Phase I Amount
$1,137,469
Motion related artifacts are a significant source of cost to the healthcare system. With over 12,000 MRI scanners in the U.S. and estimates that $434,000 are lost per scanner each year, motion in MRIs is costing our health care system approximately $4B yearly. Our FDA-cleared software solution Framewise Integrated Real- Time MRI Monitoring (FIRMM) mitigates data lost due to motion. However, the majority of paying customers so far are academic neuroimaging research centers; in order to ensure the commercial success of FIRMM, we need to expand the customer base to clinical institutions. The goal of this CRP application is to fill gaps in FIRMM clinical commercialization sales by partnering with Siemens and building functionality to streamline clinical use of FIRMM and FIRMM-pix. Leading hospitals have expressed enthusiasm to use FIRMM for clinical care; however, two main barriers to clinical adoption remain: a reduction in technician critical decision making and a seamless integration into existing clinical workflows. Both of these barriers can be overcome via Siemens' Access-I, which provides an FDA approved licensing and authentication scheme to enable secure and direct operation of Siemens systems from any 3rd party vendor device. Pairing the FIRMM tablet with Siemens' Access-I module will allow for the FIRMM tablet to re-start a scan automatically when the quality is low via a direct interaction with the clinical scanner, thus saving time, easing workflows, and standardizing decision making for technicians. Integrating the FIRMM tablet with Siemens' Access-I will lead to a more seamless integration into existing workflows; thus reducing the disruption to existing complex clinical workflows. In addition, integrating the FIRMM tablet with Siemens' Access-I module will facilitate the wide-spread adoption of FIRMM(-pix) in the clinical market by obtaining widespread visibility via co-marketing with Siemens Healthineers and their catalog. Importantly, this partnership with Siemens is planned only as an initial step to establishing clinical commercialization sales. Although Siemens is the leading MRI manufacturer, GE and Philips combine with Siemens to account for almost 90% of the MRI market. The proposed activities in this CRP will form the basis of future work to establish similar partnerships with GE and Philips. Overall, this CRP is perfectly positioned to put FIRMM and its subsequent products on a pathway to long-term success.
Public Health Relevance Statement: Project Narrative Magnetic resonance imaging (MRI) has unrivaled clinical and research utility, is non-invasive, and provides extremely high spatial resolution; however, MRIs have an Achilles heel: subject motion during scanning greatly diminishes the quality of the resulting images. Our software solution Framewise Integrated Real-Time MRI Monitoring (FIRMM) received FDA 510(k) clearance on August 26, 2020 and is currently being used in >75 research institutions; however, to ensure the commercial success of FIRMM, we need to expand the customer base to clinical institutions. The goal of this Commercialization Readiness Program (CRP) grant is to complete late-stage development and integrate with the Access-I technology to boost clinical marketing and sales support from Siemens Healthineers, required to translate FIRMM benefits from research to clinical care.
Project Terms: Adoption; Anesthesia; Anesthesia procedures; Award; Biofeedback; Brain Mapping; Communication; Data Collection; Decision Making; Diffusion; diffused; diffuses; diffusing; diffusions; Engineering; Epilepsy; Epileptic Seizures; Epileptics; Seizure Disorder; epilepsia; epileptogenic; Feedback; Future; Goals; Grant; Head; Health; Healthcare Systems; Health Care Systems; Hospitals; Magnetic Resonance Imaging; MR Imaging; MR Tomography; MRI; MRIs; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; NMR Imaging; NMR Tomography; Nuclear Magnetic Resonance Imaging; Zeugmatography; Maps; Marketing; Motion; Movement; body movement; Neurology; neurosurgery; Patients; Psychiatry; Questionnaires; Radiology Specialty; General Radiology; Radiology; Relaxation; Research; Risk; Sales; Computer software; Software; Standardization; Suggestion; Tablets; Technology; Testing; Time; Translating; Vendor; Work; Artifacts; Morphologic artifacts; bases; base; improved; Site; Clinical; Medical; Ensure; Susceptibility; Predisposition; wasting; Licensing; satisfaction; Letters; Functional Magnetic Resonance Imaging; Functional MRI; fMRI; Catalogs; catalog; price lists; programs; Complex; Scanning; Protocols documentation; Protocol; Source; System; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; success; visual feedback; neuroregulation; neural control; neural regulation; neuromodulation; neuromodulatory; cohort; neuroimaging; neural imaging; neuro-imaging; neurological imaging; Agreement; Devices; Excision; Abscission; Extirpation; Removal; Surgical Removal; resection; Positioning Attribute; Position; Intervention; Intervention Strategies; interventional strategy; Manufacturer; Institution; image-based method; imaging method; imaging modality; Data; Randomized; randomisation; randomization; randomly assigned; Resolution; resolutions; Enrollment; enroll; Scheme; Monitor; transmission process; Transmission; Development; developmental; Image; imaging; Pathway interactions; pathway; cost; usability; commercialization; clinical care; FDA approved; Secure; operations; operation; treatment-refractory depression; treatment-resistant depression; brain magnetic resonance imaging; brain MR imaging; brain MRI; cerebral MR imaging; cerebral MRI; cerebral magnetic resonance imaging; Breakthrough device; commercialization readiness
