![]() While some training data has already been collected, including performance metrics and training meta-data, previous training sessions were focused on providing the best possible training of the trial investigators. After 2 years of intense development efforts, in the spring of 2018, Genentech and VRmagic rolled out two completely new, state-of-the-art virtual reality simulator platforms enabling its users to practice the implant insertion and the refill-exchange of the PDS, not in support of training and marketing for an existing product but as a training aid for surgeons involved in ongoing PDS clinical development. To ensure patient safety and minimize the risk of surgical errors to the overall outcome of the trial, Genentech’s development team started looking for the best possible way to train the study investigators on the PDS procedures. Furthermore, the refill-exchange procedure that exchanges the implant content with fresh drug only resembles the commonly performed intravitreal injections but requires a more precise execution. However, the implant insertion surgery involves a number of surgical steps not commonly performed by vitreo-retinal surgeons. The initial clinical experience with the implant had indicated that the implant insertion can be performed safely as an outpatient surgical procedure. The phase II Ladder study ( identifier, NCT02510794), specifically evaluated the effects of a specialized formulation of ranibizumab delivery for the treatment of neovascular (wet) age-related macular degeneration (see ). Genentech was about to start a phase II study for a new and innovative product, the Port Delivery System with ranibizumab (PDS), which is a new permanent and refillable eye implant, approximately the size of a grain of rice, that releases drug continuously into the vitreous of the human eye. and VRmagic GmbH in the autumn 2016 deviated from this pattern in that it was formed to produce a training device for a product that was still in development and had not yet been commercialized. The partnership formed between Genentech Inc. Custom development commissioned by industry partners from pharmaceutical and medical device industries constitute a segment of the surgical simulation market that extends the range of simulator solutions to product-specific and non-standardized procedures but remains limited to high revenue products to justify the investment. ![]() ![]() Consequently, the bulk of available simulator products target a rather small set of medical procedures which is particularly true for surgical simulators. This combination has the best chance of producing a profitable business case which can carry the extensive costs usually associated with the development of a new high-fidelity simulation solution, especially when virtual reality (VR) technologies are involved. The industry development of simulators in healthcare is generally focused on such surgical, procedural, or diagnostic challenges that occur with high volume and are mostly performed according to well established and possibly international standards. ![]()
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