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Training Nonhuman Primates for Cooperation with Medical Device Management to Enhance Human Factor Prediction and Usability Evaluations
Lucas A Mutch1, Jody L Janecek1, Rachael M Lee1, Melanie N Niewinski1, Lisa Yang1, Travis Navarro1, Melanie L Graham1,2.
1Department of Surgery, University of Minnesota, Minneapolis, MN, United States; 2Veterinary Population Medicine Department, University of Minnesota, Saint Paul, MN, United States
Implantable devices designed to encapsulate and support islet grafts are employing more sophisticated and dynamic designs, with some requiring continuous user management. In certain circumstances it is necessary to test devices in nonhuman primates (NHPs) to properly evaluate inflammatory and immunological responses. The biological complexity of the NHP and similar anatomical, physiological and behavioral characteristics with humans can improve prediction in studies that cannot be performed in vitro or in less sentient animal models. We have previously demonstrated that NHPs be trained to cooperate with clinical care necessary in disease modeling, and aim to expand training to manage medical devices with the perspective of most accurately modeling interactions with the user for clinical relevance. Optimization of device manipulations and user interactions, termed human factors, is a critical factor in maximizing the likelihood that the device will be safe and effective for use.
Five adolescent male cynomolgus macaques (CM) and six adolescent male rhesus macaques (RM), all socially housed, were trained for cooperation with diabetic clinical care and management of a totally implantable bioartificial pancreas device (BPD) utilizing positive reinforcement. The training program included physical examination, presentation for blood collection and drug administration, hold for BPD charge events, and shifting. Specific training for BPD management included desensitization to a charging wand, positioning for wand placement, allowing the wand to be placed on the body, and holding for at least a five minute charge. The success of behavior acquisition and ongoing cooperation was evaluated. Since animals were trained to perform multiple behaviors, cooperation with device management was assessed with the perspective of usability.
All animals completed the training program successfully, demonstrating competence with each of the behaviors. Testing inductive charging in cooperating animals allowed us to observe animals would prematurely end the planned charge session to withdraw from thermal stimulus generated by energy transfer while still remaining willing to interact with the trainer. Thermal withdrawal was not consistent with expected tolerance device temperatures. No behavioral regression was observed during followup.
Devices moving to the clinic must have a strong safety and efficacy profile, but success also hinges on patient adoption, which is largely based on usability and willingness to interact with the device. NHPs can be trained to closely approximate clinical usability and identify factors that may affect device acceptance prior to clinical testing and enhance acceptance. Alongside the scientific benefit, cooperative handling improves animal wellbeing.