Inspire Medical System

SUNY Upstate Medical University is issuing this Solicitation of Interest (“SOI”) to identify vendors capable of providing an implantable upper airway stimulation system for the treatment of obstructive sleep apnea, including associated components/accessories, patient remote/controller, programming equipment, replacement parts, and required clinical training and support services (the “System”). An implantable system designed to improve sleep apnea symptoms by stimulating the upper airway muscles during sleep. A device that can be used for patients where the CPAP/BiPAP, and mouthpeice are not options. The purpose of this SOI is to determine whether multiple responsible vendors can provide this or a similar System meeting Upstate’s clinical, technical, and operational requirements and to inform Upstate’s procurement approach. Vendors who can provide the System, or an equivalent system meeting the functional and clinical requirements, are invited to submit a written Statement of Interest and Capability. At minimum, the submission should include:1) Manufacturer name and product model(s) with pricing; confirmation that the offering is FDA cleared/approved for the intended clinical use (attach product labeling/literature);2) Description of how the offering meets the required function/clinical utility, including any required patient remote/controller and programming workflow;3) Training, implementation, and ongoing support model for a hospital environment (including service response expectations);4) Estimated lead times/availability and any required ancillary items;5) If offering an “equivalent,” documentation supporting equivalency. Upstate may require supporting documentation and product for examination, demonstration and/or clinical trial at no cost to Upstate. Vendor must be authorized by OEM to offer products. This procurement is subject to NYS Finance Law §§139-j and 139-k (Procurement Lobbying). The only permissible contact for this advertisement is the Designated Contact listed in this advertisement. Contacting any other Upstate employee regarding this notice may constitute a violation of NYS Finance Law. Following review of responses, Upstate may proceed with a competitive procurement or may seek approval from the Office of the State Comptroller for a single/sole source or other appropriate procurement method, as permitted by law. Business enterprises awarded an identical or substantially similar procurement contract within the past five years: Inspire Medical