Device development hurdles

The end-user helps maintain a practical and focused vision of the technology and can help prevent losing sight of the final device s applicability. 

The end-user ean help the researcher understand the broad applications of the technology, which is important for submitting broad and all-encompassing patent claims for the current treatment focus or future treatment options. 

A strong relationship with the end-user can evolve into a qualified advocate for the deviee. Someone with credibility in the field of application that can speak to the device s utility during pre-IDE and PMA meetings with the FDA, and also attest to the device s benefits during funding pitches, partnership diseussions, and acquisition opportunities. 

As summarized by the FDA, an investigational device exemption (IDE) allows a device to be used in a clinical study to collect safety and effectiveness data required to support a PMA application or a Premarket Notification [510(k)j submission to FDA. All clinical evaluations of investigational devices must have an approved IDE before a clinical study can be initiated. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Eood, Drug, and Cosmetic Act that would apply to devices in commercial distribution (FDA, 2009). 

The IDE submission is the cmcial hurdle and major milestone that transitions a promising material into a viable and testworthy medical device. The IDE s format is a testament to this transformation. The first half of the submission is a detailed report of the injectable biomaterial s evolution and optimization -including all background data and all reports of prior investigation. This section includes the history of the material, all current mechanical and chemical testing, in vitro and in vivo modeling, and biocompatibility results. The second half of the submission, however, focuses on the injectable biomaterial as a device. This 

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Crystallization from solution is a widely utilized separation and purification technique in chemical industry. It is characterized by the formation of a spectrum of differently sized crystals. This spectrum, called the Crystal Size Distribution or CSD, is highly important for the performance of the crystallizer, the crystal handling equipment like centrifuges and dryers, and the marketability of the produced crystals. However, in many industrial crystallizers, the observed CSD s show large transients due to disturbances or are unstable because of the internal feedback mechanisms of the crystallization process ). The main limitation for effective CSD control was the lack of a good on-line CSD measurement device, but recent developments show that this hurdle is taken (2). 

A new development in the field of potentiometric enzyme sensors came in the 1980s from the work of Caras and Janata (72). They describe a penicillin-responsive device which consists of a pH-sensitive, ion-selective field effect transistor (ISFET) and an enzyme-immobilized ISFET (ENFET). Determining urea with ISFETs covered with immobilized urease is also possible (73). Current research is focused on the construction and characterization of ENFETs (27,73). Although ISFETs have several interesting features, the need to compensate for variations in the pH and buffering capacity of the sample is a serious hurdle for the rapid development of ENFETs. For detailed information on the principles and applications of ENFETs, the reader is referred to several recent reviews (27, 74) and Chapter 8. 

This chapter will provide a systematic and standard a [Hoach to developing a comprehensive package system that meets regulatory hurdles and ensures a high degree of confidence that the sterile medical device product will meet its perfoimance specifications at the point of end use. These elements include ... 

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