample .

While its scientists conducted rigorous research , GlucoModicum sought an experienced contract development and manufacturing organisation ( CDMO ) to assist in realising its vision for a new device , called Talisman . This device is designed to adhere to a patient ' s arm , and integrates the MHD technology , ultra-sensitive biosensors and advanced algorithms while connecting to a smartphone app for data collection and reporting . The device is not yet FDA approved and does not have the CE mark . of units on time and in a cost-effective manner . That ' s a big benefit to this project ."

Since a CGM informs treatment decisions , the clinical efficacy and documentation required by notified bodies and similar regulators , such as Food and Drug Administration ( FDA ) and Pharmaceutical and Medical Device Agency ( PMDA ), are critical to planning a successful launch . The Phillips-Medisize Design and Development team offers its medical customers regulatory capabilities customised to each company ' s needs – from regulatory documentation to guidance on device classification , risk assessments and device-specific submission requirements for regulatory bodies . In this case , Phillips-Medisize counselled GlucoModicum on what will be required for submissions to regulatory bodies in the markets where the company plans to launch this device . The GlucoModicum team found the advice and regulatory knowledge insightful and beneficial to its commercial launch plans .

Preparations are underway to leverage Phillips-Medisize ' s global manufacturing footprint , extensive supply chain network and advanced assembly automation capabilities to produce hundreds of millions of devices and biosensors once in-depth clinical studies and regulatory approval are completed . Together , the companies are also beginning to explore other potential uses of this innovative technology to support management of other diseases . �

In developing the Talisman , Phillips-Medisize applied special expertise in industrial design , mechanical and electrical engineering , connectivity , material science , miniaturisation , supply chain management , software development , manufacturing , testing , quality assurance and regulatory compliance .

" We started with ideas , concepts and drawings ," said Homer Fairley , business development manager for Phillips-Medisize . " The day we provided the finished sample product to GlucoModicum was a moment of celebration for both parties , as it really brought the possibilities to life . Now that there is a proven concept , we look forward to the opportunity to leverage Phillips-Medisize ' s high-volume manufacturing capabilities to produce hundreds of millions

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